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Interagency List of Medical Devices for Essential Interventions for Reproductive, Maternal, Newborn and Child Health WHO Library Cataloguing-In-Publication Data

Interagency List of Medical Devices for Essential Interventions for Reproductive, Maternal, Newborn and Child Health WHO Library Cataloguing-In-Publication Data

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health WHO Library Cataloguing-in-Publication Data

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health.

1.Equipment and Supplies. 2.Reproductive Health. 3.Maternal Welfare. 4.Perinatal Care. 5.Child Welfare. 6.Biomedical Technology. I.World Health Organization.

ISBN 978 92 4 156502 8 (NLM classification: WA 310)

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Printed in Switzerland. Interagency list of medical devices for essential interventions for Reproductive, Maternal, Newborn and Child Health Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health child health child collaboration ofacore working group ofprofessionals from thefollowing organizations: The current documentwas developed from June2012 to January2014 through thecontinuous Design andlayout ofthedocumentwas doneby JillianReichenbach Ott(Genève Design) H4+ andby WHOthrough agrant from theUnited Nations Commission onLife Saving Commodities. provided by UNICEFthrough agrant from Foreign Affairs, Trade andDevelopment Canada(DFATD) to the through theWHOproject “Towards knowing globalneedsofmedicaldevices”. Additional fundswere The primaryfinancialsupport was received from The JapaneseMinistry ofHealth,Labourand Welfare development ofthechildren’s section,andfrom DrKimEva Dickson,UNICEF. Dr Bernadette Daelmans,WHODepartmentofMotherandChildHealth whoprovided supervisionfor the Gilles Forte andDrKees deJoncheere oftheWHODepartmentEMP. Technical supportwas received from The documentwas developed undertheoverall coordination ofAdriana Velazquez andsupervisionofDr under theauspices oftheH4partnershipto update andexpand three previous publications: Fund (UNICEF),theUnited Nations Population Fund(UNFPA), andtheWorld HealthOrganization (WHO) • • • • • • • The Acknowledgements Elvira Wi, MsSusanWilburn. Ritter von Xylander, MsAnitaSands,DrSherylZieminVanderpoel, DrWilson Milton Were, DrTeodora Garcia Moreno Esteva, DrSelmaKhamassi, DrViviana Mangiaterra, DrMeenaNathan Cherian,DrSeverin Chitsva, MsAliciaDeHoyos Reyes, DrNeelamDhingra-Kumar, DrMarioPhilipFestin, DrClaudiaM. Various WHOdepartments:DrBenedettaAllegranzi, DrMaurice Bucagu,MrJamesFarukai Tsimba Alejandra Velez MsMeganM.Smith,Adriana RuizGaitan, Velazquez Berumen. child WHO DepartmentofEssential MedicinesandHealthTechnologies (EMP):DrYukiko Nakatani, MsLaura and newborn and MsClara Aranda. maternal, UNICEF: MsMoniqueSupiot,Etleva Kadilli, MsShaunaMullally, DrHeleneMoller, MrLudoScheerlinck child and reproductive, UNFPA:for MsAgnes Chidanyika, DrWilma Doedens,MsIsabelLucasManzano. newborn guidelines maternal, and care, ( commodities health, safe planning, reproductive interventions, for family for Essential devices medical interventions of essential of Packages list Interagency health health health Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and and newborn maternal, reproductive, for interventions essential for devices medical of list Interagency (2011). (2010); was initiated inJune2012 through ajointcollaboration between theUnited Nations Children’s 2008); Table of contents

Abbreviations ...... 3 . .

Overview ...... 4. .

Definitions ...... 5

1 . Background and methodology ...... 6 . 1.1 Introduction ...... 6 1.2 Objective 6 1.3 Scope ...... 7 1.4 Background methodology, workshops and peer-review meetings 7 1.5 Methodology 9 1.5.1 Identification of levels of care and health-care facilities ...... 9 Table 1. Level of care and health-care facility ...... 9.. 1.5.2 Identification of essential interventions 9 1.5.3 Systematic search for evidence and documentation ...... 10 Table 2. Classification of interventions ...... 11 1.5.4 Identification of commodities 11 1.6 References 12

2 . Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn and child health ...... 13 2.1 Essential interventions for reproductive, maternal, newborn and child health 13 Table 3. Essential interventions for reproductive, maternal, newborn and child health ...... 14 2.2 Relevant evidence-based guidelines supporting essential interventions for reproductive, maternal, newborn and child health ...... 20 Table 4. Evidence-based guidelines supporting essential interventions for family planning and reproductive health 20 Table 5. Evidence-based guidelines supporting essential interventions for ...... 24 Table 6. Evidence-based guidelines supporting essential interventions for ...... 28 Table 7. Evidence-based guidelines supporting essential interventions for the postnatal ...... 30 Table 8. Evidence-based guidelines supporting essential interventions for the postnatal baby 32 Table 9. Evidence-based guidelines supporting essential interventions for infancy and childhood 36 Table 10. References 40 2.3 References 43

3 . Medical devices for different health-care facilities ...... 45. 3.1 Medical devices for different health-care facilities ...... 45 Table 11. Medical devices for different health-care facilities ...... 45 3.2 Groups of medical devices ...... 49 3.2.1 Grouping of common medical equipment by clinical area in health-care facility 49 Table 12. Medical equipment for medical examination and diagnosis ...... 49 Table 13. Medical equipment for emergency preparedness and referral 51 Table 14. Medical equipment for labour, delivery and recovery ...... 54 Table 15. Medical equipment for surgery and anaesthesia 56 Table 16. Medical equipment for inpatient care - mother and newborn 58 Table 17. Medical equipment for inpatient care – child 59 Table 18. Medical equipment for intensive care (in district hospital or higher level) ...... 60 3.2.2 Grouping of medical device consumables by size and capacity ...... 62 Table 19. Medical device consumables by size and capacity ...... 62 3.3 References 66

4 . Matrix of medical devices in each stage of continuum of care, in each level of health-care facility 67 4.1 Continuum of care matrix 67 Table 20. Medical devices for Family planning and reproductive health at HEALTH POST ...... 68 Table 21. Medical devices for pregnancy at HEALTH POST ...... 70 Table 22. Medical devices for post-natal baby (newborn) at HEALTH POST ...... 72 Table 23. Medical devices for infancy and childhood at HEALTH POST 74 Table 24. Medical devices for family planning and reproductive health at HEALTH CENTRE ...... 76 Table 25. Medical devices for pregnancy at HEALTH CENTRE ...... 78 Table 26. Medical devices for childbirth at HEALTH CENTRE 82 Table 27. Medical devices for post-natal mother at HEALTH CENTRE ...... 84 Table 28. Medical devices for post-natal baby (newborn) at HEALTH CENTRE ...... 86

1 2 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health 5 . 8 . 7 6 . 9 . . 5.1 9.1 8.1 7.1 6.1 Laboratory supplyandbloodbankcommodities Technical notes regulation andmanagementofmedicaldevices . Infection prevention andcontrol Surgery andAnaesthesia Other healthproducts 5.3 5.2 7.4 5.4 4.4 4.3 4.2 7.3 6.5 6.3 5.5 6.4 9.3 References 9.2 8.4 8.3 8.2 7.2 8.5 6.2 7.5 8.6

Laboratory supply Building services equipment Regulations for Medicaldevices Surgery andAnaesthesia Injection safety Blood bankcommodities Diagnostic tests andLaboratory Healthcare waste management Safe bloodand clinicaltransfusion References Innovative healthtechnologies Devices andinterventions inspecialized care Sterilization equipment References Surgical instrument stainless steel References Surgical sutures Health counselling, education andpromotion Textiles usedfor linenandclothinginhealth-care facilities Units andbiomaterials usedfor medicaldevices Labels andinstructions for useofmedicaldevices Decontamination andSterilization at healthcare facilities Health Technology Management Grouping ofcommon surgical instruments by surgical procedure References References DISTRICT HOSPITAL care HOSPITAL DISTRICT specialized at for DISTRICT at devices childhood HOSPITAL and (newborn) Medical HOSPITAL DISTRICT baby 35. infancy at for Table HOSPITAL DISTRICT mother post-natal at devices for HOSPITAL health DISTRICT Medical post-natal at devices 35. for CENTRE DISTRICT Table Medical at childbirth reproductive devices 34. for and HEALTH at Table Medical pregnancy devices 33. planning for Table childhood Medical family devices and 32. for Table Medical infancy devices 31. for Table Medical devices 30. Table Medical 29. Table Table 45. Basic sterilization equipment and other relevant equipment (12) equipment relevant other and equipment sterilization Basic 45. Table transfusion, clinical processing, and testing collection, blood transportation bank: blood blood diagnostics for and of items storage selection for blood Essential 39. Table facilities considerations Specific health-care 38. health by Table child supplies and newborn Laboratory 37. Table maternal, reproductive, for technologies health Innovative 36. Table Table 44. Size of non-absorbable and absorbable synthetic sutures synthetic absorbable and instruments non-absorbable of surgical for Size 44. steel steel of Table grades stainless of Standard types sets 43. main Table Two 42. instrument Table surgical of Contents 41. Table Settings Emergency in Transfusion Blood for Items Essential 40. Table

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122 135 152 100 140 104 140 144 146 149 108 148 166 170 170 145 134 169 142 148 156 136 163 129 143 158 136 135 132 129 152 122 173 133 127 122 127 119 114 118 90 141 151 119 121 118 94 88 Abbreviations

MDG Millennium Development Goal

UN United Nations

UNFPA United Nations Population Fund

UNICEF United Nations Children’s Fund

WHO World Health Organization

Colour codes

Family planning and reproductive health Clinical transfusion

Pregnancy/maternal health Laboratory

Childbirth Surgery and anesthesia

Post-Natal Mother Injection safety

Post-Natal Baby (Newborn) Health care facilities

Infancy and childhood

3 4 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Points outotherhealthproducts required inhealth-care facilities to provide comprehensive services. Section 9 specifications and standards for qualityofhealthproducts. including management technology health devicesand regulationmedical on view of point technical Guides Section 8 facilities such as injectionsafety, sterilization andwaste management. keyDescribes relatedpreventionprogramsinformationtechnicalinfection to and health-carecontrol in and Section 7 by surgical procedure inthematrix ofmedicaldevices inSection4. Notes important guidance for providing safe surgery and anaesthesia and lists common surgical instruments Section 6 for bloodtransfusion. procedureof steps the by listed are bank blood for commodities facility.essential health-careThe levelsof 4 by listed is supply laboratory The bank. blood and laboratory for commodities and devices medical Lists Section 5 for devices “Medical entitled table pregnancy at district hospital”. the see please hospital, district a in womenfor devices pregnant medical for the intervention find to example, For 3.2. Section in explained are devices these of groupings the grouped been have devices medical Specific to tables. name one avoidunder having complicateda extensive listdevices of 16 by intervention. For analysis,further in to presented centre is health information to The post health hospital. from district facility, reproductive, health-care for of procedures level by clinical health, for child care, and of newborn maternal, continuum per devices medical of matrix the Presents Section 4 health-care facility. of levelby devices medical of matrix each of development the for devices medical of sources the Includes Section 3 for guidelines evidence-based WHO current reproductive, with maternal, newborn andchildhealth. reference in interventions essential of list the Includes Section 2 the current of document. context the in definitions related and methodology objectives, background, the Describes Section 1 This publication iscomposed ofthefollowing sections: Overview Definitions

Health technology Health technology is the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of life. The term is used interchangeably with “health-care technology” (1).

Medical device In the current document, the definition of medical devices, including in vitro diagnostic medical devices, is based on that documented by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory authorities and regulated industry (2):

“Medical device” means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: • diagnosis, prevention, , treatment or alleviation of disease; • diagnosis, monitoring, treatment, alleviation of or compensation for an injury; • investigation, replacement, modification, or support of the anatomy or of a physiological process; • supporting or sustaining life; • control of conception; • disinfection of medical devices; • providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.

Products that may be considered to be medical devices in some jurisdictions but not in others include: • disinfection substances; • aids for people with disabilities; • devices incorporating or human tissues; • devices for in vitro fertilization or assisted reproduction technologies. In vitro diagnostic medical devices are medical devices, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. In vitro diagnostic medical devices include reagents, calibrators, control materials, specimen receptacles, software, and related instruments, apparatus and other articles and are used for diagnosis, aiding diagnosis, screening, monitoring, predisposition and prognosis prediction, and determination of physiological status.

In some jurisdictions, certain in vitro diagnostic medical devices may be covered by other regulations (3).

References 1. WHO 60.29 Health Technologies Resolution (http://apps.who.int/iris/bitstream/10665/22609/1/A60_R29-en.pdf?ua=1) 2. Definition of the terms “medical device” and “in vitro diagnostic (IVD) medical device”. GHTF/SG1/N071:2012. Tokyo: Global Harmonization Task Force; 2012 (http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n071-2012- definition-of-terms-120516.pdf, accessed 22 May 2014). 3. Medical devices: managing the mismatch – an outcome of the Priority Medical Devices project. Geneva: World Health Organization; 2010 (http://whqlibdoc.who.int/publications/2010/9789241564045_eng.pdf, accessed 22 May 2014).

5 6 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health and childhealthcontinuum ofcare according to thelevel ofhealth-care delivery. strengthen health-care system. The medical devices are allocated across the reproductive, maternal, newborn and care, of quality support countries, middle-income and low-devices in improvetothese orderaccessto in publications, and guidelines WHO existing by defined interventions health child and newborn maternal, reproductive,essential the provideto requireddevices medical the list to was project this of objective The 1.2 maternal, reproductive, essential for newborn challenge andchildhealthinterventions. significant a pose use appropriate and selection their but Medical devices are indispensable tools for health care in prevention, diagnosis, treatment and rehabilitation, medical including devices, medicinesandvaccines. technologies, health affordable appropriate, policies, and good health, information, for resources available human infrastructure, available health adequate include also should systems Health and population, the educating finding innovative coverage, technologies willsupportthedelivery ofbetter healthservices to achieve theMDGs. health universal supporting and systems, health Strengthening essential UNICEF andWHOcollaboration. for devices medical UNFPA, a of through done was list work This health. Interagency child and newborn the reproductive,maternal, for interventions update to was objectives partnership’s the of One was calledtheH4Partnership. countries and define the necessary actions, was recognized. This agreement for joint work between agencies the 25 countries with the highest burden of maternal mortality, and then identify the needs prioritize and togaps in need those the agreement, joint this from Resulting (4). improvereproductivehealth to and 5 and 4 aimed to harmonize the support provided by these agencies to accelerate progressthat towardsdocument achievingworking MDGs a endorsed (WHO) Organization Health World the and Bank World the (UNICEF), In July 2008, the heads of the United Nations Population Fund (UNFPA), the United Nations Children’s Fund children, and for life better Innovativeespecially inlow-resource a settings. provide mothers. and and MDGs children the achieve these to of needed lives are efforts the coordinated support to implemented be to have strategies New Goals Development(MDGs) 4and5callfor areduction inchildmortalityandimprovements Millennium inmaternalprevented. health,respectively (3). be can deaths these of most as unacceptable, is situation This and socioeconomic exclusion. every Andevery day, For about10000babiesaged28days oryounger die(2). (1). Asia South and Africa sub-Saharan maternal death, in another 30 women them suffer long-lasting injury of or illness that most can result in childbirth, lifelong pain, disability and complications related pregnancy- from die women 1000 day,approximatelyYetevery care. health in made been have advances At the present, the beginning of the twenty first century, many scientific, social, economic and technological 1.1 1. Objective Introduction Background andmethodology 1.3 Scope 1. Background and methodology In the context of this document, the scope was defined as: • Health interventions are limited to reproductive, maternal, newborn and child health, based on WHO recommendations. • The level of health-care delivery is defined by the publication “Essential interventions, commodities and guidelines for reproductive, maternal, newborn and child health” (5) and is detailed in the next section. This classification defines three levels of care: community level/health post, health centre and district hospital. It should be reviewed and adapted to the local context as needed. • The lists represent the technological options currently available, by type of medical device and hospital furniture. These lists should be adapted and reviewed according to national policies and regulatory frameworks. • The target audience of this document consists of health professionals in the areas of reproductive, maternal, newborn and child health policies, strategic planning, health technology assessment, resource allocation, procurement, biomedical engineering, regulation, facility assessment and reproductive health specialties. • Given the importance of the intervention generated, and in order to facilitate the use of these tools, a parallel web-based medical devices database is being developed. This database will contain all the interventions, levels of care, medical devices and technical information, increasing the availability of the data and facilitating decision-making.

1.4 Background methodology, workshops and peer-review meetings The current document was developed by a consensus of UNICEF, UNFPA and WHO to update and expand the existing publications to describe more specifically the medical devices required for essential clinical interventions in reproductive, maternal, newborn and child health (Box 1).

7 8 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health (hereafter, ‘Essential interventions’) (5). interventions’) ‘Essential (hereafter, Essential interventions, commodities and guidelines for reproductive, maternal, newborn and child health, 2011 2011 health, child and newborn maternal, reproductive, for guidelines and commodities interventions, Essential (hereafter, ‘Packages of interventions’) (7); interventions’) of ‘Packages (hereafter, Packages of interventions for family planning, safe abortion care, maternal, newborn and child health, 2010 2010 health, child and newborn maternal, care, abortion safe planning, family for interventions of Packages Interagency list of essential medical devices for reproductive health, 2008 (hereafter, ‘Interagency list, 2008’) (6); 2008’) list, publications ‘Interagency Previous 1 (hereafter, 2008 Figure health, reproductive for devices medical essential of list Interagency with clinicalinterventions: care, level devices of project the the by medical continuum defining the health-care associated and of facilities, the project and devise a workplan. The following WHO publications were reviewed to determine the scope of the medicines for reproductive, maternal, newborn and and devices child health in medical Copenhagen, Denmark, essential to define of the scope list of Interagency the on consultation first the held WHO and UNICEF UNFPA, JUNE 2012 Box 1.Development process ofthecurrent document grouping ofcommodities. meeting held fifth was A (Copenhagen) to review the including final agree document, the and the on of version JANUARY 2014 which during from (Geneva), different countries. Devices Medical participants 40 approximately on by received were tool Forum the of implementation Global and use the WHO regarding comments Second the during held was workshop A NOVEMBER 2013 to lists for procurement. linked be it suggested and purposes planning for useful it considered tool, this developmentof the supported the World Bank, the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNICEF, UNFPA and WHO. The group First draft was presented to the members of the Interagency Pharmaceutical Coordination group, which includes MAY 2013 users. devices, reviewing the specialists’ inputs, and investigating an appropriate way to present the information to end The objectives of a fourth meeting (Copenhagen) were to agree on the most appropriate classification of medical FEBRUARY 2013 was splitinto district hospital andreferral hospital. care referrallevelof The areas. clinical complexaccommodateto devices medical of accuratelist an having of A third meeting (Geneva) redefined the levels of care included in the first draftNOVEMBER of 2012 the list, reflecting the importance list in the of draft first the to led accordance withthelatest reviews recommendations by WHO. peer These cancer. management, and waste infertility health, infections, neonatal transmitted sexually health, maternal health, reproductive work, laboratory and diagnostic development the surgery,safety,safe injection transfusion, in blood of collaborateareas the fromwere to specialists The data. invited the reviewof and was group working larger A information. available the verify and A second meeting was held in Geneva, Switzerland during which experts in specific clinical areas could complete AUGUST 2012

2008

2010 2011 Throughout the entire process, the core working group held regular teleconferences to define medical devices 1. Background and methodology necessary for each intervention at each level of health-care facility related to existing WHO guidelines and publications.

1.5 Methodology

1 .5 1. Identification of levels of care and health-care facilities

To develop the current document, the definitions of level of care and health-care facilities were derived from Essential interventions (5). The classifications for interventions and medical devices proposed for these facilities should be adapted to national regulations and the local context. To ensure relevance of the continuum of care in the local environment, results in a continuum of care for the patient.

According to the staff, capabilities, type of care and interventions required, three levels of delivery of care were defined (Table 1):

Table 1 . Level of care and health-care facility

Level of care Health-care facility Community level Health post First level Health centre Referral level District hospital or Referral hospital COMMUNITY LEVEL

The health post level includes community health workers and outreach workers that deliver interventions related to safe motherhood, nutrition and simple prevention and treatment. The community level of care is context-specific depending on the availability and development of infrastructure, services and socioeconomic resources. FIRST LEVEL

The health center level incudes trained health professionals. The interventions offered are related to maternity care (such as prenatal care, skilled attendance and family planning), childhood diseases (such as vaccine- preventable diseases, acute respiratory infections and diarrhoea), and prevention and treatment of major infectious diseases. These health facilities include outpatient services and observation areas for patients staying longer but do not generally include inpatient areas. They might have a labour room and outpatient surgery areas. REFERRAL LEVEL

This level of delivery of interventions requires more complex facilities and equipment, such as hospitals where providers are professional practitioners. In the current document, only district hospitals are considered in the reference tables. District hospitals usually include outpatient and inpatient areas, emergency services, surgical areas, health professionals and infrastructure in at least the following four areas of specialization: internal medicine, surgery, paediatrics and obstetric care. Many district hospitals also include other special areas, depending on the settings, context and resources available.

Medical devices for highly specialized hospitals and other specialized technologies such as intensive care are described in Annex 3.

1 .5 .2 Identification of essential interventions

With the objective of harmonizing an evidence-based set of essential interventions for reproductive, maternal, newborn and child health, two publications were used as the basis for the review and analysis for compiling the current document: Essential interventions (5) and Packages of interventions (7).

Following the same strategy as the two previous reports, the current document interventions were classified by level of care, across the reproductive, maternal, newborn and child health continuum of care stages (Figure 2):

9 10 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health commodities (medicaldevices andmedicines) describedornamedintheclinicalguidelinesandreports. required the of identification the to leads A, category from mostlyinterventions, these on research Further deliverystrategy. deliverystrategy.the evidenceinterventions on consensusno includes or Categorywith C the on haveconsensus not do thatinterventions includes B Category A. category into strategyfalldelivery agreed an and evidence well-documented with Interventions (Table2). groups three into them categorize r nt rsne i ti pbiain eas te d nt mat n h soe f h poet o reduce to project the of scope the on maternal andnewborn mortalityfrom apublichealthapproach. impact not do they because publication this in presented not are devices medical related and health child and reproductive,newbornprocedures maternal,for clinical Some are required by sub-interventions, for example thediagnosisandtreatment ofanaemia. The continued review of interventions and sub-interventions was due to the fact that different medical devices commodities andfacilities. Derived from this classification, research sought areas where updates were required in terms of interventions, 3 Systematic search for evidence and documentation and (5) evidence for interventions search Essential Systematic .3 .5 1 • 2014). May 2011 22 • accessed Organization; Health • World Geneva: • care. of continuum • RMNCH sheet: • fact PMNCH from (http://www.who.int/pmnch/media/press_materials/fs/continuum_of_care/en/index.html, Adapted Source: care health of continuum health child and newborn maternal, Reproductive, 2. Figure infancy andchildhood(upto agefive years). postnatal baby (upto two monthsafter birth); postnatal mother(upto sixweeks after childbirth); childbirth; pregnancy; family planningandreproductive health; health reproductive planning and Family responds to the need torespondsdeliverneed to the evidence-based information on interventions and Pregnancy Childbirth (newborn) Post-Natal (motherhood) Post-Natal childhood Infancy and

Table 2 . Classification of interventions 1. Background and methodology Evidence for intervention Category Delivery strategies Action categories A Intervention evidence agreed Delivery strategy agreed Disseminate for rapid scale-up

B Intervention evidence agreed Delivery strategy no Collate evidence and define consensus gaps in evidence for delivery strategies – seek consensus C Intervention evidence still Delivery strategy no Further research required questioned consensus Source: Essential interventions, commodities and guidelines for reproductive, maternal, newborn and child health. Geneva: World Health Organization; 2011 (http://www.who.int/pmnch/topics/part_publications/essential_interventions_18_01_2012. pdf, accessed 22 May 2014).

Although evidence on the use of medicines is well documented, evidence is not widely available for medical devices, especially with regard to their performance in low-resource settings. In the literature review, case studies of medical devices used in high-income settings were found, but their applicability to low-resource settings is uncertain and not yet proven. Thus, a list of evidence-based guidelines and reports related to reproductive, maternal, newborn and child health was compiled, devices included in the current document were identified from clinical guidelines and later revised by the core working group and WHO specialists. This revision process was also applied to the interventions.

1 .5 .4 Identification of commodities

In the areas of reproductive, maternal, newborn and child health, the commodities listed in Essential interventions (5) considered the Interagency list, 2008 (6), Packages of interventions (7) and the recommendations from the UN Commission on Life-Saving Commodities (8), comprising 13 life-saving commodities such as female condoms, neonatal resuscitation equipment and injectable antibiotics.

The development of the medical devices section of the current document followed the methodology described in the Priority Medical Devices report from WHO (9): (1) identify the disease burden of the target population, (2) select the associated WHO evidence base clinical guidelines, (3) identify care pathways and protocols, (4) list medical devices according to the protocols and type of intervention (preventive, diagnostic, therapeutic or assistive), and (5) develop a list of medical devices needed to manage and treat the identified diseases.

The development of the medical devices list is based on the Interagency list, 2008 (6) and UNICEF’s Supply Catalogue (10). Based on this methodology, the medical devices were identified according to the interventions for reproductive, maternal, newborn and child health.

The list of medical devices had to be organized into categories and sub-categories to facilitate grouping and to make the list more user-friendly. This process was challenging because no WHO global harmonized nomenclature system currently exists for medical devices. Many of the terms used in the current document are based on the UNICEF reference specifications for the devices included in the UNICEF standard product range (10). These terms were used because they are commonly used in low- and middle-income countries. The list does not represent the complete description of the medical devices, particularly complex devices; the list must therefore be used as a reference, and technical specifications for these devices must be reviewed and developed thoroughly for planning purposes.

The current document is not a restrictive list of priority medical devices: it covers only the minimum reference for the equipment of medical units to ensure that clinical interventions can be provided in a complete, safe and effective manner. Other devices can be added to match the specific infrastructure settings.

11 12 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health 10. 9. 8. 7. 6. 5. 4. 3. 2. 1. 1.6 displayApp/%28layout=7.0-12_1_66_67_115&carea=%24ROOT%29/.do?rf=y, accessed 22May 2014). UNICEF supplycatalogue. New York: United Nations Children’s Fund;2014 (https://supply.unicef.org/unicef_b2c/app/ Organization; 2010 (http://whqlibdoc.who.int/publications/2010/9789241564045_eng.pdf, accessed 22May 2014). Medical devices: managingthemismatch –anoutcome ofthePriorityMedicalDevices project. Geneva: World Health resources/un-commission-on-life-saving-commodities/life-saving-commodities, accessed 22May 2014). Life-saving commodities. Washington, DC:United Nations Foundation; 2012 (http://www.everywomaneverychild.org/ Health Organization; 2010. (http://whqlibdoc.who.int/hq/2010/WHO_FCH_10.06_eng.pdf, accessed 22May 2014). Packages ofinterventions for family planning,safe abortioncare, maternal, newborn andchildhealth.Geneva: World int/medicinedocs/documents/s16440e/s16440e.pdf, accessed 22May 2014). Inc., PATH, Population Action International, United Nations Population FundandWorld Bank;2008(http://apps.who. Interagency list ofessential medicaldevices for reproductive health.Geneva: World HealthOrganization, JohnSnow interventions_18_01_2012.pdf, accessed 22May 2014). Geneva: World HealthOrganization; 2011 (http://www.who.int/pmnch/topics/part_publications/essential_ Essential interventions, commodities andguidelinesfor reproductive, maternal, newborn andchildhealth. who.int/publications/2010/9789241599733_eng.pdf, accessed 22May 2014). mapping ofin-country activities–jointcountry support.Geneva: World HealthOrganization; 2010 (http://whqlibdoc. Accelerated implementation ofmaternal andnewborn continuum ofcare aspartofimproving reproductive health: millennium_development_goals/en/, accessed 22May 2014). Millennium Development Goals(MDGs). Geneva: World HealthOrganization; 2014 (http://www.who.int/topics/ (http://www.unicef.org/cotedivoire/SOWC_2009_.pdf, accessed 22May 2014). The state oftheworld’s children 2009:maternal andnewborn health.New York: United Nations Children’s Fund;2008 monitoring/9789241500265/en/, accessed 22May 2014). United Nations Population FundandWorld Bank;2010 (http://www.who.int/reproductivehealth/publications/ Trends inmaternal mortality:1990to 2008. Geneva: World HealthOrganization, United Nations Children’s Fund, References 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn and child health

This section includes the sources of information for the development of each table of medical devices by level 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn of health-care facility.

2.1 Essential interventions for reproductive, maternal, newborn and child health

Based on Essential interventions (1), Table 3 contains the priority clinical interventions provided during the continuum of care for reproductive, maternal, newborn and child health, divided into six different stages: • family planning and reproductive health; • pregnancy; • childbirth; • postnatal mother; • postnatal baby (newborn); • infancy and childhood.

The column “Continuum of care” corresponds to the six stages of the continuum of care.

The column “General action” corresponds to the interventions listed chronologically for each of the stages, from the first assessment, through the diagnosis and treatment of infections and illness, and ending with surgery or, in some cases, emergency and pre-referral treatment.

The column “Conditions” corresponds to the specific conditions related to the interventions.

The column “Steps of specific procedures” corresponds to the steps or procedures applied to deliver each intervention; the steps are labelled (a), (b), (c) and (d) to clarify the chronological steps for some procedures.

In the table, each procedure shows the health-care facility (health post, health centre or district hospital) where it would be delivered according to the evidence-based guidelines presented in Tables 4–9. Note that sometimes the diagnosis can be done at a lower level than the assessment or treatment.

13 14 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 3.Essential interventions for reproductive, maternal, newborn andchildhealth Health Reproductive Planning and Family Care Continuum of Table 3.Essential interventions for reproductive, maternal, newborn andchildhealth First assessment Treatment and Pre-referral / Emergency Illness /Surgery / Infections / First assessment chronologically: General Action by contraceptives Provision of other infections Infection (STI) and Transmitted of Sexually management Detection and system reproductive cancers ofthe management of Screening and violence (GBV) gender-based Management of Immunization Preventive Examination Basic Medical Conditions selection method Contraceptive infections Other Malaria Chlamydia Gonorrhoea Virus (HIV) nodeficiency Human Immu- Syphilis Breast cancer Cervix cancer Post-rape care a) Vaccine for Hepatitis B b) Pelvic examination Anthropometry a) Check-up vitalsigns/measuringweight andheight/ Steps ofspecific procedures a) Tubal ligation a) Vasectomy withlocalanaesthesia a) Provision ofvaginal ringsandpatches a) Provision ofemergency contraception a) Provision ofbarriersmethods anaesthesia a) Insertionandremoval ofcontraceptive implantswithlocal a) Insertionandremoval ofIntrauterine device (IUD)s a) Provision ofinjectablecontraceptives a) Provision oforal contraceptives trichomonas, candidiasis a) Diagnosisandtreatment for bacterial vaginosis, bacteriuria, pyelonephritis a) Diagnosisandtreatment for urinarytract infections: c) Managementofmalaria b) Diagnosisofmalaria Treatment (IPT)) a) Prophylactic antimalarial(Intermittent Preventive b) Treatment for Chlamydia a) Screening /diagnosisofChlamydia b) Treatment for Gonorrhoea a) Screening /diagnosisofGonorrhoea Immunodeficiency Virus (HIV)discordant couple c) Provide post exposure prophylaxis for Human (Antiretroviral Therapy (ART) ) b) Treatment for HumanImmunodeficiency Virus (HIV) a) Screening ofHumanImmunodeficiency Virus (HIV) b) Treatment for Syphilis a) Screening /diagnosisofSyphilis by laboratory test c) Biopsy /Pathology lab-test b) Diagnostic by image(mammography, ultrasound) a) Breast examination f) Treatmentf) for precancerous lesion(cryotherapy) e) Colposcopy andBiopsy /Pathology lab-test d) Colposcopy c) HumanPapilloma Virus (HPV) test (VIAM) b) Visual InspectionwithAcetic Acid (VIA)/Magnified VIA a) Papanicolaou test a) Managementofpost-rape care X X X X X X X X X X X X X X X HEALTH POST X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X HEALTH CENTER X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X DISTRICT HOSPITAL 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn Table 3. Essential interventions for reproductive, maternal, newborn and child health Table 3. Essential interventions for reproductive, maternal, newborn and child health Continuum of General Action by Conditions Steps of specifi c procedures Continuum of General Action by Conditions Steps of specifi c procedures Care chronologically: Care chronologically: First assessment First assessment / Infections / / Infections / Illness / Surgery Illness / Surgery / Emergency / Emergency and Pre-referral and Pre-referral Treatment Treatment HEALTH POST HEALTH CENTER HEALTH HOSPITAL DISTRICT POST HEALTH CENTER HEALTH HOSPITAL DISTRICT Family First assessment Basic Medical a) Check-up / measuring weight and height / X X X Pregnancy First assessment Basic Medical a) Check-up vital signs / measuring weight and height / X X X Planning and Examination Anthropometry Examination Anthropometry/ Vaginal examination Reproductive b) Pelvic examination X X X Preventive a) Vaccine for Tetanus X X X Health Preventive a) Vaccine for Hepatitis B X X X Immunization Immunization Emergency Emergency a) Emergency care and pre-referral treatment X X Provision of Contraceptive a) Provision of oral contraceptives X X X assessment preparedness and referral contraceptives method a) Provision of injectable contraceptives X X selection Detection and Syphilis a) Screening / diagnosis of Syphilis by laboratory test X X X a) Insertion and removal of Intrauterine device (IUD)s X X management b) Treatment for Syphilis X X a) Insertion and removal of contraceptive implants with local X X of Sexually anaesthesia Transmitted Human Immu- a) Screening of Human Immunodefi ciency Virus (HIV) X X X Infection (STI) and nodefi ciency a) Provision of barriers methods X X X b) Prevention Mother To Child Transmission (PMTCT) X X X other infections Virus (HIV) a) Provision of emergency contraception X X X c) Treatment for Human Immunodefi ciency Virus (HIV) ( X X X Antiretroviral Therapy (ART) ) a) Provision of vaginal rings and patches X X Malaria a) Prophylactic antimalarial (Intermittent Preventive X X X a) Vasectomy with local anaesthesia X X Treatment (IPT)) a) Tubal ligation X b) Diagnosis of malaria X X X Detection and Syphilis a) Screening / diagnosis of Syphilis by laboratory test X X X c) Management of malaria X X X management b) Treatment for Syphilis X X of Sexually Rubella a) Diagnosis and treatment for rubella X X Transmitted Human Immu- a) Screening of Human Immunodefi ciency Virus (HIV) X X X Tuberculosis a) Diagnosis and treatment for tuberculosis X X Infection (STI) and nodefi ciency b) Treatment for Human Immunodefi ciency Virus (HIV) X X X Virus (HIV) Other a) Diagnosis and treatment for urinary tract infections: X X other infections (Antiretroviral Therapy (ART) ) infections bacteriuria, pyelonephritis c) Provide post exposure prophylaxis for Human X X X a) Diagnosis and treatment of other Sexually Transmitted X X Immunodefi ciency Virus (HIV) discordant couple Infection (STI) /Reproductive Tract Infections (RTI): Candida Gonorrhoea a) Screening / diagnosis of Gonorrhoea X X vaginitis, gonorrhoea, chlamydia, bacterial vaginosis and trichomoniasis b) Treatment for Gonorrhoea X X Detection and Iron Defi ciency a) Diagnosis of Anaemia X X X Chlamydia a) Screening / diagnosis of Chlamydia X X management of Anaemia b) Iron and folic acid supplementation X X X b) Treatment for Chlamydia X X maternal chronic c) Anthelminthic (deworm) X X X Malaria a) Prophylactic antimalarial (Intermittent Preventive X X X medical conditions Treatment (IPT)) d) Management of severe Anaemia (considering blood X transfusion) b) Diagnosis of malaria X X X a) Diagnosis of Preclampsia-Eclampsia X X c) Management of malaria X X X and pre- b) Supplemment calcium X X Other a) Diagnosis and treatment for urinary tract infections: X X eclampsia infections bacteriuria, pyelonephritis c) Low-dose aspirin X X a) Diagnosis and treatment for bacterial vaginosis, X X d) Antihypertensive drugs X X trichomonas, candidiasis e) Magnesium sulfate X X Screening and Cervix cancer a) Papanicolaou test X X f) Fetal monitoring X management of b) Visual Inspection with Acetic Acid (VIA)/Magnifi ed VIA X X g) Induction of labour X cancers of the (VIAM) reproductive Diabetes a) Glucose testing for detection X X X c) Human Papilloma Virus (HPV) test X X system b) Treatment for insulin-dependent diabetic mother X X d) Colposcopy X Management of Assessment of a) Diagnosis and laboratory test X X e) Colposcopy and Biopsy / Pathology lab-test X prelabour rupture PRM b) Fetal monitoring X X f) Treatment for precancerous lesion (cryotherapy) X of the membranes (PRM) Preterm a) Provision antibiotics if indicated X X Breast cancer a) Breast examination X X X b) Provision of tocolytics to prolong pregnancy if indicated X b) Diagnostic by image (mammography, ultrasound) X c) Provision of corticosteroids for prevention of neonatal X c) Biopsy / Pathology lab-test X respiratory distress syndrome Management of Post-rape care a) Management of post-rape care X X X d) Provision of magnesium sulfate for neuroprotection of the X gender-based newborn violence (GBV) Term a) Provision antibiotics if indicated X b) Induction of labour X Management of Malpresenta- a) Diagnosis of breech at term X malpresentation at tion at term b) External Cephalic Version X term c) Monitoring progress of labour X Management of Female genital a) Perineal incision with local anaesthesia X female genital mutilation b) Identify the need of caesarean section X mutilation

15 16 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Care Continuum of Table 3.Essential interventions for reproductive, maternal, newborn andchildhealth Childbirth ectopic pregnancy Management of Treatment and Pre-referral / Emergency Illness /Surgery / Infections / First assessment chronologically: General Action by abortion and Management of First assessment assessment Emergency Mother care labour anddelivery complications of Management of pregnancy Ectopic Conditions permitted and legally when indicated Safe abortion Miscarriage and abortion Miscarriage Examination Basic Medical and referral preparedness Emergency Childbirth women (HIV) positive ciency Virus munodefi- Human Im- complication on the depending procedures Other surgical indication maternal/fetal section due Caesarean (PPH) haemorrhage Postpartum complications for Assessment d) Bloodtransfusion c) Laparotomy b) Ultrasound scan a) Pregnancy test Steps ofspecific procedures c) Medicaluterine evacuation beyond thefirst trimester b) Vacuum Aspiration for thefirst trimester a) Medicaluterine evacuation for thefirst trimester c) Managementofmajorinjuries(considering laparotomy) and bloodtransfusion) b) Managementofbleeding(considering Vacuum Aspiration a) Treatment ofinfections b) Ultrasound scan a) Pregnancy test a) Check-up vitalsigns/Vaginal examination a) Emergency care andpre-referral treatment d) Assisted delivery (vacuum extraction) ifneeded c) Spontaneousdelivery Prophylactic useofuterotonics b) Active managementofthethird stage oflabour(AMTSL): a) Monitoring progress oflabour b) Prevention MotherTo ChildTransmission (PMTCT) a) Screening ofHumanImmunodeficiency Virus (HIV) a) Craniotomy andcraniocentesis during childbirth a) Laparotomy orotherabdominalsurgical interventions a) Correct uterine inversion a) Repair ofruptured a) Episiotomy c) Useofuterotonics b) Caesarean section a) Useofprophylactic antibiotic f) Hysterectomyf) e) Useofartery embolization d) Useofballoontamponade c) Bloodtransfusion and uterotonics) b) Manualremoval ofplacenta (includeuseofantibiotics a) Useofuterotonics ofchoice for thetreatment ofPPH b) Fetal monitoring a) Diagnosisofcomplications

HEALTH POST X X X X X X X X X X X HEALTH CENTER X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X DISTRICT HOSPITAL 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn Table 3. Essential interventions for reproductive, maternal, newborn and child health Continuum of General Action by Conditions Steps of specifi c procedures Care chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment HEALTH POST HEALTH CENTER HEALTH HOSPITAL DISTRICT Post-Natal First assessment Basic Medical a) Check-up vital signs X X X Mother Examination b) Screening for cervix and breast cancer X X Support for a) Management of mastitis / breast abscess X X breast feeding Emergency Emergency a) Emergency care and pre-referral treatment X X assessment preparedness and referral Prevention and Anaemia a) Management of post partum bleeding X X management b) Diagnosis of anaemia X X of post partum bleeding c) Iron supplementation X X d) Anthelminthic (deworm) X X e) Management of severe anaemia (considering blood X transfusion) Detection and Human Immu- a) Diagnosis and treatment for Human Immunodefi ciency X X management nodefi ciency Virus (HIV) (Antiretroviral Therapy (ART)) of post partum Virus (HIV) infection Malaria a) Diagnosis and management of malaria X X Other a) Diagnosis and management of postpartum endometritis X X infection and salpingitis a) Diagnosis and treatment for urinary tract infections: X X bacteriuria, pyelonephritis Postoperative care Assessment of a) Postcaesarean care X postoperative b) Diagnosis of pelvic abscess, peritonitis or other X care postoperative complication Surgical c) Surgical management of pelvic abscess, peritonitis or X procedure other postoperative complication with laparotomy Post- Childbirth: Immediate a) Dry baby thoroughly on mother's chest skin to skin and X X Natal Baby Essential newborn care at birth cover (Newborn) care b) Assess breathing X X c) Clamp and cut cord / Check cord vessels / Check for X X bleeding and signs of cord infection d) Prevent hypothermia when skin to skin is not possible X X e) Support breastfeeding within the fi rst hour X X Emergency a) Basic neonatal resuscitation X X support b) Management of brain injury and intracranial haemorrhage X (ICH) Routine care a) Full clinical examination / Check vital signs / measuring X X X weight b) Thermal Care X X X c) Breastfeeding support X X X d) Vitamin K prophylaxis and Immunization X X X

e) Cord care X X X f) Prophylaxis for eye infection X X g) Prophylactic antibiotics for neonates at risk of infection X X Detection and Congenital a) Diagnosis of congenital syphilis X X management infections b) Prophylactic treatment for congenital syphilis X X of congenital infections c) Screening of Human Immunodefi ciency Virus (HIV) (Dried X X Blood Spot (DBS)) d) Prophylactic treatment for Human Immunodefi ciency X X Virus (HIV) (Antiretroviral Therapy (ART))

17 18 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Care Continuum of Table 3.Essential interventions for reproductive, maternal, newborn andchildhealth young infant in theneonate and and complications infections, illness of common management Detection and Treatment and Pre-referral / Emergency Illness /Surgery / Infections / First assessment chronologically: General Action by babies birth andpre-term small, low weight interventions for Specific infant and sickyoung for allsickneonate Supportive care young infant assessment for all Further meningitis and/or Septicaemia Diarrhoea Pneumonia Anaemia Jaundice Cord infection Conditions enterocolitis Necrotizing (RDS) Syndrome Distress Respiratory Apnoea and referral preparedness emergency Triage, care Supportive interventions Optional Clinical visit complications b) Managementofsepticaemiaand/or meningitisandits Culture, LumbarPuncture, UrineAnalysis a) Diagnosisofsepticaemiaand/or meningitis:Blood a) Detection andmanagementofdiarrhoea b) Managementofpneumoniaanditscomplications a) Diagnosisofpneumonia transfusion) c) Pre-referral treatment for severe anaemia(blood b) Managementofanaemia a) Diagnosisofanaemia b) Managementofjaundice a) Diagnosisofjaundice a) Detection andmanagementofcord infection Steps ofspecific procedures b) Managementofnecrotizing enterocolitis a) Diagnosisofnecrotizing enterocolitis Pressure (CPAP) mechanical ventilation andContinuous Positive Airway c) Ventilatory supportandoxygen therapy including nasal cannulaorface mask b) ApplyContinuous Positive Airway Pressure (CPAP) with a) DiagnosisofRDS andprovision ofprophylaxis surfactant a) Prevention ofApnoea b) Advanced resuscitation referral treatment a) Detection ofemergency signs,emergency care andpre- e) Monitor oxygenation andmanagementofhypoxia (Kangaroo mothercare) d) Monitor temperature andmanagementofhypothermia c) Provision of intravenous therapy b) Monitor nutritionandprovision of tubefeeding support hypoglycaemia a) Monitor bloodglucose andmanagementof a) Malecircumcision d) Monitoring growth anddevelopment necessary c) Breastfeeding supportandreplacement feeding if (OPV), Hepatitis B) + HaemophilusInfluenza typeB(HIB),Oral Polio Vaccine b) Provision ofvaccines (DiphtheriaPertussis Tetanus (DPT) weight /checkhaemoglobin a) Fullclinicalexamination /checkvitalsignsmeasuring

X X X X HEALTH POST X X X X X X X X HEALTH CENTER X X X X X X X X X X X X X X X X X X X X X X X X X X X X X DISTRICT HOSPITAL 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn Table 3. Essential interventions for reproductive, maternal, newborn and child health Continuum of General Action by Conditions Steps of specifi c procedures Care chronologically: First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment HEALTH POST HEALTH CENTER HEALTH HOSPITAL DISTRICT Infancy and Essential care Routine care a) Full clinical examination / check vital signs / measuring X X X childhood for monitoring weight growth and b) Provision of vaccines X X X early childhood development c) Growth monitoring X X X d) Early childhood development monitoring X X X e) Breastfeeding support and replacement feeding if X X X necessary f) Vitamin A supplementation X X X g) Deworming (Mebendazole) X X X Detection and Severe Acute a) Diagnosis of SAM X X X management Malnutrition b) Feeding support X X of common (SAM) infections, illness c) Pre-referral treatment for SAM X X and complications Anaemia a) Diagnosis of anaemia X X in infancy and b) Management of anaemia X X childhood c) Pre-referral treatment for severe anaemia (Blood X transfusion) Pneumonia a) Differential diagnosis for pneumonia X X X b) Management of pneumonia and its complications X X X Wheeze a) Diagnosis of condition with wheeze X X X (Asthma, b) Management of condition with wheeze X X X Bronchiolitis) Tuberculosis a) Diagnosis of tuberculosis X X b) Management of tuberculosis X X Diarrhoea a) Differential diagnosis and management of diarrhoea and X X X dysentery Septicaemia a) Diagnosis of septicaemia and/or meningitis : Blood X and/or Culture, Lumbar Puncture, Urine Analysis meningitis Septicaemia b) Management of septicaemia and/or meningitis and its X and/or complications meningitis Malaria a) Diagnosis and management of malaria X X Dengue fever a) Diagnosis and management of dengue fever X X Measles a) Diagnosis and management of measles X X Human Immu- a) Diagnosis of Human Immunodefi ciency Virus (HIV) X X X nodefi ciency b) Treatment for Human Immunodefi ciency Virus (HIV) X X X Virus (HIV) (Antiretroviral Therapy (ART)) c) Management of other opportunistic infections in Human X X X Immunodefi ciency Virus (HIV) Eye infection a) Detection and management of eye infection / X X X conjunctivitis Ear infection a) Detection and management of ear infection X X X Mouth a) Detection and management of mouth infection / thrush X X X infection Skin infection a) Diagnosis and management of skin infections X X X Chicken pox a) Detection and management of chicken pox X X X Supportive care Supportive a) Management of hypoglycaemia X for all sick infant care b) Tube feeding support X and child c) Intravenous therapy X d) Management of hypothermia X e) Management of hypoxia X f) Pain control X Triage, a) Detection of emergency signs, emergency care and pre- X X emergency referral treatment preparedness b) Advanced resuscitation X and referral Further Optional a) Male circumcision X assessment for all interventions infant and child

19 20 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health reproductive health Table 4.Evidence-based guidelinessupportingessential interventions for family planningand health other workers inmedicalprocedures.and clinicians guide to references more lists 1 Annex procedures. the support reproductive,that WHO by for published care of continuum guidelines evidence-basedrelevant the to the respect with Tables4–9 in during presented health child provided and newborn maternal, interventions clinical priority the contains section This 2.2 Health Reproductive Planning and Family of Care Continuum eeat vdnebsd udlns uprig seta interventions for reproductive, maternal, newborn andchildhealth essential supporting guidelines evidence-based Relevant other infections Infection (STI) and Transmitted of Sexually management Detection and contraceptives Provision of First assessment Treatment and Pre-referral / Emergency Illness /Surgery / Infections / First assessment chronologically: General Action by Virus (HIV) Immunodeficiency Human Syphilis method selection Contraceptive Examination Basic Medical Immunization Preventive Other infections Malaria Chlamydia Gonorrhoea Conditions Immunodeficiency Virus (HIV) a) Screening ofHuman b) Treatment for Syphilis laboratory test a) Screening /diagnosisofSyphilis by a) Provision oforal contraceptives weight andheight/Anthropometry a) Check-up vitalsigns/measuring h) Vasectomy withlocalanaesthesia g) Provision ofvaginal ringsandpatches Provisionf) ofemergency contraception e) Provision ofbarriersmethods anaesthesia contraceptive implantswithlocal d) Insertionandremoval of device (IUD)s c) Insertionandremoval ofIntrauterine b) Provision ofinjectablecontraceptives a) Vaccine for Hepatitis B b) Pelvic examination pyelonephritis urinary tract infections: bacteriuria, a) Diagnosisandtreatment for c) Managementofmalaria b) Diagnosis ofmalaria Preventive Treatment (IPT)) a) Prophylactic antimalarial (Intermittent b) Treatment for Chlamydia a) Screening /diagnosisofChlamydia b) Treatment for Gonorrhoea a) Screening /diagnosisofGonorrhoea discordant couple Human Immunodeficiency Virus (HIV) c) Provide post exposure prophylaxis for (Antiretroviral Therapy (ART) ) Immunodeficiency Virus (HIV) b) Treatment for Human i) Tubal ligation Steps ofspecific procedures for providers (2) global handbook Family planning:a guidelines Evidence based (IPTp-SP) (11) Sulfadoxine-Pyrimethamine in pregnancy using Treatment ofmalaria Intermittent Preventive Recommendation: Updated WHOPolicy tool (7) living withHIV-Counselling family planningfor people Reproductive choices and contraceptive use(4) Medical eligibilitycriteria for task shifting(3) health interventions through key maternal andnewborn roles to improve access to Optimizing healthworker Evidence basedguidelines (9) processing of human semen for theexamination and WHO laboratory manual contraceptive use(5) recommendations for Selected practice surgery (8) WHO Guidelinesfor safe (10) strategic policy framework counselling (HTC): A to HIVtesting and Service delivery approaches workers andtheirclients(6) for community health A guideto family planning tool (7) living withHIV-Counselling family planningfor people Reproductive choices and 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Continuum General Action by Conditions Steps of specifi c procedures Evidence based Evidence based guidelines of Care chronologically: guidelines First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Family First assessment Basic Medical a) Check-up vital signs / measuring Family planning: a Optimizing health worker Planning and Examination weight and height / Anthropometry global handbook roles to improve access to Reproductive for providers (2) key maternal and newborn b) Pelvic examination Health health interventions through Preventive a) Vaccine for Hepatitis B task shifting (3) Immunization Provision of Contraceptive a) Provision of oral contraceptives Medical eligibility criteria for Selected practice A guide to family planning Reproductive choices and contraceptives method selection contraceptive use (4) recommendations for for community health family planning for people b) Provision of injectable contraceptives contraceptive use (5) workers and their clients (6) living with HIV - Counselling c) Insertion and removal of Intrauterine tool (7) device (IUD)s d) Insertion and removal of contraceptive implants with local anaesthesia e) Provision of barriers methods f) Provision of emergency contraception g) Provision of vaginal rings and patches h) Vasectomy with local anaesthesia WHO Guidelines for safe surgery (8) i) Tubal ligation Detection and Syphilis a) Screening / diagnosis of Syphilis by management laboratory test of Sexually b) Treatment for Syphilis Transmitted Infection (STI) and Human a) Screening of Human Reproductive choices and WHO laboratory manual Service delivery approaches other infections Immunodefi ciency Immunodefi ciency Virus (HIV) family planning for people for the examination and to HIV testing and Virus (HIV) living with HIV - Counselling processing of human semen counselling (HTC): A b) Treatment for Human tool (7) (9) strategic policy framework Immunodefi ciency Virus (HIV) (10) (Antiretroviral Therapy (ART) ) c) Provide post exposure prophylaxis for Human Immunodefi ciency Virus (HIV) discordant couple Gonorrhoea a) Screening / diagnosis of Gonorrhoea b) Treatment for Gonorrhoea Chlamydia a) Screening / diagnosis of Chlamydia b) Treatment for Chlamydia Malaria a) Prophylactic antimalarial (Intermittent Updated WHO Policy Preventive Treatment (IPT)) Recommendation: Intermittent Preventive Treatment of malaria in pregnancy using b) Diagnosis of malaria Sulfadoxine-Pyrimethamine (IPTp-SP) (11) c) Management of malaria Other infections a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis

21 22 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health of Care Continuum violence (GBV) gender-based Management of system reproductive cancers ofthe management of Screening and Treatment and Pre-referral / Emergency Illness /Surgery / Infections / First assessment chronologically: General Action by Post-rape care Cervix cancer Breast cancer Conditions a) Managementofpost-rape care a) Papanicolaou test c) Biopsy /Pathology lab-test ultrasound) b) Diagnostic by image(mammography, a) Breast examination (cryotherapy) Treatmentf) for precancerous lesion lab-test e) Colposcopy andBiopsy /Pathology d) Colposcopy c) HumanPapilloma Virus (HPV) test (VIA)/Magnified VIA(VIAM) b) Visual InspectionwithAcetic Acid vaginosis, trichomonas,candidiasis a) Diagnosisandtreatment for bacterial Steps ofspecific procedures neoplasia (12) intraepithelial for cervical Use ofcryotherapy WHO guidelines: guidelines Evidence based (9) processing of humansemen for theexamination and WHO laboratory manual intraepithelial neoplasia(12) cryotherapy for cervical WHO guidelines:Useof Evidence basedguidelines 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Continuum General Action by Conditions Steps of specifi c procedures Evidence based Evidence based guidelines of Care chronologically: guidelines First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment a) Diagnosis and treatment for bacterial vaginosis, trichomonas, candidiasis Screening and Cervix cancer a) Papanicolaou test WHO guidelines: Use of management of cryotherapy for cervical b) Visual Inspection with Acetic Acid cancers of the intraepithelial neoplasia (12) (VIA)/Magnifi ed VIA (VIAM) c) Human Papilloma Virus (HPV) test d) Colposcopy e) Colposcopy and Biopsy / Pathology lab-test f) Treatment for precancerous lesion (cryotherapy) Breast cancer a) Breast examination b) Diagnostic by image (mammography, ultrasound) c) Biopsy / Pathology lab-test Management of Post-rape care a) Management of post-rape care WHO guidelines: WHO laboratory manual gender-based Use of cryotherapy for the examination and violence (GBV) for cervical processing of human semen intraepithelial (9) neoplasia (12)

23 24 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 5.Evidence-based guidelinessupportingessential interventions for pregnancy Pregnancy of Care Continuum Table 5.Evidence-based guidelinessupportingessential interventions for pregnancy other infections Infection (STI) and Transmitted of Sexually management Detection and assessment Emergency medical conditions maternal chronic management of Detection and First assessment Treatment and Pre-referral / Emergency Illness /Surgery / Infections / First assessment chronologically: General Action by Malaria Virus (HIV) Immunodeficiency Human Syphilis referral preparedness and Emergency Anaemia Iron Deficiency Examination Basic Medical Immunization Preventive pre-eclampsia Hypertension and Other infections Tuberculosis Rubella Conditions Preventive Treatment (IPT)) a) Prophylactic antimalarial(Intermittent ( Antiretroviral Therapy (ART) ) Immunodeficiency Virus (HIV) c) Treatment for Human Transmission (PMTCT) b) Prevention MotherTo Child Virus (HIV) a) Screening ofHumanImmunodeficiency b) Treatment for Syphilis laboratory test a) Screening /diagnosisofSyphilis by treatment a) Emergency care andpre-referral a) Diagnosisofanaemia Vaginal examination weight andheight/Anthropometry/ a) Check-up vitalsigns/measuring a) Vaccine for Tetanus a) DiagnosisofPre-eclampsia-Eclampsia (considering bloodtransfusion) d) Managementofsevere anaemia c) Anthelminthic(deworm) b) Iron andfolic acidsupplementation bacterial vaginosis andtrichomoniasis Candida vaginitis, gonorrhoea,chlamydia, Reproductive Tract Infections (RTI): Sexually Transmitted Infection (STI) / a) Diagnosisandtreatment ofother tract infections: bacteriuria, pyelonephritis a) Diagnosisandtreatment for urinary tuberculosis a) Diagnosisandtreatment for a) Diagnosisandtreatment for rubella c) Managementofmalaria b) Diagnosisofmalaria g) Inductionoflabour Fetal monitoring f) e) Magnesium sulfate d) Antihypertensive drugs c) Low-dose aspirin b) Supplementcalcium Steps ofspecific procedures perinatal health(11) on maternal and Recommendations adolescent health: newborn, childand on maternal, Guidelines guidelines Evidence based newborn health(14) improving maternal and interventions for WHO recommended Evidence basedguidelines task shifting(3) health interventions through key maternal andnewborn roles to improve access to Optimizing healthworker (20) pre-eclampsia andeclampsia Prevention andtreatment of and childhealth(18) promoting optimalmaternal reproductive age: its role in supplementation inwomen of Weekly iron-folic acid (IPTp-SP)Pyrimethamine (11) pregnancy usingSulfadoxine- ventive Treatment ofmalariain mendation: Intermittent Pre- Updated WHOPolicy Recom- handbook for buildingskills(15) and newborn healthcare, a Counselling for maternal induction oflabour(21) WHO recommendations for in pregnant women (19) folic acidsupplementation Guideline: Dailyiron and of Malaria(17) Guidelines for thetreatment pregnant women (16) supplementation in Guideline: Vitamin A 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn Table 5. Evidence-based guidelines supporting essential interventions for pregnancy Continuum General Action by Conditions Steps of specifi c procedures Evidence based Evidence based guidelines of Care chronologically: guidelines First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Pregnancy First assessment Basic Medical a) Check-up vital signs / measuring Examination weight and height / Anthropometry/ Counselling for maternal Guideline: Vitamin A Vaginal examination and newborn health care, a supplementation in Preventive a) Vaccine for Tetanus handbook for building skills (15) pregnant women (16) Immunization Emergency Emergency a) Emergency care and pre-referral assessment preparedness and treatment referral Detection and Syphilis a) Screening / diagnosis of Syphilis by management laboratory test of Sexually b) Treatment for Syphilis Transmitted Infection (STI) and Human a) Screening of Human Immunodefi ciency other infections Immunodefi ciency Virus (HIV) Virus (HIV) b) Prevention Mother To Child Transmission (PMTCT) c) Treatment for Human Immunodefi ciency Virus (HIV) ( Antiretroviral Therapy (ART) ) Malaria a) Prophylactic antimalarial (Intermittent Updated WHO Policy Recom- Preventive Treatment (IPT)) mendation: Intermittent Pre- Guidelines for the treatment ventive Treatment of malaria in b) Diagnosis of malaria of Malaria (17) pregnancy using Sulfadoxine- c) Management of malaria Pyrimethamine (IPTp-SP) (11) Guidelines Rubella a) Diagnosis and treatment for rubella on maternal, Optimizing health worker WHO recommended Tuberculosis a) Diagnosis and treatment for newborn, child and roles to improve access to interventions for tuberculosis adolescent health: key maternal and newborn improving maternal and Recommendations health interventions through Other infections a) Diagnosis and treatment for urinary newborn health (14) tract infections: bacteriuria, pyelonephritis on maternal and task shifting (3) perinatal health (11) a) Diagnosis and treatment of other Sexually Transmitted Infection (STI) / Reproductive Tract Infections (RTI): Candida vaginitis, gonorrhoea, chlamydia, bacterial vaginosis and trichomoniasis Detection and Iron Defi ciency a) Diagnosis of anaemia management of Anaemia Weekly iron-folic acid b) Iron and folic acid supplementation maternal chronic supplementation in women of Guideline: Daily iron and medical conditions c) Anthelminthic (deworm) reproductive age: its role in folic acid supplementation promoting optimal maternal in pregnant women (19) d) Management of severe anaemia and child health (18) (considering blood transfusion) Hypertension and a) Diagnosis of Pre-eclampsia-Eclampsia pre-eclampsia b) Supplement calcium c) Low-dose aspirin

Prevention and treatment of pre-eclampsia and eclampsia (20) d) Antihypertensive drugs e) Magnesium sulfate f) Fetal monitoring g) Induction of labour WHO recommendations for induction of labour (21)

25 26 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health of Care Continuum Table 5.Evidence-based guidelinessupportingessential interventions for pregnancy ectopic pregnancy Management of mutilation female genital Management of (PRM) of themembranes prelabour rupture Management of abortion miscarriage and Management of term malpresentation at Management of Treatment and Pre-referral / Emergency Illness /Surgery / Infections / First assessment chronologically: General Action by Ectopic pregnancy mutilation Female genital PRM Assessment of abortion Miscarriage and term Malpresentation at Diabetes permitted and legally when indicated Safe abortion Miscarriage Term Preterm Conditions a) Pregnancy test b) Identifytheneedofcaesarean section a) Perineal incisionwithlocalanaesthesia a) Diagnosisandlaboratory test a) Pregnancy test c) Monitoring progress oflabour b) External Cephalic Version a) Diagnosisofbreech at term diabetic mother b) Treatment for insulin-dependent a) Glucose testing for detection first trimester c) Medicaluterine evacuation beyond the trimester b) Vacuum Aspiration for thefirst trimester a) Medicaluterine evacuation for thefirst (considering laparotomy) c) Managementofmajorinjuries Vacuum Aspiration andbloodtransfusion) b) Managementofbleeding(considering a) Treatment ofinfections b) Ultrasound scan b) Inductionoflabour a) Provision antibioticsifindicated neuroprotection ofthenewborn d) Provision ofmagnesiumsulfate for syndrome prevention ofneonatal respiratory distress c) Provision ofcorticosteroids for pregnancy ifindicated b) Provision oftocolytics to prolong a) Provision antibioticsifindicated b) Fetal monitoring d) Bloodtransfusion c) Laparotomy b) Ultrasound scan Steps ofspecific procedures perinatal health on maternal and Recommendations adolescent health: newborn, childand on maternal, Guidelines guidelines Evidence based Evidence basedguidelines (22) guide for midwives anddoctors pregnancy andchildbirth:A Managing complications in (22) guide for midwives anddoctors pregnancy andchildbirth:A Managing complications in systems (23) policy guidance for health Safe abortion:technical and induction oflabour(21) WHO recommendations for 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn Table 5. Evidence-based guidelines supporting essential interventions for pregnancy Continuum General Action by Conditions Steps of specifi c procedures Evidence based Evidence based guidelines of Care chronologically: guidelines First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Diabetes a) Glucose testing for detection b) Treatment for insulin-dependent diabetic mother Management of Assessment of a) Diagnosis and laboratory test prelabour rupture PRM b) Fetal monitoring of the membranes (PRM) Preterm a) Provision antibiotics if indicated b) Provision of tocolytics to prolong pregnancy if indicated Managing complications in c) Provision of corticosteroids for pregnancy and childbirth: A prevention of neonatal respiratory distress guide for midwives and doctors syndrome (22) d) Provision of magnesium sulfate for neuroprotection of the newborn Term a) Provision antibiotics if indicated b) Induction of labour WHO recommendations for induction of labour (21) Management of Malpresentation at a) Diagnosis of breech at term malpresentation at term b) External Cephalic Version Guidelines term on maternal, c) Monitoring progress of labour newborn, child and Management of Female genital a) Perineal incision with local anaesthesia adolescent health: female genital mutilation Recommendations b) Identify the need of caesarean section mutilation on maternal and perinatal health Management of Ectopic pregnancy a) Pregnancy test ectopic pregnancy b) Ultrasound scan c) Laparotomy d) Blood transfusion Management of Miscarriage and a) Pregnancy test miscarriage and abortion b) Ultrasound scan abortion Miscarriage a) Treatment of infections Managing complications in b) Management of bleeding (considering pregnancy and childbirth: A Vacuum Aspiration and blood transfusion) guide for midwives and doctors (22) c) Management of major injuries Safe abortion: technical and (considering laparotomy) policy guidance for health systems (23) Safe abortion a) Medical uterine evacuation for the fi rst when indicated trimester and legally b) Vacuum Aspiration for the fi rst permitted trimester c) Medical uterine evacuation beyond the fi rst trimester

27 28 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 6.Evidence-based guidelinessupportingessential interventions for childbirth Childbirth of Care Continuum labour anddelivery complications of Management of Mother care assessment Emergency First assessment Treatment and Pre-referral / Emergency Illness /Surgery / Infections / First assessment chronologically: General Action by complications Assessment for Childbirth referral preparedness and Emergency Examination Basic Medical indication due maternal/fetal Caesarean section (PPH) haemorrhage Postpartum positive women Virus (HIV) Immunodeficiency Human complication depending onthe procedures Other surgical Conditions a) Diagnosisofcomplications if needed d) Assisted delivery (vacuum extraction) c) Spontaneousdelivery uterotonics of labour(AMTSL): Prophylactic useof b) Active managementofthethird stage a) Monitoring progress oflabour treatment a) Emergency care andpre-referral examination a) Check-up vitalsigns/Vaginal a) Useofprophylactic antibiotic Hysterectomyf) e) Useofartery embolization d) Useofballoontamponade c) Bloodtransfusion use ofantibioticsanduterotonics) b) Manualremoval ofplacenta (include treatment ofPPH a) Useofuterotonics ofchoice for the b) Fetal monitoring Transmission (PMTCT) b) Prevention MotherTo Child Virus (HIV) a) Screening ofHumanImmunodeficiency a) Craniotomy andcraniocentesis surgical interventions during childbirth a) Laparotomy orotherabdominal a) Correct uterine inversion a) Repair ofruptured uterus a) Episiotomy c) Useofuterotonics b) Caesarean section Steps ofspecific procedures health (14) and newborn improving maternal interventions for recommended WHO guidelines Evidence based task shifting(3) health interventions through key maternal andnewborn roles to improve access to Optimizing healthworker Evidence basedguidelines doctors (22) A guidefor midwives and pregnancy andchildbirth: Managing complications in surgery (8) WHO Guidelinesfor safe 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Continuum General Action by Conditions Steps of specifi c procedures Evidence based Evidence based guidelines of Care chronologically: guidelines First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Childbirth First assessment Basic Medical a) Check-up vital signs / Vaginal Examination examination Emergency Emergency a) Emergency care and pre-referral assessment preparedness and treatment referral Mother care Childbirth a) Monitoring progress of labour b) Active management of the third stage of labour (AMTSL): Prophylactic use of uterotonics c) Spontaneous delivery d) Assisted delivery (vacuum extraction) if needed Management of Assessment for a) Diagnosis of complications complications of complications labour and delivery b) Fetal monitoring Postpartum a) Use of uterotonics of choice for the haemorrhage treatment of PPH (PPH) WHO b) Manual removal of (include Optimizing health worker recommended use of antibiotics and uterotonics) roles to improve access to interventions for key maternal and newborn c) Blood transfusion improving maternal health interventions through and newborn d) Use of balloon tamponade task shifting (3) health (14) e) Use of embolization f) Hysterectomy Caesarean section a) Use of prophylactic antibiotic Managing complications in due maternal/fetal pregnancy and childbirth: b) Caesarean section indication A guide for midwives and c) Use of uterotonics doctors (22) Other surgical a) Episiotomy procedures WHO Guidelines for safe a) Repair of ruptured uterus depending on the surgery (8) complication a) Correct uterine inversion a) Laparotomy or other abdominal surgical interventions during childbirth a) Craniotomy and craniocentesis Human a) Screening of Human Immunodefi ciency Immunodefi ciency Virus (HIV) Virus (HIV) b) Prevention Mother To Child positive women Transmission (PMTCT)

29 30 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 7 Mother Post-Natal Mother Post-Natal of Care Continuum .Evidence-based guidelinessupportingessential interventions for thepostnatal mother bleeding of post partum management Prevention and Postoperative care assessment Emergency infection of post partum management Detection and First assessment Treatment and Pre-referral / Emergency Illness /Surgery / Infections / First assessment chronologically: General Action by Anaemia postoperative care Assessment of referral preparedness and Emergency Malaria Virus (HIV) Immunodeficiency Human Examination Basic Medical Other infection feeding Support for breast Surgical procedure Conditions a) Managementofpost partumbleeding a) Postcaesarean care treatment a) Emergency care andpre-referral a) Diagnosisandmanagementofmalaria (Antiretroviral Therapy (ART)) Human Immunodeficiency Virus (HIV) a) Diagnosisandtreatment for a) Check-up vitalsigns tract infections: bacteriuria, pyelonephritis a) Diagnosisandtreatment for urinary postpartum endometritisandsalpingitis a) Diagnosisandmanagementof abscess a) Managementofmastitis /breast (considering bloodtransfusion) e) Managementofsevere anaemia d) Anthelminthic(deworm) c) Iron supplementation b) Diagnosisofanaemia b) Screening for cervix andbreast cancer complication withlaparotomy abscess, peritonitis orotherpostoperative c) Surgical managementofpelvic or otherpostoperative complication b) Diagnosisofpelvicabscess, peritonitis Steps ofspecific procedures health (14) and newborn improving maternal interventions for recommended WHO guidelines Evidence based task shifting(3) health interventions through key maternal andnewborn roles to improve access to Optimizing healthworker Evidence basedguidelines intraepithelial neoplasia(12) cryotherapy for cervical WHO guidelines:Useof doctors (22) A guidefor midwives and pregnancy andchildbirth: Managing complications in (IPTp-SP) (11) Sulfadoxine-Pyrimethamine in pregnancy using Treatment ofmalaria Intermittent Preventive Recommendation: Updated WHOPolicy haemorrhage (24) treatment ofpostpartum for theprevention and WHO recommendations of Malaria(17) Guidelines for thetreatment 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn

Continuum General Action by Conditions Steps of specifi c procedures Evidence based Evidence based guidelines of Care chronologically: guidelines First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Post-Natal First assessment Basic Medical a) Check-up vital signs Mother Examination b) Screening for cervix and breast cancer WHO guidelines: Use of cryotherapy for cervical intraepithelial neoplasia (12) Support for breast a) Management of mastitis / breast feeding abscess Emergency Emergency a) Emergency care and pre-referral assessment preparedness and treatment referral Prevention and Anaemia a) Management of post partum bleeding management b) Diagnosis of anaemia of post partum WHO recommendations bleeding c) Iron supplementation for the prevention and treatment of postpartum d) Anthelminthic (deworm) haemorrhage (24) e) Management of severe anaemia (considering blood transfusion) WHO Optimizing health worker recommended Detection and Human a) Diagnosis and treatment for roles to improve access to interventions for management Immunodefi ciency Human Immunodefi ciency Virus (HIV) key maternal and newborn improving maternal of post partum Virus (HIV) (Antiretroviral Therapy (ART)) health interventions through and newborn infection task shifting (3) Malaria a) Diagnosis and management of malaria health (14) Updated WHO Policy Recommendation: Intermittent Preventive Guidelines for the treatment Treatment of malaria of Malaria (17) in pregnancy using Sulfadoxine-Pyrimethamine (IPTp-SP) (11) Other infection a) Diagnosis and management of postpartum endometritis and salpingitis a) Diagnosis and treatment for urinary tract infections: bacteriuria, pyelonephritis Postoperative care Assessment of a) Postcaesarean care postoperative care b) Diagnosis of pelvic abscess, peritonitis Managing complications in or other postoperative complication pregnancy and childbirth: A guide for midwives and Surgical procedure c) Surgical management of pelvic doctors (22) abscess, peritonitis or other postoperative complication with laparotomy

31 32 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 8.Evidence-based guidelinessupportingessential interventions for thepostnatal baby Care Continuum of Table 8.Evidence-based guidelinessupportingessential interventions for thepostnatal baby (Newborn) Baby Post-Natal young infant in theneonate and and complications infections, illness of common management Detection and infections of congenital management Detection and referral Treatment Emergency andPre- Illness /Surgery / / Infections / First assessment chronologically: General Action by newborn care Childbirth: Essential Cord infection infections Congenital Conditions birth Immediate care at Jaundice Emergency support Routine care infection a) Detection andmanagementofcord a) Diagnosisofcongenital syphilis Steps ofspecific procedures skin to skinandcover a) Drybaby thoroughly onmother'schest b) Managementofjaundice a) Diagnosisofjaundice a) Basicneonatal resuscitation c) Breastfeeding support b) Thermal Care signs /measuringweight a) Fullclinicalexamination /Checkvital intracranial haemorrhage(ICH) b) Managementofbrain injuryand hour e) Supportbreastfeeding withinthefirst is notpossible d) Prevent hypothermia whenskinto skin cord infection vessels /Checkfor bleedingandsignsof c) Clampandcutcord /Checkcord b) Assess breathing (Antiretroviral Therapy (ART)) Immunodeficiency Virus (HIV) d) Prophylactic treatment for Human Virus (HIV) (DriedBloodSpot(DBS)) c) Screening ofHumanImmunodeficiency syphilis b) Prophylactic treatment for congenital risk ofinfection g) Prophylactic antibioticsfor neonates at Prophylaxisf) for eye infection e) Cord care Immunization d) Vitamin Kprophylaxis and (25) on newborn health Recommendations adolescent health: newborn, childand on maternal, Guidelines guidelines Evidence based common illnesses (26) the managementof children: guidelinesfor hospital care for Pocket bookof Evidence basedguidelines Booklet (27) the SickChild,Chart Community. Caringfor and Children inthe Caring for Newborns childhood illness (IMCI): management of Integrated conditions (28) common childhood for managementof Recommendations chart booklet(31) for highHIVsettings, childhood illness(IMCI) management of Integrated conditions (28) common childhood for managementof Recommendations (32) public healthapproach recommendations for a universal access, children: towards in infants and for HIVinfection Antiretroviral therapy (31) newborn resuscitation Guidelines onbasic staff (30) course for maternity hospital: a20-hour in ababy-friendly promotion andsupport Breastfeeding Initiative(BFHI), Baby-Friendly Hospital maternity staff (30) 20-hour course for friendly hospital:a support inababy- promotion and Breastfeeding Initiative(BFHI), Baby-Friendly Hospital children (33) infection ininfants and the diagnosisofHIV recommendations on WHO 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn Table 8. Evidence-based guidelines supporting essential interventions for the postnatal baby Continuum of General Action by Conditions Steps of specifi c procedures Evidence based Evidence based guidelines Care chronologically: guidelines First assessment / Infections / Illness / Surgery / Emergency and Pre- referral Treatment Post-Natal Childbirth: Essential Immediate care at a) Dry baby thoroughly on mother's chest Baby newborn care birth skin to skin and cover (Newborn) b) Assess breathing c) Clamp and cut cord / Check cord vessels / Check for bleeding and signs of cord infection d) Prevent hypothermia when skin to skin is not possible e) Support breastfeeding within the fi rst Baby-Friendly Hospital hour Initiative(BFHI), Breastfeeding promotion and support in a baby-friendly hospital: a 20-hour course for maternity staff (30) Emergency support a) Basic neonatal resuscitation Guidelines on basic newborn resuscitation Recommendations (31) for management of b) Management of brain injury and common childhood intracranial haemorrhage (ICH) conditions (28) Routine care a) Full clinical examination / Check vital signs / measuring weight b) Thermal Care c) Breastfeeding support Baby-Friendly Hospital Integrated Guidelines Initiative(BFHI), management of on maternal, Pocket book of Breastfeeding childhood illness (IMCI): newborn, child and hospital care for promotion and Caring for Newborns adolescent health: children: guidelines for support in a baby- and Children in the Recommendations the management of friendly hospital: a Community. Caring for on newborn health common illnesses (26) 20-hour course for the Sick Child, Chart (25) maternity staff (30) Booklet (27) d) Vitamin K prophylaxis and Immunization e) Cord care f) Prophylaxis for eye infection g) Prophylactic antibiotics for neonates at risk of infection Detection and Congenital a) Diagnosis of congenital syphilis management infections b) Prophylactic treatment for congenital of congenital syphilis infections c) Screening of Human Immunodefi ciency Integrated Antiretroviral therapy Virus (HIV) (Dried Blood Spot (DBS)) management of for HIV infection WHO childhood illness(IMCI) in infants and d) Prophylactic treatment for Human recommendations on for high HIV settings, children: towards Immunodefi ciency Virus (HIV) the diagnosis of HIV chart booklet (31) universal access, (Antiretroviral Therapy (ART)) infection in infants and recommendations for a children (33) public health approach (32) Detection and Cord infection a) Detection and management of cord management infection of common Jaundice a) Diagnosis of jaundice Recommendations infections, illness b) Management of jaundice for management of and complications common childhood in the neonate and conditions (28) young infant

33 34 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health (Newborn) Baby Post-Natal Care Continuum of Table 8.Evidence-based guidelinessupportingessential interventions for thepostnatal baby sick young infant all sickneonate and Supportive care for babies birth andpre-term small, low weight interventions for Specific for allyoung infant Further assessment referral Treatment Emergency andPre- Illness /Surgery / / Infections / First assessment chronologically: General Action by Supportive care enterocolitis Necrotizing (RDS) Distress Syndrome Respiratory Apnoea interventions Optional Clinical visit Conditions Anaemia meningitis Septicaemia and/or Diarrhoea Pneumonia referral preparedness and Triage, emergency management ofhypoglycaemia a) Monitor bloodglucose and enterocolitis b) Managementofnecrotizing a) Diagnosisofnecrotizing enterocolitis (CPAP) Continuous Positive Airway Pressure including mechanicalventilation and c) Ventilatory supportandoxygen therapy mask Pressure (CPAP) withnasalcannulaorface b) ApplyContinuous Positive Airway prophylaxis surfactant a) DiagnosisofRDS andprovision of a) Prevention ofApnoea a) Malecircumcision d) Monitoring growth anddevelopment feeding ifnecessary c) Breastfeeding supportandreplacement (OPV), Hepatitis B) Influenza typeB(HIB),Oral Polio Vaccine Pertussis Tetanus (DPT)+Haemophilus b) Provision ofvaccines (Diphtheria haemoglobin vital signs/measuringweight /check a) Fullclinicalexamination /check Steps ofspecific procedures a) Diagnosisofanaemia meningitis anditscomplications b) Managementofsepticaemiaand/or Puncture, UrineAnalysis or meningitis:BloodCulture, Lumbar a) Diagnosisofsepticaemiaand/ diarrhoea a) Detection andmanagementof complications b) Managementofpneumoniaandits a) Diagnosisofpneumonia anaemia (bloodtransfusion) c) Pre-referral treatment for severe b) Managementofanaemia b) Advanced resuscitation emergency care andpre-referral treatment a) Detection ofemergency signs, of hypoxia e) Monitor oxygenation andmanagement of hypothermia (Kangaroo mothercare) d) Monitor temperature andmanagement c) Provision ofintravenous therapy feeding support b) Monitor nutritionandprovision oftube (25) on newborn health Recommendations adolescent health: newborn, childand on maternal, Guidelines guidelines Evidence based Evidence basedguidelines common illnesses (26) the managementof children: guidelinesfor hospital care for Pocket bookof (27) Child, ChartBooklet Caring for theSick in theCommunity. Newborns and Children (IMCI): Caringfor childhood illness management of Integrated anaesthesia (36) under local male circumcision Manual for earlyinfant emergencies (35) in humanitarian care ofchildren Manual for thehealth income countries (34) in low- andmiddle- birthweight infants Optimal feeding oflow 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn Table 8. Evidence-based guidelines supporting essential interventions for the postnatal baby Continuum of General Action by Conditions Steps of specifi c procedures Evidence based Evidence based guidelines Care chronologically: guidelines First assessment / Infections / Illness / Surgery / Emergency and Pre- referral Treatment Post-Natal Anaemia a) Diagnosis of anaemia Baby b) Management of anaemia (Newborn) c) Pre-referral treatment for severe anaemia (blood transfusion) Pneumonia a) Diagnosis of pneumonia b) Management of pneumonia and its complications Diarrhoea a) Detection and management of diarrhoea Septicaemia and/or a) Diagnosis of septicaemia and/ meningitis or meningitis: Blood Culture, Lumbar Puncture, Urine Analysis b) Management of septicaemia and/or meningitis and its complications Specifi c Apnoea a) Prevention of Apnoea interventions for Respiratory a) Diagnosis of RDS and provision of small, low weight Distress Syndrome prophylaxis surfactant birth and pre-term (RDS) b) Apply Continuous Positive Airway babies Pressure (CPAP) with nasal cannula or face mask c) Ventilatory support and oxygen therapy including mechanical ventilation and Continuous Positive Airway Pressure (CPAP) Necrotizing a) Diagnosis of necrotizing enterocolitis Integrated enterocolitis b) Management of necrotizing Guidelines management of enterocolitis on maternal, Pocket book of childhood illness Supportive care for Supportive care a) Monitor blood glucose and newborn, child and hospital care for (IMCI): Caring for Optimal feeding of low all sick neonate and management of hypoglycaemia adolescent health: children: guidelines for Newborns and Children birthweight infants sick young infant Recommendations the management of in the Community. in low- and middle- on newborn health common illnesses (26) Caring for the Sick income countries (34) (25) Child, Chart Booklet b) Monitor nutrition and provision of tube (27) feeding support c) Provision of intravenous therapy d) Monitor temperature and management of hypothermia (Kangaroo mother care) e) Monitor oxygenation and management of hypoxia Triage, emergency a) Detection of emergency signs, Manual for the health preparedness and emergency care and pre-referral treatment care of children referral in humanitarian emergencies (35) b) Advanced resuscitation Further assessment Clinical visit a) Full clinical examination / check for all young infant vital signs / measuring weight / check haemoglobin b) Provision of vaccines (Diphtheria Pertussis Tetanus (DPT) + Haemophilus Infl uenza type B (HIB), Oral Polio Vaccine (OPV), Hepatitis B) c) Breastfeeding support and replacement feeding if necessary d) Monitoring growth and development Optional a) Male circumcision Manual for early infant interventions male circumcision under local anaesthesia (36)

35 36 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 9 Table 9. Evidence-based guidelinessupportingessential interventions for infancy andchildhood childhood Infancy and Care Continuum of .Evidence-based guidelinessupportingessential interventions for infancy andchildhood childhood in infancy and and complications infections, illness of common management Detection and Treatment and Pre-referral / Emergency Illness /Surgery / Infections / First assessment chronologically: General Action by development early childhood growth and for monitoring Essential care Malnutrition (SAM) Severe Acute Conditions Routine care Measles Dengue fever Malaria or meningitis Septicaemia and/ or meningitis Septicaemia and/ Diarrhoea Tuberculosis Bronchiolitis) Wheeze (Asthma, Pneumonia Anaemia a) DiagnosisofSAM Steps ofspecific procedures signs /measuringweight a) Fullclinicalexamination /checkvital a) Diagnosisandmanagementofmeasles fever a) Diagnosisandmanagementofdengue a) Diagnosisandmanagementofmalaria meningitis anditscomplications b) Managementofsepticaemiaand/or Puncture, UrineAnalysis meningitis :BloodCulture, Lumbar a) Diagnosisofsepticaemiaand/or of diarrhoeaanddysentery a) Differential diagnosisandmanagement b) Managementoftuberculosis a) Diagnosisoftuberculosis b) Managementofcondition withwheeze a) Diagnosisofcondition withwheeze complications b) Managementofpneumoniaandits a) Differential diagnosisfor pneumonia anaemia (Bloodtransfusion) c) Pre-referral treatment for severe b) Managementofanaemia a) Diagnosisofanaemia c) Pre-referral treatment for SAM b) Feeding support g) Deworming (Mebendazole) Vitamin Asupplementation f) feeding ifnecessary e) Breastfeeding support and replacement monitoring d) Earlychildhooddevelopment c) Growth monitoring b) Provision ofvaccines on childhealth(37) Recommendations adolescent health: newborn, childand on maternal, Guidelines guidelines Evidence based (26) common illnesses management of guidelines for the for children: hospital care Pocket bookof Evidence basedguidelines Booklet (27) Sick Child,Chart Caring for the Community. Children inthe Newborns and Caring for illness(IMCI): of childhood management Integrated (38) Booklet, standard (IMCI): Chart childhood illness management of Integrated conditions (28) childhood of common for management Recommendations countries (34) middle- income infants inlow- and of low birthweight Optimal feeding (29) for maternity staff a 20-hourcourse friendly hospital: support inababy- promotion and Breastfeeding Initiative(BFHI), Hospital Baby-Friendly 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn Table 9. Evidence-based guidelines supporting essential interventions for infancy and childhood Continuum of General Action by Conditions Steps of specifi c procedures Evidence based Evidence based guidelines Care chronologically: guidelines First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Infancy and Essential care Routine care a) Full clinical examination / check vital childhood for monitoring signs / measuring weight growth and b) Provision of vaccines early childhood development c) Growth monitoring d) Early childhood development monitoring e) Breastfeeding support and replacement Baby-Friendly feeding if necessary Hospital Initiative(BFHI), Breastfeeding promotion and support in a baby- friendly hospital: a 20-hour course for maternity staff (29) f) Vitamin A supplementation g) Deworming (Mebendazole) Detection and Severe Acute a) Diagnosis of SAM Optimal feeding management Malnutrition (SAM) Integrated of low birthweight b) Feeding support of common management infants in low- and Pocket book of of childhood infections, illness c) Pre-referral treatment for SAM Guidelines Integrated middle- income hospital care illness(IMCI): Recommendations and complications on maternal, management of countries (34) for children: Caring for for management in infancy and newborn, child and childhood illness Anaemia a) Diagnosis of anaemia guidelines for the Newborns and of common childhood adolescent health: (IMCI): Chart management of Children in the childhood b) Management of anaemia Recommendations Booklet, standard common illnesses Community. conditions (28) c) Pre-referral treatment for severe on child health (37) (38) (26) Caring for the anaemia (Blood transfusion) Sick Child, Chart Pneumonia a) Differential diagnosis for pneumonia Booklet (27) b) Management of pneumonia and its complications Wheeze (Asthma, a) Diagnosis of condition with wheeze Bronchiolitis) b) Management of condition with wheeze Tuberculosis a) Diagnosis of tuberculosis b) Management of tuberculosis Diarrhoea a) Differential diagnosis and management of diarrhoea and dysentery Septicaemia and/ a) Diagnosis of septicaemia and/or or meningitis meningitis : Blood Culture, Lumbar Puncture, Urine Analysis Septicaemia and/ b) Management of septicaemia and/or or meningitis meningitis and its complications Malaria a) Diagnosis and management of malaria Dengue fever a) Diagnosis and management of dengue fever Measles a) Diagnosis and management of measles

37 38 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 9. Evidence-based guidelinessupportingessential interventions for infancy andchildhood childhood Infancy and Care Continuum of child all sickinfant and Supportive care for infant andchild assessment for all Further Treatment and Pre-referral / Emergency Illness /Surgery / Infections / First assessment chronologically: General Action by Supportive care interventions Optional Conditions Chicken pox Skin infection Mouth infection Ear infection Virus (HIV) Immunodeficiency Human referral preparedness and Triage, emergency Eye infection a) Managementofhypoglycaemia a) Malecircumsicion Steps ofspecific procedures pox a) Detection andmanagementofchicken infections a) Diagnosisandmanagementofskin infection /thrush a) Detection andmanagementofmouth infection a) Detection andmanagementofear Virus (HIV) a) DiagnosisofHumanImmunodeficiency treatment emergency care andpre-referral a) Detection ofemergency signs, Pain controlf) e) Managementofhypoxia d) Managementofhypothermia c) Intravenous therapy b) Tube feeding support infection /conjunctivitis a) Detection andmanagementofeye Virus (HIV) infections inHumanImmunodeficiency c) Managementofotheropportunistic (Antiretroviral Therapy (ART)) Immunodeficiency Virus (HIV) b) Treatment for Human b) Advanced resuscitation on childhealth(37) Recommendations adolescent health: newborn, childand on maternal, Guidelines guidelines Evidence based (26) common illnesses management of guidelines for the for children: hospital care Pocket bookof Evidence basedguidelines Booklet (27) Sick Child,Chart Caring for the Community. Children inthe Newborns and Caring for illness(IMCI): of childhood management Integrated (38) Booklet, standard (IMCI): Chart childhood illness management of Integrated chart booklet(31) high HIVsettings, illness(IMCI) for of childhood management Integrated (36) local anaesthesia circumcision under infant male Manual for early emergencies (35) humanitarian of children in health care Manual for the countries (34) middle- income infants inlow- and of low birthweight Optimal feeding conditions (28) childhood of common for management Recommendations approach (32) for apublichealth recommendations universal access, children: towards in infants and HIV infection therapy for Antiretroviral children (33) in infants and of HIVinfection on thediagnosis recommendations WHO 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn Table 9. Evidence-based guidelines supporting essential interventions for infancy and childhood Continuum of General Action by Conditions Steps of specifi c procedures Evidence based Evidence based guidelines Care chronologically: guidelines First assessment / Infections / Illness / Surgery / Emergency and Pre-referral Treatment Infancy and Human a) Diagnosis of Human Immunodefi ciency Antiretroviral childhood Immunodefi ciency Virus (HIV) therapy for Integrated WHO Virus (HIV) HIV infection b) Treatment for Human management recommendations in infants and Immunodefi ciency Virus (HIV) of childhood on the diagnosis children: towards (Antiretroviral Therapy (ART)) illness(IMCI) for of HIV infection universal access, high HIV settings, in infants and c) Management of other opportunistic recommendations chart booklet (31) children (33) infections in Human Immunodefi ciency for a public health Virus (HIV) approach (32) Eye infection a) Detection and management of eye infection / conjunctivitis Ear infection a) Detection and management of ear infection Recommendations for management Mouth infection a) Detection and management of mouth of common infection / thrush Integrated childhood Skin infection a) Diagnosis and management of skin management conditions (28) Pocket book of of childhood infections Guidelines Integrated hospital care illness(IMCI): on maternal, management of Chicken pox a) Detection and management of chicken for children: Caring for newborn, child and childhood illness pox guidelines for the Newborns and adolescent health: (IMCI): Chart management of Children in the Supportive care for Supportive care a) Management of hypoglycaemia Recommendations Booklet, standard Optimal feeding all sick infant and common illnesses Community. of low birthweight b) Tube feeding support on child health (37) (38) child (26) Caring for the infants in low- and c) Intravenous therapy Sick Child, Chart middle- income Booklet (27) countries (34) d) Management of hypothermia e) Management of hypoxia f) Pain control Triage, emergency a) Detection of emergency signs, Manual for the preparedness and emergency care and pre-referral health care referral treatment of children in b) Advanced resuscitation humanitarian emergencies (35) Further Optional a) Male circumsicion Manual for early assessment for all interventions infant male infant and child circumcision under local anaesthesia (36)

39 40 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 10. References Subject Table 10. References

MATERNAL HEALTH REPRODUCTIVE HEALTH handbook for buildingskills(15) Counselling for maternal andnewborn healthcare, a maternal andchildhealth(18) of reproductive age: itsrole inpromoting optimal Weekly iron-folic acidsupplementation inwomen Guidelines for the treatment ofMalaria(17) WHO recommendations for inductionoflabour(21) eclampsia (20) Prevention andtreatment ofpre-eclampsia and women (16) Guideline: Vitamin Asupplementation inpregnant treatment ofpostpartum haemorrhage (24) WHO recommendations for theprevention and Sulfadoxine-Pyrimethamine (IPTp-SP) (11) preventive treatment ofmalariainpregnancy using Updated WHOPolicy Recommendation: Intermittent health systems (23) Safe abortion:technical andpolicy guidance for pregnant women (19) Guideline: Dailyiron andfolic acidsupplementation in perinatal health(13) adolescent health:Recommendations onmaternal and Guidelines onmaternal, newborn, childand violence Guidelines for medico-legal care for victimsofsexual displaced persons protocols for usewithrefugees andinternally Clinical managementofrape survivors: Developing providers Decision makingtool for family planningclientsand essential practice Comprehensive cervical cancer control, aguideto living withHIV-Counselling tool (7) Reproductive choices andfamily planningfor people use (5) Selected practice recommendations for contraceptive Medical eligibilitycriteria for contraceptive use(4) Procurement Specification, Prequalifi cation andGuidelinesfor The TCu380A Intrauterine Contraceptive Device (IUD): processing ofhumansemen (9) WHO laboratory manualfor theexamination and and Guidelinesfor Procurement Male Latex Condom: Specification, Prequalifi cation intraepithelial neoplasia(12) WHO guidelines:Useofcryotherapy for cervical Family planning:aglobalhandbookfor providers (2) prequalification andguidelinesfor procurement Female Condom: genericspecification, cervical cancer precancerous cervical lesionsandprevention of Cryosurgical equipmentfor thetreatment of through taskshifting(3) to key maternal andnewborn healthinterventions Optimizing healthworker roles to improve access workers andtheirclients(6) A guideto family planningfor community health based programmes assurance for visualinspectionwithacetic acid(VIA)- control programmes: qualitycontrol andquality Monitoring national cervical cancer prevention and Title 2004 2009 2009 2006 2009 2008 2005 2003 2007 2010 2010 2010 2013 2013 2012 2012 2012 2012 2012 2012 2012 2012 Year 2011 2011 2011 2011 2011 2011 publications/2010/9789241563888_eng.pdf http://whqlibdoc.who.int/ family_planning/9789241500999/en/ http://www.who.int/reproductivehealth/publications/ infertility/9789241547789/en/ http://www.who.int/reproductivehealth/publications/ family_planning/9789241599900/en/ http://www.who.int/reproductivehealth/publications/ publications/2011/9789241502856_eng.pdf http://whqlibdoc.who.int/ family_planning/9780978856304/en/ http://www.who.int/reproductivehealth/publications/ Generic%20Specification%20EN.pdf procurement/08_QA/Female%20Condom%20 http://www.unfpa.org/webdav/site/global/shared/ bitstream/10665/75853/1/9789241504560_eng.pdf http://apps.who.int/iris/ maternal_perinatal_health/978924504843/en/ http://www.who.int/reproductivehealth/publications/ family_planning/9789241503754/en/index.html http://www.who.int/reproductivehealth/publications/ bitstream/10665/79316/1/9789241505260_eng.pdf http://apps.who.int/iris/ documents/9789241547628/en/ http://www.who.int/maternal_child_adolescent/ micronutrients/weekly_iron_folicacid.pdf http://www.who.int/nutrition/publications/ publications/2010/9789241547925_eng.pdf http://whqlibdoc.who.int/ publications/2011/9789241501156_eng.pdf http://whqlibdoc.who.int/ publications/2011/9789241548335_eng.pdf http://whqlibdoc.who.int/ micronutrients/guidelines/vas_pregnant/en/ http://www.who.int/nutrition/publications/ bitstream/10665/75411/1/9789241548502_eng.pdf http://apps.who.int/iris/ recommendation_en_102012.pdf http://www.who.int/malaria/iptp_sp_updated_policy_ bitstream/10665/70914/1/9789241548434_eng.pdf http://apps.who.int/iris/ bitstream/10665/77770/1/9789241501996_eng.pdf http://apps.who.int/iris/ health.pdf documents/guidelines-recommendations-maternal- http://www.who.int/maternal_child_adolescent/ publications/2004/924154628X.pdf http://whqlibdoc.who.int/ publications/2004/924159263X.pdf http://whqlibdoc.who.int/ family_planning/9241593229/en/index.html http://www.who.int/reproductivehealth/publications/ publications/2006/9241547006_eng.pdf http://whqlibdoc.who.int/ family_planning/9241595132/en/index.html http://www.who.int/reproductivehealth/publications/ RHR_08.17_eng.pdf http://whqlibdoc.who.int/hq/2008/WHO_ family_planning/9241562846index/en/ http://www.who.int/reproductivehealth/publications/ Link 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn Table 10. References

Subject Title Year Link

Managing complications in pregnancy and childbirth: 2007 http://whqlibdoc.who.int/ A guide for midwives and doctors (22) publications/2007/9241545879_eng.pdf WHO recommended interventions for improving 2007 http://www.who.int/maternal_child_adolescent/ maternal and newborn health (14) documents/who_mps_0705/en/index.html Consolidated guidelines on the use of antiretroviral 2013 http://www.who.int/hiv/pub/guidelines/arv2013/ drugs for treating and preventing HIV infection, download/en/ recommendations for a public health approach Guidelines on maternal, newborn, child and adolescent 2013 http://www.who.int/maternal_child_adolescent/ health: Recommendations on child health (37) documents/guidelines-recommendations-child- health.pdf Guidelines on maternal, newborn, child and adolescent 2013 http://www.who.int/maternal_child_adolescent/ health: Recommendations on newborn health (25) documents/guidelines-recommendations-newborn- health.pdf Pocket book of hospital care for children: guidelines 2013 http://www.who.int/maternal_child_adolescent/ for the management of common illnesses (26) documents/child_hospital_care/en/index.html Born too soon: The global action report on preterm 2012 http://www.who.int/pmnch/media/news/2012/ birth preterm_birth_report/en/ Caring for the newborn at home: A training course for 2012 http://www.who.int/maternal_child_adolescent/ community health workers documents/caring_for_newborn/en/index.html Guidelines on basic newborn resuscitation (30) 2012 http://www.who.int/maternal_child_adolescent/ documents/basic_newborn_resuscitation/en/ Recommendations for management of common 2012 http://www.who.int/maternal_child_adolescent/ childhood conditions (28) documents/management_childhood_conditions/en/ index.html Integrated management of childhood illness(IMCI): 2011 http://whqlibdoc.who.int/ Caring for Newborns and Children in the Community. publications/2011/9789241548045_Chart_Booklet_ Caring for the Sick Child, Chart Booklet (27) eng.pdf Manual for early infant male circumcision under local 2011 http://www.who.int/hiv/pub/malecircumcision/ anaesthesia (36) manual_infant/en/index.html Optimal feeding of low birthweight infants in low-and 2011 http://www.who.int/maternal_child_adolescent/ middle-income countries (34) documents/9789241548366.pdf Antiretroviral therapy for HIV infection in infants and 2010 http://whqlibdoc.who.int/ children: towards universal access, recommendations publications/2010/9789241599801_eng.pdf CHILD HEALTH for a public health approach (32) WHO recommendations on the diagnosis of HIV 2010 http://whqlibdoc.who.int/ infection in infants and children (33) publications/2010/9789241599085_eng.pdf Baby-Friendly Hospital Initiative(BFHI), Breastfeeding 2009 http://whqlibdoc.who.int/ promotion and support in a baby-friendly hospital: a publications/2009/9789241594981_eng.pdf 20-hour course for maternity staff (29) Home visits for the newborn child: a strategy to 2009 http://whqlibdoc.who.int/hq/2009/WHO_FCH_ improve survival CAH_09.02_eng.pdf Integrated management of childhood illness(IMCI) for 2008 http://whqlibdoc.who.int/ high HIV settings, chart booklet (31) publications/2008/9789241597388_eng.pdf Integrated management of childhood illness(IMCI): 2008 http://whqlibdoc.who.int/ Chart Booklet, standard (38) publications/2008/9789241597289_eng.pdf Manual for the health care of children in humanitarian 2008 http://whqlibdoc.who.int/ emergencies (35) publications/2008/9789241596879_eng.pdf Emergency Triage Assessment and Treatment(ETAT), 2005 http://www.who.int/maternal_child_adolescent/ Manual for participants documents/9241546875/en/index.html Kangaroo mother care, a practical guide 2003 http://whqlibdoc.who.int/ publications/2003/9241590351.pdf Managing newborn problems: a guide for doctors, 2003 http://whqlibdoc.who.int/ nurses, and midwives publications/2003/9241546220.pdf Screening Donated Blood for Transfusion 2010 http://www.who.int/bloodsafety/ Transmissible Infections - Recommendations ScreeningDonatedBloodforTransfusion.pdf Screening Donated Blood for Transfusion 2009 http://whqlibdoc.who.int/ Transmissible Infections - Recommendations publications/2009/9789241547888_eng.pdf Safe Blood and Blood Products: Module 1 - Safe Blood 2009 http://www.who.int/entity/bloodsafety/transfusion_ Donation services/Module1.pdf Safe Blood and Blood Products: Module 3 - Blood 2009 http://www.who.int/entity/bloodsafety/transfusion_ Group Serology services/Module3.pdf Safe Blood and Blood Products: Manual on the 2005 http://www.who.int/entity/bloodsafety/Manual_on_ management, maintenance and use of blood cold Management,Maintenance_and_Use_of_Blood_Cold_ chain equipment Chain_Equipment.pdf External Quality Assessment of Transfusion 2004 http://www.who.int/entity/bloodsafety/EQA_in_ Laboratory Practice - Guidelines on Establishing an Blood_Group_Serology.pdf EQA Scheme in Blood Group Serology

CLINICAL TRANSFUSION The Blood Cold Chain - Guide to the selection and 2002 http://www.who.int/entity/bloodsafety/testing_ procurement of equipment and accessories processing/components/en/BloodColdChain.pdf 41 42 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Subject Table 10. References SURGERY AND INJECTION SAFETY ANESTHESIA LABORATORY Document No. WHO/V&B/99.25 of autoÐdisable syringes inimmunization services. WHOÐUNICEFÐUNFPA Jointstatement ontheuse WHO Aidememoire oninjection safety security. DocumentNo. WHO/BCT/03 WHO Guidingprinciplesto ensure injectiondevice Injection Equipment A guidefor theQualityAssurance ofSingleUse procedures WHO Best practices for injectionsandrelated Safe InjectionGlobalNetwork. Advocacy Booklet activities Safe managementofwastes from health-care check list mass immunization campaigns,aide-memoire and Department ofVaccines andBiologicals:Safety of obstetrical care at first referral level WHO Aidememoire onsurgical andemergency WHO Guidelinesfor safe surgery (8) essential surgical care (IMEESC)toolkit WHO Integrated managementfor emergency and WHO Emergency andessential surgical care Technologies inAfrica Guidelines for Appropriate Evaluations ofHIVTesting Manual ofBasicTechniques for aHealthLaboratory Basic Laboratory Procedure inClinicalBacteriology Laboratory biosafety manual HIV rapid test training package HIV rapid testing: Applyingaqualitysystem approach Guidelines for assuring theaccuracy andreliability of Manual for Laboratory EquipmentmMaintenance Report ofaWHOtechnical consultation Parasitological confirmation ofmalariadiagnosis, Malaria Microscopy QualityAssurance Manual toolkit Laboratory qualitymanagementsystem training malaria for selectingandprocuring rapid diagnostic tests for WHO GlobalMalariaProgramme -Goodpractices and Plan Development ofNational HealthLaboratory Policy related diagnostics (10) longer term product development prioritiesinHIV- WHO expert meetingreport onshort,medium,and counselling (HTC): Astrategic policy framework Service delivery approaches to HIVtesting and Trauma &Burns Obstetrics, Paediatrics, Surgery &Anaesthesia, The ClinicalUseofBloodinGeneral Medicine, The ClinicalUseofBlood-Handbook Title 2004 2009 2009 2009 2009 2009 2008 2005 2005 2003 2003 2003 2003 2003 2002 2002 2010 2001 1999 1999 2013 2013 2013 2012 2012 Year 2011 2011 2011 index.html documents/guidance/hivrttraining_overview/en/ http://www.who.int/diagnostics_laboratory/ publications/2005/9241593563_eng.pdf http://whqlibdoc.who.int/ publications/2008/9789241596350_eng_low.pdf http://whqlibdoc.who.int/ publications/2010/9789241599412_eng.pdf http://whqlibdoc.who.int/ microscopy_QA_manual.pdf http://www.who.int/malaria/publications/malaria_ en/index.html http://www.who.int/ihr/training/laboratory_quality/ publications/2011/9789241501125_eng.pdf http://whqlibdoc.who.int/ documents/docs/Nationalhealthlab2_0F38.pdf http://www.wpro.who.int/health_technology/ bitstream/10665/75971/1/9789241504522_eng.pdf http://apps.who.int/iris/ http://www.who.int/hiv/pub/vct/htc_framework/en/ en/Manual_EN.pdf http://www.who.int/entity/bloodsafety/clinical_use/ en/Handbook_EN.pdf http://www.who.int/entity/bloodsafety/clinical_use/ en/Bundling.pdf http://www.who.int/entity/injection_safety/toolbox/ en/AMENG.pdf http://www.who.int/injection_safety/about/country/ docs/en/Guiding_Principle_Inj.pdf http://www.who.int/entity/injection_safety/toolbox/ docs/en/InjEquQualityGuiden.pdf http://www.who.int/entity/injection_safety/toolbox/ publications/2010/9789241599252_eng.pdf http://whqlibdoc.who.int/ advocacy_booklet.pdf http://www.who.int/injection_safety/sign/sign_ Health-Care-Activities-2.pdf upload/resources/Safe-Management-of-Wastes-from- http://www.healthcarewaste.org/fileadmin/user_ en/AM_SafetyCampaigns.pdf http://www.who.int/entity/injection_safety/toolbox/ Memoire_surgery.pdf http://www.who.int/surgery/publications/en/Aide- publications/2009/9789241598552_eng.pdf http://whqlibdoc.who.int/ dlan=1&codcol=99&codcch=42 http://apps.who.int/bookorders/anglais/detart1.jsp?co index.html http://www.who.int/surgery/publications/imeesc/en/ http://www.who.int/surgery/activities/en/ http://www.who.int/surgery/en/ http://whqlibdoc.who.int/afro/2002/a82959_eng.pdf publications/2003/9241545305.pdf http://whqlibdoc.who.int/ publications/2003/9241545453.pdf http://whqlibdoc.who.int/ publications/2004/9241546506.pdf http://whqlibdoc.who.int/ Link 2. Evidence-based guidelines, and essential interventions for reproductive, maternal, newborn Table 10. References

Subject Title Year Link

Mercury and health. Fact sheet No. 361 2013 http://www.who.int/mediacentre/factsheets/fs361/ en/ Safe management of wastes from health-care 2013 http://www.healthcarewaste.org/fi leadmin/user_ activities upload/resources/Safe-Management-of-Wastes-from- Health-Care-Activities-2.pdf Replacement of mercury thermometers and 2011 http://whqlibdoc.who.int/ sphygmomanometers in health care: Technical publications/2011/9789241548182_eng.pdf guidance Natural Ventilation for Infection Control in Health-Care 2009 http://whqlibdoc.who.int/ Settings publications/2009/9789241547857_eng.pdf Sterilization manual for health centres 2009 http://www2.paho.org/hq/dmdocuments/2009/ sterilization_manual_2009.pdf WHO guidelines on Hand Hygiene in healthcare 2009 http://whqlibdoc.who.int/ publications/2009/9789241597906_eng.pdf Standard precautions in healthcare 2007 http://www.who.int/csr/resources/publications/ EPR_AM2_E7.pdf Mercury in health care, Policy paper 2005 http://www.who.int/water_sanitation_health/ medicalwaste/mercurypolpap230506.pdf Infection control 2004 http://www.who.int/injection_safety/AM_ InfectionControl_Final.pdf Safe health-care waste management, policy paper 2004 http://www.who.int/water_sanitation_health/ HEALTH CARE FACILITIES HEALTH medicalwaste/en/hcwmpolicye.pdf Healthcare worker safety, aide-memoire 2003 http://www.who.int/injection_safety/toolbox/docs/ en/AM_HCW_Safety.pdf Safe health-care waste management, aide-memoire 2000 http://www.who.int/water_sanitation_health/ medicalwaste/aidemem.pdf Useful site for Healthcare Waste Management n/a http://www.healthcarewaste.org/ http://www.healthcarewaste.org/resources/ technologies/

2.3 References 1. Essential interventions, commodities and guidelines for reproductive, maternal, newborn and child health. Geneva: World Health Organization; 2011 (http://www.who.int/pmnch/topics/part_publications/essential_interventions_18_01_2012.pdf, accessed 22 May 2014). 2. Family planning: a global handbook for providers. Geneva: World Health Organization;2011. (http://www.who.int/ reproductivehealth/publications/family_planning/9780978856304/en/, accessed 22 May 2014). 3. Optimizing health worker roles to improve access to key maternal and newborn health interventions through task shifting. Geneva: World Health Organization;2012. (http://www.who.int/reproductivehealth/publications/maternal_perinatal_ health/978924504843/en/, accessed 22 May 2014). 4. Medical eligibility criteria for contraceptive use. Geneva: World Health Organization;2009. (http://whqlibdoc.who.int/ publications/2010/9789241563888_eng.pdf, accessed 22 May 2014). 5. Selected practice recommendations for contraceptive use. Geneva: World Health Organization;2008. (http://www.who.int/ reproductivehealth/publications/family_planning/9241562846index/en/ http://whqlibdoc.who.int/hq/2008/WHO_RHR_08.17_ eng.pdf, accessed 22 May 2014).” 6. A guide to family planning for community health workers and their clients. Geneva: World Health Organization;2012. (http://www. who.int/reproductivehealth/publications/family_planning/9789241503754/en/index.html, accessed 22 May 2014). 7. Reproductive choices and family planning for people living with HIV - Counselling tool. Geneva: World Health Organization;2007. (http://www.who.int/reproductivehealth/publications/family_planning/9241595132/en/index.html, accessed 22 May 2014). 8. WHO Guidelines for safe surgery. Geneva: World Health Organization;2009. (http://whqlibdoc.who.int/ publications/2009/9789241598552_eng.pdf, accessed 22 May 2014). 9. WHO laboratory manual for the examination and processing of human semen. Geneva: World Health Organization;2010. (http:// www.who.int/reproductivehealth/publications/infertility/9789241547789/en/, accessed 22 May 2014). 10. Service delivery approaches to HIV testing and counselling (HTC): A strategic policy framework . Geneva: World Health Organization;2012. (http://www.who.int/hiv/pub/vct/htc_framework/en/, accessed 22 May 2014). 11. Updated WHO Policy Recommendation: Intermittent preventive treatment of malaria in pregnancy using Sulfadoxine- Pyrimethamine (IPTp-SP). Geneva: World Health Organization;2012. (http://www.who.int/malaria/iptp_sp_updated_policy_ recommendation_en_102012.pdf, accessed 22 May 2014). 12. WHO guidelines: Use of cryotherapy for cervical intraepithelial neoplasia. Geneva: World Health Organization;2011. (http:// whqlibdoc.who.int/publications/2011/9789241502856_eng.pdf, accessed 22 May 2014). 13. Guidelines on maternal, newborn, child and adolescent health: Recommendations on maternal and perinatal health. Geneva: World Health Organization;2013. (http://www.who.int/maternal_child_adolescent/documents/guidelines-recommendations- maternal-health.pdf, accessed 22 May 2014). 14. WHO recommended interventions for improving maternal and newborn health. Geneva: World Health Organization;2007. (http:// www.who.int/maternal_child_adolescent/documents/who_mps_0705/en/index.html, accessed 22 May 2014). 15. Counselling for maternal and newborn health care, a handbook for building skills. Geneva: World Health Organization;2009. (http://www.who.int/maternal_child_adolescent/documents/9789241547628/en/, accessed 22 May 2014).

43 44 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health 38. 37. 36. Manualfor earlyinfant malecircumcision underlocalanaesthesia. Geneva: World HealthOrganization;2011. (http://www.who.int/ 35. 34. Optimalfeeding oflow birthweight infants inlow-and middle-income countries .Geneva: World HealthOrganization;2011. (http:// 33. 32. 31. 30. Guidelinesonbasicnewborn resuscitation. Geneva: World HealthOrganization;2012. (http://www.who.int/maternal_child_ 29. 28. 27. 26. 25. 24. 23. 22. 21. 20. Prevention andtreatment ofpre-eclampsia andeclampsia.Geneva: World HealthOrganization;2011. (http://whqlibdoc.who.int/ 19. 18. 17. 16. whqlibdoc.who.int/publications/2008/9789241597289_eng.pdf, accessed 22May 2014). Integrated managementofchildhoodillness(IMCI): ChartBooklet,standard. Geneva: World HealthOrganization;2008. (http:// accessed 22May 2014). Organization;2013. (http://www.who.int/maternal_child_adolescent/documents/guidelines-recommendations-child-health.pdf, Guidelines onmaternal, newborn, childandadolescent health:Recommendations onchildhealth.Geneva: World Health hiv/pub/malecircumcision/manual_infant/en/index.html, accessed 22May 2014). who.int/publications/2008/9789241596879_eng.pdf, accessed 22May 2014). Manual for thehealthcare ofchildren inhumanitarianemergencies. Geneva: World HealthOrganization;2008. (http://whqlibdoc. www.who.int/maternal_child_adolescent/documents/9789241548366.pdf, accessed 22May 2014). (http://whqlibdoc.who.int/publications/2010/9789241599085_eng.pdf, accessed 22May 2014). WHO recommendations onthediagnosisofHIVinfection ininfants andchildren. Geneva: World HealthOrganization;2010. accessed 22May 2014). approach. Geneva: World HealthOrganization;2010. (http://whqlibdoc.who.int/publications/2010/9789241599801_eng.pdf, Antiretroviral therapy for HIVinfection ininfants andchildren: towards universal access, recommendations for apublichealth (http://whqlibdoc.who.int/publications/2008/9789241597388_eng.pdf, accessed 22May 2014). Integrated managementofchildhoodillness(IMCI) for highHIVsettings,chartbooklet.Geneva: World HealthOrganization;2008. adolescent/documents/basic_newborn_resuscitation/en/, accessed 22May 2014). accessed 22May 2014). maternity staff. Geneva: World HealthOrganization;2009. (http://whqlibdoc.who.int/publications/2009/9789241594981_eng.pdf, Baby-Friendly HospitalInitiative(BFHI), Breastfeeding promotion andsupportinababy-friendly hospital:a20-hourcourse for int/maternal_child_adolescent/documents/management_childhood_conditions/en/index.html, accessed 22May 2014). Recommendations for management of common childhood conditions. Geneva: World Health Organization;2012. (http://www.who. Booklet_eng.pdf, accessed 22May 2014). Chart Booklet.Geneva: World HealthOrganization;2011. (http://whqlibdoc.who.int/publications/2011/9789241548045_Chart_ Integrated management of childhood illness(IMCI): Caring for Newborns and Children in the Community. Caring for the Sick Child, May 2014). Organization;2013. (http://www.who.int/maternal_child_adolescent/documents/child_hospital_care/en/index.html, accessed 22 Pocket bookofhospitalcare for children: guidelinesfor themanagementofcommon illnesses. Geneva: World Health pdf, accessed 22May 2014). Organization;2013. (http://www.who.int/maternal_child_adolescent/documents/guidelines-recommendations-newborn-health. Guidelines onmaternal, newborn, childandadolescent health:Recommendations onnewborn health.Geneva: World Health (http://apps.who.int/iris/bitstream/10665/75411/1/9789241548502_eng.pdf, accessed 22May 2014). WHO recommendations for theprevention andtreatment ofpostpartum haemorrhage. Geneva: World HealthOrganization;2012. iris/bitstream/10665/70914/1/9789241548434_eng.pdf, accessed 22May 2014). Safe abortion:technical andpolicy guidance for healthsystems. Geneva: World HealthOrganization;2012. (http://apps.who.int/ Organization;2007. (http://whqlibdoc.who.int/publications/2007/9241545879_eng.pdf, accessed 22May 2014). Managing complications inpregnancy andchildbirth:Aguidefor midwives anddoctors (21).Geneva: World Health publications/2011/9789241501156_eng.pdf, accessed 22May 2014). WHO recommendations for inductionoflabour. Geneva: World HealthOrganization;2011. (http://whqlibdoc.who.int/ publications/2011/9789241548335_eng.pdf, accessed 22May 2014). who.int/iris/bitstream/10665/77770/1/9789241501996_eng.pdf, accessed 22May 2014). Guideline: Dailyiron andfolic acidsupplementation inpregnant women. Geneva: World Health Organization;2012. (http://apps. accessed 22May 2014). Geneva: World HealthOrganization;2009. (http://www.who.int/nutrition/publications/micronutrients/weekly_iron_folicacid.pdf, Weekly iron-folic acidsupplementation inwomen ofreproductive age:itsrole inpromoting optimalmaternal andchildhealth. publications/2010/9789241547925_eng.pdf, accessed 22May 2014). Guidelines for thetreatment ofMalaria.Geneva: World HealthOrganization;2010. (http://whqlibdoc.who.int/ nutrition/publications/micronutrients/guidelines/vas_pregnant/en/, accessed 22May 2014). Guideline: Vitamin Asupplementation inpregnant women. Geneva: World Health Organization;2011. (http://www.who.int/ Colour coding usedbelow X X X X X X Grouping Equipment grouping -seeTable 12-18 (Medicalequipmentgroups) related items covered by eachGenericline Disposable Genericitem line-seeTable 19(Medicaldevice consumables by size andcapacity)with Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Blood Bankdevices Blood Bankdevices Blood Bankdevices Blood Bankdevices Blood Bankdevices Blood Bankdevices Blood Bankdevices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Blood Bankdevices General type - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices Blood Transfusion devices Blood Transfusion devices Blood Transfusion devices Blood Transfusion devices Blood Transfusion devices Blood Transfusion devices Blood Transfusion devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices Blood Transfusion devices Specific area /type Tube, vacuum, plain/dry, sterile (Capacity*) acetic Acid (EDTA), sterile (Capacity*) Tube, vacuum, Ethylene DiamineTetra- Tube, capillary, heparin acetic Acid (EDTA) Tube, capillary, Ethylene DiamineTetra- blood, sterile Tube, bloodcollection, newborn cord Swab, cotton-tip, tube, sterile Paper, drybloodspot, Needle, vacuum tube, sterile (Size*) Needle holder, vacuum tubes Lancet, blood,safety, sterile (Sizes*) Container, sample, 50ml Wooden orplastic applicator sticks disposable, plastic non-sterile, 3ml Pasteur pipettes withintegral bulb, glassware Markers, fine point,permanentblack,for Glass slides,25x75mm Blood administration set,sterile (Saline/monoclonal) Anti-D bloodgroup reagent Anti-B bloodgroup reagent, monoclonal Anti-A bloodgroup reagent, monoclonal Name ofdevices X X Health post X X X Health center X X X X X X X X X X X X X X X X X X X District hospital 3. Medical devices for different health-care facilities

3.1 Medical devices for different health-care facilities 3. Medical devices for different health-care facilities Table 11 contains the complete list of medical devices needed for the application of the clinical interventions described in Table 3. To identify the location of the medical devices, the UNICEF classification of product groups was followed (first column), with each of the six major categories divided into sub-groups (second column). All products from this list are identified with a short general description. The technical specifications, accessories and disposables related to such products are mostly based on UNICEF’s Supply Catalogue (1). There are also two separate lists for the medical devices needed in the laboratory and the blood bank to complete the implementation of reproductive, maternal, newborn and child health interventions.

Table 11. Medical devices for different health-care facilities Colour coding used below X Disposable Generic item line - see Table 19 (Medical device consumables by size and capacity) with related items covered by each Generic line X Equipment grouping - see Table 12-18 (Medical equipment groups)

General type Specifi c area / type Name of devices Grouping Health post Health center hospitalDistrict Blood Bank devices Blood Transfusion devices Anti-A blood group reagent, monoclonal X Blood Bank devices Blood Transfusion devices Anti-B blood group reagent, monoclonal X Blood Bank devices Blood Transfusion devices Anti-D blood group reagent X (Saline/monoclonal) Blood Bank devices Blood Transfusion devices Blood administration set, sterile X Blood Bank devices Blood Transfusion devices Glass slides, 25x75mm X Blood Bank devices Blood Transfusion devices Markers, fi ne point, permanent black, for X glassware Blood Bank devices Blood Transfusion devices Pasteur pipettes with integral bulb, X disposable, plastic non-sterile, 3 ml Blood Bank devices Blood Transfusion devices Wooden or plastic applicator sticks X Clinical laboratory devices Clinical laboratory devices Container, sample, 50 ml X X - Disposable X Clinical laboratory devices Clinical laboratory devices Lancet, blood, safety, sterile (Sizes*) X X X - Disposable Clinical laboratory devices Clinical laboratory devices Needle holder, vacuum tubes X - Disposable X Clinical laboratory devices Clinical laboratory devices Needle, vacuum tube, sterile (Size*) X - Disposable Clinical laboratory devices Clinical laboratory devices Paper, dry blood spot, X - Disposable Clinical laboratory devices Clinical laboratory devices Swab, cotton-tip, tube, sterile X X X - Disposable Clinical laboratory devices Clinical laboratory devices Tube, blood collection, newborn cord X - Disposable blood, sterile Clinical laboratory devices Clinical laboratory devices Tube, capillary, Ethylene Diamine Tetra- X - Disposable acetic Acid (EDTA) Clinical laboratory devices Clinical laboratory devices Tube, capillary, heparin X - Disposable X Clinical laboratory devices Clinical laboratory devices Tube, vacuum, Ethylene Diamine Tetra- X - Disposable acetic Acid (EDTA), sterile (Capacity*) X Clinical laboratory devices Clinical laboratory devices Tube, vacuum, plain/dry, sterile (Capacity*) X - Disposable

45 46 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health

Grouping Family planning devices Family planningdevices Family planningdevices Family planningdevices Family planningdevices Family planningdevices Family planningdevices Family planningdevices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices General type Disposable Family planning devices - Disposable Family planningdevices - Disposable Family planningdevices - Disposable Family planningdevices - Disposable Family planningdevices - Disposable Family planningdevices - Disposable Family planningdevices - Disposable Family planningdevices - - Test strips Clinical laboratory devices - Test strips Clinical laboratory devices - Test strips Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Test kits Clinical laboratory devices - Equipment Clinical laboratory devices - Equipment Clinical laboratory devices - Equipment Clinical laboratory devices Specific area /type insertion device) Sub-dermal implants (includedthe Male condoms Lubricants Levonorgestrel Intra-Uterine Device (IUD) copper IUDs) Intra-Uterine Devices (only prequalified Female condoms Diaphragm Cervical cap Test strip, vaginal infection, pH Test strip, urinalysis (10parameter) Test strip, pregnancy Assay (TPHA),syphilis, kit Treponema Pallidum Haemagglutination Rapid PlasmaReagin (RPR),syphilis, kit syphilis, kit Rapid Diagnostic Test (RDT), Treponemal, Rapid Diagnostic Test (RDT), malaria,kit Immunodeficiency Virus (HIV),kit Rapid Diagnostic Test (RDT), Human Virus (HPV), kit Nucleic Acid Test (NAT), HumanPapilloma Nucleic Acid Test (NAT), gonorrhea,kit Nucleic Acid Test (NAT), chlamydia, kit Haemoglobin colour scale(starter kit) Haemoglobin colour scale(refill kit) Enzyme ImmunoAssay (EIA),Rubella,kit Immunodeficiency Virus (HIV),kit Enzyme ImmunoAssay (EIA),Human Ag, kit Enzyme ImmunoAssay (EIA),gonorrhea Cytology stain, kit Hemoglobinometer, withaccessories Blood glucometer, withaccessories Analyzer, bloodgas Name ofdevices X X X X X X X X X X X X Health post X X X X X X X X X X X X X X X X X Health center X X X X X X X X X X X X X X X X X X X X X X X X X X District hospital 3. Medical devices for different health-care facilities General type Specifi c area / type Name of devices Grouping Health post Health center hospitalDistrict Medical devices - Disposable Dressing devices Bandage, elastic, 7.5cmx5m, roll X X X Medical devices - Disposable Dressing devices Blanket, survival, 220x140cm, non-sterile X X X X Medical devices - Disposable Dressing devices Bracelet, identifi cation (Sizes*) X X X Medical devices - Disposable Dressing devices Compress, gauze,sterile & non-sterile, X X X single use Medical devices - Disposable Dressing devices Cotton wool, 500g, roll, non-sterile X X X X Medical devices - Disposable Dressing devices Tape, medical, roll (Sizes*) X X X Medical devices - Disposable Dressing devices Umbilical clamp, sterile,single use X X Medical devices - Disposable Dressing devices Umbilical tape, 3mmx50m, roll, non-sterile X X X Medical devices - Disposable Injection devices Cannulas, Intra Venous (IV) short, sterile, X X single use (Sizes G*) Medical devices - Disposable Injection devices Catheter, Intra Venous (IV) umbilical vein, X sterile, single use Medical devices - Disposable Injection devices Infusion giving set, burette 100-150ml, X X sterile, single use Medical devices - Disposable Injection devices Infusion giving set, sterile, single use X X X Medical devices - Disposable Injection devices Needles, luer, sterile, single use (Sizes G*) X X X X Medical devices - Disposable Injection devices Needles, scalp vein, sterile, single use X X (Sizes G*) X Medical devices - Disposable Injection devices Needles, spinal, sterile, single use (Sizes*) X Medical devices - Disposable Injection devices Safety box, for used syringes/needles X X X Medical devices - Disposable Injection devices Stopcock, 3-way, sterile, single use X X X Medical devices - Disposable Injection devices Syringes, auto-disable (AD), X X X (Capacities ml*) Medical devices - Disposable Injection devices Syringe for insulin, sterile, single use X X Medical devices - Disposable Injection devices Syringe for tuberculin, sterile, single use X X Medical devices - Disposable Injection devices Syringes, luer, sterile, single use X X X (Capacities ml*) X Medical devices - Disposable Injection devices Syringes, reuse prevention (RUP), X X X (Capacities ml*) X Medical devices - Disposable Tube/catheter/drain Airway, Guedel, translucent (Sizes*) X Medical devices - Disposable Tube/catheter/drain Bag, urine, collecting, 2000ml X X Medical devices - Disposable Tube/catheter/drain Catheter, balloon tamponade, post partum X hemorrhage X Medical devices - Disposable Tube/catheter/drain Catheter, Foley, sterile, single use X X (Sizes CH*) X Medical devices - Disposable Tube/catheter/drain Catheter, urethral, sterile, single use X X (Sizes CH*) Medical devices - Disposable Tube/catheter/drain Collector, urine, adhesive, 10-100ml X X Medical devices - Disposable Tube/catheter/drain Prongs, nasal, oxygen, non sterile, single X X use (Sizes *) Medical devices - Disposable Tube/catheter/drain Syringe, feeding, catheter tip, 50ml, sterile, X single use Medical devices - Disposable Tube/catheter/drain Syringe, feeding, luer tip, 50ml, sterile, X single use X Medical devices - Disposable Tube/catheter/drain Tube, endotracheal, without cuff, sterile, X single use (Sizes ID*) X Medical devices - Disposable Tube/catheter/drain Tube, endotracheal, with cuff, sterile, single X use (Sizes ID*) X Medical devices - Disposable Tube/catheter/drain Tube, feeding/aspirating, L120cm,catheter X tip, sterile, single use (Sizes CH*)

47 48 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health X X X X X X X X X X X X X X X X Grouping Counselling material Grouping Medical devices -Equipment Grouping Medical devices -Equipment Grouping Medical devices -Equipment Grouping Medical devices -Equipment Grouping Medical devices -Equipment Grouping Medical devices -Equipment Grouping Medical devices -Equipment Grouping Medical devices -Equipment Grouping Medical devices -Equipment Medical devices -Equipment Medical devices -Equipment Medical devices -Equipment Medical devices -Equipment Medical devices -Equipment Medical devices -Equipment Medical devices -Equipment Medical devices -Equipment Medical devices -Equipment Medical devices -Equipment Medical devices -Equipment Medical devices -Equipment Medical devices -Equipment Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable General type Counselling material Medical EquipmentGroup Medical EquipmentGroup Medical EquipmentGroup Medical EquipmentGroup Medical EquipmentGroup Medical EquipmentGroup Medical EquipmentGroup Medical EquipmentGroup Medical EquipmentGroup Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Miscellaneous equipment Surgical sutures Surgical sutures Gloves Gloves Gloves Tube/catheter/drain Tube/catheter/drain Specific area /type Counselling material Commodities for intensive care ofnewborn Commodities for intensive care ofchild Commodities for intensive care ofmother Commodities for inpatient child newborn Commodities for inpatient motherand (see table15) Commodities for surgery &anesthesia (see table14) Commodities for labour, delivery & recovery and referral (see table13) Commodities for emergency preparedness diagnosis (see table12) Commodities for medicalexamination & accessories Phototherapy light,mobile, with (NASG) Non-Pneumatic Anti-ShockGarment Mammograph withprinter andaccesories Acetic Acid Magnifying lensfor Visual Inspectionwith with accessories Doppler, foetal heartrate (FHR)detector, Cryosurgical unitwithtankandaccesories Colposcope withbiopsy set Cardiotocograph (CTG), withaccessories Breastpump, manual,withaccessories Breast biopsy system Bilirubinometer newborn Auditory, functionscreening devices, Apnoea monitor sizes*), sterile, singleuse USP/DEC*) withneedle(Shapes*and Suture, synthetic, non-absorbable(Sizes sterile, singleuse DEC*) withneedle(Shapes*andsizes*), Suture, synthetic, absorbable(Sizes USP/ (Sizes*) Gloves, surgical, sterile, singleuse, pair pair (Sizes*) Gloves, gynaecological, sterile, singleuse, single use(Sizes*) Gloves, examination, latex, non-sterile, single use(Sizes CH*) Tube, suction,L50cm,catheter tip, sterile, single use(Sizes CH*) Tube, feeding, L40cm,luertip, sterile, Name ofdevices X X X X Health post X X X X X X X X X X X X X X X X X Health center X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X District hospital Table 12.Medicalequipmentfor medicalexamination anddiagnosis Renewable Medical devices - Equipment Medical devices - General type Medical utensils and accessories Clothing medical Medical furniture type Specific area / Gown, patient, woven Drawsheet, plastic, approx. 90x180cm Drape, surgical woven -#sizes Coat, medical,woven, white -#sizes Tray, dressing, stainless steel ,approx. 300x200x30mm Receptacle, waste, stainless steel, pedalaction Jar, thermometer, polypropylene Jar, forceps, polypropylene Brush, hand,scrubbing,plastic Bowl, polypropylene Bedpan, polypropylene Basin, kidney, stainless steel Basin, kidney, polypropylene Trolley, soiled linen Trolley, dressing, stainless steel, 2trays Table, instruments, Mayo type, stainless steel, oncastors Table, gynaecology, delivery, withaccessories Table, examination Stretcher, patient, withsiderails Stretcher, foldable Stool, adjustable, oncastors Stand, infusion,doublehook,oncastors Footstool, two steps Cabinet, medicine, doubledoor Cap, surgical, non-woven Cabinet, instruments, doubledoor Bedscreen, hospital,oncastors Name ofdevices for medicalexamination anddiagnosis X X X X X X X X X X X X X X X X X X Health post X X X X X X X X X X X X X X X X X X X X X X X X X X X Health center X X X X X X X X X X X X X X X X X X X X X X X X X X X District hospital 3. Medical devices for different health-care facilities General type Specifi c area / type Name of devices 3.2 Groups of medical devices The majority of medical devices, including equipment and surgical instruments sets, are required for multiple interventions across the continuum of care. To simplify the main matrix, many of these devices were grouped together. Many consumable devices are available in various sizes, and these were also grouped together.

Grouping Health post Health center hospitalDistrict It is important to apply judgement and knowledge of the local context to interpret the groupings, particularly when X Medical devices - Disposable Tube/catheter/drain Tube, feeding, L40cm, luer tip, sterile, X used in supply planning, as each facility and system is different. single use (Sizes CH*) X Medical devices - Disposable Tube/catheter/drain Tube, suction, L50cm, catheter tip, sterile, X 3.2.1 Grouping of common medical equipment by clinical area in health-care facility single use (Sizes CH*) The equipment commodities were grouped according to the clinical area of a health-care facility in which they would X Medical devices - Disposable Gloves Gloves, examination, latex, non-sterile, X X X single use (Sizes*) most commonly be found, such as an examination room or intensive care unit (Table 12-18). These medical device equipment groupings were then allocated to interventions across the continuum. X Medical devices - Disposable Gloves Gloves, gynaecological, sterile, single use, X X pair (Sizes*) The groupings also correspond, to a certain extent, to the types of intervention performed in particular clinical areas. X Medical devices - Disposable Gloves Gloves, surgical, sterile, single use, pair X X For example, basic medical examinations typically happen in an examination area or room, while ventilation typically (Sizes*) occurs within an intensive care setting. X Medical devices - Disposable Surgical sutures Suture, synthetic, absorbable (Sizes USP/ X X DEC*) with needle (Shapes* and sizes*), sterile, single use Table 12. Medical equipment for medical examination and diagnosis Table 12. Medical equipment for medical examination and diagnosis X Medical devices - Disposable Surgical sutures Suture, synthetic, non-absorbable (Sizes X X General type Specifi c area / Name of devices for medical examination and diagnosis USP/DEC*) with needle (Shapes* and type sizes*), sterile, single use Medical devices - Equipment Miscellaneous equipment Apnoea monitor X Medical devices - Equipment Miscellaneous equipment Auditory, function screening devices, X newborn Health post Health center hospital District Medical devices - Equipment Miscellaneous equipment Bilirubinometer X Medical devices - Medical furniture Bedscreen, hospital, on castors X X X Equipment Medical devices - Equipment Miscellaneous equipment Breast biopsy system X Cabinet, instruments, double door X X Medical devices - Equipment Miscellaneous equipment Breastpump, manual, with accessories X X Cabinet, medicine, double door X X X Medical devices - Equipment Miscellaneous equipment Cardiotocograph (CTG), with accessories X X Footstool, two steps X X X Medical devices - Equipment Miscellaneous equipment Colposcope with biopsy set X Stand, infusion, double hook, on castors X X Medical devices - Equipment Miscellaneous equipment Cryosurgical unit with tank and accesories X Stool, adjustable, on castors X X Medical devices - Equipment Miscellaneous equipment Doppler, foetal rate (FHR) detector, X X Stretcher, foldable X X X with accessories Stretcher, patient, with side rails X X Medical devices - Equipment Miscellaneous equipment Magnifying lens for Visual Inspection with X X Acetic Acid Table, examination X X X Medical devices - Equipment Miscellaneous equipment Mammograph with printer and accesories X Table, gynaecology, delivery, with accessories X X Medical devices - Equipment Miscellaneous equipment Non-Pneumatic Anti-Shock Garment X X Table, instruments, Mayo type, stainless steel, on castors X X (NASG) Trolley, dressing, stainless steel, 2 trays X X X Medical devices - Equipment Miscellaneous equipment Phototherapy light, mobile, with X Trolley, soiled linen X X X accessories Medical utensils Basin, kidney, polypropylene X X X X Medical devices - Equipment Medical Equipment Group Commodities for medical examination & X X X Grouping diagnosis (see table 12) Basin, kidney, stainless steel X X X X Medical devices - Equipment Medical Equipment Group Commodities for emergency preparedness X X X Bedpan, polypropylene X X Grouping and referral (see table 13) Bowl, polypropylene X X X X Medical devices - Equipment Medical Equipment Group Commodities for labour, delivery & recovery X X Brush, hand, scrubbing, plastic X X X Grouping (see table 14) Jar, forceps, polypropylene X X X X Medical devices - Equipment Medical Equipment Group Commodities for surgery & anesthesia X X Grouping (see table 15) Jar, thermometer, polypropylene X X X X Medical devices - Equipment Medical Equipment Group Commodities for inpatient mother and X X Receptacle, waste, stainless steel, pedal action X X X Grouping newborn Tray, dressing, stainless steel ,approx. 300x200x30mm X X X X Medical devices - Equipment Medical Equipment Group Commodities for inpatient child X X Medical devices - Clothing medical Cap, surgical, non-woven X X Grouping Renewable and accessories Coat, medical, woven, white - # sizes X X X X Medical devices - Equipment Medical Equipment Group Commodities for intensive care of mother X Grouping Drape, surgical woven - # sizes X X X X Medical devices - Equipment Medical Equipment Group Commodities for intensive care of child X Drawsheet, plastic, approx. 90x180cm X X X Grouping Gown, patient, woven X X X Medical devices - Equipment Medical Equipment Group Commodities for intensive care of newborn X Grouping Counselling material Counselling material Counselling material X X X

49 50 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 12.Medicalequipmentfor medicalexamination anddiagnosis instruments - Surgical Medical devices Equipment Medical devices - General type instruments set Surgical instrument Surgical equipment Anaesthesia Resuscitation/ equipment Medical diagnostic equipment Hospital equipment Anthropometric type Specific area / Surgical instruments, dressing set(see table 41) Speculum, vaginal, Graves, 115x35mm Speculum, vaginal, Graves, 95x35mm Speculum, vaginal, Graves, 75x20mm Forceps, dressing, Cheron, 250mm oximeter,Pulse spotcheck, withaccessories Pulse oximeter,Pulse portable, withaccessories X-ray, viewer (negatoscope), 1to 3bodies X-ray system, mobile, withaccessories X-ray system, fixed, withaccessories andinfrastructure Tongue depressor,wooden,single use Tourniquet, rubber, approx. 50cm Timer, respiration, for Acute Respiratory Infection (ARI) Thermometer, clinical,digital32-43°C Stethoscope, pediatric, binaural Stethoscope, foetal, monaural Stethoscope, adult,binaural Sphygmomanometer, child,aneroid Sphygmomanometer, adult,aneroid Scanner, ultrasound, mobile, withaccessories Otoscope, set Ophtalmoscope, set Electrocardiogram (ECG) recorder, portable, withaccessories Light, examination, mobile, withaccessories Scale, springtype,infant,25kg x100gwithsetofweighing trousers Scale,beamtype, adult,6-180kg x100g Scale, beamtype, infant,16kgx10g Scale, electronic, infant,10kgx5g Scale, electronic, mother/child, 150kgx100g newborn Mid UpperArmCircumference (MUAC) measuringtape, infant/ Measuring board, portableinfant/child length/height Name ofdevices for medicalexamination anddiagnosis X X X X X X X X X X X X X X X Health post X X X X X X X X X X X X X X X X X X X X X X X X X X X Health center X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X District hospital 3. Medical devices for different health-care facilities Table 13. Medical equipment for emergency preparedness and referral Table 13. Medical equipment for emergency preparedness and referral General type Specifi c area / Name of devices for emergency preparedness and referral type Health post Health center hospital District Medical devices - Medical furniture Bedscreen, hospital, on castors X X X Equipment Bucket, kick, stainless steel, on castors X X Cabinet, instruments, double door X X Cabinet, medicine, double door X X X Footstool, two steps X X X Stand, infusion, double hook, on castors X X Stool, adjustable, on castors X X Stretcher, foldable X X X Stretcher, patient, with side rails X X Table, examination X X X Table, instruments, Mayo type, stainless steel, on castors X X Table, instruments, stainless steel, on castors X X Trolley, dressing, stainless steel, 2 trays X X X Trolley, emergency, with drawers X X Trolley, soiled linen X X X Wheel chair, adult X X Wheel chair, child X X Medical utensils Basin, kidney, polypropylene X X X Basin, kidney, stainless steel X X X Bedpan, polypropylene X X Bowl, polypropylene X X X Bowl, round, stainless steel, approx. 4L X X Bowl, stainless steel, approx. 180ml X X Bowl, stainless steel, approx. 600ml X X Brush, hand, scrubbing, plastic X X X Jar, forceps, polypropylene X X X Jar, thermometer, polypropylene X X X Receptacle, waste, stainless steel, pedal action X X X Tray, dressing, stainless steel ,approx. 300x200x30mm X X X Medical devices - Clothing medical Apron, protection, plastic X X Renewable and accessories Cap, surgical, non-woven X X Clogs, plastic - # sizes X X Coat, medical, woven, white - # sizes X X X Drape, surgical woven - # sizes X X X Drawsheet, plastic, approx. 90x180cm X X X Glasses, safety, regular size X X Gown, patient, woven X X Gown, surgical, woven - # sizes X X Mask, surgical, non-woven, X X Trousers, surgical, woven - # sizes X X Tunic, surgical, woven - # sizes X X

51 52 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 13.Medicalequipmentfor emergency preparedness andreferral Equipment Medical devices - General type equipment Anaesthesia Resuscitation/ equipment Medical diagnostic equipment Hospital equipment Anthropometric type Specific area / Suction, bulb Resuscitator, hand-operated, newborn, set Resuscitator, hand-operated, child,set Resuscitator, hand-operated, adult,set Pump, suction,newborn resuscitation Pump, suction, foot-operated Pulse oximeter,Pulse spotcheck, withaccessories Pulse oximeter,Pulse portable, withaccessories Oxygen concentrator, withaccessories Nebulizer, withaccessories Monitor, patient, portable, withaccessories Laryngoscope, newborn, set Laryngoscope, adult/child, set Infusion pump, withaccessories Incubator, newborn, transport, withaccessories Forceps, Magill,child Forceps, Magill,adult Defibrillator, basic,withaccessories accessories Continuous Positive Airway Pressure (CPAP) system, with X-ray, viewer (negatoscope), 1to 3bodies X-ray system, mobile, withaccessories X-ray system, fixed, withaccessories andinfrastructure Tongue depressor,wooden,single use Tourniquet, rubber, approx. 50cm Timer, respiration, for Acute Respiratory Infection (ARI) Thermometer, clinical,digital32-43°C Stethoscope, pediatric, binaural Stethoscope, foetal, monaural Stethoscope, adult,binaural Sphygmomanometer, child,aneroid Sphygmomanometer, adult,aneroid Otoscope, set Ophtalmoscope, set Electrocardiogram (ECG) recorder, portable, withaccessories Pump, suction,electrical,2bottles,withaccessories Pump, suction,electrical,1bottle, withaccessories Light, examination, mobile, withaccessories Scale, springtype,infant,25kg x100gwithsetofweighing trousers Scale,beamtype, adult,6-180kg x100g Scale, beamtype, infant,16kgx10g Scale, electronic, infant,10kgx5g Scale, electronic, mother/child, 150kgx100g Measuring board, portableinfant/child length/height Name ofdevices for emergency preparedness andreferral X X X X X X X X X X X X X Health post X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Health center X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X District hospital 3. Medical devices for different health-care facilities Table 13. Medical equipment for emergency preparedness and referral General type Specifi c area / Name of devices for emergency preparedness and referral type Health post Health center hospital District Syringe pump, with accessories X Table, resuscitation, newborn, with accessories X Ventilator medical, adult, with accessories X Ventilator medical, adult, transport, with accessories X Ventilator medical, child/newborn, with Continuous Positive Airway X Pressure (CPAP) and accessories Ventilator medical, child/newborn, transport, with accessories X Warmer, heating pad, newborn, with accessories X X Warmer, sleeping bag, newborn, with accessories X X Warmer, radiant heater, freestanding, with accessories X Medical devices Surgical Forceps, dressing, Cheron, 250mm X X X - Surgical instrument Scalpel blade, no.22, sterile, single use (for Scalpel Handle n0.4) X X instruments Scalpel blade, no.10, sterile, single use (for Scalpel Handle n0.3) X X Speculum, vaginal, Graves, 75x20mm X X Speculum, vaginal, Graves, 95x35mm X X Speculum, vaginal, Graves, 115x35mm X X Surgical Surgical instruments, dressing set (see table 41) X X X instruments set Surgical instruments, suture set (see table 41) X X

53 54 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 14.Medicalequipmentfor labour, delivery andrecovery Table 14.Medicalequipmentfor labour, delivery andrecovery Equipment Medical devices - Renewable Medical devices - Equipment Medical devices - General type equipment Hospital equipment Anthropometric and accessories Clothing medical Medical utensils Medical furniture type Specific area / Vacuum extractor, Bird, manual,complete set Pump, suction,electrical,1bottle, withaccessories Light, examination, mobile, withaccessories Scale, beamtype, infant,16kgx10g Scale, electronic, infant,10kgx5g Tunic, surgical, woven -#sizes Trousers, surgical, woven -#sizes Mask, surgical, non-woven, Gown, surgical, woven -#sizes Gown, patient, woven Glasses, safety, regular size Drawsheet, plastic, approx. 90x180cm Drape, surgical woven -#sizes Clogs, plastic -#sizes Cap, surgical, non-woven Apron, protection, plastic Tray, dressing, stainless steel ,approx. 300x200x30mm Receptacle, waste, stainless steel, pedalaction Jar, thermometer, polypropylene Jar, forceps, polypropylene Brush, hand,scrubbing,plastic Bowl, stainless steel, approx. 600ml Bowl, stainless steel, approx. 180ml Bowl, round, stainless steel, approx. 4L Bowl, polypropylene Bedpan, polypropylene Basin, kidney, stainless steel Basin, kidney, polypropylene Trolley, soiled linen Trolley, emergency, withdrawers Trolley, dressing, stainless steel, 2trays Table, instruments, Mayo type, stainless steel, oncastors Table, gynaecology, delivery, withaccessories Table, baby dressing Stretcher, patient, withsiderails Stool, adjustable, oncastors Stand, singlebowl, oncastors Stand, infusion,doublehook,oncastors Footstool, two steps Cabinet, medicine, doubledoor Cabinet, instruments, doubledoor Bucket, kick,stainless steel, oncastors Bed, labour/delivery, withmattress &accessories Name ofdevices for labour, delivery and recovery

Health post X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Health center X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X District hospital 3. Medical devices for different health-care facilities Table 14. Medical equipment for labour, delivery and recovery General type Specifi c area / Name of devices for labour, delivery and recovery type Health post Health center hospital District Medical diagnostic Partograph X X equipment Scanner, ultrasound, mobile, with accessories X X Sphygmomanometer, adult, aneroid X X Stethoscope, adult, binaural X X Stethoscope, foetal, monaural X X Thermometer, clinical, digital 32-43 °C X X Tourniquet, rubber, approx. 50cm X X Resuscitation/ Oxygen concentrator, with accessories X X Anaesthesia Pulse oximeter, portable, with accessories X X equipment Pulse oximeter, spotcheck, with accessories X X Pump, suction, foot-operated X X Pump, suction, newborn resuscitation X Resuscitator, hand-operated, adult, set X X X Resuscitator, hand-operated, newborn, set X X Suction, bulb X X Table, resuscitation, newborn, with accessories X Medical devices Surgical Forceps, dressing, Cheron, 250mm X X - Surgical instrument Scalpel blade, no.22, sterile, single use (for Scalpel Handle n0.4) X X instruments Speculum, vaginal, Graves, 75x20mm X X Speculum, vaginal, Graves, 95x35mm X X Speculum, vaginal, Graves, 115x35mm X X Surgical Surgical instruments, delivery set X X instruments set Surgical instruments, dressing set X X Surgical instruments, suture set X X

55 56 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 15.Medicalequipmentfor surgery andanaesthesia Table 15.Medicalequipmentfor surgery andanaesthesia Equipment Medical devices - Renewable Medical devices - Equipment Medical devices - General type equipment Hospital and accessories Clothing medical Medical utensils Medical furniture type Specific area / Pump, suction,electrical,2bottles, withaccessories Pump, suction,electrical,1bottle, withaccessories Manual vacuum aspiration (MVA), complete set Electrical vacuum aspiration (EVA), complete set Light, operating theatre, mobile, withaccessories Light, operating theatre, ceiling, withaccessories Table, operating theater, withaccessories Electrosurgical unit,withaccessories Tunic, surgical, woven -#sizes Trousers, surgical, woven -#sizes Mask, surgical, non-woven, Gown, surgical, woven -#sizes Gown, patient, woven Glasses, safety, regular size Drawsheet, plastic, approx. 90x180cm Drape, surgical woven -#sizes Clogs, plastic -#sizes Cap, surgical, non-woven Apron, protection, plastic Tray, dressing, stainless steel ,approx. 300x200x30mm Receptacle, waste, stainless steel, pedalaction Jar, thermometer, polypropylene Jar, forceps, polypropylene Brush, hand,scrubbing,plastic Bowl, stainless steel, approx. 600ml Bowl, stainless steel, approx. 180ml Bowl, round, stainless steel, approx. 4L Bowl, polypropylene Bedpan, polypropylene Basin, kidney, stainless steel Basin, kidney, polypropylene Trolley, soiledlinen Trolley, emergency, withdrawers Trolley, dressing, stainless steel, 2trays Table, instruments, stainless steel, oncastors Table, instruments, Mayo type, stainless steel, oncastors Table, baby dressing Stretcher, patient, withsiderails Stool, adjustable, oncastors Stand, singlebowl, oncastors Stand, infusion,doublehook,oncastors Footstool, two steps Cabinet, medicine, doubledoor Cabinet, instruments, doubledoor Bucket, kick,stainless steel, oncastors Name ofdevices for surgery andanaesthesia

Health post X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Health center X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X District hospital 3. Medical devices for different health-care facilities Table 15. Medical equipment for surgery and anaesthesia General type Specifi c area / Name of devices for surgery and anaesthesia type Health post Health center hospital District Medical diagnostic Sphygmomanometer, adult, aneroid X X equipment Stethoscope, adult, binaural X X Tourniquet, rubber, approx. 50cm X X X-ray system, mobile, with accessories X X X-ray, viewer (negatoscope), 1 to 3 bodies X Resuscitation/ Anaesthesia system, basic, free-standing, with accessories X Anaesthesia Anaesthesia unit, with ventilator and accessories X equipment Defi brillator, basic, with accessories X Forceps, Magill, adult X Laryngoscope, adult/child, set X Monitor, patient, portable, with accessories X Oxygen concentrator, with accessories X X Pulse oximeter, portable, with accessories X X Pulse oximeter, spotcheck, with accessories X X Pump, suction, foot-operated X Pump, suction, newborn resuscitation X Resuscitator, hand-operated, adult, set X Resuscitator, hand-operated, newborn, set X Suction, bulb X Table, resuscitation, newborn, with accessories X Medical devices Surgical Forceps, dressing, Cheron, 250mm X - Surgical instrument Scalpel blade, no.22, sterile, single use (for Scalpel Handle n0.4) X instruments Speculum, vaginal, Graves, 75x20mm X Speculum, vaginal, Graves, 95x35mm X Speculum, vaginal, Graves, 115x35mm X Surgical Surgical instruments, basic surgery set X instruments set Surgical instruments, delivery set X (see table 41) Surgical instruments, dilatation/evacuation (D&E) set X Surgical instruments, dressing set X X Surgical instruments, early infant male circumcision, set X Surgical instruments, embryotomy set X Surgical instruments, examination/suturing, vaginal/cervical, set X Surgical instruments, intra uterin device (IUD) insertion/removal, set X X Surgical instruments, laparotomy (Gyn/Obs) set X Surgical instruments, suture set X X Surgical instruments, vacuum aspiration set X Surgical instruments, vasectomy set X X Surgical instruments, vasectomy non-scalpel set X X

57 58 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 16.Medicalequipmentfor inpatient care -motherandnewborn instruments - Surgical Medical devices Equipment Medical devices - Renewable Medical devices - Equipment Medical devices - General type Table 16.Medicalequipmentfor inpatient care -motherandnewborn instruments set Surgical equipment Anaesthesia Resuscitation/ equipment Medical diagnostic equipment Hospital Medical utensils instrument Surgical equipment Anthropometric and accessories Clothing medical Medical furniture Specific area /type Surgical instruments, dressing set Nebulizer, withaccessories Infusion pump, withaccessories Sphygmomanometer, adult,aneroid Light, examination, mobile, withaccessories Basin, kidney, polypropylene Forceps, dressing, Cheron, 250mm Warmer, radiant heater, freestanding, withaccessories Warmer, sleepingbag,newborn, withaccessories Warmer, heating pad,newborn, withaccessories Syringe pump, withaccessories oximeter,Pulse spotcheck, withaccessories oximeter,Pulse portable, withaccessories Oxygen concentrator, withaccessories Oxygen concentrator, flowsplitter for newborn/child X-ray, viewer (negatoscope), 1to 3bodies X-ray system, mobile, withaccessories Tongue depressor,wooden,single use Tourniquet, rubber, approx. 50cm Timer, respiration, for Acute Respiratory Infection (ARI) Thermometer, clinical,digital32-43°C Stethoscope, adult,binaural Scale, beamtype, infant,16kgx10g Scale, electronic, infant,10kgx5g Scale, electronic, mother/child, 150kgx100g Gown, patient, woven Drawsheet, plastic, approx. 90x180cm Drape, surgical woven -#sizes Coat, medical,woven, white -#sizes Tray, dressing, stainless steel ,approx. 300x200x30mm Receptacle, waste, stainless steel, pedalaction Jar, thermometer, polypropylene Jar, forceps, polypropylene Brush, hand,scrubbing,plastic Bowl, polypropylene Bedpan, polypropylene Basin, kidney, stainless steel Wheel chair, adult Trolley, soiledlinen Trolley, dressing, stainless steel, 2trays Table, instruments, Mayo type, stainless steel, oncastors Table, baby dressing Stretcher, patient, withsiderails Stand, infusion,doublehook,oncastors Cot, baby, hospital,withbassinet, oncastors Cabinet, medicine, doubledoor Cabinet, bedside, standard Bedscreen, hospital,oncastors Bed, hospital,standard,adult,with mattress Name ofdevices for inpatient motherandnewborn X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Health center X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X District hospital 3. Medical devices for different health-care facilities TableTable 17.17. Medical Medical equipment equipment for inpatient for inpatient care – child care – child General type Specifi c area / type Name of devices for inpatient child Health center hospital District Medical devices - Medical furniture Bed, hospital, standard, child, with mattress X X Equipment Bedscreen, hospital, on castors X X Cabinet, bedside, standard X X Cabinet, medicine, double door X X Stand, infusion, double hook, on castors X X Stretcher, patient, with side rails X X Table, baby dressing X X Trolley, dressing, stainless steel, 2 trays X X Trolley, soiled linen X X Wheel chair, adult X X Wheel chair, child X X Medical utensils Basin, kidney, polypropylene X X Basin, kidney, stainless steel X X Bedpan, polypropylene X X Bowl, polypropylene X X Brush, hand, scrubbing, plastic X X Jar, forceps, polypropylene X X Jar, thermometer, polypropylene X X Receptacle, waste, stainless steel, pedal action X X Tray, dressing, stainless steel ,approx. 300x200x30mm X X Medical devices - Clothing medical Coat, medical, woven, white - # sizes X X Renewable and accessories Drape, surgical woven - # sizes X X Drawsheet, plastic, approx. 90x180cm X X Medical devices - Anthropometric Scale, electronic, mother/child, 150kgx100g X X Equipment equipment Scale, electronic, infant,10kgx5g X Scale, beamtype, infant,16kgx10g X X Scale, springtype,infant,25kg x 100g with set of weighing trousers X X Hospital Light, examination, mobile, with accessories X X equipment Medical diagnostic Sphygmomanometer, child, aneroid X X equipment Stethoscope, pediatric, binaural X X Thermometer, clinical, digital 32-43 °C X X Timer, respiration, for Acute Respiratory Infection (ARI) X X Tourniquet, rubber, approx. 50cm X X Tongue depressor,wooden,single use X X X-ray system, mobile, with accessories X X-ray, viewer (negatoscope), 1 to 3 bodies X Resuscitation/ Infusion pump, with accessories X Anaesthesia Nebulizer, with accessories X X equipment Oxygen concentrator, fl owsplitter for newborn/child X Oxygen concentrator, with accessories X X Pulse oximeter, portable, with accessories X X Pulse oximeter, spotcheck, with accessories X X Syringe pump, with accessories X Warmer, heating pad, newborn, with accessories X X Warmer, sleeping bag, newborn, with accessories X X Medical devices Surgical Forceps, dressing, Cheron, 250mm X X - Surgical instrument instruments Surgical Surgical instruments, dressing set X X instruments set

59 60 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 18.Medicalequipmentfor intensive care (indistrict hospitalorhigherlevel) Table 18.Medicalequipmentfor intensive care (indistrict hospitalorhigherlevel) Equipment Medical devices - Renewable Medical devices - Equipment Medical devices - General type equipment Hospital equipment Anthropometric and accessories Clothing medical Medical utensils Medical furniture type Specific area / Pump, suction,electrical,1bottle, withaccessories Light, examination, mobile, withaccessories Scale, springtype,infant,25kg x100gwithsetof weighing trousers Scale, beamtype, infant,16kgx10g Scale, electronic, infant,10kgx5g newborn Mid UpperArmCircumference (MUAC) measuringtape, infant/ Tunic, surgical, woven -#sizes Trousers, surgical, woven -#sizes Mask, surgical, non-woven, Gown, surgical, woven -#sizes Gown, patient, woven Drawsheet, plastic, approx. 90x180cm Drape, surgical woven -#sizes Clogs, plastic -#sizes Cap, surgical, non-woven Tray, dressing, stainless steel ,approx. 300x200x30mm Receptacle, waste, stainless steel, pedalaction Jar, thermometer, polypropylene Jar, forceps, polypropylene Brush, hand,scrubbing,plastic Bowl, stainless steel, approx. 600ml Bowl, stainless steel, approx. 180ml Bowl, round, stainless steel, approx. 4L Bowl, polypropylene Bedpan, polypropylene Basin, kidney, stainless steel Basin, kidney, polypropylene Trolley, soiled linen Trolley, emergency, withdrawers Trolley, dressing, stainless steel, 2trays Table, instruments, Mayo type, stainless steel, oncastors Table, baby dressing Stretcher, patient, withsiderails Stand, infusion,doublehook,oncastors Cot, baby, hospital,withbassinet, oncastors Cabinet, medicine, doubledoor Cabinet, instruments, doubledoor Cabinet, bedside, standard Bedscreen, hospital,oncastors Bed, hospital,standard, child,withmattress Bed, hospital,Intensive Care Unit(ICU),withmattress Name ofdevices for intensive care (indistrict hospital) X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Intensive

Mother care of: X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Newborn X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Child 3. Medical devices for different health-care facilities Table 18. Medical equipment for intensive care (in district hospital or higher level) General type Specifi c area / Name of devices for intensive care (in district hospital) Intensive type care of: Mother Newborn Child Medical diagnostic Electrocardiogram (ECG) recorder, portable, with accessories X X X equipment Sphygmomanometer, adult, aneroid X Sphygmomanometer, child, aneroid X Stethoscope, adult, binaural X Stethoscope, pediatric, binaural X X Thermometer, clinical, digital 32-43 °C X X X Timer, respiration, for Acute Respiratory Infection (ARI) X X X Tourniquet, rubber, approx. 50cm X X X Tongue depressor,wooden,single use X X X X-ray system, mobile, with accessories X X X X-ray, viewer (negatoscope), 1 to 3 bodies X X X Resuscitation/ Continuous Positive Airway Pressure (CPAP) system, with X X Anaesthesia accessories equipment Defi brillator, basic, with accessories X X Forceps, Magill, adult X Forceps, Magill, child X Incubator, newborn, automatic, basic, with accessories X Infusion pump, with accessories X X X Laryngoscope, adult/child, set X X Laryngoscope, newborn, set X Monitor, patient, portable, with accessories X X X Oxygen concentrator, fl owsplitter for newborn/child X X Oxygen concentrator, with accessories X X X Pulse oximeter, portable, with accessories X X X Pulse oximeter, spotcheck, with accessories X X X Pump, suction, foot-operated X X X Pump, suction, newborn resuscitation X Resuscitator, hand-operated, adult, set X Resuscitator, hand-operated, child, set X Resuscitator, hand-operated, newborn, set X Suction, bulb X X Syringe pump, with accessories X X X Ventilator medical, adult, with accessories X Ventilator medical, child/newborn, with Continuous Positive Airway X X Pressure (CPAP) and accessories Warmer, heating pad, newborn, with accessories X Warmer, sleeping bag, newborn, with accessories X Warmer, radiant heater, freestanding, with accessories X Medical devices Surgical Forceps, dressing, Cheron, 250mm X X X - Surgical instrument instruments Surgical Surgical instruments, dressing set (see table 41) X X X instruments set

61 62 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Tablecapacity 19. Medicaldevice consumables by size andcapacity and size by related to eachgenericitem lineare listed inthemaster list (Table 19). product ranges and continuum, the interventions across to allocated is type product one reflecting line item generic consumables device one Tomatrix, capacities. main and differentthe sizesrequired arein simplify types product same the cases many in medical of The majority of medical device consumables are required for multiple interventions across the continuum of care, and Grouping 3.2.2 Colour coding usedbelow Table 19. Medicaldevice consumables by size andcapacity X x X X X X X X X X x x x x x x x x x x x x x x x x x Related items covered by theGenericline(note: sizes listed from smallerto bigger) Disposable Genericitem line(see Table 11Medicaldevices for different health-care facilities) Medical devices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices Clinical laboratory devices General type Injection devices Injection devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices Dressing devices devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory devices - Disposable Clinical laboratory Specific area /type Cannula, IVshort,24G, sterile, single use use (Sizes G*) Cannulas, Intra Venous (IV)short, sterile, single Tape, medical,10cmx5m,roll Tape, medical,2.5cmx5m,roll Tape, medical,roll (Sizes*) single use Compress, gauze, paraffin, 10x 10cm, sterile, Compress, gauze, 10x10cm, sterile, singleuse Compress, gauze, 10x10cm, non-sterile Compress, gauze,sterile &non-sterile, singleuse Bracelet, identification adult Bracelet, identification infant Bracelet, identification newborn Bracelet, identification (Sizes*) Tube, vacuum, plain/dry, 6ml,sterile Tube, vacuum, plain/dry, 4ml,sterile Tube, vacuum, plain/dry, sterile (Capacity*) (EDTA), 4ml,sterile Tube, vacuum, Ethylene DiamineTetra-acetic Acid (EDTA), 2ml,sterile Tube, vacuum, Ethylene DiamineTetra-acetic Acid (EDTA), sterile (Capacity*) Tube, vacuum, Ethylene DiamineTetra-acetic Acid Needle, vacuum tube, 22G,sterile Needle, vacuum tube, 20G,sterile Needle, vacuum tube, sterile (Size*) Lancet, safety, 2.4mm,sterile Lancet, safety, 2.0 mm,sterile Lancet, blood,safety, sterile (Sizes*) Name ofdevices X X X Health post X X X X X Health center X X X X X X X X District hospital 3. Medical devices for different health-care facilities Table 19. Medical device consumables by size and capacity General type Specifi c area / type Name of devices Health post Health center hospital District x Medical devices - Disposable Injection devices Cannula, IV short, 22G, sterile, single use

x Medical devices - Disposable Injection devices Cannula, IV short, 20G, sterile, single use

x Medical devices - Disposable Injection devices Cannula, IV short, 18G, sterile, single use

x Medical devices - Disposable Injection devices Cannula, IV short, 16G, sterile, single use

X Medical devices - Disposable Injection devices Needles, luer, sterile, single use (Sizes G*) X X X

x Medical devices - Disposable Injection devices Needle, luer, 25G(0.5x16mm), sterile, single use

x Medical devices - Disposable Injection devices Needle, luer, 23G(0.6x25mm), sterile, single use

x Medical devices - Disposable Injection devices Needle, luer, 21G(0.8x40mm), sterile, single use

x Medical devices - Disposable Injection devices Needle, luer, 19G(1.1x40mm), sterile, single use

X Medical devices - Disposable Injection devices Needles, scalp vein, sterile, single use (Sizes G*) X X

x Medical devices - Disposable Injection devices Needle, scalp vein, 25G, sterile, single use

x Medical devices - Disposable Injection devices Needle, scalp vein, 21G, sterile, single use

X Medical devices - Disposable Injection devices Needles, spinal,sterile, single use (Sizes*) X

x Medical devices - Disposable Injection devices Needle, spinal, 22G (0.7x40mm),sterile, single use

x Medical devices - Disposable Injection devices Needle, spinal, 25G(0.5x90mm), sterile, single use

X Medical devices - Disposable Injection devices Syringes, auto-disable (AD), (Capacities ml*) X X X

x Medical devices - Disposable Injection devices Syringe, auto-disable, 0.05 ml

x Medical devices - Disposable Injection devices Syringe, auto-disable, 0.5 ml

X Medical devices - Disposable Injection devices Syringes, luer, sterile, single use (Capacities ml*) X X X

x Medical devices - Disposable Injection devices Syringe, luer, 1ml, sterile, single use

x Medical devices - Disposable Injection devices Syringe, luer, 2ml, sterile, single use

x Medical devices - Disposable Injection devices Syringe, luer, 5ml, sterile, single use

x Medical devices - Disposable Injection devices Syringe, luer, 10ml, sterile, single use

x Medical devices - Disposable Injection devices Syringe, luer, 20ml, sterile, single use

X Medical devices - Disposable Injection devices Syringes, reuse prevention (RUP), (Capacities ml*) X X X

x Medical devices - Disposable Injection devices Syringe, reuse prevention(RUP), 1ml

x Medical devices - Disposable Injection devices Syringe, reuse prevention(RUP), 2ml

x Medical devices - Disposable Injection devices Syringe, reuse prevention(RUP), 5ml

x Medical devices - Disposable Injection devices Syringe, reuse prevention(RUP), 10ml

x Medical devices - Disposable Injection devices Syringe, reuse prevention(RUP), 20ml

X Medical devices - Disposable Tube/catheter/drain Airway, Guedel, translucent (Sizes*) X

x Medical devices - Disposable Tube/catheter/drain Airway, Guedel, translucent, size 000

x Medical devices - Disposable Tube/catheter/drain Airway, Guedel, translucent, size 00

x Medical devices - Disposable Tube/catheter/drain Airway, Guedel, translucent, size 0

x Medical devices - Disposable Tube/catheter/drain Airway, Guedel, translucent, size 1

x Medical devices - Disposable Tube/catheter/drain Airway, Guedel, translucent, size 2

x Medical devices - Disposable Tube/catheter/drain Airway, Guedel, translucent, size 3

x Medical devices - Disposable Tube/catheter/drain Airway, Guedel, translucent, size 4

X Medical devices - Disposable Tube/catheter/drain Catheter, Foley, sterile, single use (Sizes CH*) X X

x Medical devices - Disposable Tube/catheter/drain Catheter, Foley, CH08, sterile, single use

63 64 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 19. Medicaldevice consumables by size andcapacity X X X X X X x x x x x x x x x x x x x x x x x x x x x x x x Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable General type Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain Specific area /type Tube/catheter/drain Tube/catheter/drain Tube/catheter/drain (Sizes CH*) Tube, feeding, L40cm, luertip, sterile, singleuse tip, sterile, singleuse Tube, aspirating/feeding, CH16,L120cm,catheter tip, sterile, singleuse Tube, aspirating/feeding, CH12,L120cm,catheter tip, sterile, singleuse Tube, aspirating/feeding, CH10, L120cm,catheter tip, sterile, singleuse Tube, aspirating/feeding, CH08,L120cm,catheter tip, sterile, singleuse Tube, aspirating/feeding, CH06,L120cm,catheter sterile, singleuse(Sizes CH*) Tube, feeding/aspirating, L120cm,catheter tip, Tube, endotracheal, 8,with cuff, sterile, singleuse use Tube, endotracheal, 7.5, withcuff, sterile, single Tube, endotracheal, 7, withcuff, sterile, singleuse use Tube, endotracheal, 6.5,withcuff, sterile, single (Sizes ID*) Tube, endotracheal, withcuff, sterile, singleuse use Tube, endotracheal, 5.5,withoutcuff, sterile, single use Tube, endotracheal, 5,withoutcuff, sterile, single single use Tube, endotracheal, 4.5,withoutcuff, sterile, use Tube, endotracheal, 4,withoutcuff, sterile, single use Tube, endotracheal, 3.5,withoutcuff, sterile, single use Tube, endotracheal, 3,withoutcuff, sterile, single use Tube, endotracheal, 2.5,withoutcuff, sterile, single (Sizes ID*) Tube, endotracheal, withoutcuff, sterile, singleuse Prongs, nasal,oxygen, adult,nonsterile, singleuse use Prongs, nasal,oxygen, infant, nonsterile, single use Prongs, nasal,oxygen, neonate, nonsterile, single Prongs, nasal,oxygen, nonsterile, singleuse(Sizes *) Catheter, urethral, CH14,sterile, singleuse Catheter, urethral, CH12,sterile, singleuse Catheter, urethral, sterile, singleuse(Sizes CH*) Name ofdevices Catheter, Foley, CH14,sterile, singleuse Catheter, Foley, CH12,sterile, singleuse Catheter, Foley, CH10, sterile, singleuse

Health post X X Health center X X X X X X District hospital 3. Medical devices for different health-care facilities Table 19. Medical device consumables by size and capacity General type Specifi c area / type Name of devices Health post Health center hospital District x Medical devices - Disposable Tube/catheter/drain Tube, feeding, CH05, L40cm, luer tip, sterile, single use x Medical devices - Disposable Tube/catheter/drain Tube, feeding, CH08, L40cm, luer tip, sterile, single use x Medical devices - Disposable Tube/catheter/drain Tube, feeding, CH10, L40cm, luer tip, sterile, single use x Medical devices - Disposable Tube/catheter/drain Tube, feeding, CH12, L40cm, luer tip, sterile, single use X Medical devices - Disposable Tube/catheter/drain Tube, suction, L50cm, catheter tip, sterile, single X use (Sizes CH*) x Medical devices - Disposable Tube/catheter/drain Tube, suction, CH06, L50cm, catheter tip, sterile, single use x Medical devices - Disposable Tube/catheter/drain Tube, suction, CH08, L50cm, catheter tip, sterile, single use x Medical devices - Disposable Tube/catheter/drain Tube, suction, CH10, L50cm, catheter tip, sterile, single use x Medical devices - Disposable Tube/catheter/drain Tube, suction, CH12, L50cm, catheter tip, sterile, single use x Medical devices - Disposable Tube/catheter/drain Tube, suction, CH14, L50cm, catheter tip, sterile, single use x Medical devices - Disposable Tube/catheter/drain Tube, suction, CH16, L50cm, catheter tip, sterile, single use X Medical devices - Disposable Gloves Gloves, examination, latex, non-sterile, single use X X X (Sizes*) x Medical devices - Disposable Gloves Gloves, examination, latex,small, non-sterile,single use x Medical devices - Disposable Gloves Gloves, examination, latex, medium, non-sterile, single use x Medical devices - Disposable Gloves Gloves, examination, latex, large, non-sterile, single use X Medical devices - Disposable Gloves Gloves, gynaecological, sterile, single use, pair X X (Sizes*) x Medical devices - Disposable Gloves Gloves, gynaecological, small, sterile, single use, pair x Medical devices - Disposable Gloves Gloves, gynaecological, medium, sterile, single use, pair x Medical devices - Disposable Gloves Gloves, gynaecological, large, sterile, single use, pair X Medical devices - Disposable Gloves Gloves, surgical, sterile, single use, pair (Sizes*) X X

x Medical devices - Disposable Gloves Gloves, surgical, 6.5, sterile, single use, pair

x Medical devices - Disposable Gloves Gloves, surgical, 7, sterile, single use, pair

x Medical devices - Disposable Gloves Gloves, surgical, 7.5, sterile, single use, pair

x Medical devices - Disposable Gloves Gloves, surgical, 8, sterile, single use, pair

x Medical devices - Disposable Gloves Gloves, surgical, 8.5, sterile, single use, pair

X Medical devices - Disposable Surgical sutures Suture, synthetic, absorbable (Sizes USP/DEC*) X X with needle (Shapes* and sizes*), sterile, single use x Medical devices - Disposable Surgical sutures Suture,synthetic,absorbable,DEC2(USP3/0),need le 3/8 18mm,round,ster,s.u. x Medical devices - Disposable Surgical sutures Suture,synthetic,absorbable,DEC2(USP3/0),need le 3/8,26mm,triangular, sterile, single use x Medical devices - Disposable Surgical sutures Suture,synthetic,absorbable,DEC3(USP2/0),need le 1/2 30mm,round, sterile, single use

65 66 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health 1. 3.3 Table 19. Medicaldevice consumables by size andcapacity X x x x x x displayApp/%28layout=7.0-12_1_66_67_115&carea=%24ROOT%29/.do?rf=y, accessed 22May 2014). UNICEF supplycatalogue. New York: United Nations Children’s Fund;2014 (https://supply.unicef.org/unicef_b2c/app/ Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable Medicaldevices -Disposable General type Medicaldevices -Disposable Medicaldevices -Disposable References Surgical sutures Surgical sutures Surgical sutures Surgical sutures Specific area /type Surgical sutures Surgical sutures sterile, singleuse absorbable,DEC4(USP1),needle 1/2 30mm,round, Suture,synthetic,non- 30mm,triangular, sterile, singleuse absorbable,DEC3(USP2/0),needle 3/8 Suture,synthetic,non- eedle3/8 18mm,triangular, sterile, singleuse Suture,synthetic,non-absorbable,DEC2(USP3/0),n single use DEC*) withneedle(Shapes*andsizes*), sterile, Suture, synthetic, non-absorbable(Sizes USP/ Name ofdevices 3/8 50mm,round, sterile, singleuse Suture,synthetic,absorbable,DEC4(USP1),needle 1/2 30mm,round, sterile, singleuse Suture,synthetic,absorbable,DEC4(USP1), needle

Health post X Health center X District hospital 4. Matrix of medical devices in each stage of continuum of care, in each level of health-care facility

4.1 Continuum of care matrix 4.Matrix of medical devices in each stage of continuum of care This section contains 17 different tables (Tables 20–35). For each of the six stages of the continuum of care described in Section 2.1, three levels of health-care facility are considered: health posts, health centres and district hospitals. For childbirth, only health centres and district hospitals are considered because delivery in a health post is not recommended.

The title of the table shows the stage and health-care facility referenced; for example, “Medical devices for family planning and reproductive health at health post” covers the stage of family planning and reproductive health in a health post. The priority interventions included in Table 3 are listed in the horizontal axis. The vertical axis consists of the medical devices included in Table 11.

To read the tables, locate the “X” below each priority intervention and trace it to the left to find the associated medical device. References to other tables indicate that the intervention is associated with a group of medical devices. The tables can be found in Section 3.2.

67 68 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 20. Medicaldevices for Family planningandreproductive healthat HEALTH POST General type Counselling material Medical devices -EquipmentGrouping Medicaldevices -Disposable Family planningdevices Clinical laboratory devices Name ofdevices Gloves, examination, latex, non-sterile, singleuse(Sizes*) Syringes, reuse prevention (RUP), (Capacities ml*) Syringes, luer, sterile, singleuse(Capacities ml*) Syringes, auto-disable (AD), (Capacities ml*) Safety box, for usedsyringes/needles Needles, luer, sterile, singleuse(Sizes G*) Cotton wool, 500g,roll, non-sterile Male condoms Lubricants Test strip, pregnancy Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit Rapid Diagnostic Test (RDT), malaria,kit Rapid Diagnostic Test (RDT), HumanImmunodeficiency Virus (HIV),kit Swab, cotton-tip, tube, sterile Counselling material Commodities for medicalexamination &diagnosis Compress, gauze,sterile &non-sterile, single use Female condoms Lancet, blood,safety, sterile (Sizes*) Basic Medical a) Check-up vital signs / Examination X X measuring weight and height / First assessment Anthropometry X X b) Pelvic examination Immuni- Preven- zation tive X X X X X a) Vaccine for Hepatitis B method selection X a) Provision of oral contraceptives Contraceptive

contraceptives Provision of X X X X X a) Provision of barriers methods X X a) Provision of emergency contraception Detection andmanagementofSexually Transmitted Syph- ilis X X X X X a) Screening / diagnosis of Syphilis by laboratory test Infection (STI) andotherinfections Immunodeficiency X X X X X a) Screening of HIV Virus (HIV) Human

X b) Treatment for HIV (Antiretroviral Therapy (ART))

c) Provide post exposure X X prophylaxis for HIV discordant couple X X X X X X X a) Prophylactic antimalarial (IPT) Malaria X X X X b) Diagnosis of malaria X X X X X X X X X c) Management of malaria reproductive ment ofcan- and manag- cers ofthe Screening system cancer Breast

X a) Breast examination Management lence (gbv) of gender- based vio- Post-rape care X X X X X X a) Management of post-rape care 4.Matrix of medical devices in each stage of continuum of care Screening and manag- Management Provision of Detection and management of Sexually Transmitted ment of can- of gender- First assessment contraceptives Infection (STI) and other infections cers of the based vio- reproductive lence (gbv) system

Preven- Human Basic Medical tive Contraceptive Syph- Breast Post-rape Immunodefi ciency Malaria Examination Immuni- method selection ilis cancer care Virus (HIV) zation

General type Name of devices a) Check-up vital signs / a) Check-up and height / measuring weight Anthropometry examination Pelvic b) B Hepatitis for a) Vaccine of oral a) Provision contraceptives of barriers methods a) Provision of emergency a) Provision contraception / diagnosis of a) Screening test laboratory by Syphilis of HIV a) Screening HIV for Treatment b) (ART)) Therapy (Antiretroviral exposure post Provide c) HIV discordant for prophylaxis couple antimalarial a) Prophylactic (IPT) Diagnosis of malaria b) Management of malaria c) examination a) Breast a) Management of post-rape care Clinical laboratory devices Lancet, blood, safety, sterile (Sizes*) X X X X

Swab, cotton-tip, tube, sterile X X X

Rapid Diagnostic Test (RDT), Human Immunodefi ciency Virus (HIV), kit X X

Rapid Diagnostic Test (RDT), malaria, kit X

Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit X X

Test strip, pregnancy X

Family planning devices Female condoms X

Lubricants X

Male condoms X

Medical devices - Disposable Compress, gauze,sterile & non-sterile, single use X

Cotton wool, 500g, roll, non-sterile X X

Needles, luer, sterile, single use (Sizes G*) X X

Safety box, for used syringes/needles X X X

Syringes, auto-disable (AD), (Capacities ml*) X Syringes, luer, sterile, single use (Capacities ml*) X X

Syringes, reuse prevention (RUP), (Capacities ml*) X X

Gloves, examination, latex, non-sterile, single use (Sizes*) X X X X X X X

Medical devices - Equipment Grouping Commodities for medical examination & diagnosis X X X X X X X X X X X X X X

Counselling material Counselling material X X X X X X X

69 70 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 21.Medicaldevices for pregnancy at HEALTH POST devices laboratory Clinical General type Grouping Equipment devices - Medical Disposable devices - Medical devices planning Family material Counselling Name ofdevices Lancet, blood,safety, sterile (Sizes*) Commodities for medicalexamination &diagnosis Compress, gauze,sterile &non-sterile, singleuse Female condoms Counselling material Commodities for emergency preparedness (Sizes*) Gloves, examination, latex, non-sterile, singleuse Syringes, reuse prevention (RUP),(Capacities ml*) Syringes, luer, sterile, singleuse(Capacities ml*) Syringes, auto-disable (AD), (Capacities ml*) Safety box, for usedsyringes/needles Needles, luer, sterile, singleuse(Sizes G*) Cotton wool, 500g,roll, non-sterile Male condoms Lubricants Test strip, urinalysis (10parameter) Test strip, pregnancy Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit Rapid Diagnostic Test (RDT), malaria,kit Virus (HIV),kit Rapid Diagnostic Test (RDT), HumanImmunodefi ciency Haemoglobin colour scale(starter kit) Haemoglobin colour scale (refill kit) Hemoglobinometer, withaccessories Blood glucometer, withaccessories Swab, cotton-tip, tube, sterile Basic Medi- cal Exami-

a) Check-up vital signs / nation First assessment X X X measuring weight and height / Anthropometry/ Vaginal examination Immuniza- Preventive tion X X X X a) Vaccine for Tetanus assessment Emergency Emergency prepared- ness and referral

X a) Emergency care and pre-referral treatment Syphi- lis Detection andmanagementofSexually Transmitted X X X X X a) Screening / diagnosis of Syphilis by laboratory test Human Immunodefi- Infection (STI) andotherinfections X X X X X a) Screening of HIV ciency Virus (HIV) X X X X X b) Prevention Mother To Child Transmission (PMTCT) X X c) Treatment for HIV (Antiretroviral Therapy (ART)) X X a) Prophylactic antimalarial (IPT) Malaria X X X X b) Diagnosis of malaria X X X X X X X X X c) Management of malaria Iron Deficiency Anae- of maternal chronic medical Detection andmanagement X X X X X a) Diagnosis of anaemia mia X X b) Iron and folic acid conditions supplementation X X c) Anthelminthic (deworm) Diabe- tes X X X X a) Glucose testing for detection 4.Matrix of medical devices in each stage of continuum of care

Detection and management Emergency Detection and management of Sexually Transmitted First assessment of maternal chronic medical assessment Infection (STI) and other infections conditions

Emergency Basic Medi- Preventive prepared- Syphi- Human Immunodefi - Iron Defi ciency Anae- Diabe- cal Exami- Immuniza- Malaria ness and lis ciency Virus (HIV) mia tes nation tion referral

General type Name of devices a) Check-up vital signs / a) Check-up and height measuring weight Vaginal / Anthropometry/ examination Tetanus for a) Vaccine and pre-referral care a) Emergency treatment / diagnosis of Syphilis a) Screening test laboratory by of HIV a) Screening Child Mother To Prevention b) (PMTCT) Transmission HIV (Antiretroviral for Treatment c) (ART)) Therapy antimalarial (IPT) a) Prophylactic Diagnosis of malaria b) Management of malaria c) a) Diagnosis of anaemia acid and folic Iron b) supplementation Anthelminthic (deworm) c) detection for testing a) Glucose Clinical Lancet, blood, safety, sterile (Sizes*) X X X X X laboratory devices Swab, cotton-tip, tube, sterile X X

Blood glucometer, with accessories X

Hemoglobinometer, with accessories X

Haemoglobin colour scale (refi ll kit) X

Haemoglobin colour scale (starter kit) X Rapid Diagnostic Test (RDT), Human Immunodefi ciency X Virus (HIV), kit

Rapid Diagnostic Test (RDT), malaria, kit X

Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit X

Test strip, pregnancy X

Test strip, urinalysis (10 parameter) X X

Family Female condoms X planning devices Lubricants X

Male condoms X

Medical Compress, gauze,sterile & non-sterile, single use X devices - Disposable Cotton wool, 500g, roll, non-sterile X

Needles, luer, sterile, single use (Sizes G*) X

Safety box, for used syringes/needles X X

Syringes, auto-disable (AD), (Capacities ml*) X

Syringes, luer, sterile, single use (Capacities ml*) X

Syringes, reuse prevention (RUP), (Capacities ml*) X Gloves, examination, latex, non-sterile, single use X X X X X (Sizes*) Medical Commodities for medical examination & diagnosis X X X X X X X X X X X X X devices - Equipment Commodities for emergency preparedness Grouping X

Counselling Counselling material material X X X X X X

71 72 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health at at Table 22.Medicaldevices for post-natal baby (newborn) material Counselling Grouping - Equipment Medical devices Equipment Medical devices - Disposable Medical devices - devices Clinical laboratory General type HEALTH POST Syringes, auto-disable (AD), (Capacities ml*) Safety box, for usedsyringes/needles Tape, medical,roll (Sizes*) Haemoglobin colour scale(starter kit) Gloves, examination, latex, non-sterile, singleuse(Sizes*) Counselling material Commodities for medicalexamination &diagnosis Breastpump, manual,withaccessories Cotton wool, 500g,roll, non-sterile Compress, gauze, sterile &non-sterile, singleuse Blanket, survival, 220x140cm,non-sterile Haemoglobin colour scale(refill kit) Name ofdevices

X a) Full clinical examination / Check vital signs / measuring weight Childbirth: Essential newborn care X X X b) Thermal Care Routine care X X c) Breastfeeding support

X d) Vitamin K prophylaxis and Immunization X X X e) Cord care

a) Full clinical examination / check Further assessment for allyoung X X X X X vital signs / measuring weight / check haemoglobin

b) Provision of vaccines (Diphtheria Clinical visit X X X X X X Pertussis Tetanus (DPT) +

Haemophilus Infl uenzae type B (HIB), infant Oral Polio Vaccine (OPV), Hepatitis B) X X X c) Breastfeeding support and replacement feeding if necessary

X X d) Monitoring growth and development 4.Matrix of medical devices in each stage of continuum of care

Further assessment for all young Childbirth: Essential newborn care infant

Routine care Clinical visit

General type Name of devices a) Full clinical examination / Check a) Full clinical examination vital signs / measuring weight Care Thermal b) support Breastfeeding c) and K prophylaxis d) Vitamin Immunization care Cord e) / check a) Full clinical examination / vital signs / measuring weight check haemoglobin (Diphtheria of vaccines Provision b) (DPT) + Tetanus Pertussis uenzae type B (HIB), Haemophilus Infl B) Hepatitis (OPV), Vaccine Polio Oral support and Breastfeeding c) if necessary feeding replacement and growth d) Monitoring development Clinical laboratory devices Haemoglobin colour scale (refi ll kit) X

Haemoglobin colour scale (starter kit) X

Medical devices - Disposable Blanket, survival, 220x140cm, non-sterile X

Compress, gauze, sterile & non-sterile, single use X

Cotton wool, 500g, roll, non-sterile X

Tape, medical, roll (Sizes*) X

Safety box, for used syringes/needles X

Syringes, auto-disable (AD), (Capacities ml*) X

Gloves, examination, latex, non-sterile, single use (Sizes*) X X X X X X

Medical devices - Breastpump, manual, with accessories X Equipment Medical devices - Equipment Commodities for medical examination & diagnosis X X X X Grouping Counselling Counselling material X X X X X X X material

73 74 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health at at Table 23.Medicaldevices for infancy andchildhood material Counselling Grouping - Equipment Medical devices Equipment Medical devices - Disposable Medicaldevices - devices Clinical laboratory General type HEALTH POST Counselling material Commodities for medicalexamination &diagnosis Breastpump, manual,withaccessories Compress, gauze, sterile &non-sterile, singleuse Lancet, blood,safety, sterile (Sizes*) Name ofdevices Syringes, luer, sterile, singleuse(Capacities ml*) Syringes, auto-disable (AD), (Capacities ml*) Safety box, for usedsyringes/needles Needles, luer, sterile, singleuse(Sizes G*) Tape, medical,roll (Sizes*) Cotton wool, 500g,roll, non-sterile Immunodeficiency Virus (HIV),kit Rapid Diagnostic Test (RDT), Human Haemoglobin colour scale(starter kit) Haemoglobin colour scale(refill kit) Swab, cotton-tip, tube, sterile (Sizes*) Gloves, examination, latex, non-sterile, singleuse Syringes, reuse prevention (RUP), (Capacities ml*) X X X

a) Full clinical examination / check Essential care for monitoring growth andearly vital signs / measuring weight X X X X X X X X b) Provision of vaccines childhood development

X X c) Growth monitoring Routine care

X d) Early childhood development monitoring X X X e) Breastfeeding support and replacement feeding if necessary

X f) Vitamin A supplementation

X g) Deworming (Mebendazole) tion (SAM) Malnutri- Severe Acute

X X X X a) Diagnosis of SAM Detection andmanagementofcommon infections, illness andcomplications ininfancy andchildhood Pneumonia

X a) Differential diagnosis for pneumonia X X X X X X X b) Management of pneumonia and its complications Bronchiolitis) X (Asthma,

a) Diagnosis of condition with Wheeze wheeze X X X X X X X b) Management of condition with wheeze Diarrhoea a) Differential diagnosis and X X X X X X X management of diarrhoea and dysentery Immunodeficiency X X X X X X X X X a) Diagnosis of HIV Virus (HIV) Human X X b) Treatment for HIV (Antiretroviral Therapy (ART))

X c) Management of other opportunistic infections in HIV infec- tion Eye Eye X X X X a) Detection and management of eye infection / conjunctivitis infec- tion Ear X X X X a) Detection and management of ear infection Mouth infec- tion X X X X a) Detection and management of mouth infection / thrush infec- Skin tion X X X X a) Diagnosis and management of skin infections en pox Chick- X X X X a) Detection and management of chicken pox 4.Matrix of medical devices in each stage of continuum of care

Essential care for monitoring growth and early Detection and management of common infections, illness and complications in infancy and childhood childhood development

Severe Wheeze Human Eye Ear Mouth Skin Acute Chick- Routine care Pneumonia (Asthma, Diarrhoea Immunodefi ciency infec- infec- infec- infec- Malnutri- en pox Bronchiolitis) Virus (HIV) tion tion tion tion tion (SAM)

General type Name of devices a) Full clinical examination / check a) Full clinical examination vital signs / measuring weight of vaccines Provision b) monitoring Growth c) d) Early childhood development monitoring support and Breastfeeding e) if necessary feeding replacement f) A supplementation Vitamin (Mebendazole) g) Deworming a) Diagnosis of SAM diagnosis for a) Differential pneumonia Management of pneumonia and b) its complications with a) Diagnosis of condition wheeze with Management of condition b) wheeze diagnosis and a) Differential management of diarrhoea and dysentery a) Diagnosis of HIV HIV (Antiretroviral for Treatment b) (ART)) Therapy Management of other c) in HIV infections opportunistic and management of a) Detection / conjunctivitis infection eye and management of a) Detection ear infection and management of a) Detection / thrush mouth infection a) Diagnosis and management of skin infections and management of a) Detection pox chicken Clinical laboratory Lancet, blood, safety, sterile (Sizes*) X devices Swab, cotton-tip, tube, sterile X

Haemoglobin colour scale (refi ll kit) X

Haemoglobin colour scale (starter kit) X Rapid Diagnostic Test (RDT), Human X Immunodefi ciency Virus (HIV), kit Medical devices - Compress, gauze, sterile & non-sterile, single use X X X X X X Disposable Cotton wool, 500g, roll, non-sterile X X X X X X X X X X

Tape, medical, roll (Sizes*) X X X X X

Needles, luer, sterile, single use (Sizes G*) X X X X

Safety box, for used syringes/needles X X X X X

Syringes, auto-disable (AD), (Capacities ml*) X

Syringes, luer, sterile, single use (Capacities ml*) X X Syringes, reuse prevention (RUP), (Capacities ml*) X X X X Gloves, examination, latex, non-sterile, single use X X X X X X X X X X X (Sizes*) Medical devices - Equipment Breastpump, manual, with accessories X

Medical devices - Equipment Commodities for medical examination & diagnosis X X X X X X X X X X X X X X X Grouping

Counselling Counselling material X X X X X X X X X material

75 76 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health reproductive healthat HEALTH CENTRE Table 24. Medicaldevices for family planningand Disposable devices - Medical material Counselling General type Grouping - Equipment Medical devices devices Family planning devices laboratory Clinical Blanket, survival, 220x140cm,non-sterile Name ofdevices Acid Magnifying lensfor Visual InspectionwithAcetic Intra-Uterine Devices (only prequalified copper IUDs) Female condoms Container, sample, 50ml Counselling material needle (Shapes*andsizes*), sterile, singleuse Suture, synthetic, absorbable(Sizes USP/DEC*) with Gloves, surgical, sterile, singleuse, pair(Sizes*) (Sizes*) Gloves, gynaecological, sterile, singleuse, pair (Sizes*) Gloves, examination, latex, non-sterile, singleuse Syringes, reuse prevention (RUP),(Capacities ml*) Syringes, luer, sterile, singleuse(Capacities ml*) Syringes, auto-disable (AD), (Capacities ml*) Safety box, for usedsyringes/needles Needles, scalpvein, sterile, singleuse(Sizes G*) Needles, luer, sterile, singleuse(Sizes G*) Tape, medical,roll (Sizes*) Cotton wool, 500g,roll, non-sterile Compress, gauze,sterile &non-sterile, singleuse Sub-dermal implants (included the insertion device) Male condoms Lubricants Test strip, vaginal infection, pH Test strip, urinalysis (10parameter) Test strip, pregnancy Rapid PlasmaReagin (RPR),syphilis, kit Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit Rapid Diagnostic Test (RDT), malaria,kit Immunodeficiency Virus (HIV),kit Rapid Diagnostic Test (RDT), Human Cytology stain, kit Swab, cotton-tip, tube, sterile Lancet, blood,safety, sterile (Sizes*) Commodities for surgery &anaesthesia Commodities for medicalexamination & diagnosis with needle(Shapes*andsizes*), sterile, singleuse Suture, synthetic, non-absorbable(Sizes USP/DEC*) Basic Medical Examination First assessment X X a) Check-up vital signs / measuring weight and height / Anthropometry X X X X X b) Pelvic examination Immuni- Preven- zation tive X X X X X a) Vaccine for Hepatitis B

X a) Provision of oral contraceptives Contraceptive methodselection X X X X X X X X X a) Provision of injectable Provision ofcontraceptives contraceptives X X X X X X a) Insertion and removal of Intrauterine device (IUD)s

a) Insertion and removal of X X X X X X X X X X X X contraceptive implants with anaesthesia X X X X X a) Provision of barriers methods X X X X X X a) Provision of emergency contraception X X a) Provision of vaginal rings and patches X X X X X X X X X X X X a) Vasectomy with local anaesthesia Detection andmanagementofSexually Transmitted Infection (STI) andotherinfections Syphilis X X X X X X a) Screening / diagnosis of Syphilis by laboratory test X X X X X X X X b) Treatment for Syphilis Immunodeficiency X X X X X a) Screening of HIV Virus (HIV) Human

X b) Treatment for HIV (Antiretroviral Therapy (ART)) c) Provide post exposure X X prophylaxis for HIV discordant couple Gonorrhoea X X X X X X a) Screening / diagnosis of Gonorrhoea X X X X X X X X b) Treatment for Gonorrhoea Chlamydia X X X X X X a) Screening / diagnosis of Chlamydia X X X X X X X X b) Treatment for Chlamydia X X X X X X X a) Prophylactic antimalarial (IPT) Malaria X X X X b) Diagnosis of malaria X X X X X X X X X c) Management of malaria

a) Diagnosis and treatment for infections X X X X X X X X X X

urinary tract infections: bacteriuria, Other pyelonephritis a) Diagnosis and treatment for X X X X X X X X X X X X bacterial vaginosis, trichomonas, candidiasis Cervix cancer Screening andman- agement ofcancers of thereproductive X X X X a) Papanicolaou test X X X X X X X X X X

b) Visual Inspection with Acetic system Acid (VIA / VIAM) X X X c) Human Papilloma Virus (HPV) test cancer Breast X X a) Breast examination (GBV) violence based gender- ment of Manage- care Post-rape X X X X X X X X X X X X X X X X X X X X X X a) Management of post-rape care 4.Matrix of medical devices in each stage of continuum of care Manage- Screening and man- ment of agement of cancers gender- First assessment Provision of contraceptives Detection and management of Sexually Transmitted Infection (STI) and other infections of the reproductive based system violence (GBV) Preven- Human Basic Medical tive Other Breast Post-rape Contraceptive method selection Syphilis Immunodefi ciency Gonorrhoea Chlamydia Malaria Cervix cancer Examination Immuni- infections cancer care Virus (HIV) zation

General type Name of devices a) Check-up vital signs / measuring a) Check-up and height / Anthropometry weight examination Pelvic b) B Hepatitis for a) Vaccine contraceptives of oral a) Provision of injectable a) Provision contraceptives of a) Insertion and removal (IUD)s device Intrauterine of a) Insertion and removal implants with contraceptive anaesthesia of barriers methods a) Provision of emergency a) Provision contraception rings and of vaginal a) Provision patches with local a) Vasectomy anaesthesia / diagnosis of Syphilis a) Screening test laboratory by Syphilis for Treatment b) of HIV a) Screening HIV (Antiretroviral for Treatment b) (ART)) Therapy exposure post Provide c) HIV discordant for prophylaxis couple / diagnosis of a) Screening Gonorrhoea Gonorrhoea for Treatment b) / diagnosis of a) Screening Chlamydia Chlamydia for Treatment b) antimalarial (IPT) a) Prophylactic Diagnosis of malaria b) Management of malaria c) for a) Diagnosis and treatment bacteriuria, infections: urinary tract pyelonephritis for a) Diagnosis and treatment trichomonas, vaginosis, bacterial candidiasis test a) Papanicolaou Inspection with Acetic Visual b) (VIA / VIAM) Acid test (HPV) Virus Human Papilloma c) examination a) Breast care a) Management of post-rape Clinical Container, sample, 50 ml X X X X X laboratory devices Lancet, blood, safety, sterile (Sizes*) X X X X Swab, cotton-tip, tube, sterile X X X X X X X X X Cytology stain, kit X Rapid Diagnostic Test (RDT), Human X X Immunodefi ciency Virus (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit X Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit X X Rapid Plasma Reagin (RPR), syphilis, kit X X Test strip, pregnancy X X Test strip, urinalysis (10 parameter) X X X X X Test strip, vaginal infection, pH X X X X Family planning Female condoms X devices Intra-Uterine Devices (only prequalifi ed copper IUDs) X X X Lubricants X Male condoms X Sub-dermal implants (included the insertion device) X Medical Blanket, survival, 220x140cm, non-sterile X devices - Disposable Compress, gauze,sterile & non-sterile, single use X X X X X X X X X X X X X X Cotton wool, 500g, roll, non-sterile X X X X X X X X X X Tape, medical, roll (Sizes*) X Needles, luer, sterile, single use (Sizes G*) X X X X X X X X X X X X Needles, scalp vein, sterile, single use (Sizes G*) X Safety box, for used syringes/needles X X X X X X X X X X X X X Syringes, auto-disable (AD), (Capacities ml*) X Syringes, luer, sterile, single use (Capacities ml*) X X X X X X X X X X X X Syringes, reuse prevention (RUP), (Capacities ml*) X X X X X X X X X X X X Gloves, examination, latex, non-sterile, single use (Sizes*) X X X X X X X X X X X X X X X X X X X X X X X X Gloves, gynaecological, sterile, single use, pair (Sizes*) X X X X Gloves, surgical, sterile, single use, pair (Sizes*) X X Suture, synthetic, absorbable (Sizes USP/DEC*) with X X needle (Shapes* and sizes*), sterile, single use Suture, synthetic, non-absorbable (Sizes USP/DEC*) X X with needle (Shapes* and sizes*), sterile, single use Medical devices Magnifying lens for Visual Inspection with Acetic X - Equipment Acid Grouping Commodities for medical examination & diagnosis X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Commodities for surgery & anaesthesia X Counselling Counselling material X X X X X X X X X X X X material 77 78 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health HEALTH CENTRE Table 25.Medicaldevices for pregnancy at Table 25Medicaldevices for pregnancy at Healthcentre General type devices laboratory Clinical Disposable devices - Medical devices Family planning Name ofdevices Container, sample, 50ml Compress, gauze, sterile &non-sterile, singleuse Blanket, survival, 220x140cm,non-sterile Bandage, elastic, 7.5cmx5m, roll Male condoms Lubricants Female condoms Syringes, auto-disable (AD), (Capacities ml*) Stopcock, 3-way, sterile, singleuse Safety box, for used syringes/needles Needles, luer, sterile, singleuse (Sizes G*) Infusion givingset,sterile, singleuse (Sizes G*) Cannulas, Intra Venous (IV)short,sterile, singleuse Tape, medical,roll (Sizes*) Cotton wool, 500g,roll, non-sterile Test strip, urinalysis (10parameter) Test strip, pregnancy Rapid PlasmaReagin (RPR),syphilis, kit Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit Rapid Diagnostic Test (RDT), malaria,kit Immunodeficiency Virus (HIV),kit Rapid Diagnostic Test (RDT), Human Nucleic Acid Test (NAT), gonorrhea,kit Nucleic Acid Test (NAT), chlamydia, kit Haemoglobin colour scale(starter kit) Haemoglobin colour scale (refill kit) Enzyme ImmunoAssay (EIA), gonorrhea Ag, kit Hemoglobinometer, withaccessories Blood glucometer, withaccessories Swab, cotton-tip, tube, sterile Lancet, blood,safety, sterile (Sizes*) Examina- Medical First assessment

a) Check-up vital signs / Basic tion X X X measuring weight and height / Anthropometry/ Vaginal examination Immuni- Preven- zation tive X X X a) Vaccine for Tetanus assessment Emergency Emergency prepared- ness and referral X X X X X X X X X X X X X X a) Emergency care and pre-referral treatment Detection andmanagement Syphilis X X X X

a) Screening / diagnosis of Syphilis Infection (STI) andother by laboratory test of Sexually Transmitted X X X X b) Treatment for Syphilis infections Immunodeficiency X X X a) Screening of HIV Virus (HIV) Human

X X X b) Prevention Mother To Child Transmission (PMTCT)

c) Treatment for HIV (Antiretroviral Therapy (ART))

a) Prophylactic antimalarial (IPT) Malaria

X X b) Diagnosis of malaria

X X X X c) Management of malaria bella Ru-

X a) Diagnosis and treatment for rubella losis ber- cu- a) Diagnosis and treatment for Tu- tuberculosis

a) Diagnosis and treatment for Other infections X X X X urinary tract infections: bacteriuria, pyelonephritis a) Diagnosis and treatment of other STI/Reproductive Tract Infections X X X X X X (RTI): Candida vaginitis, gonorrhoea, chlamydia, bacterial vaginosis and trichomoniasis Detection andmanagementofmaternal chronic medical X X X X a) Diagnosis of anaemia Iron Deficiency Anaemia

b) Iron and folic acid supplementation

c) Anthelminthic (deworm) X X X a) Diagnosis of Pre-eclampsia- conditions Eclampsia Hypertension and pre-eclampsia

b) Supplement calcium

c) Low-dose aspirin

d) Antihypertensive drugs

e) Magnesium sulfate X X X a) Glucose testing for detection Diabetes X X X b) Treatment for insulin-dependent diabetic mother Management of ment of Assess- rupture ofthe X X X X X X X membranes a) Diagnosis and laboratory test PRM prelabour (PRM) b) Fetal monitoring term Pre- X X X X X X X X a) Provision antibiotics if indicated 4.Matrix of medical devices in each stage of continuum of care Table 25 Medical devices for pregnancy at Health centre Management of Detection and management prelabour Emergency of Sexually Transmitted Detection and management of maternal chronic medical First assessment rupture of the assessment Infection (STI) and other conditions membranes infections (PRM)

Basic Preven- Emergency Tu- Human Assess- Medical tive prepared- Ru- ber- Iron Defi ciency Hypertension and Pre- Syphilis Immunodefi ciency Malaria Other infections Diabetes ment of Examina- Immuni- ness and bella cu- Anaemia pre-eclampsia term Virus (HIV) PRM tion zation referral losis

General type Name of devices a) Check-up vital signs / a) Check-up and height measuring weight Vaginal / Anthropometry/ examination Tetanus for a) Vaccine and pre-referral care a) Emergency treatment / diagnosis of Syphilis a) Screening test laboratory by Syphilis for Treatment b) of HIV a) Screening Child Mother To Prevention b) (PMTCT) Transmission HIV (Antiretroviral for Treatment c) (ART)) Therapy antimalarial (IPT) a) Prophylactic Diagnosis of malaria b) Management of malaria c) for a) Diagnosis and treatment rubella for a) Diagnosis and treatment tuberculosis for a) Diagnosis and treatment bacteriuria, infections: urinary tract pyelonephritis of other a) Diagnosis and treatment Infections Tract STI/Reproductive gonorrhoea, Candida vaginitis, (RTI): and vaginosis bacterial chlamydia, trichomoniasis a) Diagnosis of anaemia acid and folic Iron b) supplementation Anthelminthic (deworm) c) a) Diagnosis of Pre-eclampsia- Eclampsia Supplement calcium b) aspirin Low-dose c) drugs d) Antihypertensive Magnesium sulfate e) detection for testing a) Glucose insulin-dependent for Treatment b) diabetic mother test a) Diagnosis and laboratory monitoring Fetal b) antibiotics if indicated a) Provision Clinical Container, sample, 50 ml X X laboratory devices Lancet, blood, safety, sterile (Sizes*) X X X X X X

Swab, cotton-tip, tube, sterile X X X

Blood glucometer, with accessories X X X

Hemoglobinometer, with accessories X X

Enzyme Immuno Assay (EIA), gonorrhea Ag, kit X

Haemoglobin colour scale (refi ll kit) X X

Haemoglobin colour scale (starter kit) X X

Nucleic Acid Test (NAT), chlamydia, kit X

Nucleic Acid Test (NAT), gonorrhea, kit X Rapid Diagnostic Test (RDT), Human X Immunodefi ciency Virus (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit X

Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit X

Rapid Plasma Reagin (RPR), syphilis, kit X

Test strip, pregnancy X

Test strip, urinalysis (10 parameter) X X X X X

Family planning Female condoms X devices Lubricants X

Male condoms X

Medical Bandage, elastic, 7.5cmx5m, roll X devices - Disposable Blanket, survival, 220x140cm, non-sterile X

Compress, gauze, sterile & non-sterile, single use X X X X X X X

Cotton wool, 500g, roll, non-sterile X X X X X

Tape, medical, roll (Sizes*) X X X Cannulas, Intra Venous (IV) short, sterile, single use X X X (Sizes G*) Infusion giving set, sterile, single use X X X

Needles, luer, sterile, single use (Sizes G*) X X X X X X X

Safety box, for used syringes/needles X X X X X X X X X X

Stopcock, 3-way, sterile, single use X X

Syringes, auto-disable (AD), (Capacities ml*) X

79 80 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 25Medicaldevices for pregnancy at Healthcentre General type Grouping Equipment devices - Medical material Counselling Equipment devices - Medical Name ofdevices Commodities for emergency preparedness accessories Doppler, foetal heartrate (FHR)detector, with (Sizes*) Gloves, gynaecological, sterile, singleuse, pair (Sizes*) Gloves, examination, latex, non-sterile, singleuse use (Sizes CH*) Tube, suction,L50cm,catheter tip, sterile, single (Sizes*) Prongs, nasal,oxygen, nonsterile, single use Catheter, Foley, sterile, singleuse(Sizes CH*) Bag, urine, collecting, 2000ml Syringes, reuse prevention (RUP),(Capacities ml*) Syringes, luer, sterile, singleuse(Capacities ml*) Syringe for insulin,sterile, singleuse Commodities for medicalexamination &diagnosis Counselling material Cardiotocograph (CTG), withaccessories Gloves, surgical, sterile, singleuse, pair(Sizes*) Examina- Medical First assessment

a) Check-up vital signs / Basic tion X X X measuring weight and height / Anthropometry/ Vaginal examination Immuni- Preven- zation tive X X a) Vaccine for Tetanus assessment Emergency Emergency prepared- ness and referral X X X X X X X X X X X a) Emergency care and pre-referral treatment Detection andmanagement Syphilis X X

a) Screening / diagnosis of Syphilis Infection (STI) andother by laboratory test of Sexually Transmitted X X X X b) Treatment for Syphilis infections Immunodeficiency X X a) Screening of HIV Virus (HIV) Human X X b) Prevention Mother To Child Transmission (PMTCT) X X c) Treatment for HIV (Antiretroviral Therapy (ART))

X X a) Prophylactic antimalarial (IPT) Malaria X X b) Diagnosis of malaria X X X X X c) Management of malaria bella Ru-

X X a) Diagnosis and treatment for rubella losis ber- cu- Tu-

X X a) Diagnosis and treatment for tuberculosis

a) Diagnosis and treatment for Other infections X X X X X urinary tract infections: bacteriuria, pyelonephritis a) Diagnosis and treatment of other STI/Reproductive Tract Infections X X X X X (RTI): Candida vaginitis, gonorrhoea, chlamydia, bacterial vaginosis and trichomoniasis Detection andmanagementofmaternal chronic medical X a) Diagnosis of anaemia Iron Deficiency Anaemia X X b) Iron and folic acid supplementation X X c) Anthelminthic (deworm) X X X X X X X a) Diagnosis of Pre-eclampsia- conditions Eclampsia Hypertension and pre-eclampsia X X b) Supplement calcium

X c) Low-dose aspirin

X d) Antihypertensive drugs

X e) Magnesium sulfate X a) Glucose testing for detection Diabetes X X X b) Treatment for insulin-dependent diabetic mother Management of ment of Assess- X X rupture ofthe X X membranes a) Diagnosis and laboratory test PRM prelabour (PRM) X X X b) Fetal monitoring term Pre- X X X X a) Provision antibiotics if indicated 4.Matrix of medical devices in each stage of continuum of care Table 25 Medical devices for pregnancy at Health centre Management of Detection and management prelabour Emergency of Sexually Transmitted Detection and management of maternal chronic medical First assessment rupture of the assessment Infection (STI) and other conditions membranes infections (PRM)

Basic Preven- Emergency Tu- Human Assess- Medical tive prepared- Ru- ber- Iron Defi ciency Hypertension and Pre- Syphilis Immunodefi ciency Malaria Other infections Diabetes ment of Examina- Immuni- ness and bella cu- Anaemia pre-eclampsia term Virus (HIV) PRM tion zation referral losis

General type Name of devices a) Check-up vital signs / a) Check-up and height measuring weight Vaginal / Anthropometry/ examination Tetanus for a) Vaccine and pre-referral care a) Emergency treatment / diagnosis of Syphilis a) Screening test laboratory by Syphilis for Treatment b) of HIV a) Screening Child Mother To Prevention b) (PMTCT) Transmission HIV (Antiretroviral for Treatment c) (ART)) Therapy antimalarial (IPT) a) Prophylactic Diagnosis of malaria b) Management of malaria c) for a) Diagnosis and treatment rubella for a) Diagnosis and treatment tuberculosis for a) Diagnosis and treatment bacteriuria, infections: urinary tract pyelonephritis of other a) Diagnosis and treatment Infections Tract STI/Reproductive gonorrhoea, Candida vaginitis, (RTI): and vaginosis bacterial chlamydia, trichomoniasis a) Diagnosis of anaemia acid and folic Iron b) supplementation Anthelminthic (deworm) c) a) Diagnosis of Pre-eclampsia- Eclampsia Supplement calcium b) aspirin Low-dose c) drugs d) Antihypertensive Magnesium sulfate e) detection for testing a) Glucose insulin-dependent for Treatment b) diabetic mother test a) Diagnosis and laboratory monitoring Fetal b) antibiotics if indicated a) Provision Syringe for insulin, sterile, single use X

Syringes, luer, sterile, single use (Capacities ml*) X X X X X X X X

Syringes, reuse prevention (RUP), (Capacities ml*) X X X X X X X X

Bag, urine, collecting, 2000ml X

Catheter, Foley, sterile, single use (Sizes CH*) X Prongs, nasal, oxygen, non sterile, single use X X (Sizes*) Tube, suction, L50cm, catheter tip, sterile, single X use (Sizes CH*) Gloves, examination, latex, non-sterile, single use X X X X X X X X X X X X X X (Sizes*) Gloves, gynaecological, sterile, single use, pair X X (Sizes*) Gloves, surgical, sterile, single use, pair (Sizes*) X

Medical Cardiotocograph (CTG), with accessories X devices - Doppler, foetal (FHR) detector, with Equipment X X accessories Medical Commodities for medical examination & diagnosis X X X X X X X X X X X X X X X X X X X X X X X X X devices - Equipment Grouping Commodities for emergency preparedness X X Counselling Counselling material X X X X X X X X X X X X X X material

81 82 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 26.Medicaldevices for childbirth at HEALTH CENTRE material Counselling Grouping - Equipment Medical devices - Equipment Medical devices devices laboratory Clinical General type Disposable devices - Medical Cardiotocograph (CTG), withaccessories Container, sample, 50ml Name ofdevices Bracelet, identification (Sizes*) Blanket, survival, 220x140cm,non-sterile Bandage, elastic, 7.5cmx5m, roll Gloves, surgical, sterile, singleuse, pair(Sizes*) Gloves, gynaecological, sterile, singleuse, pair(Sizes*) Gloves, examination, latex, non-sterile, singleuse(Sizes*) Tube, suction,L50cm,catheter tip, sterile, singleuse(Sizes CH*) Prongs, nasal, oxygen, non sterile, singleuse(Sizes*) Catheter, urethral, sterile, singleuse(Sizes CH*) Catheter, Foley, sterile, singleuse(Sizes CH*) Bag, urine, collecting, 2000ml Syringes, reuse prevention (RUP),(Capacities ml*) Syringes, luer, sterile, single use(Capacities ml*) Stopcock, 3-way, sterile, singleuse Safety box, for usedsyringes/needles Needles, luer, sterile, singleuse(Sizes G*) Infusion givingset,sterile, singleuse Infusion givingset,burette 100-150ml, sterile, singleuse Cannulas, Intra Venous (IV)short,sterile, singleuse(Sizes G*) Umbilical tape, 3mmx50m,roll, non-sterile Umbilical clamp, sterile, singleuse Tape, medical,roll (Sizes*) Cotton wool, 500g,roll, non-sterile Compress, gauze,sterile &non-sterile, singleuse Test strip, urinalysis (10parameter) Test strip, pregnancy Rapid Diagnostic Test (RDT), HumanImmunodeficiency Virus (HIV),kit Hemoglobinometer, withaccessories Blood glucometer, withaccessories Swab, cotton-tip, tube, sterile Lancet, blood,safety, sterile (Sizes*) Counselling material (see table14) Commodities for labour, delivery &recovery (see table 13) Commodities for emergency preparedness (see table 12) Commodities for medicalexamination &diagnosis (NASG)Non-Pneumatic Anti-ShockGarment Doppler, foetal heartrate (FHR)detector, withaccessories Basic Medical Examination assessment First X X X X X X X a) Check-up vital signs / Vaginal examination preparedness assessment Emergency and referral Emergency X X X X X X X X X X X X X X X X X X X X X X X X X X X a) Emergency care and pre- referral treatment Mother Child- birth care X X a) Monitoring progress of labour

b) Active management of the X X X X X X X X X X X X X third stage of labour (AMTSL): Prophylactic use of uterotonics X X X X X X X X X X c) Spontaneous delivery X X X X X X X X X X X X X X X d) Assisted delivery (vacuum extraction) if needed Assessment for complications Management ofcomplications oflabouranddelivery X X X X X X X X X X X X X X X X a) Diagnosis of complications X X X X b) Fetal monitoring haemorrhage Postpartum (PPH) X X X X X X X X X X X X X X X X a) Use of uterotonics of choice for the treatment of PPH Immunodeficiency Virus (HIV) positive women X X X X X X a) Screening of HIV Human X X X b) Prevention Mother To Child Transmission (PMTCT) 4.Matrix of medical devices in each stage of continuum of care

First Emergency Mother Management of complications of labour and delivery assessment assessment care

Emergency Postpartum Human Basic Medical Child- Assessment for preparedness haemorrhage Immunodefi ciency Virus Examination birth complications and referral (PPH) (HIV) positive women

General type Name of devices a) Check-up vital signs / Vaginal vital signs / Vaginal a) Check-up examination and pre- care a) Emergency treatment referral of labour progress a) Monitoring management of the Active b) of labour (AMTSL): stage third use of uterotonics Prophylactic Spontaneous delivery c) (vacuum delivery d) Assisted if needed extraction) a) Diagnosis of complications monitoring Fetal b) of choice a) Use of uterotonics of PPH the treatment for of HIV a) Screening Child Mother To Prevention b) (PMTCT) Transmission Clinical Container, sample, 50 ml X laboratory devices Lancet, blood, safety, sterile (Sizes*) X Swab, cotton-tip, tube, sterile X Blood glucometer, with accessories X Hemoglobinometer, with accessories X Rapid Diagnostic Test (RDT), Human Immunodefi ciency Virus (HIV), kit X Test strip, pregnancy X Test strip, urinalysis (10 parameter) X Medical Bandage, elastic, 7.5cmx5m, roll X devices - Disposable Blanket, survival, 220x140cm, non-sterile X Bracelet, identifi cation (Sizes*) X X Compress, gauze,sterile & non-sterile, single use X X X X X X X Cotton wool, 500g, roll, non-sterile X X X X X Tape, medical, roll (Sizes*) X X X X X Umbilical clamp, sterile, single use X X Umbilical tape, 3mmx50m, roll, non-sterile X X Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) X X X X X Infusion giving set, burette 100-150ml, sterile, single use X Infusion giving set, sterile, single use X X X X X Needles, luer, sterile, single use (Sizes G*) X X X X Safety box, for used syringes/needles X X X X X Stopcock, 3-way, sterile, single use X X X X Syringes, luer, sterile, single use (Capacities ml*) X X X X Syringes, reuse prevention (RUP), (Capacities ml*) X X X X Bag, urine, collecting, 2000ml X X Catheter, Foley, sterile, single use (Sizes CH*) X X Catheter, urethral, sterile, single use (Sizes CH*) X X X Prongs, nasal, oxygen, non sterile, single use (Sizes*) X X X Tube, suction, L50cm, catheter tip, sterile, single use (Sizes CH*) X X X Gloves, examination, latex, non-sterile, single use (Sizes*) X X X X X X X X Gloves, gynaecological, sterile, single use, pair (Sizes*) X X X X X X Gloves, surgical, sterile, single use, pair (Sizes*) X X X X Medical devices Cardiotocograph (CTG), with accessories X - Equipment Doppler, foetal heart rate (FHR) detector, with accessories X X Non-Pneumatic Anti-Shock Garment (NASG) X Medical devices Commodities for medical examination & diagnosis X X X X X X X - Equipment Grouping Commodities for emergency preparedness (see table 12) X X Commodities for labour, delivery & recovery (see table 13) X X X X X X X X X Counselling material Counselling material (see table 14) X

83 84 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health HEALTH CENTRE Table 27. Medicaldevices for post-natal motherat material Counselling Disposable devices - Medical devices laboratory Clinical General type and 16) tables 12,13 Grouping (see Equipment devices - Medical Equipment devices - Medical Counselling material Compress, gauze, sterile &non-sterile, singleuse Blanket, survival, 220x140cm,non-sterile Bandage, elastic, 7.5cmx5m, roll Container, sample, 50ml Name ofdevices Commodities for inpatient motherandnewborn Commodities for emergency preparedness Commodities for medicalexamination &diagnosis Breastpump, manual,withaccessories Gloves, surgical, sterile, singleuse, pair(Sizes*) Gloves, examination, latex, non-sterile, singleuse(Sizes*) CH*) Tube, suction,L50cm,catheter tip, sterile, singleuse(Sizes Prongs, nasal, oxygen, non sterile, singleuse(Sizes*) Catheter, Foley, sterile, singleuse(Sizes CH*) Bag, urine, collecting, 2000ml Syringes, reuse prevention (RUP),(Capacities ml*) Syringes, luer, sterile, single use(Capacities ml*) Stopcock, 3-way, sterile, singleuse Safety box, for usedsyringes/needles Needles, luer, sterile, singleuse(Sizes G*) Infusion givingset,sterile, singleuse G*) Cannulas, Intra Venous (IV)short,sterile, singleuse(Sizes Tape, medical,roll (Sizes*) Cotton wool, 500g,roll, non-sterile Test strip, vaginal infection, pH Test strip, urinalysis (10parameter) Rapid Diagnostic Test (RDT), malaria,kit Virus (HIV),kit Rapid Diagnostic Test (RDT), HumanImmunodefi ciency Haemoglobin colour scale (starter kit) Haemoglobin colour scale(refill kit) Hemoglobinometer, withaccessories Swab, cotton-tip, tube, sterile Lancet, blood,safety, sterile (Sizes*) Basic MedicalEx- X a) Check-up vital signs amination First assessment X X X b) Screening for cervix and breast cancer breast feed- Support for ing X X X X X X X X X X a) Management of mastitis / breast abscess preparedness assessment Emergency Emergency Emergency and referral X X X X X X X X X X X X X X X X X X X X a) Emergency care and pre-referral treatment Prevention andmanagementofpost

X X X X X X X X X X X X X X a) Management of post partum bleeding partum bleeding X X X X X

b) Diagnosis of anaemia Anaemia X X c) Iron supplementation X X d) Anthelminthic (deworm) management ofpost partuminfection HIV X X X X X a) Diagnosis and treatment for HIV (Antiretroviral Therapy (ART)) Malaria Detection and X X X X X X X X a) Diagnosis and management of malaria

a) Diagnosis and management X X X X X X X X X

of postpartum endometritis and infection

salpingitis Other

a) Diagnosis and treatment for X X X X X X X X X urinary tract infections: bacteriuria, pyelonephritis 4.Matrix of medical devices in each stage of continuum of care

Emergency Prevention and management of post Detection and First assessment assessment partum bleeding management of post partum infection

Support for Basic Medical Ex- Emergency Other breast feed- preparedness Anaemia HIV Malaria amination infection ing and referral

General type Name of devices a) Check-up vital signs a) Check-up and breast cervix for Screening b) cancer / breast a) Management of mastitis abscess and pre-referral care a) Emergency treatment partum a) Management of post bleeding Diagnosis of anaemia b) supplementation Iron c) d) Anthelminthic (deworm) HIV for a) Diagnosis and treatment (ART)) Therapy (Antiretroviral a) Diagnosis and management of malaria a) Diagnosis and management endometritis and of postpartum salpingitis for a) Diagnosis and treatment bacteriuria, infections: urinary tract pyelonephritis Clinical Container, sample, 50 ml X laboratory devices Lancet, blood, safety, sterile (Sizes*) X X X Swab, cotton-tip, tube, sterile X X Hemoglobinometer, with accessories X Haemoglobin colour scale (refi ll kit) X Haemoglobin colour scale (starter kit) X Rapid Diagnostic Test (RDT), Human Immunodefi ciency X Virus (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit X Test strip, urinalysis (10 parameter) X X Test strip, vaginal infection, pH X X Medical Bandage, elastic, 7.5cmx5m, roll X devices - Disposable Blanket, survival, 220x140cm, non-sterile X Compress, gauze, sterile & non-sterile, single use X X X X X X Cotton wool, 500g, roll, non-sterile X X X X X X Tape, medical, roll (Sizes*) X X X X X X Cannulas, Intra Venous (IV) short, sterile, single use (Sizes X X G*) Infusion giving set, sterile, single use X X Needles, luer, sterile, single use (Sizes G*) X X X Safety box, for used syringes/needles X X X Stopcock, 3-way, sterile, single use X X Syringes, luer, sterile, single use (Capacities ml*) X X X Syringes, reuse prevention (RUP), (Capacities ml*) X X X Bag, urine, collecting, 2000ml X Catheter, Foley, sterile, single use (Sizes CH*) X

Prongs, nasal, oxygen, non sterile, single use (Sizes*) X Tube, suction, L50cm, catheter tip, sterile, single use (Sizes X CH*) Gloves, examination, latex, non-sterile, single use (Sizes*) X X X X X X X X

Gloves, surgical, sterile, single use, pair (Sizes*) X Medical devices - Breastpump, manual, with accessories X Equipment Medical Commodities for medical examination & diagnosis X X X X X X X X X X X X devices - Equipment Grouping (see Commodities for emergency preparedness X X tables 12, 13 and 16) Commodities for inpatient mother and newborn X Counselling Counselling material X X X X X X material

85 86 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health (newborn) at HEALTH CENTRE Table 28.Medicaldevices for post-natal baby devices laboratory Clinical material Counselling Grouping - Equipment Medical devices - Equipment Medical devices Disposable devices - Medical General type (see table16) Commodities for inpatient mother andnewborn Container, sample, 50ml (see table12) Commodities for medicalexamination &diagnosis Breastpump, manual,withaccessories Bandage, elastic, 7.5cmx5m, roll Name ofdevices Lancet, blood,safety, sterile (Sizes*) Counselling material (see table14) Commodities for labour, delivery & recovery Commodities for emergency preparedness (see table13) Gloves, surgical, sterile, singleuse, pair(Sizes*) Gloves, examination, latex, non-sterile, singleuse(Sizes*) (Sizes CH*) Tube, suction,L50cm,catheter tip, sterile, singleuse Prongs, nasal, oxygen, nonsterile, singleuse(Sizes*) Syringes, reuse prevention (RUP),(Capacities ml*) Syringes, luer, sterile, singleuse(Capacities ml*) Syringes, auto-disable (AD), (Capacities ml*) Safety box, for usedsyringes/needles Needles, scalpvein, sterile, singleuse(Sizes G*) Needles, luer, sterile, singleuse(Sizes G*) Infusion givingset,burette 100-150ml, sterile, singleuse Umbilical tape, 3mmx50m,roll, non-sterile Umbilical clamp, sterile, singleuse Tape, medical,roll (Sizes*) Cotton wool, 500g,roll, non-sterile Compress, gauze, sterile &non-sterile, singleuse Bracelet, identification (Sizes*) Blanket, survival, 220x140cm,non-sterile (TPHA), syphilis, kit Treponema Pallidum Haemagglutination Assay Rapid PlasmaReagin (RPR),syphilis, kit Immunodeficiency Virus (HIV),kit Rapid Diagnostic Test (RDT), Human Haemoglobin colour scale (starter kit) Haemoglobin colour scale(refill kit) Hemoglobinometer, withaccessories Swab, cotton-tip, tube, sterile X X X X a) Dry baby thoroughly on mother's

chest skin to skin and cover Immediate care at birth X X X b) Assess breathing Childbirth: Essential newborn care

c) Clamp and cut cord / Check cord X X X X X X X vessels / Check for bleeding and signs of cord infection X X X X X d) Prevent hypothermia when skin to skin is not possible X X X X e) Support breastfeeding within the fi rst hour Emergency X X X X X X

a) Basic neonatal resuscitation support

b) Management of brain injury and intracranial haemorrhage (ICH) Routine X X X a) Full clinical examination / Check vital signs / measuring weight care X X X X X b) Thermal Care X X X X c) Breastfeeding support X X X X X X X X X X X d) Vitamin K prophylaxis and Immunization X X X X X X e) Cord care X X X X f) Prophylaxis for eye infection X X X X X X X X g) Prophylactic antibiotics for neonates at risk of infection management ofcongenital X X X X X X X X

a) Diagnosis of congenital syphilis Congenital infections Detection and infections X X X X X X X X b) Prophylactic treatment for congenital syphilis X X X X X X X c) Screening of HIV (Dried Blood Spot (DBS))

X X X d) Prophylactic treatment for HIV (Antiretroviral Therapy (ART)) infec- Cord complications intheneonate and tion common infections, illness and Detection andmanagementof X X X X X X X X X X X X a) Detection and management of cord infection monia Pneu- X X a) Diagnosis of pneumonia young infant rhoea Diar- X X X X X X X X X X a) Detection and management of diarrhoea emergency prepared- ness and referral Triage, a) Detection of emergency signs, X X X X X X X X X X X emergency care and pre-referral treatment

a) Full clinical examination / check Further assessment for all X X X X X X X X X X vital signs / measuring weight / check haemoglobin young infant

b) Provision of vaccines (Diphtheria Clinical visit Pertussis Tetanus (DPT) + X X X X X X Haemophilus Infl uenzae type B (HIB), Oral Polio Vaccine (OPV), Hepatitis B) X X X c) Breastfeeding support and replacement feeding if necessary X X d) Monitoring growth and development 4.Matrix of medical devices in each stage of continuum of care

Detection and management of Detection and common infections, illness and Further assessment for all Childbirth: Essential newborn care management of congenital complications in the neonate and young infant infections young infant

Triage, Cord emergency Emergency Routine Pneu- Diar- Immediate care at birth Congenital infections infec- prepared- Clinical visit support care monia rhoea tion ness and referral

General type Name of devices a) Dry baby thoroughly on mother's on thoroughly baby Dry a) skin and cover skin to chest breathing Assess b) cord Check / cord cut and Clamp c) bleeding and / Check for vessels infection signs of cord when skin hypothermia d) Prevent skin is not possible to within the Support breastfeeding e) hour rst fi resuscitation a) Basic neonatal injury and Management of brain b) haemorrhage (ICH) intracranial / Check a) Full clinical examination vital signs / measuring weight Care Thermal b) support Breastfeeding c) and K prophylaxis d) Vitamin Immunization care Cord e) infection eye for f) Prophylaxis antibiotics for g) Prophylactic risk of infection at neonates syphilis a) Diagnosis of congenital for treatment Prophylactic b) syphilis congenital of HIV (Dried Blood Screening c) Spot (DBS)) HIV for treatment d) Prophylactic (ART)) Therapy (Antiretroviral and management of a) Detection infection cord a) Diagnosis of pneumonia and management of a) Detection diarrhoea signs, of emergency a) Detection and pre-referral care emergency treatment / check a) Full clinical examination / vital signs / measuring weight check haemoglobin (Diphtheria of vaccines Provision b) (DPT) + Tetanus Pertussis uenzae type B (HIB), Haemophilus Infl Hepatitis (OPV), Vaccine Polio Oral B) support and Breastfeeding c) if necessary feeding replacement and growth d) Monitoring development Clinical Container, sample, 50 ml X laboratory devices Lancet, blood, safety, sterile (Sizes*) X X Swab, cotton-tip, tube, sterile X X Hemoglobinometer, with accessories X Haemoglobin colour scale (refi ll kit) X Haemoglobin colour scale (starter kit) X Rapid Diagnostic Test (RDT), Human X Immunodefi ciency Virus (HIV), kit Rapid Plasma Reagin (RPR), syphilis, kit X Treponema Pallidum Haemagglutination Assay X (TPHA), syphilis, kit Medical Bandage, elastic, 7.5cmx5m, roll X devices - Disposable Blanket, survival, 220x140cm, non-sterile X X X Bracelet, identifi cation (Sizes*) X X Compress, gauze, sterile & non-sterile, single use X X X X X X X X X X X X Cotton wool, 500g, roll, non-sterile X X X X Tape, medical, roll (Sizes*) X X Umbilical clamp, sterile, single use X Umbilical tape, 3mmx50m, roll, non-sterile X Infusion giving set, burette 100-150ml, sterile, single use X Needles, luer, sterile, single use (Sizes G*) X X X X X X Needles, scalp vein, sterile, single use (Sizes G*) X X Safety box, for used syringes/needles X X X X X X X X Syringes, auto-disable (AD), (Capacities ml*) X X Syringes, luer, sterile, single use (Capacities ml*) X X X X X X Syringes, reuse prevention (RUP), (Capacities ml*) X X X X X X Prongs, nasal, oxygen, non sterile, single use (Sizes*) X Tube, suction, L50cm, catheter tip, sterile, single use X (Sizes CH*) Gloves, examination, latex, non-sterile, single use (Sizes*) X X X X X X X X X X X X X X X X X X X X X X Gloves, surgical, sterile, single use, pair (Sizes*) X X Medical devices Breastpump, manual, with accessories X - Equipment Medical devices Commodities for medical examination & diagnosis X X X X X X X X X X X X X X X X X X X X X X X X X - Equipment (see table 12) Grouping Commodities for emergency preparedness (see table 13) X X X Commodities for labour, delivery & recovery X X X X X X (see table 14) Commodities for inpatient mother and newborn X X X X X X X X X X X X X (see table 16) Counselling Counselling material X X X X X X X X X X material 87 88 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health childhood at HEALTH CENTRE Table 29. Medicaldevices for infancy and General type devices laboratory Clinical Disposable devices - Medical Equipment devices - Medical Grouping Equipment devices - Medical material Counselling Name ofdevices Swab, cotton-tip, tube, sterile Blood glucometer, withaccessories Hemoglobinometer, withaccessories Haemoglobin colour scale(refill kit) Haemoglobin colour scale(starter kit) Immunodeficiency Virus (HIV),kit Rapid Diagnostic Test (RDT), Human Rapid Diagnostic Test (RDT), malaria,kit Test strip, urinalysis (10parameter) Lancet, blood,safety, sterile (Sizes*) Blanket, survival, 220x140cm,non-sterile Bracelet, identification (Sizes*) Compress, gauze, sterile &non-sterile, single use Cotton wool, 500g,roll, non-sterile Tape, medical,roll (Sizes*) use (Sizes G*) Cannulas, Intra Venous (IV)short,sterile, single single use Infusion givingset,burette 100-150ml, sterile, Needles, luer, sterile, singleuse(Sizes G*) Bandage, elastic, 7.5cmx5m, roll Needles, scalpvein, sterile, singleuse(Sizes G*) Safety box, for usedsyringes/needles Stopcock, 3-way, sterile, single use Syringes, auto-disable (AD), (Capacities ml*) Syringes, luer, sterile, singleuse(Capacities ml*) Syringes, reuse prevention (RUP), (Capacities ml*) Prongs, nasal,oxygen, nonsterile, singleuse(Sizes*) use (Sizes CH*) Tube, suction,L50cm,catheter tip, sterile, single (Sizes*) Gloves, examination, latex, non-sterile, singleuse Gloves, surgical, sterile, singleuse, pair(Sizes*) (see table 13) Commodities for emergency preparedness Commodities for inpatient child(see table 17) Breastpump, manual,with accessories (see table12) Commodities for medicalexamination &diagnosis Counselling material X X X a) Full clinical examination / check Essential care for monitoring vital signs / measuring weight growth andearlychildhood X X X X X X X X b) Provision of vaccines development Routine care X X c) Growth monitoring

X d) Early childhood development monitoring X X X e) Breastfeeding support and replacement feeding if necessary X f) Vitamin A supplementation

X g) Deworming (Mebendazole) Severe Acute infancy andchildhood Malnutrition X X X X X X X X X X X X a) Diagnosis of SAM common infections, complications in (SAM) management of Detection and X X X X X X X X X X X X X X X X X b) Feeding support illness and X X X X X X X X X X X X X X X X X X X c) Pre-referral treatment for SAM Anaemia X X X X X X X X X X X a) Diagnosis of anaemia X X X X X X X X X X X X X X X X X X b) Management of anaemia Pneumo- X X a) Differential diagnosis for pneumonia nia X X X X X X X X X X X X X X X X b) Management of pneumonia and its complications (Asthma, Bronchi- Wheeze X X a) Diagnosis of condition with olitis) wheeze X X X X X X X X X X X X X b) Management of condition with wheeze Tubercu- X X a) Diagnosis of tuberculosis losis X X X X X X X X X X X X X X X X b) Management of tuberculosis rhoea a) Differential diagnosis and Diar- X X X X X X X X X X X X X X management of diarrhoea and dysentery Malaria X X X X X a) Diagnosis and management of malaria fever Den- gue X X X X a) Diagnosis and management of dengue fever Mea- sles X X X X X X X X X a) Diagnosis and management of measles Human Immu- nodeficiency X X X X X X X X X a) Diagnosis of HIV Virus (HIV) X X b) Treatment for HIV (Antiretroviral Therapy (ART)) X X X X X X X X X X X X X X c) Management of other opportunistic infections in HIV infec- tion Eye Eye X X X X X X X X X a) Detection and management of eye infection / conjunctivitis infec- tion Ear X X X X X X X X X a) Detection and management of ear infection Mouth infec- tion X X X X X X X X X a) Detection and management of mouth infection / thrush infec- Skin tion X X X X X X X X X a) Diagnosis and management of skin infections en pox Chick- X X X X X X X X X a) Detection and management of chicken pox preparedness and referral Supportive emergency care for all sick infant and child Triage, a) Detection of emergency signs, X X X X X X X X X X X X X X X X X X X emergency care and pre-referral treatment 4.Matrix of medical devices in each stage of continuum of care Detection and management of Supportive Essential care for monitoring common infections, care for all growth and early childhood illness and sick infant development complications in and child infancy and childhood Wheeze Triage, Severe Acute Den- Human Immu- Eye Ear Mouth Skin Pneumo- (Asthma, Tubercu- Diar- Mea- Chick- emergency Routine care Malnutrition Anaemia Malaria gue nodefi ciency infec- infec- infec- infec- nia Bronchi- losis rhoea sles en pox preparedness (SAM) fever Virus (HIV) tion tion tion tion olitis) and referral

General type Name of devices a) Full clinical examination / check a) Full clinical examination vital signs / measuring weight of vaccines Provision b) monitoring Growth c) d) Early childhood development monitoring support and Breastfeeding e) if necessary feeding replacement f) A supplementation Vitamin (Mebendazole) g) Deworming a) Diagnosis of SAM support Feeding b) SAM for treatment Pre-referral c) a) Diagnosis of anaemia Management of anaemia b) diagnosis for a) Differential pneumonia Management of pneumonia and b) its complications with a) Diagnosis of condition wheeze with Management of condition b) wheeze a) Diagnosis of tuberculosis Management of tuberculosis b) diagnosis and a) Differential management of diarrhoea and dysentery a) Diagnosis and management of malaria a) Diagnosis and management of dengue fever a) Diagnosis and management of measles a) Diagnosis of HIV HIV (Antiretroviral for Treatment b) (ART)) Therapy Management of other c) in HIV infections opportunistic and management of a) Detection / conjunctivitis infection eye and management of a) Detection ear infection and management of a) Detection / thrush mouth infection a) Diagnosis and management of skin infections and management of a) Detection pox chicken signs, of emergency a) Detection and pre-referral care emergency treatment Clinical Lancet, blood, safety, sterile (Sizes*) X X X X X X laboratory devices Swab, cotton-tip, tube, sterile X X X X Blood glucometer, with accessories X Hemoglobinometer, with accessories X X X Haemoglobin colour scale (refi ll kit) X X Haemoglobin colour scale (starter kit) X X Rapid Diagnostic Test (RDT), Human X Immunodefi ciency Virus (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit X Test strip, urinalysis (10 parameter) X Medical Bandage, elastic, 7.5cmx5m, roll X X devices - Disposable Blanket, survival, 220x140cm, non-sterile X X Bracelet, identifi cation (Sizes*) X X X X Compress, gauze, sterile & non-sterile, single use X X X X X X X X X X X X X X X X X X Cotton wool, 500g, roll, non-sterile X X X X X X X X X X X X X X X X X X X Tape, medical, roll (Sizes*) X X X X X X X X X X X X X Cannulas, Intra Venous (IV) short, sterile, single X X X X X X X X use (Sizes G*) Infusion giving set, burette 100-150ml, sterile, X X X X X X X X single use Needles, luer, sterile, single use (Sizes G*) X X X X X X X X X X X X X X X X Needles, scalp vein, sterile, single use (Sizes G*) X X X X X X X X Safety box, for used syringes/needles X X X X X X X X X X X X X X X X X X X Stopcock, 3-way, sterile, single use X X X X X Syringes, auto-disable (AD), (Capacities ml*) X Syringes, luer, sterile, single use (Capacities ml*) X X X X X X X X X X X X X X X Syringes, reuse prevention (RUP), (Capacities ml*) X X X X X X X X X X X X X X X X Prongs, nasal, oxygen, non sterile, single use (Sizes*) X X X X X X Tube, suction, L50cm, catheter tip, sterile, single X X X X X X use (Sizes CH*) Gloves, examination, latex, non-sterile, single use X X X X X X X X X X X X X X X X X X X X (Sizes*) Gloves, surgical, sterile, single use, pair (Sizes*) X Medical devices - Breastpump, manual, with accessories X X Equipment Medical Commodities for medical examination & diagnosis X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X devices - (see table 12) Equipment Commodities for emergency preparedness X X X X X X Grouping (see table 13) Commodities for inpatient child (see table 17) X X X X X X X X X Counselling Counselling material X X X X X X X X X X X X material 89 90 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health reproductive healthat DISTRICT HOSPITAL Table 30. Medicaldevices for family planningand health at DISTRICT HOSPITAL Table 30Medicaldevices for family planningandreproductive General type devices laboratory Clinical devices Family planning Name ofdevices Container, sample, 50ml Lancet, blood,safety, sterile (Sizes*) Needle holder, vacuum tubes,sterile Needle, vacuum tube, sterile (Size*) Swab, cotton-tip, tube, sterile (EDTA) Tube, capillary, Ethylene DiamineTetra-acetic Acid (EDTA), sterile (Capacity*) Tube, vacuum, Ethylene DiamineTetra-acetic Acid Tube, vacuum, plain/dry, sterile (Capacity*) Cytology stain, kit Enzyme ImmunoAssay (EIA), gonorrhea Ag, kit ciency Virus (HIV),kit Enzyme ImmunoAssay (EIA), Human Immunodefi- Nucleic Acid Test (NAT), chlamydia, kit Nucleic Acid Test (NAT), gonorrhea,kit Intra-Uterine Devices (only prequalified copper IUDs) Female condoms Diaphragm Cervical cap (HPV), kit Nucleic Acid Test (NAT), HumanPapilloma Virus ciency Virus (HIV),kit Rapid Diagnostic Test (RDT), HumanImmunodefi- Rapid Diagnostic Test (RDT), malaria,kit Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit Rapid PlasmaReagin (RPR),syphilis, kit (TPHA), syphilis, kit Treponema Pallidum Haemagglutination Assay Test strip, pregnancy Test strip, urinalysis (10parameter) Test strip, vaginal infection, pH Sub-dermal implants(included theinsertiondevice) Male condoms Lubricants Levonorgestrel Intra Uterin Device (IUD) cal Examina- Basic Medi-

a) Check-up vital signs / measuring First assessment

weight and height / Anthropometry tion

X b) Pelvic examination Immuni- Preven- zation tive a) Vaccine for Hepatitis B

a) Provision of oral contraceptives Contraceptive methodselection a) Provision of injectable Provision ofcontraceptives contraceptives X X a) Insertion and removal of Intrauterine device (IUD)s

X a) Insertion and removal of contra- ceptive implants with anaesthesia X X X X X a) Provision of barriers methods

X a) Provision of emergency contraception a) Provision of vaginal rings and patches a) Vasectomy with local anaesthe- sia

a) Tubal ligation Detection andmanagementofSexually Transmitted Infection (STI) and Syphilis X X X X X a) Screening / diagnosis of Syphilis by laboratory test b) Treatment for Syphilis Immunodefi- X X X X X X X X X a) Screening of HIV ciency Virus Human Human (HIV) b) Treatment for HIV (Antiretroviral Therapy (ART)) c) Provide post exposure prophy- laxis for HIV discordant couple Gonor- X X X X X X

a) Screening / diagnosis of Gonor- rhoea

rhoea other infections b) Treatment for Gonorrhoea X X X X X mydia

a) Screening / diagnosis of Chla- Chla- mydia b) Treatment for Chlamydia

a) Prophylactic antimalarial (IPT) Malaria X X b) Diagnosis of malaria

c) Management of malaria a) Diagnosis and treatment for infections X X

urinary tract infections: bacteriuria, Other pyelonephritis a) Diagnosis and treatment for X X X X bacterial vaginosis, trichomonas, candidiasis Screening andmanagementofcancers of X X a) Papanicolaou test

X b) Visual Inspection with Acetic Acid (VIA / VIAM) Cervix cancer the reproductive system X X c) Human Papilloma Virus (HPV) test

X d) Colposcopy

X e) Colposcopy and Biopsy / Pa- thology lab-test

X f) Treatment for precancerous le- sion (cryotherapy) Breast cancer a) Breast examination b) Diagnostic by image (mammography, ultrasound) c) Biopsy / Pathology lab-test Post-rape Manage- violence gender- ment of (GBV) based care X X X X X X X X X X X X X X X X X X X X a) Management of post-rape care 4. Matrix of medical devices in each stage of continuum of care Table 30 Medical devices for family planning and reproductive Manage- health at DISTRICT HOSPITAL ment of Detection and management of Sexually Transmitted Infection (STI) and Screening and management of cancers of gender- First assessment Provision of contraceptives other infections the reproductive system based violence (GBV)

Preven- Human Basic Medi- tive Immunodefi - Gonor- Chla- Other Post-rape cal Examina- Contraceptive method selection Syphilis Malaria Cervix cancer Breast cancer Immuni- ciency Virus rhoea mydia infections care tion zation (HIV)

General type Name of devices a) Check-up vital signs / measuring a) Check-up and height / Anthropometry weight examination Pelvic b) B Hepatitis for a) Vaccine contraceptives of oral a) Provision of injectable a) Provision contraceptives of a) Insertion and removal (IUD)s device Intrauterine of contra- a) Insertion and removal implants with anaesthesia ceptive of barriers methods a) Provision of emergency a) Provision contraception rings and of vaginal a) Provision patches with local anaesthe- a) Vasectomy sia ligation a) Tubal / diagnosis of Syphilis a) Screening test laboratory by Syphilis for Treatment b) of HIV a) Screening HIV (Antiretroviral for Treatment b) (ART)) Therapy prophy- exposure post Provide c) couple HIV discordant laxis for / diagnosis of Gonor- a) Screening rhoea Gonorrhoea for Treatment b) / diagnosis of Chla- a) Screening mydia Chlamydia for Treatment b) antimalarial (IPT) a) Prophylactic Diagnosis of malaria b) Management of malaria c) for a) Diagnosis and treatment bacteriuria, infections: urinary tract pyelonephritis for a) Diagnosis and treatment trichomonas, vaginosis, bacterial candidiasis test a) Papanicolaou Acid Inspection with Acetic Visual b) (VIA / VIAM) (HPV) Virus Human Papilloma c) test d) Colposcopy / Pa- and Biopsy Colposcopy e) thology lab-test le- precancerous for f) Treatment sion (cryotherapy) examination a) Breast image by Diagnostic b) ultrasound) (mammography, lab-test / Pathology Biopsy c) care a) Management of post-rape Clinical Container, sample, 50 ml X X X X X laboratory devices Lancet, blood, safety, sterile (Sizes*) X X X X Needle holder, vacuum tubes, sterile X X Needle, vacuum tube, sterile (Size*) X X Swab, cotton-tip, tube, sterile X X X X X X X X X X X X Tube, capillary, Ethylene Diamine Tetra-acetic Acid X X (EDTA) Tube, vacuum, Ethylene Diamine Tetra-acetic Acid X X (EDTA), sterile (Capacity*) Tube, vacuum, plain/dry, sterile (Capacity*) X X Cytology stain, kit X Enzyme Immuno Assay (EIA), gonorrhea Ag, kit X X Enzyme Immuno Assay (EIA), Human Immunodefi - X X ciency Virus (HIV), kit Nucleic Acid Test (NAT), chlamydia, kit X X Nucleic Acid Test (NAT), gonorrhea, kit X X Nucleic Acid Test (NAT), Human Papilloma Virus X (HPV), kit Rapid Diagnostic Test (RDT), Human Immunodefi - X X ciency Virus (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit X Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit X X Rapid Plasma Reagin (RPR), syphilis, kit X X Treponema Pallidum Haemagglutination Assay X X (TPHA), syphilis, kit Test strip, pregnancy X X Test strip, urinalysis (10 parameter) X X X X X Test strip, vaginal infection, pH X X X X Family planning Cervical cap X devices Diaphragm X Female condoms X Intra-Uterine Devices (only prequalifi ed copper IUDs) X X X Levonorgestrel Intra Uterin Device (IUD) X Lubricants X Male condoms X Sub-dermal implants (included the insertion device) X

91 92 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health health at DISTRICT HOSPITAL Table 30Medicaldevices for family planningandreproductive General type Disposable devices - Medical Equipment devices - Medical Grouping Equipment devices - Medical material Counselling Name ofdevices Blanket, survival, 220x140cm,non-sterile Compress, gauze,sterile &non-sterile, singleuse Cotton wool, 500g,roll, non-sterile Tape, medical,roll (Sizes*) use (Sizes G*) Cannulas, Intra Venous (IV)short,sterile, single Infusion givingset,sterile, singleuse Needles, luer, sterile, singleuse(Sizes G*) Needles, spinal,sterile, singleuse(Sizes*) Needles, scalpvein, sterile, single use (Sizes G*) Safety box, for usedsyringes/needles Syringes, luer, sterile, singleuse(Capacities ml*) Syringes, auto-disable (AD), (Capacities ml*) Syringes, reuse prevention (RUP),(Capacities ml*) Airway, Guedel,translucent (Sizes*) Catheter, urethral, sterile, singleuse(Sizes CH*) (Sizes*) Prongs, nasal,oxygen, nonsterile, single use (Sizes ID*) Tube, endotracheal, withcuff, sterile, singleuse use (Sizes CH*) Tube, suction,L50cm,catheter tip, sterile, single (Sizes*) Gloves, gynaecological, sterile, singleuse, pair (Sizes*) Gloves, examination, latex, non-sterile, singleuse Gloves, surgical, sterile, singleuse, pair(Sizes*) with needle(Shapes*andsizes*), sterile, singleuse Suture, synthetic, absorbable(Sizes USP/DEC*) single use DEC*) withneedle(Shapes*andsizes*), sterile, Suture, synthetic, non-absorbable(Sizes USP/ Breast biopsy system Colposcope withbiopsy set Cryosurgical unitwithtankandaccesories Acid Magnifying lensfor Visual InspectionwithAcetic Mammograph withprinter andaccessories Commodities for surgery &anaesthesia Commodities for medicalexamination &diagnosis Commodities for inpatient motherand newborn Counselling material cal Examina- Basic Medi- First assessment X X a) Check-up vital signs / measuring

weight and height / Anthropometry tion X X X X b) Pelvic examination Immuni- Preven- zation tive X X X X X a) Vaccine for Hepatitis B

X a) Provision of oral contraceptives Contraceptive methodselection Provision ofcontraceptives X X X X X X X X X a) Provision of injectable contraceptives X X X X X a) Insertion and removal of Intrauterine device (IUD)s X X X X X X X X X X X a) Insertion and removal of contra- ceptive implants with anaesthesia X X a) Provision of barriers methods X X X X X a) Provision of emergency contraception X X a) Provision of vaginal rings and patches X X X X X X X X X X X X X a) Vasectomy with local anaesthe- sia X X X X X X X X X X X X X X X X X X X X X X a) Tubal ligation Detection andmanagementofSexually Transmitted Infection (STI) and Syphilis X X a) Screening / diagnosis of Syphilis by laboratory test X X X X X X X X b) Treatment for Syphilis Immunodefi- X X a) Screening of HIV ciency Virus Human Human (HIV)

X b) Treatment for HIV (Antiretroviral Therapy (ART)) X X c) Provide post exposure prophy- laxis for HIV discordant couple Gonor- X X

a) Screening / diagnosis of Gonor- rhoea

rhoea other infections X X X X X X X X b) Treatment for Gonorrhoea X X mydia

a) Screening / diagnosis of Chla- Chla- mydia X X X X X X X X b) Treatment for Chlamydia X X X X X X X a) Prophylactic antimalarial (IPT) Malaria X X b) Diagnosis of malaria X X X X X X X X X X X X X c) Management of malaria a) Diagnosis and treatment for infections X X X X X X X X X X X X

urinary tract infections: bacteriuria, Other pyelonephritis a) Diagnosis and treatment for X X X X X X X X X X X X bacterial vaginosis, trichomonas, candidiasis Screening andmanagementofcancers of X X a) Papanicolaou test X X X X X X X X X b) Visual Inspection with Acetic Acid (VIA / VIAM) Cervix cancer the reproductive system X X c) Human Papilloma Virus (HPV) test X X X X d) Colposcopy X X X X e) Colposcopy and Biopsy / Pa- thology lab-test X X X X X f) Treatment for precancerous le- sion (cryotherapy) Breast cancer X X a) Breast examination X X b) Diagnostic by image (mammography, ultrasound) X X X X X X X X X X c) Biopsy / Pathology lab-test X Post-rape Manage- violence gender- ment of (GBV) based care X X X X X X X X X X X X a) Management of post-rape care 4. Matrix of medical devices in each stage of continuum of care Table 30 Medical devices for family planning and reproductive Manage- health at DISTRICT HOSPITAL ment of Detection and management of Sexually Transmitted Infection (STI) and Screening and management of cancers of gender- First assessment Provision of contraceptives other infections the reproductive system based violence (GBV)

Preven- Human Basic Medi- tive Immunodefi - Gonor- Chla- Other Post-rape cal Examina- Contraceptive method selection Syphilis Malaria Cervix cancer Breast cancer Immuni- ciency Virus rhoea mydia infections care tion zation (HIV)

General type Name of devices a) Check-up vital signs / measuring a) Check-up and height / Anthropometry weight examination Pelvic b) B Hepatitis for a) Vaccine contraceptives of oral a) Provision of injectable a) Provision contraceptives of a) Insertion and removal (IUD)s device Intrauterine of contra- a) Insertion and removal implants with anaesthesia ceptive of barriers methods a) Provision of emergency a) Provision contraception rings and of vaginal a) Provision patches with local anaesthe- a) Vasectomy sia ligation a) Tubal / diagnosis of Syphilis a) Screening test laboratory by Syphilis for Treatment b) of HIV a) Screening HIV (Antiretroviral for Treatment b) (ART)) Therapy prophy- exposure post Provide c) couple HIV discordant laxis for / diagnosis of Gonor- a) Screening rhoea Gonorrhoea for Treatment b) / diagnosis of Chla- a) Screening mydia Chlamydia for Treatment b) antimalarial (IPT) a) Prophylactic Diagnosis of malaria b) Management of malaria c) for a) Diagnosis and treatment bacteriuria, infections: urinary tract pyelonephritis for a) Diagnosis and treatment trichomonas, vaginosis, bacterial candidiasis test a) Papanicolaou Acid Inspection with Acetic Visual b) (VIA / VIAM) (HPV) Virus Human Papilloma c) test d) Colposcopy / Pa- and Biopsy Colposcopy e) thology lab-test le- precancerous for f) Treatment sion (cryotherapy) examination a) Breast image by Diagnostic b) ultrasound) (mammography, lab-test / Pathology Biopsy c) care a) Management of post-rape Medical Blanket, survival, 220x140cm, non-sterile X devices - Disposable Compress, gauze,sterile & non-sterile, single use X X X X X X X X X X X X X X X X X X X Cotton wool, 500g, roll, non-sterile X X X X X X X X X X Tape, medical, roll (Sizes*) X X X X X Cannulas, Intra Venous (IV) short, sterile, single X X X X use (Sizes G*) Infusion giving set, sterile, single use X X X X Needles, luer, sterile, single use (Sizes G*) X X X X X X X X X X X X X X Needles, scalp vein, sterile, single use (Sizes G*) X Needles, spinal, sterile, single use (Sizes*) X Safety box, for used syringes/needles X X X X X X X X X X X X X X X Syringes, auto-disable (AD), (Capacities ml*) X Syringes, luer, sterile, single use (Capacities ml*) X X X X X X X X X X X X X X Syringes, reuse prevention (RUP), (Capacities ml*) X X X X X X X X X X X X X X Airway, Guedel, translucent (Sizes*) X Catheter, urethral, sterile, single use (Sizes CH*) X Prongs, nasal, oxygen, non sterile, single use X (Sizes*) Tube, endotracheal, with cuff, sterile, single use X (Sizes ID*) Tube, suction, L50cm, catheter tip, sterile, single X use (Sizes CH*) Gloves, examination, latex, non-sterile, single use X X X X X X X X X X X X X X X X X X X X X X X X X X X X X (Sizes*) Gloves, gynaecological, sterile, single use, pair X X X X (Sizes*) Gloves, surgical, sterile, single use, pair (Sizes*) X X X Suture, synthetic, absorbable (Sizes USP/DEC*) X X X with needle (Shapes* and sizes*), sterile, single use Suture, synthetic, non-absorbable (Sizes USP/ DEC*) with needle (Shapes* and sizes*), sterile, X X X single use Medical Breast biopsy system X devices - Equipment Colposcope with biopsy set X X X X Cryosurgical unit with tank and accesories X Magnifying lens for Visual Inspection with Acetic X Acid Mammograph with printer and accessories X X Medical Commodities for medical examination & diagnosis X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X devices - Equipment Commodities for surgery & anaesthesia X X X X Grouping Commodities for inpatient mother and newborn X X X X Counselling material Counselling material X X X X X X X X X X X X X 93 94 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health DISTRICT HOSPITAL Table 31.Medicaldevices for pregnancy at General type Table 31.Medicaldevices for pregnancy at DISTRICT HOSPITAL devices Blood Bank devices laboratory Clinical Nameofdevices Anti-A bloodgroup reagent, monoclonal Anti-B bloodgroup reagent, monoclonal Container, sample, 50ml Anti-D bloodgroup reagent (Saline/monoclonal) Blood administration set,sterile Glass slides,25x75mm Markers, fine point,permanentblack,for glassware non-sterile, 3ml Pasteur pipettes withintegral bulb, disposable, plastic Wooden orplastic applicator sticks Lancet, blood,safety, sterile (Sizes*) Swab, cotton-tip, tube, sterile Needle, vacuum tube, sterile (Size*) Needle holder, vacuum tubes,sterile Blood glucometer, withaccessories Tube, vacuum, plain/dry, sterile (Capacity*) (EDTA), sterile (Capacity*) Tube, vacuum, Ethylene DiamineTetra-acetic Acid (EDTA) Tube, capillary, Ethylene DiamineTetra-acetic Acid Hemoglobinometer, withaccessories Enzyme ImmunoAssay (EIA),gonorrheaAg, kit Nucleic Acid Test (NAT), chlamydia, kit Enzyme ImmunoAssay (EIA),Rubella,kit Virus (HIV),kit Enzyme ImmunoAssay (EIA),HumanImmunodefi ciency Nucleic Acid Test (NAT), gonorrhea,kit Test strip, pregnancy syphilis, kit Treponema Pallidum Haemagglutination Assay (TPHA), Rapid PlasmaReagin (RPR),syphilis, kit Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit Rapid Diagnostic Test (RDT), malaria,kit Virus (HIV),kit Rapid Diagnostic Test (RDT), HumanImmunodefi ciency Test strip, urinalysis (10parameter) Test strip, vaginal infection, pH Exami- nation Medi- Basic assessment

a) Check-up vital signs / measuring cal X X weight and height / Anthropometry/ Vaginal examination First Immu- niza- ven- Pre- tion tive a) Vaccine for Tetanus prepar- assess- referral edness gency Emer- gency Emer- ment and X X a) Emergency care and pre-referral treatment Syphilis Detection andmanagementofSexually Transmitted Infection (STI) andother X X X X X a) Screening / diagnosis of Syphilis by laboratory test b) Treatment for Syphilis Virus (HIV) X X X X X X X X X deficiency Immuno-

a) Screening of HIV Human b) Prevention Mother To Child Transmission (PMTCT) infections c) Treatment for HIV (Antiretroviral Therapy (ART)) a) Prophylactic antimalarial (IPT) Malaria X X b) Diagnosis of malaria c) Management of malaria bella Ru- X X a) Diagnosis and treatment for rubella culo- ber- Tu- a) Diagnosis and treatment for sis tuberculosis X X X a) Diagnosis and treatment for urinary infections

tract infections: bacteriuria, pyelonephritis Other a) Diagnosis and treatment of other STI/ X X X X X Reproductive Tract Infections (RTI): Candida vaginitis, gonorrhoea, chlamydia, bacterial vaginosis and trichomoniasis Iron Deficien- X X Detection andmanagementofmaternal a) Diagnosis of anaemia cy Anaemia b) Iron and folic acid supplementation

c) Anthelminthic (deworm) chronic medicalconditions X X X X X X X X X d) Management of severe anaemia (considering blood transfusion) X

a) Diagnosis of Pre-eclampsia-Eclampsia Hypertension and pre-eclampsia b) Supplement calcium c) Low-dose aspirin d) Antihypertensive drugs e) Magnesium sulfate f) Fetal monitoring g) Induction of labour Diabe- X X X

a) Glucose testing for detection tes X X b) Treatment for insulin-dependent diabetic mother ment sess- PRM As- rupture ofthemembranes Management ofprelabour a) Diagnosis and laboratory test of b) Fetal monitoring a) Provision antibiotics if indicated

b) Provision of tocolytics to prolong Preterm pregnancy if indicated (PRM) c) Provision of corticosteroids for prevention of neonatal respiratory distress syndrome d) Provision of magnesium sulfate for neuroprotection of the newborn Term a) Provision antibiotics if indicated b) Induction of labour Manage- ment of malpre- Malpre- tion at tion at senta- senta- term a) Diagnosis of breech at term term b) External Cephalic Version c) Monitoring progress of labour ment of Female mutila- genital mutila- female genital Man- age- tion a) Perineal incision with local anaesthesia tion

b) Identify the need of caesarean section pregnancy pregnancy X Manage- ment of ectopic a) Pregnancy test Ectopic b) Ultrasound scan c) Laparotomy X X X X X X X X X d) Blood transfusion abor- riage Management ofmiscarriage X Mis- car- tion a) Pregnancy test and b) Ultrasound scan carriage a) Treatment of infections and abortion Mis- X X X X X X X X X b) Management of bleeding (considering Vacuum Aspiration and blood transfusion) c) Management of major injuries (considering laparotomy) and legally permitted indicated a) Medical uterine evacuation for the fi rst abortion when trimester Safe b) Vacuum Aspiration for the fi rst trimester c) Medical uterine evacuation beyond the fi rst trimester 4. Matrix of medical devices in each stage of continuum of care Table 31. Medical devices for pregnancy at DISTRICT HOSPITAL Manage- Man- Emer- age- Detection and management of Sexually Management of prelabour ment of ment of Manage- First gency Transmitted Infection (STI) and other Detection and management of maternal malpre- ment of Management of miscarriage assessment assess- chronic medical conditions rupture of the membranes senta- female ectopic and abortion ment infections (PRM) genital tion at mutila- pregnancy term tion Pre- Emer- Mis- Safe Basic ven- gency Human Tu- As- Malpre- Female car- abortion Medi- tive prepar- Immuno- Ru- ber- Other Iron Defi cien- Hypertension and Diabe- sess- senta- genital Ectopic riage Mis- when cal Immu- edness Syphilis defi ciency Malaria bella culo- infections cy Anaemia pre-eclampsia tes ment Preterm Term tion at mutila- pregnancy and carriage indicated Exami- niza- and Virus (HIV) sis of term tion abor- and legally nation tion referral PRM tion permitted

General type Name of devices a) Check-up vital signs / measuring a) Check-up and height / Anthropometry/ weight examination Vaginal Tetanus for a) Vaccine and pre-referral care a) Emergency treatment by / diagnosis of Syphilis a) Screening test laboratory Syphilis for Treatment b) of HIV a) Screening Child Mother To Prevention b) (PMTCT) Transmission HIV (Antiretroviral for Treatment c) (ART)) Therapy antimalarial (IPT) a) Prophylactic Diagnosis of malaria b) Management of malaria c) rubella for a) Diagnosis and treatment for a) Diagnosis and treatment tuberculosis urinary for a) Diagnosis and treatment pyelonephritis bacteriuria, infections: tract of other STI/ a) Diagnosis and treatment (RTI): Infections Tract Reproductive gonorrhoea, chlamydia, Candida vaginitis, and trichomoniasis vaginosis bacterial a) Diagnosis of anaemia acid supplementation and folic Iron b) Anthelminthic (deworm) c) anaemia d) Management of severe blood transfusion) (considering a) Diagnosis of Pre-eclampsia-Eclampsia Supplement calcium b) aspirin Low-dose c) drugs d) Antihypertensive Magnesium sulfate e) f) monitoring Fetal g) Induction of labour detection for testing a) Glucose insulin-dependent diabetic for Treatment b) mother test a) Diagnosis and laboratory monitoring Fetal b) antibiotics if indicated a) Provision prolong to of tocolytics Provision b) if indicated pregnancy for of corticosteroids Provision c) distress respiratory of neonatal prevention syndrome for of magnesium sulfate d) Provision of the newborn neuroprotection antibiotics if indicated a) Provision Induction of labour b) term at a) Diagnosis of breech Version Cephalic External b) of labour progress Monitoring c) incision with local anaesthesia a) Perineal section Identify the need of caesarean b) test a) Pregnancy scan Ultrasound b) Laparotomy c) d) Blood transfusion test a) Pregnancy scan Ultrasound b) of infections a) Treatment Management of bleeding (considering b) and blood transfusion) Aspiration Vacuum Management of major injuries c) laparotomy) (considering rst the fi for evacuation a) Medical uterine trimester trimester rst the fi for Aspiration Vacuum b) the beyond evacuation Medical uterine c) trimester rst fi Blood Bank Anti-A blood group reagent, monoclonal X X X devices Anti-B blood group reagent, monoclonal X X X Anti-D blood group reagent (Saline/monoclonal) X X X Blood administration set, sterile X X X Glass slides, 25x75mm X X X Markers, fi ne point, permanent black, for glassware X X X Pasteur pipettes with integral bulb, disposable, plastic non-sterile, 3 ml X X X Wooden or plastic applicator sticks X X X Clinical Container, sample, 50 ml X X laboratory devices Lancet, blood, safety, sterile (Sizes*) X X X X X X Needle holder, vacuum tubes, sterile X Needle, vacuum tube, sterile (Size*) X Swab, cotton-tip, tube, sterile X X X Tube, capillary, Ethylene Diamine Tetra-acetic Acid (EDTA) X Tube, vacuum, Ethylene Diamine Tetra-acetic Acid (EDTA), sterile (Capacity*) X Tube, vacuum, plain/dry, sterile (Capacity*) X Blood glucometer, with accessories X X X Hemoglobinometer, with accessories X X X X X Enzyme Immuno Assay (EIA), gonorrhea Ag, kit X Enzyme Immuno Assay (EIA), Human Immunodefi ciency Virus (HIV), kit X Enzyme Immuno Assay (EIA), Rubella, kit X Nucleic Acid Test (NAT), chlamydia, kit X Nucleic Acid Test (NAT), gonorrhea, kit X Rapid Diagnostic Test (RDT), Human Immunodefi ciency Virus (HIV), kit X Rapid Diagnostic Test (RDT), malaria, kit X Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit X

Rapid Plasma Reagin (RPR), syphilis, kit X Treponema Pallidum Haemagglutination Assay (TPHA), syphilis, kit X Test strip, pregnancy X X X

Test strip, urinalysis (10 parameter) X X X X X

Test strip, vaginal infection, pH X

95 96 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health - Disposable Medicaldevices General type Table 31.Medicaldevices for pregnancy at DISTRICT HOSPITAL devices Family planning Bracelet, identification (Sizes*) Blanket, survival, 220x140cm,non-sterile Bandage, elastic, 7.5cmx5m, roll Nameofdevices Male condoms Lubricants Female condoms Compress, gauze,sterile &non-sterile, singleuse Cotton wool, 500g,roll, non-sterile Tape, medical,roll (Sizes*) (Sizes G*) Cannulas, Intra Venous (IV) short,sterile, singleuse Infusion givingset,sterile, singleuse Infusion givingset,burette 100-150ml, sterile, singleuse Needles, luer, sterile, singleuse(Sizes G*) Needles, spinal,sterile, singleuse(Sizes*) Safety box, for usedsyringes/needles Stopcock, 3-way, sterile, singleuse Syringe for insulin, sterile, singleuse Syringes, auto-disable (AD), (Capacities ml*) Syringes, luer, sterile, singleuse(Capacities ml*) Syringe for tuberculin, sterile, singleuse Syringes, reuse prevention (RUP),(Capacities ml*) Airway, Guedel, translucent (Sizes*) Bag, urine, collecting, 2000ml Catheter, Foley, sterile, singleuse(Sizes CH*) Exami- nation Medi- Basic assessment

a) Check-up vital signs / measuring cal X weight and height / Anthropometry/ Vaginal examination First Immu- niza- ven- Pre- tion tive X X X a) Vaccine for Tetanus prepar- assess- referral edness gency Emer- gency Emer- ment and X X X X X X X X X X X X X X X X a) Emergency care and pre-referral treatment Syphilis Detection andmanagementofSexually

a) Screening / diagnosis of Syphilis by Transmitted Infection (STI) andother laboratory test X X X X X X b) Treatment for Syphilis Virus (HIV) deficiency Immuno-

a) Screening of HIV Human

X X X b) Prevention Mother To Child Transmission (PMTCT) infections c) Treatment for HIV (Antiretroviral Therapy (ART)) a) Prophylactic antimalarial (IPT) Malaria b) Diagnosis of malaria X X X X X X X X X c) Management of malaria bella Ru- X X X X X a) Diagnosis and treatment for rubella culo- ber- Tu- sis X X X X X X X X X a) Diagnosis and treatment for tuberculosis X X X X X X X X X a) Diagnosis and treatment for urinary infections

tract infections: bacteriuria, pyelonephritis Other a) Diagnosis and treatment of other STI/ X X X X X X X X X Reproductive Tract Infections (RTI): Candida vaginitis, gonorrhoea, chlamydia, bacterial vaginosis and trichomoniasis Iron Deficien- Detection andmanagementofmaternal a) Diagnosis of anaemia cy Anaemia b) Iron and folic acid supplementation

c) Anthelminthic (deworm) chronic medicalconditions X X X X X X X X X X d) Management of severe anaemia (considering blood transfusion) X X X X X X X X X X X X

a) Diagnosis of Pre-eclampsia-Eclampsia Hypertension and pre-eclampsia b) Supplement calcium c) Low-dose aspirin X X X X X X X X X X d) Antihypertensive drugs X X X X X X X X X X e) Magnesium sulfate f) Fetal monitoring X X X X X X X X X X g) Induction of labour Diabe-

a) Glucose testing for detection tes X X X X X X X b) Treatment for insulin-dependent diabetic mother ment sess- PRM X X X X X X X X X X As- rupture ofthemembranes Management ofprelabour a) Diagnosis and laboratory test of b) Fetal monitoring X X X X X X X X X X a) Provision antibiotics if indicated X X X X X X X X X X

b) Provision of tocolytics to prolong Preterm pregnancy if indicated (PRM) c) Provision of corticosteroids for X X X X X X X X X X prevention of neonatal respiratory distress syndrome X X X X X X X X X X d) Provision of magnesium sulfate for neuroprotection of the newborn Term X X X X X X X X X X a) Provision antibiotics if indicated X X X X X X X X X X b) Induction of labour Manage- ment of malpre- Malpre- X X X X X X X tion at tion at senta- senta- term a) Diagnosis of breech at term term X X X X X X X b) External Cephalic Version X X X X X X X c) Monitoring progress of labour ment of Female mutila- genital mutila- female genital X X X X X X X X X X Man- age- tion a) Perineal incision with local anaesthesia tion X X X X X X X X X X X X X b) Identify the need of caesarean section pregnancy pregnancy Manage- ment of ectopic a) Pregnancy test Ectopic X b) Ultrasound scan X X X X X X X X X X X X c) Laparotomy X X X X X d) Blood transfusion abor- riage Management ofmiscarriage Mis- car- tion a) Pregnancy test and b) Ultrasound scan X X X X X X X X X X carriage a) Treatment of infections and abortion Mis- X X X X X X X X X X X X X X b) Management of bleeding (considering Vacuum Aspiration and blood transfusion) X X X X X X X X X X X X X X c) Management of major injuries (considering laparotomy) and legally permitted indicated a) Medical uterine evacuation for the fi rst abortion when trimester Safe X X X X X X X X b) Vacuum Aspiration for the fi rst trimester X X X X X X X X c) Medical uterine evacuation beyond the fi rst trimester 4. Matrix of medical devices in each stage of continuum of care Table 31. Medical devices for pregnancy at DISTRICT HOSPITAL Manage- Man- Emer- age- Detection and management of Sexually Management of prelabour ment of ment of Manage- First gency Transmitted Infection (STI) and other Detection and management of maternal malpre- ment of Management of miscarriage assessment assess- chronic medical conditions rupture of the membranes senta- female ectopic and abortion ment infections (PRM) genital tion at mutila- pregnancy term tion Pre- Emer- Mis- Safe Basic ven- gency Human Tu- As- Malpre- Female car- abortion Medi- tive prepar- Immuno- Ru- ber- Other Iron Defi cien- Hypertension and Diabe- sess- senta- genital Ectopic riage Mis- when cal Immu- edness Syphilis defi ciency Malaria bella culo- infections cy Anaemia pre-eclampsia tes ment Preterm Term tion at mutila- pregnancy and carriage indicated Exami- niza- and Virus (HIV) sis of term tion abor- and legally nation tion referral PRM tion permitted

General type Name of devices a) Check-up vital signs / measuring a) Check-up and height / Anthropometry/ weight examination Vaginal Tetanus for a) Vaccine and pre-referral care a) Emergency treatment by / diagnosis of Syphilis a) Screening test laboratory Syphilis for Treatment b) of HIV a) Screening Child Mother To Prevention b) (PMTCT) Transmission HIV (Antiretroviral for Treatment c) (ART)) Therapy antimalarial (IPT) a) Prophylactic Diagnosis of malaria b) Management of malaria c) rubella for a) Diagnosis and treatment for a) Diagnosis and treatment tuberculosis urinary for a) Diagnosis and treatment pyelonephritis bacteriuria, infections: tract of other STI/ a) Diagnosis and treatment (RTI): Infections Tract Reproductive gonorrhoea, chlamydia, Candida vaginitis, and trichomoniasis vaginosis bacterial a) Diagnosis of anaemia acid supplementation and folic Iron b) Anthelminthic (deworm) c) anaemia d) Management of severe blood transfusion) (considering a) Diagnosis of Pre-eclampsia-Eclampsia Supplement calcium b) aspirin Low-dose c) drugs d) Antihypertensive Magnesium sulfate e) f) monitoring Fetal g) Induction of labour detection for testing a) Glucose insulin-dependent diabetic for Treatment b) mother test a) Diagnosis and laboratory monitoring Fetal b) antibiotics if indicated a) Provision prolong to of tocolytics Provision b) if indicated pregnancy for of corticosteroids Provision c) distress respiratory of neonatal prevention syndrome for of magnesium sulfate d) Provision of the newborn neuroprotection antibiotics if indicated a) Provision Induction of labour b) term at a) Diagnosis of breech Version Cephalic External b) of labour progress Monitoring c) incision with local anaesthesia a) Perineal section Identify the need of caesarean b) test a) Pregnancy scan Ultrasound b) Laparotomy c) d) Blood transfusion test a) Pregnancy scan Ultrasound b) of infections a) Treatment Management of bleeding (considering b) and blood transfusion) Aspiration Vacuum Management of major injuries c) laparotomy) (considering rst the fi for evacuation a) Medical uterine trimester trimester rst the fi for Aspiration Vacuum b) the beyond evacuation Medical uterine c) trimester rst fi Family planning devices Female condoms X

Lubricants X Male condoms X Medical devices - Disposable Bandage, elastic, 7.5cmx5m, roll X

Blanket, survival, 220x140cm, non-sterile X

Bracelet, identifi cation (Sizes*) X X X X X

Compress, gauze,sterile & non-sterile, single use X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Cotton wool, 500g, roll, non-sterile X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Tape, medical, roll (Sizes*) X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Infusion giving set, burette 100-150ml, sterile, single use X

Infusion giving set, sterile, single use X X X X X X X X X X X X X X X X X X X X X X X X X X X

Needles, luer, sterile, single use (Sizes G*) X X X X X X X X X X X X X X X X X X X X X X X X X X X

Needles, spinal, sterile, single use (Sizes*) X X X X X

Safety box, for used syringes/needles X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Stopcock, 3-way, sterile, single use X X X X X X X X X X X X X X X X X X

Syringes, auto-disable (AD), (Capacities ml*) X

Syringe for insulin, sterile, single use X

Syringe for tuberculin, sterile, single use X

Syringes, luer, sterile, single use (Capacities ml*) X X X X X X X X X X X X X X X X X X X X X X X X X

Syringes, reuse prevention (RUP), (Capacities ml*) X X X X X X X X X X X X X X X X X X X X X X X

Airway, Guedel, translucent (Sizes*) X X X X X X

Bag, urine, collecting, 2000ml X X X X X

Catheter, Foley, sterile, single use (Sizes CH*) X X X X X

97 98 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health General type Table 31.Medicaldevices for pregnancy at DISTRICT HOSPITAL Equipment Medical devices - Grouping - Equipment Medical devices material Counselling Nameofdevices Catheter, urethral, sterile, singleuse(Sizes CH*) Prongs, nasal,oxygen, nonsterile, singleuse(Sizes*) ID*) Tube, endotracheal, withcuff, sterile, singleuse(Sizes (Sizes CH*) Tube, suction,L50cm,catheter tip, sterile, singleuse single use(Sizes CH*) Tube, feeding/aspirating, L120cm,catheter tip, sterile, Cardiotocograph (CTG), withaccessories Gloves, examination, latex, non-sterile, singleuse(Sizes*) (see table12) Commodities for medical examination &diagnosis Gloves, gynaecological, sterile, singleuse, pair(Sizes*) Gloves, surgical, sterile, singleuse, pair(Sizes*) needle (Shapes*andsizes*), sterile, singleuse Suture, synthetic, absorbable(Sizes USP/DEC*) with needle (Shapes*andsizes*), sterile, singleuse Suture, synthetic, non-absorbable(Sizes USP/DEC*) with accessories Doppler, foetal heartrate (FHR)detector, with Counselling material Commodities for emergency preparedness (see table13) Commodities for labour, delivery &recovery (see table14) Commodities for surgery &anaesthesia (see table15) table 16) Commodities for inpatient motherandnewborn (see Commodities for intensive care ofmother(see table18) Exami- nation Medi- Basic assessment

a) Check-up vital signs / measuring cal X X X weight and height / Anthropometry/ Vaginal examination First Immu- niza- ven- Pre- tion tive X X a) Vaccine for Tetanus prepar- assess- referral edness gency Emer- gency Emer- ment and X X X X X X X X X X a) Emergency care and pre-referral treatment Syphilis Detection andmanagementofSexually Transmitted Infection (STI) andother X X a) Screening / diagnosis of Syphilis by laboratory test X X b) Treatment for Syphilis Virus (HIV) X X deficiency Immuno-

a) Screening of HIV Human X X b) Prevention Mother To Child Transmission (PMTCT) infections X X c) Treatment for HIV (Antiretroviral Therapy (ART)) X X a) Prophylactic antimalarial (IPT) Malaria X X b) Diagnosis of malaria X X X X c) Management of malaria bella Ru- X X X a) Diagnosis and treatment for rubella culo- ber- Tu- sis X X X X a) Diagnosis and treatment for tuberculosis X X X X a) Diagnosis and treatment for urinary infections

tract infections: bacteriuria, pyelonephritis Other a) Diagnosis and treatment of other STI/ X X X X Reproductive Tract Infections (RTI): Candida vaginitis, gonorrhoea, chlamydia, bacterial vaginosis and trichomoniasis Iron Deficien- X Detection andmanagementofmaternal a) Diagnosis of anaemia cy Anaemia X X b) Iron and folic acid supplementation X X c) Anthelminthic (deworm) chronic medicalconditions X X X X d) Management of severe anaemia (considering blood transfusion) X X X X X X

a) Diagnosis of Pre-eclampsia-Eclampsia Hypertension and pre-eclampsia X X b) Supplement calcium X X c) Low-dose aspirin X X d) Antihypertensive drugs X X e) Magnesium sulfate X X X X f) Fetal monitoring X X X X X X g) Induction of labour Diabe- X

a) Glucose testing for detection tes X X b) Treatment for insulin-dependent diabetic mother ment sess- PRM X X As- rupture ofthemembranes Management ofprelabour a) Diagnosis and laboratory test of X X X X b) Fetal monitoring X X X a) Provision antibiotics if indicated X X X

b) Provision of tocolytics to prolong Preterm pregnancy if indicated (PRM) c) Provision of corticosteroids for X X X prevention of neonatal respiratory distress syndrome X X X d) Provision of magnesium sulfate for neuroprotection of the newborn Term X X X a) Provision antibiotics if indicated X X X X X X b) Induction of labour Manage- ment of malpre- Malpre- X X X X tion at tion at senta- senta- term a) Diagnosis of breech at term term X X X X b) External Cephalic Version X X X X c) Monitoring progress of labour ment of Female mutila- genital mutila- female genital X X X X X X X X X Man- age- tion a) Perineal incision with local anaesthesia tion X X X X X X X X X b) Identify the need of caesarean section pregnancy pregnancy X Manage- ment of ectopic a) Pregnancy test Ectopic X b) Ultrasound scan X X X X X X X X c) Laparotomy X X d) Blood transfusion abor- riage Management ofmiscarriage X Mis- car- tion a) Pregnancy test and X X b) Ultrasound scan X X carriage a) Treatment of infections and abortion Mis- X X X X X X X X b) Management of bleeding (considering Vacuum Aspiration and blood transfusion) X X X X X X X X X c) Management of major injuries (considering laparotomy) and legally permitted indicated X X a) Medical uterine evacuation for the fi rst abortion when trimester Safe X X X X X X X X X b) Vacuum Aspiration for the fi rst trimester X X X X X X X X X c) Medical uterine evacuation beyond the fi rst trimester 4. Matrix of medical devices in each stage of continuum of care Table 31. Medical devices for pregnancy at DISTRICT HOSPITAL Manage- Man- Emer- age- Detection and management of Sexually Management of prelabour ment of ment of Manage- First gency Transmitted Infection (STI) and other Detection and management of maternal malpre- ment of Management of miscarriage assessment assess- chronic medical conditions rupture of the membranes senta- female ectopic and abortion ment infections (PRM) genital tion at mutila- pregnancy term tion Pre- Emer- Mis- Safe Basic ven- gency Human Tu- As- Malpre- Female car- abortion Medi- tive prepar- Immuno- Ru- ber- Other Iron Defi cien- Hypertension and Diabe- sess- senta- genital Ectopic riage Mis- when cal Immu- edness Syphilis defi ciency Malaria bella culo- infections cy Anaemia pre-eclampsia tes ment Preterm Term tion at mutila- pregnancy and carriage indicated Exami- niza- and Virus (HIV) sis of term tion abor- and legally nation tion referral PRM tion permitted

General type Name of devices a) Check-up vital signs / measuring a) Check-up and height / Anthropometry/ weight examination Vaginal Tetanus for a) Vaccine and pre-referral care a) Emergency treatment by / diagnosis of Syphilis a) Screening test laboratory Syphilis for Treatment b) of HIV a) Screening Child Mother To Prevention b) (PMTCT) Transmission HIV (Antiretroviral for Treatment c) (ART)) Therapy antimalarial (IPT) a) Prophylactic Diagnosis of malaria b) Management of malaria c) rubella for a) Diagnosis and treatment for a) Diagnosis and treatment tuberculosis urinary for a) Diagnosis and treatment pyelonephritis bacteriuria, infections: tract of other STI/ a) Diagnosis and treatment (RTI): Infections Tract Reproductive gonorrhoea, chlamydia, Candida vaginitis, and trichomoniasis vaginosis bacterial a) Diagnosis of anaemia acid supplementation and folic Iron b) Anthelminthic (deworm) c) anaemia d) Management of severe blood transfusion) (considering a) Diagnosis of Pre-eclampsia-Eclampsia Supplement calcium b) aspirin Low-dose c) drugs d) Antihypertensive Magnesium sulfate e) f) monitoring Fetal g) Induction of labour detection for testing a) Glucose insulin-dependent diabetic for Treatment b) mother test a) Diagnosis and laboratory monitoring Fetal b) antibiotics if indicated a) Provision prolong to of tocolytics Provision b) if indicated pregnancy for of corticosteroids Provision c) distress respiratory of neonatal prevention syndrome for of magnesium sulfate d) Provision of the newborn neuroprotection antibiotics if indicated a) Provision Induction of labour b) term at a) Diagnosis of breech Version Cephalic External b) of labour progress Monitoring c) incision with local anaesthesia a) Perineal section Identify the need of caesarean b) test a) Pregnancy scan Ultrasound b) Laparotomy c) d) Blood transfusion test a) Pregnancy scan Ultrasound b) of infections a) Treatment Management of bleeding (considering b) and blood transfusion) Aspiration Vacuum Management of major injuries c) laparotomy) (considering rst the fi for evacuation a) Medical uterine trimester trimester rst the fi for Aspiration Vacuum b) the beyond evacuation Medical uterine c) trimester rst fi

Catheter, urethral, sterile, single use (Sizes CH*) X X

Prongs, nasal, oxygen, non sterile, single use (Sizes*) X X X X X X X X X X X

Tube, endotracheal, with cuff, sterile, single use (Sizes ID*) X X X X X X X Tube, feeding/aspirating, L120cm,catheter tip, sterile, single use (Sizes CH*) X

Tube, suction, L50cm, catheter tip, sterile, single use X X X X X X X X X X (Sizes CH*) X

Gloves, examination, latex, non-sterile, single use (Sizes*) X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

Gloves, gynaecological, sterile, single use, pair (Sizes*) X X X X X X X X

Gloves, surgical, sterile, single use, pair (Sizes*) X X X X X X X X

Suture, synthetic, absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use X X X X Suture, synthetic, non-absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use X X X X Medical devices - Equipment Cardiotocograph (CTG), with accessories X X

Doppler, foetal heart rate (FHR) detector, with accessories X X X Medical devices Commodities for medical examination & diagnosis X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X - Equipment (see table 12) X X X X X X X X X X X X X Grouping Commodities for emergency preparedness (see table 13) X X X

Commodities for labour, delivery & recovery (see table 14) X X X X X X X

Commodities for surgery & anaesthesia (see table 15) X X X X X X X

Commodities for inpatient mother and newborn (see table 16) X X X X X X X X X X X X

Commodities for intensive care of mother (see table 18) X Counselling material Counselling material X X X X X X X X X X X X

99 100 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health DISTRICT HOSPITAL Table 32.Medicaldevices for childbirth at - Disposable Medical devices devices laboratory Clinical devices Blood Bank General type Table 32.Medicaldevices for childbirthat DISTRICT HOSPITAL Bracelet, identification (Sizes*) Blanket, survival, 220x140cm,non-sterile Bandage, elastic, 7.5cmx5m, roll Compress, gauze,sterile &non-sterile, singleuse Container, sample, 50ml Anti-A bloodgroup reagent, monoclonal Nameofdevices Test strip, urinalysis (10parameter) Test strip, pregnancy Immunodeficiency Virus (HIV),kit Rapid Diagnostic Test (RDT), Human Immunodeficiency Virus (HIV),kit Enzyme ImmunoAssay (EIA),Human Hemoglobinometer, withaccessories Blood glucometer, withaccessories Tube, vacuum, plain/dry, sterile (Capacity*) (EDTA), sterile (Capacity*) Tube, vacuum, Ethylene DiamineTetra-acetic Acid (EDTA) Tube, capillary, Ethylene DiamineTetra-acetic Acid Swab, cotton-tip, tube, sterile Needle, vacuum tube, sterile (Size*) Needle holder, vacuum tubes,sterile Lancet, blood,safety, sterile (Sizes*) Wooden orplastic applicator sticks plastic non-sterile, 3ml Pasteur pipettes withintegral bulb, disposable, Markers, fine point,permanentblack,for glassware Glass slides,25x75mm Blood administration set,sterile Anti-D bloodgroup reagent (Saline/monoclonal) Anti-B bloodgroup reagent, monoclonal use Infusion giving set, burette 100-150ml, sterile, single Umbilical clamp, sterile,single use Tape, medical,roll (Sizes*) Cotton wool, 500g,roll, non-sterile Umbilical tape, 3mmx50m, roll, non-sterile (Sizes G*) Cannulas, Intra Venous (IV)short,sterile, single use cal Examina- assessment Basic Medi- First tion X X X X a) Check-up vital signs / Vaginal examination assessment Emergency Emergency prepared- ness and referral X X X X X X X X X a) Emergency care and pre- referral treatment

X a) Monitoring progress of labour Mother care

b) Active management of the Childbirth X X X X X third stage of labour (AMTSL): Prophylactic use of uterotonics X X X c) Spontaneous delivery X X X X X X d) Assisted delivery (vacuum extraction) if needed for complica- Assessment X X X X X

a) Diagnosis of complications tions

b) Fetal monitoring orrhage partum haem- (PPH) Post-

X X X X a) Use of uterotonics of choice for the treatment of PPH

b) Manual removal of placenta X X X X (include use of antibiotics and uterotonics) X X X X X X X X X X X X X c) Blood transfusion Management ofcomplications oflabouranddelivery

X X X X d) Use of balloon tamponade

X X X X e) Use of artery embolization

X X X X f) Hysterectomy due maternal/fetal Caesarean section X X X X a) Use of prophylactic antibiotic indication

X X X X b) Caesarean section

X X X X c) Use of uterotonics X X X X Other surgical procedures de- a) Episiotomy pending onthecomplication

X X X X a) Repair of ruptured uterus

X X X X a) Correct uterine inversion

a) Laparotomy or other abdominal X X X X surgical interventions during childbirth

X X X X a) Craniotomy and craniocentesis ciency Virus tive women Human Im- (HIV) posi- munodefi- X X X X X X X X X a) Screening of HIV

b) Prevention Mother To Child Transmission (PMTCT) 4. Matrix of medical devices in each stage of continuum of care Table 32. Medical devices for childbirth at DISTRICT HOSPITAL

First Emergency Mother care Management of complications of labour and delivery assessment assessment

Post- Human Im- Emergency Basic Medi- Assessment partum Caesarean section munodefi - prepared- Other surgical procedures de- cal Examina- Childbirth for complica- haem- due maternal/fetal ciency Virus ness and pending on the complication tion tions orrhage indication (HIV) posi- referral (PPH) tive women

General type Name of devices a) Check-up vital signs / Vaginal vital signs / Vaginal a) Check-up examination and pre- care a) Emergency treatment referral of labour progress a) Monitoring management of the Active b) of labour (AMTSL): stage third use of uterotonics Prophylactic Spontaneous delivery c) (vacuum delivery d) Assisted if needed extraction) a) Diagnosis of complications monitoring Fetal b) for of choice a) Use of uterotonics of PPH the treatment of placenta Manual removal b) (include use of antibiotics and uterotonics) Blood transfusion c) d) Use of balloon tamponade embolization Use of artery e) f) Hysterectomy antibiotic a) Use of prophylactic section Caesarean b) Use of uterotonics c) a) Episiotomy uterus of ruptured a) Repair inversion uterine a) Correct or other abdominal a) Laparotomy during interventions surgical childbirth and craniocentesis a) Craniotomy of HIV a) Screening Child Mother To Prevention b) (PMTCT) Transmission Blood Bank Anti-A blood group reagent, monoclonal X devices Anti-B blood group reagent, monoclonal X Anti-D blood group reagent (Saline/monoclonal) X Blood administration set, sterile X Glass slides, 25x75mm X Markers, fi ne point, permanent black, for glassware X Pasteur pipettes with integral bulb, disposable, X plastic non-sterile, 3 ml Wooden or plastic applicator sticks X Clinical Container, sample, 50 ml X laboratory devices Lancet, blood, safety, sterile (Sizes*) X Needle holder, vacuum tubes, sterile X Needle, vacuum tube, sterile (Size*) X Swab, cotton-tip, tube, sterile X Tube, capillary, Ethylene Diamine Tetra-acetic Acid X (EDTA) Tube, vacuum, Ethylene Diamine Tetra-acetic Acid X (EDTA), sterile (Capacity*) Tube, vacuum, plain/dry, sterile (Capacity*) X Blood glucometer, with accessories X Hemoglobinometer, with accessories X X Enzyme Immuno Assay (EIA), Human X Immunodefi ciency Virus (HIV), kit Rapid Diagnostic Test (RDT), Human X Immunodefi ciency Virus (HIV), kit Test strip, pregnancy X Test strip, urinalysis (10 parameter) X Medical devices Bandage, elastic, 7.5cmx5m, roll X - Disposable Blanket, survival, 220x140cm, non-sterile X Bracelet, identifi cation (Sizes*) X X Compress, gauze,sterile & non-sterile, single use X X X X X X X X X X X X X X X X X X X X Cotton wool, 500g, roll, non-sterile X X X X X X X X X X X X X X X X X X Tape, medical, roll (Sizes*) X X X X X X X X X X X X X X X X X X Umbilical clamp, sterile,single use X X Umbilical tape, 3mmx50m, roll, non-sterile X X Cannulas, Intra Venous (IV) short, sterile, single use X X X X X X X X X X X X X X X X X X (Sizes G*) Infusion giving set, burette 100-150ml, sterile, single X X use 101 102 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Grouping Equipment devices - Medical material Counselling Equipment devices - Medical General type Table 32.Medicaldevices for childbirthat DISTRICT HOSPITAL Nameofdevices (see table12) Commodities for medicalexamination &diagnosis Non-Pneumatic Anti-Shock Garment (NASG)Non-Pneumatic Anti-ShockGarment accessories Doppler, foetal heartrate (FHR)detector, with with needle(Shapes*andsizes*), sterile, singleuse Suture, synthetic, non-absorbable(Sizes USP/DEC*) with needle(Shapes*andsizes*), sterile, singleuse Suture, synthetic, absorbable(Sizes USP/DEC*) Gloves, surgical, sterile, singleuse, pair(Sizes*) (Sizes*) Gloves, gynaecological, sterile, singleuse, pair (Sizes*) Gloves, examination, latex, non-sterile, singleuse use (Sizes CH*) Tube, suction,L50cm,catheter tip, sterile, single sterile, singleuse(Sizes CH*) Tube, feeding/aspirating, L120cm,catheter tip, (Sizes ID*) Tube, endotracheal, withcuff, sterile, singleuse Syringe, feeding, catheter tip, 50ml,sterile, singleuse Prongs, nasal,oxygen, nonsterile, singleuse(Sizes*) Catheter, urethral, sterile, singleuse(Sizes CH*) Catheter, Foley, sterile, singleuse(Sizes CH*) haemorrhage Catheter, balloontamponade, post partum Bag, urine, collecting, 2000ml Airway, Guedel,translucent (Sizes*) Syringes, reuse prevention (RUP),(Capacities ml*) Syringes, luer, sterile, singleuse(Capacities ml*) Stopcock, 3-way, sterile, singleuse Safety box, for usedsyringes/needles Needles, spinal,sterile, singleuse(Sizes*) Needles, luer, sterile, singleuse(Sizes G*) Infusion givingset,sterile, singleuse (see table 15) Commodities for surgery &anaesthesia (see table14) Commodities for labour, delivery &recovery (see table13) Commodities for emergency preparedness Counselling material Cardiotocograph (CTG), withaccessories cal Examina- assessment Basic Medi- First tion

X X X a) Check-up vital signs / Vaginal examination assessment Emergency Emergency prepared- ness and referral X X X X X X X X X X X X X X X X X X X X X X X X a) Emergency care and pre- referral treatment

X a) Monitoring progress of labour Mother care

b) Active management of the Childbirth X X X X X X X X X third stage of labour (AMTSL): Prophylactic use of uterotonics X X X X X X X c) Spontaneous delivery X X X X X X X X X d) Assisted delivery (vacuum extraction) if needed for complica- Assessment X X X X X X X X X X X

a) Diagnosis of complications tions X X X X b) Fetal monitoring orrhage partum haem- (PPH) Post- X X X X X X X X X X X X a) Use of uterotonics of choice for the treatment of PPH

b) Manual removal of placenta X X X X X X X X X X X X X X X X X (include use of antibiotics and uterotonics) X X X X X X X c) Blood transfusion Management ofcomplications oflabouranddelivery X X X X X X X X X X X X X X X X X X d) Use of balloon tamponade X X X X X X X X X X X X X X X X X e) Use of artery embolization X X X X X X X X X X X X X X X X X X X f) Hysterectomy due maternal/fetal Caesarean section X X X X X X X X X a) Use of prophylactic antibiotic indication X X X X X X X X X X X X X X X X X X X b) Caesarean section X X X X X X X X X c) Use of uterotonics X X X X X X X X X X X X X Other surgical procedures de- a) Episiotomy pending onthecomplication X X X X X X X X X X X X X X X X X X X a) Repair of ruptured uterus X X X X X X X X X X X X X X X X a) Correct uterine inversion

a) Laparotomy or other abdominal X X X X X X X X X X X X X X X X X X X surgical interventions during childbirth X X X X X X X X X X X X X X X X X a) Craniotomy and craniocentesis ciency Virus tive women Human Im- (HIV) posi- munodefi- X X X a) Screening of HIV X X X b) Prevention Mother To Child Transmission (PMTCT) 4. Matrix of medical devices in each stage of continuum of care Table 32. Medical devices for childbirth at DISTRICT HOSPITAL

First Emergency Mother care Management of complications of labour and delivery assessment assessment

Post- Human Im- Emergency Basic Medi- Assessment partum Caesarean section munodefi - prepared- Other surgical procedures de- cal Examina- Childbirth for complica- haem- due maternal/fetal ciency Virus ness and pending on the complication tion tions orrhage indication (HIV) posi- referral (PPH) tive women

General type Name of devices a) Check-up vital signs / Vaginal vital signs / Vaginal a) Check-up examination and pre- care a) Emergency treatment referral of labour progress a) Monitoring management of the Active b) of labour (AMTSL): stage third use of uterotonics Prophylactic Spontaneous delivery c) (vacuum delivery d) Assisted if needed extraction) a) Diagnosis of complications monitoring Fetal b) for of choice a) Use of uterotonics of PPH the treatment of placenta Manual removal b) (include use of antibiotics and uterotonics) Blood transfusion c) d) Use of balloon tamponade embolization Use of artery e) f) Hysterectomy antibiotic a) Use of prophylactic section Caesarean b) Use of uterotonics c) a) Episiotomy uterus of ruptured a) Repair inversion uterine a) Correct or other abdominal a) Laparotomy during interventions surgical childbirth and craniocentesis a) Craniotomy of HIV a) Screening Child Mother To Prevention b) (PMTCT) Transmission Infusion giving set, sterile, single use X X X X X X X X X X X X X X X X X X Needles, luer, sterile, single use (Sizes G*) X X X X X X X X X X X X X X X X X Needles, spinal, sterile, single use (Sizes*) X X X X X X X X Safety box, for used syringes/needles X X X X X X X X X X X X X X X X X X Stopcock, 3-way, sterile, single use X X X X X X X X X X X X X X X Syringes, luer, sterile, single use (Capacities ml*) X X X X X X X X X X X X X X X X Syringes, reuse prevention (RUP), (Capacities ml*) X X X X X X X X X X X X X X X X Airway, Guedel, translucent (Sizes*) X X X X X X X X X X Bag, urine, collecting, 2000ml X X X X X X X X X X Catheter, balloon tamponade, post partum X haemorrhage Catheter, Foley, sterile, single use (Sizes CH*) X X X X X X X X X Catheter, urethral, sterile, single use (Sizes CH*) X X X X X Prongs, nasal, oxygen, non sterile, single use (Sizes*) X X X X X X X X X X X X X Syringe, feeding, catheter tip, 50ml, sterile, single use X Tube, endotracheal, with cuff, sterile, single use X X X X X X X X X X (Sizes ID*) Tube, feeding/aspirating, L120cm,catheter tip, X sterile, single use (Sizes CH*) Tube, suction, L50cm, catheter tip, sterile, single X X X X X X X X X X X X X use (Sizes CH*) Gloves, examination, latex, non-sterile, single use X X X X X X X X X X X X X X X X X X X X X (Sizes*) Gloves, gynaecological, sterile, single use, pair X X X X X X X X (Sizes*) Gloves, surgical, sterile, single use, pair (Sizes*) X X X X X X X X X X X X X X Suture, synthetic, absorbable (Sizes USP/DEC*) X X X X X X with needle (Shapes* and sizes*), sterile, single use Suture, synthetic, non-absorbable (Sizes USP/DEC*) X X X X X X with needle (Shapes* and sizes*), sterile, single use Medical Cardiotocograph (CTG), with accessories X devices - Doppler, foetal heart rate (FHR) detector, with Equipment X X accessories Non-Pneumatic Anti-Shock Garment (NASG) X Medical Commodities for medical examination & diagnosis X X X X X X X X X X X X X X X X X X X X devices - (see table 12) Equipment Commodities for emergency preparedness X X Grouping (see table 13) Commodities for labour, delivery & recovery X X X X X X X X X X X (see table 14) Commodities for surgery & anaesthesia X X X X X X X X X X X (see table 15) Counselling Counselling material X material

103 104 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health DISTRICT HOSPITAL Table 33.Medicaldevices for post-natal motherat - Disposable Medical devices devices laboratory Clinical devices Blood Bank General type Table 33.Medicaldevices for post-natal motherat DISTRICT HOSPITAL Compress, gauze,sterile &non-sterile, singleuse Blanket, survival, 220x140cm,non-sterile Bandage, elastic, 7.5cmx5m, roll Container, sample, 50ml Anti-A bloodgroup reagent, monoclonal Name ofdevices Needles, spinal, sterile, singleuse(Sizes*) Needles, luer, sterile, singleuse(Sizes G*) Infusion givingset,sterile, singleuse Cannulas, Intra Venous (IV)short,sterile, singleuse(Sizes G*) Tape, medical,roll (Sizes*) Cotton wool, 500g,roll, non-sterile Test strip, vaginal infection, pH Test strip, urinalysis (10parameter) Rapid Diagnostic Test (RDT), malaria,kit (HIV), kit Rapid Diagnostic Test (RDT), HumanImmunodeficiency Virus Nucleic Acid Test (NAT), HumanPapilloma Virus (HPV), kit (HIV), kit Enzyme ImmunoAssay (EIA), Human Immunodeficiency Virus Cytology stain, kit Hemoglobinometer, withaccessories sterile (Capacity*) Tube, vacuum, Ethylene DiamineTetra-acetic Acid (EDTA), Tube, capillary, Ethylene DiamineTetra-acetic Acid (EDTA) Swab, cotton-tip, tube, sterile Needle, vacuum tube, sterile (Size*) Needle holder, vacuum tubes,sterile Lancet, blood,safety, sterile (Sizes*) Wooden orplastic applicator sticks sterile, 3ml Pasteur pipettes withintegral bulb, disposable, plastic non- Markers, fine point,permanentblack,for glassware Glass slides,25x75mm Blood administration set,sterile Anti-D bloodgroup reagent (Saline/monoclonal) Anti-B bloodgroup reagent, monoclonal First assessment Basic Medical Examination a) Check-up vital signs X X X X b) Screening for cervix and breast cancer breast feed- Support for ing X X X X a) Management of mastitis / breast abscess assessment Emergency preparedness and referral Emergency X X X X X X X X a) Emergency care and pre- referral treatment Anaemia partum bleeding Prevention andmanagementofpost

X X X X X X a) Management of post partum bleeding

X X b) Diagnosis of anaemia

c) Iron supplementation

d) Anthelminthic (deworm) X X X X X X X X X X X X X X X e) Management of severe anaemia (considering blood transfusion) (HIV) cy Virus deficien- Immuno- Human partum infection Detection andmanagementofpost X X X X X X X X a) Diagnosis and treatment for HIV (Antiretroviral Therapy (ART)) Malaria X X X X X X X X a) Diagnosis and management of malaria Other infection a) Diagnosis and management X X X X X X X X X X of postpartum endometritis and salpingitis a) Diagnosis and treatment for X X X X X X X X X urinary tract infections: bacteriuria, pyelonephritis Postoperative care Assessment erative care of postop- X X X X X X a) Postcaesarean care

b) Diagnosis of pelvic abscess, X X X X X X peritonitis or other postoperative complication procedure Surgical

c) Surgical management of pelvic X X X X X X X X abscess, peritonitis or other postoperative complication with laparotomy 4. Matrix of medical devices in each stage of continuum of care Table 33. Medical devices for post-natal mother at DISTRICT HOSPITAL

Emergency Prevention and management of post Detection and management of post First assessment Postoperative care assessment partum bleeding partum infection

Human Support for Emergency Immuno- Assessment Basic Medical Surgical breast feed- preparedness Anaemia defi cien- Malaria Other infection of postop- Examination procedure ing and referral cy Virus erative care (HIV)

General type Name of devices a) Check-up vital signs a) Check-up and breast cervix for Screening b) cancer / a) Management of mastitis abscess breast and pre- care a) Emergency treatment referral partum a) Management of post bleeding Diagnosis of anaemia b) supplementation Iron c) d) Anthelminthic (deworm) anaemia Management of severe e) blood transfusion) (considering HIV for a) Diagnosis and treatment (ART)) Therapy (Antiretroviral a) Diagnosis and management of malaria a) Diagnosis and management endometritis and of postpartum salpingitis for a) Diagnosis and treatment bacteriuria, infections: tract urinary pyelonephritis care a) Postcaesarean Diagnosis of pelvic abscess, b) or other postoperative peritonitis complication management of pelvic Surgical c) or other peritonitis abscess, with complication postoperative laparotomy Blood Bank Anti-A blood group reagent, monoclonal X devices Anti-B blood group reagent, monoclonal X Anti-D blood group reagent (Saline/monoclonal) X Blood administration set, sterile X Glass slides, 25x75mm X Markers, fi ne point, permanent black, for glassware X Pasteur pipettes with integral bulb, disposable, plastic non- X sterile, 3 ml Wooden or plastic applicator sticks X Clinical Container, sample, 50 ml X X X laboratory devices Lancet, blood, safety, sterile (Sizes*) X X X X Needle holder, vacuum tubes, sterile X Needle, vacuum tube, sterile (Size*) X Swab, cotton-tip, tube, sterile X X X Tube, capillary, Ethylene Diamine Tetra-acetic Acid (EDTA) X Tube, vacuum, Ethylene Diamine Tetra-acetic Acid (EDTA), X sterile (Capacity*) Hemoglobinometer, with accessories X X Cytology stain, kit X X Enzyme Immuno Assay (EIA), Human Immunodefi ciency Virus X (HIV), kit Nucleic Acid Test (NAT), Human Papilloma Virus (HPV), kit X Rapid Diagnostic Test (RDT), Human Immunodefi ciency Virus X (HIV), kit Rapid Diagnostic Test (RDT), malaria, kit X Test strip, urinalysis (10 parameter) X X Test strip, vaginal infection, pH X X Medical devices Bandage, elastic, 7.5cmx5m, roll X - Disposable Blanket, survival, 220x140cm, non-sterile X Compress, gauze,sterile & non-sterile, single use X X X X X X X X X X Cotton wool, 500g, roll, non-sterile X X X X X X X X X X Tape, medical, roll (Sizes*) X X X X X X X X X X Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) X X X X X X X X X Infusion giving set, sterile, single use X X X X X X X X X Needles, luer, sterile, single use (Sizes G*) X X X X X X X X X Needles, spinal, sterile, single use (Sizes*) X

105 106 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health material Counselling Equipment devices - Medical Grouping Equipment devices - Medical General type Table 33.Medicaldevices for post-natal motherat DISTRICT HOSPITAL Name ofdevices Commodities for surgery &anaesthesia (see table15) Commodities for labour, delivery &recovery (see table14) (see table16) Commodities for inpatient motherandnewborn Commodities for emergency preparedness (see table13) needle (Shapes*andsizes*), sterile, singleuse Suture, synthetic, non-absorbable(Sizes USP/DEC*) with needle (Shapes*andsizes*), sterile, singleuse Suture, synthetic, absorbable(Sizes USP/DEC*) with Gloves, surgical, sterile, singleuse, pair(Sizes*) Gloves, examination, latex, non-sterile, singleuse(Sizes*) (Sizes CH*) Tube, suction,L50cm,catheter tip, sterile, singleuse single use(Sizes CH*) Tube, feeding/aspirating, L120cm,catheter tip, sterile, Tube, endotracheal, withcuff, sterile, singleuse(Sizes ID*) Prongs, nasal,oxygen, nonsterile, single use(Sizes*) Catheter, Foley, sterile, singleuse(Sizes CH*) Bag, urine, collecting, 2000ml Airway, Guedel,translucent (Sizes*) Syringes, reuse prevention (RUP),(Capacities ml*) Syringes, luer, sterile, singleuse(Capacities ml*) Stopcock, 3-way, sterile, singleuse Safety box, for usedsyringes/needles Counselling material Colposcope withbiopsy set Breastpump, manual,withaccessories (see table12) Commodities for medicalexamination &diagnosis First assessment Basic Medical Examination X X a) Check-up vital signs X X X b) Screening for cervix and breast cancer breast feed- Support for ing X X X X X X X a) Management of mastitis / breast abscess assessment Emergency preparedness and referral Emergency X X X X X X X X X X X X X X X X a) Emergency care and pre- referral treatment Anaemia partum bleeding Prevention andmanagementofpost X X X X X X X X a) Management of post partum bleeding

X b) Diagnosis of anaemia X X c) Iron supplementation X X d) Anthelminthic (deworm) X X X X X X X e) Management of severe anaemia (considering blood transfusion) (HIV) cy Virus deficien- Immuno- Human partum infection Detection andmanagementofpost X X X a) Diagnosis and treatment for HIV (Antiretroviral Therapy (ART)) Malaria X X X X X X X X a) Diagnosis and management of malaria Other infection a) Diagnosis and management X X X X X X X X of postpartum endometritis and salpingitis a) Diagnosis and treatment for X X X X X X X X urinary tract infections: bacteriuria, pyelonephritis Postoperative care Assessment erative care of postop- X X X X X X X X a) Postcaesarean care

b) Diagnosis of pelvic abscess, X X X X X X X X peritonitis or other postoperative complication procedure Surgical

c) Surgical management of pelvic X X X X X X X X X X X X X X X X X abscess, peritonitis or other postoperative complication with laparotomy 4. Matrix of medical devices in each stage of continuum of care Table 33. Medical devices for post-natal mother at DISTRICT HOSPITAL

Emergency Prevention and management of post Detection and management of post First assessment Postoperative care assessment partum bleeding partum infection

Human Support for Emergency Immuno- Assessment Basic Medical Surgical breast feed- preparedness Anaemia defi cien- Malaria Other infection of postop- Examination procedure ing and referral cy Virus erative care (HIV)

General type Name of devices a) Check-up vital signs a) Check-up and breast cervix for Screening b) cancer / a) Management of mastitis abscess breast and pre- care a) Emergency treatment referral partum a) Management of post bleeding Diagnosis of anaemia b) supplementation Iron c) d) Anthelminthic (deworm) anaemia Management of severe e) blood transfusion) (considering HIV for a) Diagnosis and treatment (ART)) Therapy (Antiretroviral a) Diagnosis and management of malaria a) Diagnosis and management endometritis and of postpartum salpingitis for a) Diagnosis and treatment bacteriuria, infections: tract urinary pyelonephritis care a) Postcaesarean Diagnosis of pelvic abscess, b) or other postoperative peritonitis complication management of pelvic Surgical c) or other peritonitis abscess, with complication postoperative laparotomy Safety box, for used syringes/needles X X X X X X X X X X Stopcock, 3-way, sterile, single use X X X X X X X X Syringes, luer, sterile, single use (Capacities ml*) X X X X X X X X X Syringes, reuse prevention (RUP), (Capacities ml*) X X X X X X X X X Airway, Guedel, translucent (Sizes*) X X Bag, urine, collecting, 2000ml X X Catheter, Foley, sterile, single use (Sizes CH*) X X Prongs, nasal, oxygen, non sterile, single use (Sizes*) X X X Tube, endotracheal, with cuff, sterile, single use (Sizes ID*) X X Tube, feeding/aspirating, L120cm,catheter tip, sterile, X single use (Sizes CH*) Tube, suction, L50cm, catheter tip, sterile, single use X X (Sizes CH*) Gloves, examination, latex, non-sterile, single use (Sizes*) X X X X X X X X X X X X Gloves, surgical, sterile, single use, pair (Sizes*) X X X X Suture, synthetic, absorbable (Sizes USP/DEC*) with X X needle (Shapes* and sizes*), sterile, single use Suture, synthetic, non-absorbable (Sizes USP/DEC*) with X X needle (Shapes* and sizes*), sterile, single use Medical Breastpump, manual, with accessories X devices - Equipment Colposcope with biopsy set X Medical Commodities for medical examination & diagnosis X X X X X X X X X X X X X X X X devices - (see table 12) Equipment Grouping Commodities for emergency preparedness (see table 13) X X X Commodities for labour, delivery & recovery (see table 14) X Commodities for surgery & anaesthesia (see table 15) X Commodities for inpatient mother and newborn X X X X X X X X X (see table 16) Counselling material Counselling material X X X X X X

107 108 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health (newborn) at DISTRICT HOSPITAL Table 34.Medicaldevices for post-natal baby General type devices laboratory Clinical devices Blood Bank at Table 34.Medicaldevices for post-natal baby (newborn) DISTRICT HOSPITAL Test strip, urinalysis (10parameter) Assay (TPHA), syphilis, kit Treponema Pallidum Haemagglutination Rapid PlasmaReagin (RPR),syphilis, kit syphilis, kit Rapid Diagnostic Test (RDT),Treponemal, Immunodeficiency Virus (HIV),kit Rapid Diagnostic Test (RDT), Human Haemoglobin colour scale(starter kit) Haemoglobin colour scale(refill kit) Immunodeficiency Virus (HIV),kit Enzyme ImmunoAssay (EIA),Human Hemoglobinometer, withaccessories Blood glucometer, withaccessories Analyzer, bloodgas Tube, vacuum, plain/dry, sterile (Capacity*) Acid (EDTA), sterile (Capacity*) Tube, vacuum, Ethylene DiamineTetra-acetic Tube, capillary, heparin, Acid (EDTA) Tube, capillary, Ethylene DiamineTetra-acetic sterile Tube, bloodcollection, newborn cord blood, Swab, cotton-tip, tube, sterile Paper, drybloodspot Needle, vacuum tube, sterile (Size*) Needle holder, vacuum tubes,sterile Lancet, blood,safety, sterile (Sizes*) Container, sample, 50ml Wooden orplastic applicator sticks disposable, plastic non-sterile, 3ml Pasteur pipettes withintegral bulb, glassware Markers, fine point,permanentblack,for Glass slides,25x75mm Blood administration set,sterile monoclonal) Anti-D bloodgroup reagent (Saline/ Anti-B bloodgroup reagent, monoclonal Anti-A bloodgroup reagent, monoclonal Name ofdevices

a) Dry baby thoroughly on mother's chest Immediate care at skin to skin and cover b) Assess breathing c) Clamp and cut cord / Check cord birth X vessels / Check for bleeding and signs of Childbirth: Essential newborn care cord infection d) Prevent hypothermia when skin to skin is not possible e) Support breastfeeding within the fi rst hour support gency a) Basic neonatal resuscitation Emer-

b) Management of brain injury and intrac- ranial haemorrhage (ICH) a) Full clinical examination / Check vital signs / measuring weight

b) Thermal Care Routine care c) Breastfeeding support d) Vitamin K prophylaxis and Immunization e) Cord care f) Prophylaxis for eye infection g) Prophylactic antibiotics for neonates at risk of infection Detection and of congenital management X X X X X X X X X X X Congenital infections

a) Diagnosis of congenital syphilis infections b) Prophylactic treatment for congenital syphilis X X X X X X X X X X c) Screening of HIV (Dried Blood Spot (DBS)) d) Prophylactic treatment for HIV (Antiretroviral Therapy (ART)) Cord tion fec- a) Detection and management of cord in- infections, illness andcomplications inthe

infection Detection andmanagementofcommon Jaun- X X a) Diagnosis of jaundice dice

b) Management of jaundice neonate andyoung infant X X X a) Diagnosis of anaemia Anaemia X X b) Management of anaemia X X X X X X X X X X c) Pre-referral treatment for severe anaemia (blood transfusion) monia a) Diagnosis of pneumonia Pneu-

X b) Management of pneumonia and its complications rhoea Diar- a) Detection and management of diarrhoea or menin- Septicae- a) Diagnosis of septicaemia and/or mia and/ X X X X X X X X X X X X meningitis: Blood Culture, Lumbar gitis Puncture, Urine Analysis X X b) Management of septicaemia and/or meningitis and its complications noea Specific interventions for Ap- small, low weight birth

a) Prevention of Apnoea and pre-term babies drome (RDS) Distress Syn-

a) Diagnosis of RDS and provision of Respiratory prophylaxis surfactant b) Apply Continuous Positive Airway Pres- sure (CPAP) with nasal cannula or face mask

X c) Ventilatory support and oxygen therapy including mechanical ventilation and CPAP crotiz- colitis X X X X X X tero- Ne- en- a) Diagnosis of necrotizing enterocolitis ing b) Management of necrotizing enterocolitis Supportive care for allsick X X

a) Monitor blood glucose and manage- Supportive care ment of hypoglycaemia neonate andsickyoung b) Monitor nutrition and provision of tube feeding support c) Provision of intravenous therapy infant d) Monitor temperature and management of hypothermia (Kangaroo mother care)

X e) Monitor oxygenation and management of hypoxia prepar- referral edness Triage, gency X X emer- X a) Detection of emergency signs, emer- gency care and pre-referral treatment and

b) Advanced resuscitation

a) Full clinical examination / check vital Further assessment for all X X X X signs / measuring weight / check haemoglobin Clinical visit

b) Provision of vaccines (Diphtheria young infant Pertussis Tetanus (DPT) + Haemophilus Infl uenzae type B (HIB), Oral Polio Vaccine (OPV), Hepatitis B) c) Breastfeeding support and replacement feeding if necessary d) Monitoring growth and development tional inter- tions ven- Op- a) Male circumcision 4. Matrix of medical devices in each stage of continuum of care Table 34. Medical devices for post-natal baby (newborn) at DISTRICT HOSPITAL Detection and Detection and management of common Specifi c interventions for Supportive care for all sick management Further assessment for all Childbirth: Essential newborn care infections, illness and complications in the small, low weight birth neonate and sick young of congenital young infant neonate and young infant and pre-term babies infant infections

Ne- Triage, Op- Cord Septicae- crotiz- emer- Emer- Respiratory tional Immediate care at Congenital in- Jaun- Pneu- Diar- mia and/ Ap- ing gency gency Routine care Anaemia Distress Syn- Supportive care prepar- Clinical visit inter- birth infections fec- dice monia rhoea or menin- noea en- support drome (RDS) edness ven- tion gitis tero- and tions colitis referral

General type Name of devices a) Dry baby thoroughly on mother's chest thoroughly a) Dry baby skin and cover skin to breathing Assess b) / Check cord Clamp and cut cord c) bleeding and signs of / Check for vessels infection cord skin when skin to hypothermia d) Prevent is not possible rst within the fi Support breastfeeding e) hour resuscitation a) Basic neonatal injury and intrac- Management of brain b) haemorrhage (ICH) ranial / Check vital a) Full clinical examination signs / measuring weight Care Thermal b) support Breastfeeding c) and K prophylaxis d) Vitamin Immunization care Cord e) infection eye for f) Prophylaxis at neonates antibiotics for g) Prophylactic risk of infection syphilis a) Diagnosis of congenital congenital for treatment Prophylactic b) syphilis of HIV (Dried Blood Spot Screening c) (DBS)) HIV for treatment d) Prophylactic (ART)) Therapy (Antiretroviral and management of cord a) Detection infection a) Diagnosis of jaundice Management of jaundice b) a) Diagnosis of anaemia Management of anaemia b) severe for treatment Pre-referral c) anaemia (blood transfusion) a) Diagnosis of pneumonia Management of pneumonia and its b) complications and management ofa) Detection diarrhoea a) Diagnosis of septicaemia and/or Lumbar meningitis: Blood Culture, Urine Analysis Puncture, Management of septicaemia and/or b) meningitis and its complications of Apnoea a) Prevention of and provision a) Diagnosis of RDS surfactant prophylaxis Pres- Airway Positive Apply Continuous b) mask with nasal cannula or face (CPAP) sure therapy support and oxygen Ventilatory c) CPAP and ventilation mechanical including enterocolitis a) Diagnosis of necrotizing enterocolitis Management of necrotizing b) and manage- blood glucose a) Monitor ment of hypoglycaemia of tube nutrition and provision Monitor b) support feeding therapy of intravenous Provision c) and management temperature d) Monitor mother care) (Kangaroo of hypothermia and management oxygenation Monitor e) of hypoxia signs, emer- of emergency a) Detection treatment and pre-referral care gency resuscitation Advanced b) / check vital a) Full clinical examination / checksigns / measuring weight haemoglobin (Diphtheria of vaccines Provision b) (DPT) + Haemophilus Tetanus Pertussis Vaccine Polio uenzae type B (HIB), Oral Infl B) Hepatitis (OPV), support and replacement Breastfeeding c) if necessary feeding and development growth d) Monitoring a) Male circumcision Blood Bank Anti-A blood group reagent, monoclonal X devices Anti-B blood group reagent, monoclonal X Anti-D blood group reagent (Saline/ monoclonal) X Blood administration set, sterile X Glass slides, 25x75mm X Markers, fi ne point, permanent black, for glassware X Pasteur pipettes with integral bulb, disposable, plastic non-sterile, 3 ml X Wooden or plastic applicator sticks X Clinical Container, sample, 50 ml X X laboratory devices Lancet, blood, safety, sterile (Sizes*) X X X X X X Needle holder, vacuum tubes, sterile X X X X Needle, vacuum tube, sterile (Size*) X X X X Paper, dry blood spot X Swab, cotton-tip, tube, sterile X X X X Tube, blood collection, newborn cord blood, sterile X X Tube, capillary, Ethylene Diamine Tetra-acetic Acid (EDTA) X X X X Tube, capillary, heparin, X X X Tube, vacuum, Ethylene Diamine Tetra-acetic Acid (EDTA), sterile (Capacity*) X X X X Tube, vacuum, plain/dry, sterile (Capacity*) X X X Analyzer, blood gas X X X X X X X Blood glucometer, with accessories X X X Hemoglobinometer, with accessories X X X X X Enzyme Immuno Assay (EIA), Human Immunodefi ciency Virus (HIV), kit X Haemoglobin colour scale (refi ll kit) X Haemoglobin colour scale (starter kit) X Rapid Diagnostic Test (RDT), Human Immunodefi ciency Virus (HIV), kit X Rapid Diagnostic Test (RDT),Treponemal, syphilis, kit X Rapid Plasma Reagin (RPR), syphilis, kit X Treponema Pallidum Haemagglutination Assay (TPHA), syphilis, kit X Test strip, urinalysis (10 parameter) X X X X

109 110 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health General type Disposable devices - Medical at Table 34.Medicaldevices for post-natal baby (newborn) DISTRICT HOSPITAL use (Sizes*) Gloves, examination, latex, non-sterile, single single use(Sizes CH*) Tube, suction,L50cm,catheter tip, sterile, use (Sizes CH*) Tube, feeding, L40cm,luertip, sterile, single sterile, singleuse(Sizes CH*) Tube, feeding/aspirating, L120cm,catheter tip, single use(Sizes ID*) Tube, endotracheal, withoutcuff, sterile, use Syringe, feeding, luertip, 50ml,sterile, single single use Syringe, feeding, catheter tip, 50ml,sterile, (Sizes*) Prongs, nasal, oxygen, non sterile, singleuse Collector, urine, adhesive, 10-100ml Airway, Guedel,translucent (Sizes*) ml*) Syringes, reuse prevention (RUP),(Capacities ml*) Syringes, luer, sterile, singleuse(Capacities Syringes, auto-disable (AD), (Capacities ml*) Stopcock, 3-way, sterile, singleuse Safety box, for usedsyringes/needles Needles, spinal,sterile, singleuse(Sizes*) G*) Needles, scalpvein, sterile, single use(Sizes Needles, luer, sterile, singleuse(Sizes G*) single use Infusion givingset,burette 100-150ml, sterile, sterile, singleuse Catheter, Intra Venous (IV)umbilicalvein, single use(Sizes G*) Cannulas, Intra Venous (IV)short,sterile, Umbilical tape, 3mmx50m,roll, non-sterile Umbilical clamp, sterile, singleuse Tape, medical,roll (Sizes*) Cotton wool, 500g,roll, non-sterile use Compress, gauze, sterile &non-sterile, single Bracelet, identification (Sizes*) Blanket, survival, 220x140cm,non-sterile Bandage, elastic, 7.5cmx5m, roll Name ofdevices X

a) Dry baby thoroughly on mother's chest Immediate care at skin to skin and cover X b) Assess breathing c) Clamp and cut cord / Check cord birth X X X X vessels / Check for bleeding and signs of Childbirth: Essential newborn care cord infection X X d) Prevent hypothermia when skin to skin is not possible

X e) Support breastfeeding within the fi rst hour support X X X gency a) Basic neonatal resuscitation Emer- X X X X X X X X X X X X X X X X X b) Management of brain injury and intrac- ranial haemorrhage (ICH) X X a) Full clinical examination / Check vital signs / measuring weight X X

b) Thermal Care Routine care X c) Breastfeeding support X X X X X X X X d) Vitamin K prophylaxis and Immunization X X X e) Cord care X X f) Prophylaxis for eye infection X X X X X X g) Prophylactic antibiotics for neonates at risk of infection Detection and of congenital management X X Congenital infections

a) Diagnosis of congenital syphilis infections X X X X X X b) Prophylactic treatment for congenital syphilis X X c) Screening of HIV (Dried Blood Spot (DBS))

X d) Prophylactic treatment for HIV (Antiretroviral Therapy (ART)) Cord tion fec- in- X X X X X X X X X X X X a) Detection and management of cord infections, illness andcomplications inthe

infection Detection andmanagementofcommon Jaun- X X a) Diagnosis of jaundice dice X X X X X X X X X X X X X

b) Management of jaundice neonate andyoung infant X X a) Diagnosis of anaemia Anaemia X X X X X X X X X X X X X b) Management of anaemia X X X X X X X X X X X X X X X c) Pre-referral treatment for severe anaemia (blood transfusion) X monia a) Diagnosis of pneumonia Pneu- X X X X X X X X X X X X X X X X X X X X b) Management of pneumonia and its complications rhoea Diar- X X X X X X X X X X X X X X a) Detection and management of diarrhoea or menin- Septicae- a) Diagnosis of septicaemia and/or mia and/ X X X X X X X X X X X X X X X meningitis: Blood Culture, Lumbar gitis Puncture, Urine Analysis X X X X X X X X X X X X X X X X X X X X X X X b) Management of septicaemia and/or meningitis and its complications noea Specific interventions for Ap- X X small, low weight birth

a) Prevention of Apnoea and pre-term babies drome (RDS) Distress Syn- X X X X X X X X X X X X X a) Diagnosis of RDS and provision of Respiratory prophylaxis surfactant X X X X X X X X X X X X b) Apply Continuous Positive Airway Pres- sure (CPAP) with nasal cannula or face mask X X X X X X X X X X X X X X X X X X c) Ventilatory support and oxygen therapy including mechanical ventilation and CPAP crotiz- colitis X X X X X X X X X X X tero- Ne- en- a) Diagnosis of necrotizing enterocolitis ing X X X X X X X X X X X X X X X X X X X X X X X b) Management of necrotizing enterocolitis Supportive care for allsick X X X X X X X X X X X X X X X X X X

a) Monitor blood glucose and manage- Supportive care ment of hypoglycaemia neonate andsickyoung X X X X X X X X X X X X X X X X b) Monitor nutrition and provision of tube feeding support X X X X X X X X X X X X X X X X X X X X c) Provision of intravenous therapy infant X X X X X X X X X d) Monitor temperature and management of hypothermia (Kangaroo mother care) X X X X X X X X X X X X X X X X e) Monitor oxygenation and management of hypoxia prepar- referral edness Triage, gency X X X X X X X X X X X X X X X X X X X X X X X X emer- X a) Detection of emergency signs, emer- gency care and pre-referral treatment and X X X X X X X X X X X X X X X X X X X X X X X b) Advanced resuscitation

a) Full clinical examination / check vital Further assessment for all X X X X signs / measuring weight / check haemoglobin Clinical visit

b) Provision of vaccines (Diphtheria young infant X X X X Pertussis Tetanus (DPT) + Haemophilus Infl uenzae type B (HIB), Oral Polio Vaccine (OPV), Hepatitis B) c) Breastfeeding support and replacement feeding if necessary d) Monitoring growth and development tional inter- tions ven- Op- X X X X X X X X X X X X X X X a) Male circumcision 4. Matrix of medical devices in each stage of continuum of care Table 34. Medical devices for post-natal baby (newborn) at DISTRICT HOSPITAL Detection and Detection and management of common Specifi c interventions for Supportive care for all sick management Further assessment for all Childbirth: Essential newborn care infections, illness and complications in the small, low weight birth neonate and sick young of congenital young infant neonate and young infant and pre-term babies infant infections

Ne- Triage, Op- Cord Septicae- crotiz- emer- Emer- Respiratory tional Immediate care at Congenital in- Jaun- Pneu- Diar- mia and/ Ap- ing gency gency Routine care Anaemia Distress Syn- Supportive care prepar- Clinical visit inter- birth infections fec- dice monia rhoea or menin- noea en- support drome (RDS) edness ven- tion gitis tero- and tions colitis referral

General type Name of devices a) Dry baby thoroughly on mother's chest thoroughly a) Dry baby skin and cover skin to breathing Assess b) / Check cord Clamp and cut cord c) bleeding and signs of / Check for vessels infection cord skin when skin to hypothermia d) Prevent is not possible rst within the fi Support breastfeeding e) hour resuscitation a) Basic neonatal injury and intrac- Management of brain b) haemorrhage (ICH) ranial / Check vital a) Full clinical examination signs / measuring weight Care Thermal b) support Breastfeeding c) and K prophylaxis d) Vitamin Immunization care Cord e) infection eye for f) Prophylaxis at neonates antibiotics for g) Prophylactic risk of infection syphilis a) Diagnosis of congenital congenital for treatment Prophylactic b) syphilis of HIV (Dried Blood Spot Screening c) (DBS)) HIV for treatment d) Prophylactic (ART)) Therapy (Antiretroviral and management of cord a) Detection infection a) Diagnosis of jaundice Management of jaundice b) a) Diagnosis of anaemia Management of anaemia b) severe for treatment Pre-referral c) anaemia (blood transfusion) a) Diagnosis of pneumonia Management of pneumonia and its b) complications and management ofa) Detection diarrhoea a) Diagnosis of septicaemia and/or Lumbar meningitis: Blood Culture, Urine Analysis Puncture, Management of septicaemia and/or b) meningitis and its complications of Apnoea a) Prevention of and provision a) Diagnosis of RDS surfactant prophylaxis Pres- Airway Positive Apply Continuous b) mask with nasal cannula or face (CPAP) sure therapy support and oxygen Ventilatory c) CPAP and ventilation mechanical including enterocolitis a) Diagnosis of necrotizing enterocolitis Management of necrotizing b) and manage- blood glucose a) Monitor ment of hypoglycaemia of tube nutrition and provision Monitor b) support feeding therapy of intravenous Provision c) and management temperature d) Monitor mother care) (Kangaroo of hypothermia and management oxygenation Monitor e) of hypoxia signs, emer- of emergency a) Detection treatment and pre-referral care gency resuscitation Advanced b) / check vital a) Full clinical examination / checksigns / measuring weight haemoglobin (Diphtheria of vaccines Provision b) (DPT) + Haemophilus Tetanus Pertussis Vaccine Polio uenzae type B (HIB), Oral Infl B) Hepatitis (OPV), support and replacement Breastfeeding c) if necessary feeding and development growth d) Monitoring a) Male circumcision Medical Bandage, elastic, 7.5cmx5m, roll X devices - Disposable Blanket, survival, 220x140cm, non-sterile X X X Bracelet, identifi cation (Sizes*) X X X X X X X X X X X X X X X X X X X X X X Compress, gauze, sterile & non-sterile, single use X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Cotton wool, 500g, roll, non-sterile X X X X X X X X X X X X X X X X X X X X X X X X Tape, medical, roll (Sizes*) X X X X X X X X X X X X X X X X X X X X X X X Umbilical clamp, sterile, single use X Umbilical tape, 3mmx50m, roll, non-sterile X Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) X X X X X X X X X X X X X X X X X X X X X X Catheter, Intra Venous (IV) umbilical vein, sterile, single use X X X X X X X X X X X X X X X X Infusion giving set, burette 100-150ml, sterile, single use X X X X X X X X X X X X X X X X X X X X X X Needles, luer, sterile, single use (Sizes G*) X X X X X X X X X X X X X X X X X X Needles, scalp vein, sterile, single use (Sizes G*) X X X X X X X X X X X X X X X X X X X Needles, spinal, sterile, single use (Sizes*) X Safety box, for used syringes/needles X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Stopcock, 3-way, sterile, single use X X X X X X X X Syringes, auto-disable (AD), (Capacities ml*) X X Syringes, luer, sterile, single use (Capacities ml*) X X X X X X X X X X X X X X X X X Syringes, reuse prevention (RUP), (Capacities ml*) X X X X X X X X X X X X X X X X Airway, Guedel, translucent (Sizes*) X X X X X X Collector, urine, adhesive, 10-100ml X X X X X X X X Prongs, nasal, oxygen, non sterile, single use (Sizes*) X X X X X X X X X X X X X X X X Syringe, feeding, catheter tip, 50ml, sterile, single use X X X X X X X X X X X X Syringe, feeding, luer tip, 50ml, sterile, single use X X X X X X X X X X X X Tube, endotracheal, without cuff, sterile, single use (Sizes ID*) X X X X X X X Tube, feeding/aspirating, L120cm,catheter tip, sterile, single use (Sizes CH*) X X X X X X X X X X X Tube, feeding, L40cm, luer tip, sterile, single use (Sizes CH*) X X X X X X X X X X X X Tube, suction, L50cm, catheter tip, sterile, single use (Sizes CH*) X X X X X X X X X X X X X X X X X Gloves, examination, latex, non-sterile, single use (Sizes*) X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X

111 112 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health material Counselling Grouping Equipment devices - Medical Equipment devices - Medical General type at Table 34.Medicaldevices for post-natal baby (newborn) DISTRICT HOSPITAL Counselling material (see table17) Commodities for intensive care ofnewborn (see table16) Commodities for inpatient motherandnewborn table 15) Commodities for surgery &anaesthesia (see (see table14) Commodities for labour, delivery &recovery (see table13) Commodities for emergency preparedness diagnosis (see table12) Commodities for medicalexamination & Phototherapy light,mobile, withaccessories Breastpump, manual,withaccessories Bilirubinometer Auditory, function screening devices, newborn Apnoea monitor sterile, singleuse USP/DEC*) withneedle(Shapes*andsizes*), Suture, synthetic, non-absorbable(Sizes sterile, singleuse DEC*) withneedle(Shapes*andsizes*), Suture, synthetic, absorbable (Sizes USP/ (Sizes*) Gloves, surgical, sterile, singleuse, pair Name ofdevices X X X

a) Dry baby thoroughly on mother's chest Immediate care at skin to skin and cover X X b) Assess breathing c) Clamp and cut cord / Check cord birth X X X vessels / Check for bleeding and signs of Childbirth: Essential newborn care cord infection X X X d) Prevent hypothermia when skin to skin is not possible X X X e) Support breastfeeding within the fi rst hour support X X X gency a) Basic neonatal resuscitation Emer- X X X b) Management of brain injury and intrac- ranial haemorrhage (ICH) X X a) Full clinical examination / Check vital signs / measuring weight X X X

b) Thermal Care Routine care X X X c) Breastfeeding support X X X d) Vitamin K prophylaxis and Immunization X X X e) Cord care X X f) Prophylaxis for eye infection X X g) Prophylactic antibiotics for neonates at risk of infection Detection and of congenital management X X Congenital infections

a) Diagnosis of congenital syphilis infections X X b) Prophylactic treatment for congenital syphilis X X c) Screening of HIV (Dried Blood Spot (DBS)) X X d) Prophylactic treatment for HIV (Antiretroviral Therapy (ART)) Cord tion fec- in- X X a) Detection and management of cord infections, illness andcomplications inthe

infection Detection andmanagementofcommon Jaun- X X X a) Diagnosis of jaundice dice X X X X

b) Management of jaundice neonate andyoung infant X X a) Diagnosis of anaemia Anaemia X X X b) Management of anaemia X X X c) Pre-referral treatment for severe anaemia (blood transfusion) X X X monia a) Diagnosis of pneumonia Pneu- X X X b) Management of pneumonia and its complications rhoea Diar- X X X X a) Detection and management of diarrhoea or menin- Septicae- a) Diagnosis of septicaemia and/or mia and/ X X X X meningitis: Blood Culture, Lumbar gitis Puncture, Urine Analysis X X X b) Management of septicaemia and/or meningitis and its complications noea Specific interventions for Ap- X X X X small, low weight birth

a) Prevention of Apnoea and pre-term babies drome (RDS) Distress Syn- X X X a) Diagnosis of RDS and provision of Respiratory prophylaxis surfactant X X b) Apply Continuous Positive Airway Pres- sure (CPAP) with nasal cannula or face mask X X c) Ventilatory support and oxygen therapy including mechanical ventilation and CPAP crotiz- colitis X X tero- Ne- en- a) Diagnosis of necrotizing enterocolitis ing X X b) Management of necrotizing enterocolitis Supportive care for allsick X X

a) Monitor blood glucose and manage- Supportive care ment of hypoglycaemia neonate andsickyoung X X b) Monitor nutrition and provision of tube feeding support X X c) Provision of intravenous therapy infant X X X d) Monitor temperature and management of hypothermia (Kangaroo mother care) X X e) Monitor oxygenation and management of hypoxia prepar- referral edness Triage, gency X X X X X X a) Detection of emergency signs, emer- emer- gency care and pre-referral treatment and X X X b) Advanced resuscitation

a) Full clinical examination / check vital Further assessment for all X X signs / measuring weight / check haemoglobin Clinical visit

b) Provision of vaccines (Diphtheria young infant X X Pertussis Tetanus (DPT) + Haemophilus Infl uenzae type B (HIB), Oral Polio Vaccine (OPV), Hepatitis B) X X X c) Breastfeeding support and replacement feeding if necessary X X d) Monitoring growth and development tional inter- tions ven- Op- X X X X X a) Male circumcision 4. Matrix of medical devices in each stage of continuum of care TableTable 34. 34. Medical Medical devices devices for for post-natal post-natal baby baby (newborn) (newborn) atat DISTRICT DISTRICT HOSPITAL HOSPITAL DetectionDetection and and DetectionDetection and and management management of of common common SpecifiSpecifi c c interventions interventions for for SupportiveSupportive care care for for all all sick sick managementmanagement FurtherFurther assessment assessment for for all all Childbirth:Childbirth: Essential Essential newborn newborn care care infections,infections, illness illness and and complications complications in in the the small,small, low low weight weight birth birth neonateneonate and and sick sick young young ofof congenital congenital youngyoung infant infant neonateneonate and and young young infant infant andand pre-term pre-term babies babies infantinfant infectionsinfections

Ne-Ne- Triage, Triage, Op-Op- CordCord Septicae-Septicae- crotiz-crotiz- emer-emer- Emer-Emer- RespiratoryRespiratory tionaltional ImmediateImmediate care care at at CongenitalCongenital in-in- Jaun-Jaun- Pneu-Pneu- Diar-Diar- miamia and/ and/ Ap-Ap- inging gencygency gencygency RoutineRoutine care care AnaemiaAnaemia DistressDistress Syn- Syn- SupportiveSupportive care care prepar-prepar- ClinicalClinical visit visit inter-inter- birthbirth infectionsinfections fec-fec- dicedice moniamonia rhoearhoeaoror menin- menin-noeanoea en-en- supportsupport dromedrome (RDS) (RDS) ednessedness ven-ven- tiontion gitisgitis tero-tero- andand tionstions colitiscolitis referralreferral

GeneralGeneral type type NameName of of devices devices a) Dry baby thoroughly on mother's chest thoroughly a) Dry baby skin and cover skin to breathing Assess b) / Check cord Clamp and cut cord c) bleeding and signs of / Check for vessels infection cord skin when skin to hypothermia d) Prevent is not possible rst within the fi Support breastfeeding e) hour resuscitation a) Basic neonatal injury and intrac- Management of brain b) haemorrhage (ICH) ranial / Check vital a) Full clinical examination signs / measuring weight Care Thermal b) support Breastfeeding c) and K prophylaxis d) Vitamin Immunization care Cord e) infection eye for f) Prophylaxis at neonates antibiotics for g) Prophylactic risk of infection syphilis a) Diagnosis of congenital congenital for treatment Prophylactic b) syphilis of HIV (Dried Blood Spot Screening c) (DBS)) HIV for treatment d) Prophylactic (ART)) Therapy (Antiretroviral and management of cord a) Detection infection a) Diagnosis of jaundice Management of jaundice b) a) Diagnosis of anaemia Management of anaemia b) severe for treatment Pre-referral c) anaemia (blood transfusion) a) Diagnosis of pneumonia Management of pneumonia and its b) complications and management ofa) Detection diarrhoea a) Diagnosis of septicaemia and/or Lumbar meningitis: Blood Culture, Urine Analysis Puncture, Management of septicaemia and/or b) meningitis and its complications of Apnoea a) Prevention of and provision a) Diagnosis of RDS surfactant prophylaxis Pres- Airway Positive Apply Continuous b) mask with nasal cannula or face (CPAP) sure therapy support and oxygen Ventilatory c) CPAP and ventilation mechanical including enterocolitis a) Diagnosis of necrotizing enterocolitis Management of necrotizing b) and manage- blood glucose a) Monitor ment of hypoglycaemia of tube nutrition and provision Monitor b) support feeding therapy of intravenous Provision c) and management temperature d) Monitor mother care) (Kangaroo of hypothermia and management oxygenation Monitor e) of hypoxia signs, emer- of emergency a) Detection treatment and pre-referral care gency resuscitation Advanced b) / check vital a) Full clinical examination / checksigns / measuring weight haemoglobin (Diphtheria of vaccines Provision b) (DPT) + Haemophilus Tetanus Pertussis Vaccine Polio uenzae type B (HIB), Oral Infl B) Hepatitis (OPV), support and replacement Breastfeeding c) if necessary feeding and development growth d) Monitoring a) Male circumcision a) Dry baby thoroughly on mother's chest thoroughly a) Dry baby skin and cover skin to breathing Assess b) / Check cord Clamp and cut cord c) bleeding and signs of / Check for vessels infection cord skin when skin to hypothermia d) Prevent is not possible rst within the fi Support breastfeeding e) hour resuscitation a) Basic neonatal injury and intrac- Management of brain b) haemorrhage (ICH) ranial / Check vital a) Full clinical examination signs / measuring weight Care Thermal b) support Breastfeeding c) and K prophylaxis d) Vitamin Immunization care Cord e) infection eye for f) Prophylaxis at neonates antibiotics for g) Prophylactic risk of infection syphilis a) Diagnosis of congenital congenital for treatment Prophylactic b) syphilis of HIV (Dried Blood Spot Screening c) (DBS)) HIV for treatment d) Prophylactic (ART)) Therapy (Antiretroviral and management of cord a) Detection infection a) Diagnosis of jaundice Management of jaundice b) a) Diagnosis of anaemia Management of anaemia b) severe for treatment Pre-referral c) anaemia (blood transfusion) a) Diagnosis of pneumonia Management of pneumonia and its b) complications and management ofa) Detection diarrhoea a) Diagnosis of septicaemia and/or Lumbar meningitis: Blood Culture, Urine Analysis Puncture, Management of septicaemia and/or b) meningitis and its complications of Apnoea a) Prevention of and provision a) Diagnosis of RDS surfactant prophylaxis Pres- Airway Positive Apply Continuous b) mask with nasal cannula or face (CPAP) sure therapy support and oxygen Ventilatory c) CPAP and ventilation mechanical including enterocolitis a) Diagnosis of necrotizing enterocolitis Management of necrotizing b) and manage- blood glucose a) Monitor ment of hypoglycaemia of tube nutrition and provision Monitor b) support feeding therapy of intravenous Provision c) and management temperature d) Monitor mother care) (Kangaroo of hypothermia and management oxygenation Monitor e) of hypoxia signs, emer- of emergency a) Detection treatment and pre-referral care gency resuscitation Advanced b) / check vital a) Full clinical examination / checksigns / measuring weight haemoglobin (Diphtheria of vaccines Provision b) (DPT) + Haemophilus Tetanus Pertussis Vaccine Polio uenzae type B (HIB), Oral Infl B) Hepatitis (OPV), support and replacement Breastfeeding c) if necessary feeding and development growth d) Monitoring a) Male circumcision Gloves,Gloves, surgical, surgical, sterile, sterile, single single use, use, pair pair X X X X X (Sizes*)(Sizes*) X X X X X Suture,Suture, synthetic, synthetic, absorbable absorbable (Sizes (Sizes USP/ USP/ DEC*)DEC*) with with needle needle (Shapes* (Shapes* and and sizes*), sizes*), XX XX sterile,sterile, single single use use Suture,Suture, synthetic, synthetic, non-absorbable non-absorbable (Sizes (Sizes USP/DEC*)USP/DEC*) with with needle needle (Shapes* (Shapes* and and sizes*), sizes*), XX sterile,sterile, single single use use ApnoeaApnoea monitor monitor XX XX Auditory,Auditory, function function screening screening devices, devices, newborn newborn XX MedicalMedical devicesdevices - - BilirubinometerBilirubinometer XX EquipmentEquipment Breastpump,Breastpump, manual, manual, with with accessories accessories XX PhototherapyPhototherapy light, light, mobile, mobile, with with accessories accessories XX

CommoditiesCommodities for for medical medical examination examination & & X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X diagnosisdiagnosis (see (see table table 12) 12) X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X CommoditiesCommodities for for emergency emergency preparedness preparedness X X X X X X X X (see(see table table 13) 13) X X X X X X X X MedicalMedical Commodities for labour, delivery & recovery Commodities for labour, delivery & recovery XX XX XX XX XX XX devicesdevices - - (see(see table table 14) 14) EquipmentEquipment Commodities for surgery & anaesthesia (see Commodities for surgery & anaesthesia (see XX GroupingGrouping tabletable 15) 15) CommoditiesCommodities for for inpatient inpatient mother mother and and newborn newborn X X X X X X X X X X X X X X X X X X X X (see(see table table 16) 16) X X X X X X X X X X X X X X X X X X X X CommoditiesCommodities for for intensive intensive care care of of newborn newborn X X X X X X X X X X X X X X X X X X X X X X (see(see table table 17) 17) X X X X X X X X X X X X X X X X X X X X X X CounsellingCounselling CounsellingCounselling material material XX XX XX XX XX XX XX XX XX XX XX materialmaterial

113 114 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health childhood at DISTRICT HOSPITAL Table 35. Medicaldevices for infancy and DISTRICT HOSPITAL Table 35. Medicaldevices for infancy andchildhoodat type General Disposable devices - Medical devices laboratory Clinical devices Blood Bank Bracelet, identification (Sizes*) Blanket, survival, 220x140cm,non-sterile Bandage, elastic, 7.5cmx5m, roll Test strip, urinalysis (10parameter) Rapid Diagnostic Test (RDT), malaria,kit Immunodeficiency Virus (HIV),kit Rapid Diagnostic Test (RDT), Human Hemoglobinometer, withaccessories Blood glucometer, withaccessories Analyzer, bloodgas Tube, vacuum, plain/dry, sterile (Capacity*) Acid (EDTA), sterile (Capacity*) Tube, vacuum, Ethylene DiamineTetra-acetic Tube, capillary, heparin, Acid (EDTA) Tube, capillary, Ethylene DiamineTetra-acetic Swab, cotton-tip, tube, sterile Paper, drybloodspot Needle, vacuum tube, sterile (Size*) Needle holder, vacuum tubes,sterile Lancet, blood,safety, sterile (Sizes*) Container, sample, 50ml sterile, singleuse Catheter, Intra Venous (IV) umbilicalvein, use (Sizes G*) Cannulas, Intra Venous (IV)short,sterile, single Tape, medical,roll (Sizes*) Cotton wool, 500g,roll, non-sterile Compress, gauze, sterile &non-sterile, singleuse Wooden orplastic applicator sticks plastic non-sterile, 3ml Pasteur pipettes withintegral bulb, disposable, glassware Markers, fine point,permanentblack,for Glass slides,25x75mm Blood administration set,sterile monoclonal) Anti-D bloodgroup reagent (Saline/ Anti-B bloodgroup reagent, monoclonal Anti-A bloodgroup reagent, monoclonal Name ofdevices Immunodeficiency Virus (HIV),kit Enzyme ImmunoAssay (EIA),Human

a) Full clinical examination / check vital signs / measuring weight and earlychildhood monitoring growth X b) Provision of vaccines Essential care for development Routine care c) Growth monitoring d) Early childhood development monitoring e) Breastfeeding support and replacement feeding if necessary f) Vitamin A supplementation

g) Deworming (Mebendazole) Malnutrition Malnutrition X X X X X Detection andmanagementofcommon infections, illness andcomplications in

a) Diagnosis of SAM Severe (SAM) Acute X X X X b) Feeding support X X X X X X X c) Pre-referral treatment for SAM infancy andchildhood X X X X X a) Diagnosis of anaemia Anaemia X X X X X X X b) Management of anaemia X X X X X X X X X X X X X X X X X c) Pre-referral treatment for severe anaemia (Blood transfusion) monia X a) Differential diagnosis for Pneu- pneumonia X X X X X X b) Management of pneumonia and its complications (Asthma, (Asthma, Bronchi- Wheeze X a) Diagnosis of condition with wheeze olitis) X X X b) Management of condition with wheeze culosis Tuber- X a) Diagnosis of tuberculosis X X X X X b) Management of tuberculosis rhoea a) Differential diagnosis and Diar- X X X X X management of diarrhoea and dysentery mia and/or meningitis a) Diagnosis of septicaemia and/or Septicae- X X X X X X X X X X X X X meningitis : Blood Culture, Lumbar Puncture, Urine Analysis X X X X X X X b) Management of septicaemia and/ or meningitis and its complications laria Ma- X X X X X X X a) Diagnosis and management of malaria fever Den- gue gue X X X X X a) Diagnosis and management of dengue fever Mea- sles X X a) Diagnosis and management of measles ciency Virus Human Im- X X X X X X X X X X X X a) Diagnosis of HIV munodefi- (HIV) b) Treatment for HIV (Antiretroviral Therapy (ART)) X X X X c) Management of other opportunistic infections in HIV tion fec- Eye Eye in- X X X a) Detection and management of eye infection / conjunctivitis tion fec- Ear Ear in- X X X a) Detection and management of ear infection Mouth Mouth infec- tion X X X a) Detection and management of mouth infection / thrush infec- Skin Skin tion X X X a) Diagnosis and management of skin infections Chick- pox en en X X X a) Detection and management of chicken pox Supportive care for allsickinfant X X X X X X X X a) Management of hypoglycaemia Supportive care X X X X X b) Tube feeding support X X X X X c) Intravenous therapy and child X X X X X X d) Management of hypothermia X X X X X X e) Management of hypoxia X X X X X f) Pain control emergency emergency prepared- a) Detection of emergency signs, ness and referral X X X X X X X X X emergency care and pre-referral Triage, treatment X X X X X b) Advanced resuscitation all infant ment for interven- Optional Optional Further assess- child tions and X X X X X X a) Male circumcision 4. Matrix of medical devices in each stage of continuum of care Table 35. Medical devices for infancy and childhood at Further DISTRICT HOSPITAL Essential care for assess- Detection and management of common monitoring growth Supportive care for all sick infant ment for infections, illness and complications in and early childhood and child all infant infancy and childhood development and child

Severe Wheeze Human Im- Eye Ear Triage, Acute Pneu- (Asthma, Tuber- Diar- Septicae- Ma- Den- Mea- munodefi - in- in- Mouth Skin Chick- emergency Optional Routine care Anaemia mia and/or gue infec- infec- en Supportive care prepared- interven- Malnutrition monia Bronchi- culosis rhoea meningitis laria fever sles ciency Virus fec- fec- tion tion pox ness and tions (SAM) olitis) (HIV) tion tion referral

General Name of devices type a) Full clinical examination / check a) Full clinical examination vital signs / measuring weight of vaccines Provision b) monitoring Growth c) d) Early childhood development monitoring support and Breastfeeding e) if necessary feeding replacement f) A supplementation Vitamin (Mebendazole) g) Deworming a) Diagnosis of SAM support Feeding b) SAM for treatment Pre-referral c) a) Diagnosis of anaemia Management of anaemia b) severe for treatment Pre-referral c) anaemia (Blood transfusion) diagnosis for a) Differential pneumonia Management of pneumonia and b) its complications witha) Diagnosis of condition wheeze with Management of condition b) wheeze a) Diagnosis of tuberculosis Management of tuberculosis b) diagnosis and a) Differential management of diarrhoea and dysentery a) Diagnosis of septicaemia and/or Lumbar meningitis : Blood Culture, Urine Analysis Puncture, Management of septicaemia and/ b) or meningitis and its complications a) Diagnosis and management of malaria a) Diagnosis and management of dengue fever a) Diagnosis and management of measles a) Diagnosis of HIV HIV (Antiretroviral for Treatment b) (ART)) Therapy Management of otherc) in HIV infections opportunistic and management ofa) Detection / conjunctivitis infection eye and management ofa) Detection ear infection and management ofa) Detection / thrush mouth infection a) Diagnosis and management of skin infections and management ofa) Detection pox chicken a) Management of hypoglycaemia support feeding Tube b) therapy Intravenous c) d) Management of hypothermia Management of hypoxia e) f) control Pain signs,a) of emergency Detection and pre-referral care emergency treatment resuscitation Advanced b) a) Male circumcision Blood Bank Anti-A blood group reagent, monoclonal X devices Anti-B blood group reagent, monoclonal X Anti-D blood group reagent (Saline/ monoclonal) X Blood administration set, sterile X Glass slides, 25x75mm X Markers, fi ne point, permanent black, for glassware X Pasteur pipettes with integral bulb, disposable, plastic non-sterile, 3 ml X Wooden or plastic applicator sticks X Clinical Container, sample, 50 ml X laboratory devices Lancet, blood, safety, sterile (Sizes*) X X X X X X X X Needle holder, vacuum tubes, sterile X X Needle, vacuum tube, sterile (Size*) X X Paper, dry blood spot X Swab, cotton-tip, tube, sterile X X X X X Tube, capillary, Ethylene Diamine Tetra-acetic Acid (EDTA) X X Tube, capillary, heparin, X Tube, vacuum, Ethylene Diamine Tetra-acetic Acid (EDTA), sterile (Capacity*) X X Tube, vacuum, plain/dry, sterile (Capacity*) X Analyzer, blood gas X X X X X X Blood glucometer, with accessories X X X X Hemoglobinometer, with accessories X X X X

Enzyme Immuno Assay (EIA), Human X Immunodefi ciency Virus (HIV), kit Rapid Diagnostic Test (RDT), Human Immunodefi ciency Virus (HIV), kit X Rapid Diagnostic Test (RDT), malaria, kit X Test strip, urinalysis (10 parameter) X X Medical Bandage, elastic, 7.5cmx5m, roll X X X devices - Disposable Blanket, survival, 220x140cm, non-sterile X X X X Bracelet, identifi cation (Sizes*) X X X X X X X X X X X X X X X X X Compress, gauze, sterile & non-sterile, single use X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Cotton wool, 500g, roll, non-sterile X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Tape, medical, roll (Sizes*) X X X X X X X X X X X X X X X X X X X X X X X X X X X Cannulas, Intra Venous (IV) short, sterile, single use (Sizes G*) X X X X X X X X X X X X X X X X X X X X X Catheter, Intra Venous (IV) umbilical vein, sterile, single use X

115 116 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Grouping Equipment devices - Medical DISTRICT HOSPITAL Table 35. Medicaldevices for infancy andchildhoodat type General material Counselling Equipment devices - Medical diagnosis (see table12) Commodities for medicalexamination & Breastpump, manual,withaccessories Auditory, functionscreening devices, newborn single use DEC*) withneedle(Shapes*andsizes*), sterile, Suture, synthetic, non-absorbable(Sizes USP/ with needle(Shapes*andsizes*), sterile, singleuse Suture, synthetic, absorbable(Sizes USP/DEC*) Gloves, surgical, sterile, singleuse, pair(Sizes*) use (Sizes*) Gloves, examination, latex, non-sterile, single use (Sizes CH*) Tube, suction,L50cm,catheter tip, sterile, single (Sizes CH*) Tube, feeding, L40cm,luertip, sterile, single use sterile, singleuse(Sizes CH*) Tube, feeding/aspirating, L120cm,catheter tip, use (Sizes ID*) Tube, endotracheal, withoutcuff, sterile, single Syringe, feeding, luertip, 50ml,sterile, singleuse single use Syringe, feeding, catheter tip, 50ml,sterile, (Sizes*) Prongs, nasal,oxygen, nonsterile, singleuse Collector, urine, adhesive, 10-100ml Airway, Guedel,translucent (Sizes*) Syringes, reuse prevention (RUP),(Capacities ml*) Syringes, luer, sterile, single use(Capacities ml*) Syringe for tuberculin, sterile, singleuse Syringes, auto-disable (AD), (Capacities ml*) Stopcock, 3-way, sterile, singleuse Safety box, for usedsyringes/needles Needles, spinal,sterile, singleuse(Sizes*) Needles, scalpvein, sterile, singleuse(Sizes G*) Needles, luer, sterile, singleuse(Sizes G*) Counselling material table 18) Commodities for intensive care ofchild(see Commodities for inpatient child(see table 17) table 14) Commodities for surgery & anaesthesia (see (see table13) Commodities for emergency preparedness single use Infusion givingset,burette 100-150ml, sterile, Name ofdevices

X X X X a) Full clinical examination / check vital signs / measuring weight and earlychildhood monitoring growth X X X X X X X b) Provision of vaccines Essential care for development Routine care X X c) Growth monitoring

X X d) Early childhood development monitoring X X X e) Breastfeeding support and replacement feeding if necessary X f) Vitamin A supplementation

X g) Deworming (Mebendazole) Malnutrition Malnutrition X X X X X Detection andmanagementofcommon infections, illness andcomplications in

a) Diagnosis of SAM Severe (SAM) Acute X X X X X X X X X X X X X b) Feeding support X X X X X X X X X X X X X X X X X X X X c) Pre-referral treatment for SAM infancy andchildhood X X X X a) Diagnosis of anaemia Anaemia X X X X X X X X X X X b) Management of anaemia X X X X X X X X X X X X X X X X X X c) Pre-referral treatment for severe anaemia (Blood transfusion) monia X a) Differential diagnosis for Pneu- pneumonia X X X X X X X X X X X X X X X X b) Management of pneumonia and its complications (Asthma, (Asthma, Bronchi- Wheeze X a) Diagnosis of condition with wheeze olitis) X X X X X X X X X X X b) Management of condition with wheeze culosis Tuber- X a) Diagnosis of tuberculosis X X X X X X X X X X X X X b) Management of tuberculosis rhoea a) Differential diagnosis and Diar- X X X X X X X X X X X X X X X X X X management of diarrhoea and dysentery mia and/or meningitis a) Diagnosis of septicaemia and/or Septicae- X X X X X X X X X X X X X meningitis : Blood Culture, Lumbar Puncture, Urine Analysis X X X X X X X X X X X X X X X X X X b) Management of septicaemia and/ or meningitis and its complications laria Ma- X X X X X X X X X X X X X a) Diagnosis and management of malaria fever Den- gue gue X X X X X X X X X X X X a) Diagnosis and management of dengue fever Mea- sles X X X X X X X a) Diagnosis and management of measles ciency Virus Human Im- X X X X a) Diagnosis of HIV munodefi- (HIV) X X b) Treatment for HIV (Antiretroviral Therapy (ART)) X X X X X X X X X X c) Management of other opportunistic infections in HIV tion fec- Eye Eye in- X X X X X X a) Detection and management of eye infection / conjunctivitis tion fec- Ear Ear in- X X X X X X a) Detection and management of ear infection Mouth Mouth infec- tion X X X X X X a) Detection and management of mouth infection / thrush infec- Skin Skin tion X X X X X X a) Diagnosis and management of skin infections Chick- pox en en X X X X X X a) Detection and management of chicken pox Supportive care for allsickinfant X X X X X X X X X X X X X X X X a) Management of hypoglycaemia Supportive care X X X X X X X X X X X X X X b) Tube feeding support X X X X X X X X X X X X X X X c) Intravenous therapy and child X X X X X X X X X X X X d) Management of hypothermia X X X X X X X X X X X X X X X X X X e) Management of hypoxia X X X X X X X X X X f) Pain control emergency emergency prepared- a) Detection of emergency signs, ness and referral X X X X X X X X X X X X X X X X X X X X X X X emergency care and pre-referral Triage, treatment X X X X X X X X X X X X X X X b) Advanced resuscitation all infant ment for interven- Optional Optional Further assess- child tions and X X X X X X X X X X X X X X a) Male circumcision 4. Matrix of medical devices in each stage of continuum of care Table 35. Medical devices for infancy and childhood at Further DISTRICT HOSPITAL Essential care for assess- Detection and management of common monitoring growth Supportive care for all sick infant ment for infections, illness and complications in and early childhood and child all infant infancy and childhood development and child

Severe Wheeze Human Im- Eye Ear Triage, Acute Pneu- (Asthma, Tuber- Diar- Septicae- Ma- Den- Mea- munodefi - in- in- Mouth Skin Chick- emergency Optional Routine care Anaemia mia and/or gue infec- infec- en Supportive care prepared- interven- Malnutrition monia Bronchi- culosis rhoea meningitis laria fever sles ciency Virus fec- fec- tion tion pox ness and tions (SAM) olitis) (HIV) tion tion referral

General Name of devices type a) Full clinical examination / check a) Full clinical examination vital signs / measuring weight of vaccines Provision b) monitoring Growth c) d) Early childhood development monitoring support and Breastfeeding e) if necessary feeding replacement f) A supplementation Vitamin (Mebendazole) g) Deworming a) Diagnosis of SAM support Feeding b) SAM for treatment Pre-referral c) a) Diagnosis of anaemia Management of anaemia b) severe for treatment Pre-referral c) anaemia (Blood transfusion) diagnosis for a) Differential pneumonia Management of pneumonia and b) its complications witha) Diagnosis of condition wheeze with Management of condition b) wheeze a) Diagnosis of tuberculosis Management of tuberculosis b) diagnosis and a) Differential management of diarrhoea and dysentery a) Diagnosis of septicaemia and/or Lumbar meningitis : Blood Culture, Urine Analysis Puncture, Management of septicaemia and/ b) or meningitis and its complications a) Diagnosis and management of malaria a) Diagnosis and management of dengue fever a) Diagnosis and management of measles a) Diagnosis of HIV HIV (Antiretroviral for Treatment b) (ART)) Therapy Management of otherc) in HIV infections opportunistic and management ofa) Detection / conjunctivitis infection eye and management ofa) Detection ear infection and management ofa) Detection / thrush mouth infection a) Diagnosis and management of skin infections and management ofa) Detection pox chicken a) Management of hypoglycaemia support feeding Tube b) therapy Intravenous c) d) Management of hypothermia Management of hypoxia e) f) control Pain signs,a) of emergency Detection and pre-referral care emergency treatment resuscitation Advanced b) a) Male circumcision Infusion giving set, burette 100-150ml, sterile, single use X X X X X X X X X X X X X X X X X X X X X Needles, luer, sterile, single use (Sizes G*) X X X X X X X X X X X X X X X X X X X X X X X X X X X X Needles, scalp vein, sterile, single use (Sizes G*) X X X X X X X X X X X X X X X X X X X X X Needles, spinal, sterile, single use (Sizes*) X Safety box, for used syringes/needles X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Stopcock, 3-way, sterile, single use X X X X X X X X X Syringes, auto-disable (AD), (Capacities ml*) X Syringe for tuberculin, sterile, single use X Syringes, luer, sterile, single use (Capacities ml*) X X X X X X X X X X X X X X X X X X X X X X X X X X X X Syringes, reuse prevention (RUP), (Capacities ml*) X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Airway, Guedel, translucent (Sizes*) X X X X X X Collector, urine, adhesive, 10-100ml X X X X X X X X X X X Prongs, nasal, oxygen, non sterile, single use (Sizes*) X X X X X X X X X X X X X X X X Syringe, feeding, catheter tip, 50ml, sterile, single use X X X X X X X X X Syringe, feeding, luer tip, 50ml, sterile, single use X X X X X X X X X Tube, endotracheal, without cuff, sterile, single use (Sizes ID*) X X X X X X Tube, feeding/aspirating, L120cm,catheter tip, sterile, single use (Sizes CH*) X X X X X X X X X Tube, feeding, L40cm, luer tip, sterile, single use (Sizes CH*) X X X X X X X X X Tube, suction, L50cm, catheter tip, sterile, single use (Sizes CH*) X X X X X X X X X X X X X X X X X X Gloves, examination, latex, non-sterile, single use (Sizes*) X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Gloves, surgical, sterile, single use, pair (Sizes*) X X X Suture, synthetic, absorbable (Sizes USP/DEC*) with needle (Shapes* and sizes*), sterile, single use X X Suture, synthetic, non-absorbable (Sizes USP/ DEC*) with needle (Shapes* and sizes*), sterile, X single use Medical Auditory, function screening devices, newborn X X devices - Equipment Breastpump, manual, with accessories X X Commodities for medical examination & diagnosis (see table 12) X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Commodities for emergency preparedness Medical (see table 13) X X X X X X X X devices - Commodities for surgery & anaesthesia (see Equipment table 14) X Grouping Commodities for inpatient child (see table 17) X X X X X X X X X X X X X Commodities for intensive care of child (see table 18) X X X X X X X X X X X X X Counselling Counselling material X X X X X X X X X X X X X X material 117 118 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health and willsystematically take thefollowing factors into consideration: led The to consider theuseofprocedures anddevices suchasalaparoscopy system andproctoscope andanoscope system. according the not Table 35. Medicaldevices for specialized care • • • Other Devices andinterventions inspecialized care 4.2 system Laparoscope Name Imaging Resonance Magnetic System, Scanning Tomography Computed System, Scanning Systems Radiotherapy system Fluoroscopic Radiographic, unit Mammography existing replenishment/inventory system for medicaldevices –renewable/consumable andequipment. health facility –capacity, activitiesandorganization; health system –policiesandprotocols; locally. list. covered current optional This to The document will by the devices, quantity the depend principle scanning_MRI_full_body.pdf medical_devices/innovation/ http://www.who.int/ scanning_CT.pdf medical_devices/innovation/ http://www.who.int/ radiotherapy_planning.pdf medical_devices/innovation/ http://www.who.int/ radiotherapy_system.pdf medical_devices/innovation/ http://www.who.int/ pdf radiographic_fluorescence. medical_devices/innovation/ http://www.who.int/ mammography.pdf medical_devices/innovation/ http://www.who.int/ en/ publications/scdh_manual/ http://www.who.int/surgery/ Link main does which of on matrix. of medical many not health are The include considered different devices technology use guidance of needed factors such to to evaluate kidney transplant viability;andto study marrow diseases. display heart-wall structure; to stage prostate, bladder, anduterine cancer; to helpdiagnoseinfectious diseases;to detect metastatic liver disease; to It isalsousedto view cartilage, tendons, andligaments.MRIcan be used nervous system, brain, andspineto detect musculoskeletal disorders. operator console. Itisprimarily usedto identifydiseasesofthecentral system, apatient table, acomputer, display monitors, andan transmitter/receiver system withanantenna coil, agradient An MRIunitconsists ofamagnet,shimmingmagnets,anRF musculoskeletal degeneration. ventricles, thechest wall, andthelarge bloodvessels; andto assess lesions, andabdominalpelvicmalignancies;to examine thecerebral variety ofdiagnostic procedures, includingspineandheadinjuries, table, andacontrolling computer. These scanners are usedfor awide Devices that consist ofanx-ray subsystem, agantry, apatient cancer andtumorsofthehead,neck,breast. units andlow-energy linacsare usedprimarily to treat bone used inexternal-beam radiation therapy to treat cancer. Cobalt Linear accelerators (linacs) andcobalt radiotherapy unitsare congestive heartfailure; andevaluating chest pain. highlighting congenital anatomic abnormalities;diagnosing materials; localizinglesionsfor needle aspiration orbiopsy; sialography. Otherapplications includelocating ingested foreign intravenous andretrograde pyelography, myelography, and gastrointestinal andbiliarytree studies, hysterosalpingography, This technology iseffective inarthrography, bronchography, and placement ofthebreasts duringimaging. for compression power necessary to produce anx-ray beam.They alsoincludea“paddle” generator modifies incoming voltage to provide thex-ray tubewiththe generator, anx-ray tubeandgantry, andarecording medium.The x-ray A complete mammographic radiographic system includesanx-ray sterilization. pain, ectopic pregnancy, ovarian cysts, appendicitis, orfor female procedures involving theevaluation/treatment ofabdominalorpelvic or inthenearvicinity).This system ismostly usedfor gynaecological incision(s) madeintheabdominalwall (routinely just below theumbilicus cavity anditsorgans (laparoscopy). The insertionistypicallythrough an visual examination andtreatment oftheabdominal/retroperitoneal An assembly ofsterile laparoscopes andtheiraccessories usedfor the Description assessment be devices on within useful per quantification intervention and in a health-care in specialized procedures future will for work. facility, hospitals be the in based In low-resource medical specialized and and on quantification devices, assessments optional hospitals, settings sets surgery at activities should and it the would procedures kits national be covered should be assessed better level are be in 4.Matrix of medical devices in each stage of continuum of care 4.3 Innovative health technologies Since 2011 the Essential Health Technologies Department and later the Essential Medicines and Health Products department of WHO has published three editions of the Compendium of innovative health technologies for low- resource settings to distribute information about alternative, new or adapted technologies designed to fill existing gaps in the availability of health products to vulnerable populations, especially with regard to innovative medical devices for newborn and children’s health, such as bedside newborn phototherapy, compact portable ultrasound, fetal heart rate monitoring, infant warming, and oxygen concentrator-driven bubble continuous positive airway pressure.

The choice of technology depends on the capabilities of the medical unit and the intention of use. For example, to maintain the proper temperature in a baby, a traditional incubator can be used if there is a source of electricity; if not, the Compendium describes an innovative infant warmer that does not require a constant supply of electricity.

Table 36. Innovative health technologies for reproductive, maternal, newborn and child health Table 36. Innovative health technologies for reproductive, maternal, newborn and child health

Name Link Description

Bedside http://www.who.int/ Bedside Newborn Phototherapy is a device designed to treat jaundice newborn medical_devices/innovation/ in the mother’s room in rural clinics. The double-sided, high-power LED phototherapy compendium_med_ lighting cures the most severe cases of jaundice and dramatically reduces dev2013_1.pdf?ua=1 treatment time.

Birthing http://www.who.int/ The birthing simulator enables the instructor to create very compelling simulator for medical_devices/innovation/ simulations of normal to more complex birthing scenarios, and is training compendium_other2012_2. particularly suitable for training control of post-partum haemorrhage. pdf?ua=1

Compact http://www.who.int/ This device provides a non-invasive look inside the body for immediate portable medical_devices/innovation/ visual validation of what a clinician can feel or hear. The device is small ultrasound compendium_med_ and lightweight, which makes it easy to carry and its battery capacity dev2013_2.pdf?ua=1 provides over one hour of scanning on a single charge, giving it enough power for a full day’s worth of patient exams.

Fetal heart rate http://www.who.int/ Using advanced Doppler ultrasound technology, the monitor detects and monitor medical_devices/innovation/ measures the fetal heart rate. This vital indicator of fetal stress allows compendium_med_dev2011_1. rural healthcare workers to make life-saving decisions during childbirth. pdf?ua=1 Destined for use in low resource settings, its design focuses on simplicity of use, durability and electrical power independence.

Infant radiant http://www.who.int/ The device consists of a biocompatible bed on which to place the infant, warmer medical_devices/innovation/ and an overhead heater that delivers radiant heat. A skin temperature compendium_med_ probe monitors infant temperature. Heat output can be controlled dev2013_6.pdf?ua=1 manually or through baby mode (feedback mode) for thermoregulation. Visual and audio alarms are present for safety. An APGAR timer helps to effi ciently take APGAR scores post-delivery.

Infant warmer http://www.who.int/ The infant warmer works without a constant supply of electricity. It has (neonatal medical_devices/innovation/ no moving parts, and is safe and easy to use. It consists of three parts - a sleeping bag compendium_med_ sleeping bag to place the baby, a pouch of phase change material and warmer) dev2013_7.pdf?ua=1 an electric heater. The pouch is heated for 30 mins in the heater (second version uses boiling water instead of electricity to heat) and then placed in the sleeping bag. It maintains the WHO recommended temperature of 37 deg C for 4-6 hours, after which it can be reheated. LED http://www.who.int/ The device emits light through an array of high-powered light emitting phototherapy medical_devices/innovation/ diodes (LEDs). These LEDs have been specifi cally selected to emit a for neonatal compendium_med_ narrow dev2013_9.pdf?ua=1 jaundice wavelength of blue light (dominant wavelength 458nm) that maximises the rate of bilirubin breakdown. The arrangement of the LEDs along with the optics have been designed to provide uniformity of light on the patient, while minimizing unwanted spill and glare outside the treatment surface.

119 120 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health newborns indicator for hypothermia Non-invasive infants system for measurement bilirubin Transcutaneous suction device neonatal Reusable treatment jaundice for neonatal Phototherapy injection system auto-disable in prefilled Oxytocin CPAP driven bubble concentrator- Oxygen device circumcision male Non-surgical garment anti-chock Non-pneumatic training resuscitation simulator for Newborn Name Table 36.Innovative healthtechnologies for reproductive, maternal, newborn andchildhealth Link dev2011_16.pdf?ua=1 compendium_med_ medical_devices/innovation/ http://www.who.int/ dev2011_13.pdf?ua=1 compendium_med_ medical_devices/innovation/ http://www.who.int/ dev2011_8.pdf?ua=1 compendium_med_ medical_devices/innovation/ http://www.who.int/ dev2011_6.pdf?ua=1 compendium_med_ medical_devices/innovation/ http://www.who.int/ dev2013_14.pdf?ua=1 compendium_med_ medical_devices/innovation/ http://www.who.int/ dev2012_13.pdf?ua=1 compendium_med_ medical_devices/innovation/ http://www.who.int/ dev2011_5.pdf?ua=1 compendium_med_ medical_devices/innovation/ http://www.who.int/ dev2012_11.pdf?ua=1 compendium_med_ medical_devices/innovation/ http://www.who.int/ pdf?ua=1 compendium_other2011_1. medical_devices/innovation/ http://www.who.int/ Description therapeutic tools. as standard resuscitation measures. The simulator isavailable with role playing inrelevant scenarios covering basicnewborn care aswell simulator. The baby’s status canbesimulated asdesired to facilitate The proposed solutionisahighlyrealistic andaffordable newborn disinfected inaccordance withinstructions, over theproduct’s lifespan. for useindeveloping countries. Itiseasy to useandreusable when The proposed solutionisabulbsuction device that isparticularlysuitable negligible emission ofUV/IRradiation. photoisomerization. The device useshighpower LEDsfor treatment and in thebloodinto less toxic isomericforms, by photo-oxidation and blue lightover thepatient’s skin,itconverts toxic bilirubinmolecules Phototherapy isanefficient meanto treat Hyperbilirubinemia.By emitting workers to provide thePPHprevention dose. exposure. Oxytocin inthisdevice canenableminimallytrained health Oxytocin. Atime-temperature indicator oneachpackage indicates heat A compact, prefilled, auto-disable injectionsystem isusedto deliver water, andissetby asimpledialonthe bottle. controlled by abubblebottlethat dependsonthedepthoftubingunder flows ofupto 8L/min ofbothoxygen andair. Pressure inthesystem is need for expensive cylinders ofcompressed gases.The device delivers concentrator that generates oxygen from atmospheric air, eliminating the humidified oxygen andairfor CPAP treatment. Itisdriven by anoxygen This device generates anddelivers asafe, easilycontrollable mixture of bloodless, requires noinjected anaesthesia, nosutures, nosterile settings. removed after 5-7 days. The procedure takes less than5minutes, is and cutoffcirculation. The distal foreskin becomes necrotic andis device appliescontrolled radial elastic pressure to compress theforeskin The device consists ofanInnerRing,Elastic RingandApplicator. The manage PPHistheuseofanon-pneumatic anti-shockgarment(NASG). a comprehensive obstetric care facility could belifesaving. Onemethodto bleeding, reverse theshock,andstabilize thepatient for safe transport to For women suffering from uncontrollable PPH,amethodto control the operating tolerance of+/-0.5 degree Celsius. provides functionfor itto perform reliably andaccurately withinan facility. This device comes inastrip of5units.Liquidcrystal technology with two smallwhite “dots” ononeside, theothersidehasaself-adhesive The hypothermia indicator isa12mmdiameter discwithablack‘face’ Pressure LiquidChromatography (HPLC). correlated withtotal serumbilirubinconcentration measured by High in mg/dL orµmol/Lwithinaclinicallybeneficial range that hasbeen The device provides anumericalmeasurement ofpredicted bilirubincount pressure positive airway continuous Ventilator using http://www.who.int/medical_devices/innovation/compendium/en/index3.html Source: WHOCompendium ofinnovative healthtechnologies for low-resource settings2011 -2013 analyser artery doppler Umbilical Name Table 36.Innovative healthtechnologies for reproductive, maternal, newborn andchildhealth Link dev2011_17.pdf?ua=1 compendium_med_ medical_devices/innovation/ http://www.who.int/ dev2013_16.pdf?ua=1 compendium_med_ medical_devices/innovation/ http://www.who.int/ Description resources. customized for theuseinhospitalswithbasicinfrastructure andlimited positive airway pressure whilebreathing ontheirown. This solutionis CPAP assists infants withrespiratory distress inmaintainingcontinuous parts oftheprobe (hosing,acoustic nose, etc.). a graphic userinterface, operational software andthephysical mechanical laptop onwhichproprietary software isinstalled. The product consists of Doppler probe connects to theUSBportofastandard Pentium PCor and oxygen inorder to sustain adequate fetal development. The ultrasonic be madeabouttheabilityfor theplacenta to provide sufficient nutrients greater than24 weeks gestation. From suchameasurement, decisionscan The technology measures bloodflow intheumbilicalartery ofthefetus at 4.Matrix of medical devices in each stage of continuum of care Table 36. Innovative health technologies for reproductive, maternal, newborn and child health

Name Link Description

Umbilical http://www.who.int/ The technology measures blood fl ow in the umbilical artery of the at artery doppler medical_devices/innovation/ greater than 24 weeks gestation. From such a measurement, decisions can analyser compendium_med_ be made about the ability for the placenta to provide suffi cient nutrients dev2013_16.pdf?ua=1 and oxygen in order to sustain adequate fetal development. The ultrasonic Doppler probe connects to the USB port of a standard Pentium PC or laptop on which proprietary software is installed. The product consists of a graphic user interface, operational software and the physical mechanical parts of the probe (hosing, acoustic nose, etc.).

Ventilator using http://www.who.int/ CPAP assists infants with respiratory distress in maintaining continuous continuous medical_devices/innovation/ positive airway pressure while breathing on their own. This solution is positive airway compendium_med_ customized for the use in hospitals with basic infrastructure and limited pressure dev2011_17.pdf?ua=1 resources.

Source: WHO Compendium of innovative health technologies for low-resource settings 2011 - 2013 http://www.who.int/medical_devices/innovation/compendium/en/index3.html

4.4 References 1. Health technology assessment of medical devices. Geneva: World Health Organization; 2011 (http://www.who.int/medical_devices/ assessment/en/, accessed 22 May 2014). 2. Compendium of innovative health technologies for low-resource settings. Geneva: World Health Organization; 2014 (http://www. who.int/medical_devices/innovation/compendium/en/index3.html, accessed 22 May 2014).

121 122 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 37. Laboratory suppliesby health-care facilities To 5.1 Laboratory supply 5. list ofrecommended laboratory suppliesfor healthposts, healthcentres anddistrict hospitalsisgiven inTable 37. analytical testing Chemicals and (instruments) technologies CD4 enumeration Classification implement bank commodities Laboratory supplyandblood the various Sugar fermentation tests Stain, Ziehl–Neelsen,solution, bottle Stain, May-Grunwald Giemsa, set Stain, Gram, set Stain, Giemsa,solution Stain, FieldB,solution Stain, FieldA,solution Sodium persulfate Sodium hypochlorite, tablets Sodium chloride, powder, bottle Sodium bicarbonate Silica gel(desiccant for DBS),pouch Potassium iodide Plates, culture, agar-blood Plates, culture, agar-chocolate Petroleum gel,paraffin, bottle Oxidase test Oil, immersion,bottle Nitric acid Methylene blue, bottle Methanol, bottle Lugol iodine, bottle KI starch solution Indian ink,black,bottle Hydrochloric acid, 40%,bottle Glycerol, bottle Gentian violet,solution,bottle Formaldehyde, 10%,10ml,ampoule Ethanol, denaturised, 95 %,bottle Ethanol, denaturised, 70 %,bottle Drug susceptibility testing Diethyl ether, bottle Buffer, tablets,PH7.2, box Bromine solution Aglutination latex test for meningitis Acetone, bottle Acetic acid,36%,bottle Classical flow cytometry, withaccessories Dedicated flow cytometer, withaccessories PoC CD4instrument, portable, withaccessories Name ofmedicaldevice priority interventions described in this document, laboratory studies may be required. X X X Community

level Potential Useat X X X Health Center A nonexclusive X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X District Hospital Regional/ X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Provincial Hospital

5. Laboratory supply and blood bank commodities Classifi cation Name of medical device Potential Use at Community level Health Center District Hospital Regional/ Provincial Hospital Sulphuric acid, 95 % X X Test, Nickerson or saboraud medium, kit X X Test, potassium hydroxide KOH, preparation X X Trichloroacetic acid, crystals, bottle X X Urine culture agar: 5% sheep BAP and MAC X X Xylene, bottle X X Clinical chemistry Test strip, urinalysis (10 parameter) X X X X Blood glucometer, with accessories X X X X Analyser, clinical chemistry (inc. blood gas, electrolytes) X X Blood cold chain Refrigerator, laboratory, 2 to 8C, 110L/250 L X X Refrigerator/freezer, laboratory, 2 to 8C/-20C, 180L/40L X X Freezer, laboratory, -20C/-80C, 140L X X General Microscope, binocular X X X equipment Cabinet for microscope X X X Counter, hand tally, mechanical X X Counter, cell, manual differential X X Counting chamber, Neubauer X X Centrifuge, micro - haematocrit X X Centrifuge, complete with accessories for serology X X Shaker, orbital X X Rotator, blood specimen X X Rotator, agglutination test X X Vortex, test tube X X Scale, precision, digital, 500g/0.01g X X Scale, digital, 1500g/0.1g X X Pipette, digital, 2-20 ul X X Pipette, digital, 10-100 ul X X Pipette, digital, 20-200 ul X X Pipette, digital, 100-1000 ul X X Pipette, digital, 8 channel, 5-50 ul X X Pipette, digital, 8 channel, 20-200 ul X X Pipette, repeating, 5 volume X X Pipette, stand, 4 positions X X Pipette, fi ller, wheel-run, set/2 X X Pipettes, blood graduated, 0.05 ml X X Hot plate, with stirrer X X Incubator, 30 L, up to 80 C X X Water bath, 7 L X X Distillation unit, 2 L/h, with tank X X Sterilizer steam autoclave, 24 L X X Biosafety cabinet,class II,stand alone X X Timer, digital X X X X Timer, 60 min, mechanical X X X X Thermometer, glass, min/max -20C/100C X X X X Thermometer, min/max -30C/60C X X X X Magnifying glass X X X X Spatula, stainless steel, # sizes X X Forceps, dressing,155mm, straight X X X X Marker, diamond X X X Punch, Dry Blood Spot (DBS), 3.0mm X X Brush, bottles and fl asks, # sizes X X 123 124 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health instruments) technologied - molecular or quantitative (qualitative and/ Testing (NAT) Nucleic Acid Haematology ware Glass andplastic Classification Nucleic acidtesting platform, withaccessories, closedsystem (POC) Nucleic acidtesting platform, withaccessories, closedsystem Analyser, haematology, 18parameter Analyser, haematology, 8parameter Hemoglobinometer, withaccessories Haemoglobin colour scale(refill kit) Haemoglobin colour scale(starter kit) Rod, glass Petri dish,glass, withlid Cover glass, slides Slide, microscope Slide, microscope, frosted Funnel, plastic Funnel, glass Jar, Coplain, staining Bottle, culture, blood,anaerobic Bottle, culture, blood,aerobic Bottle, amber, screw cap, 100ml/2501000 Bottle, amber, dropper, 30ml Beaker, glass, 100ml/250 Cylinder, measuring,glass, ml/500ml/100 10ml/100 Water distilled, bottle Cytology stain kit pH meter Spectrophotometer, ultraviolet /visible Tourniquet, withbuckle Eye wash station Goggles, protective Bottle, plastic, 1L Wash bottle, 250ml Biosafe, puncture-proof waste disposalbox, for usedsyringes/needles, sharps Box, specimentransport, 2L/4 L Box, storage, 100slides Box, refill, pipette tips,empty Box,storage 0.5/2/5 mltubes,100 positions Rack, staining slides,horizontal, 12positions Rack, dryingslides,12positions Rack, dryingglass &plastic ware Rack,tubes, 0.5/2.0/5.0 ml,24 positions Rack, ESR,5positions Rack, test tubes,24 positions Clamp, test tubes Brush, test tubes,#sizes Name ofmedicaldevice X X X X X Community

level Potential Useat X X X X X X X X X X Health Center X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X District Hospital Regional/ X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Provincial Hospital 5. Laboratory supply and blood bank commodities Classifi cation Name of medical device Potential Use at Community level Health Center District Hospital Regional/ Provincial Hospital Reagents Reagents, HIV-1/2 RDT X X X Reagents, HIV-1/2 (antigen and antibody) EIA X X Reagents, HIV-1/2 supplemental assay X Reagents, CD4 enumeration (absolute, %) POC X X X Reagents, CD4 enumeration (absolute, %) dedicated cytometer X X Reagents, CD4 enumeration (absolute, %) classical fl ow cytomer X Reagents, HIV qualitative NAT X Reagents, HIV quantitative NAT X Reagents, Treponemal (syphilis) RDT X X X Reagents, TPHA X X Reagents, RPR X X Reagents, Treponemal (syphilis) EIA X X Reagents, HCV RDT X X X Reagents, HCV EIA X X Reagents, HCV quantitative NAT X Reagents, HBsAg RDT X X X Reagents, HBsAg EIA X X Reagents, HBsAg quantitative NAT X Reagents, malaria RDT, Pf/pan X X Reagents, malaria RDT, Pf X X Reagents, chlamydia EIA X X Reagents, chlamydia NAT X Reagents, gonorrhea antigen EIA X X Reagents, gonorrhea NAT X X Reagents, tuberculosis NAT (POC) X X Reagents, HPV NAT X Reagents, HSV II NAT X Reagents, rubella EIA X X Renewable Paper, lens X X X X Paper, pH indicator 2.0 to 9.0 X X Paper, fi lter #1 X X Paper, dry blood spot X X X X Rack, drying DBS cards, 10 positions X X X X Paper, weighing X X Film, sealing, fl exible, 10cmx38m, roll X X Sealant, compound X X Inoculation loop, plastic, sterile X X Microplate, ELISA, 96 U-well X X Tube, capillary, heparin X X X X Tube, capillary, EDTA X X X X Tube, screw cap, 0.2 ml / 0.5 ml / 2.0 ml / 5.0 ml, sterile X X Tube, screw cap, 0.2 ml / 0.5 ml / 2.0 ml / 5.0 ml, non-sterile X X Tube, screw cap, conic, 15/50ml,non-sterile X X Tube, push cap, 0.2 ml, PCR, sterile X X Tube, push cap, 5.0 ml, non-sterile X X Tube, vacuum, EDTA, 2 ml / 4 ml / 6 ml, sterile X X Tube, vacuum, serum, 4 ml / 6 ml, sterile X X Tube, vacuum, plain/dry, 4 ml / 6 ml,sterile X X Needle, vacuum tube, 20 G / 22 G, sterile X X Needle holder, vacuum tubes, sterile X X

125 126 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Test strip Serology Classification Test strip, vaginal infection, pH Test strip, pregnancy EIA, incubator, 4plate EIA, washer, 8channel EIA, reader, 8channel Kato-Katz, kit,stool samplepreparation Dressing strip, adhesive, diam3.0 cm,sterile Cotton wool, 500g,roll, non-sterile Envelope, packing,27x36 cm Label, biohazard, adhesive, 3x4cm Label, self-adhesive, freezer Label, self-adhesive, 5x10cm Bag, biohazard, 20L Bag, re-sealeable, plastic Gloves, nitrile, powder-free, non-sterile,single use Coat, labwork, mediumsize Sheet,absorbent,bench,50x40cm Monitor card,humidity,passive/cumulative Container, sample, 50ml Reservoir, reagent, 60ml Swab, cotton-tip, tube, sterile Applicator, wood, non-sterile Marker pen,cryoware, color Marker pen,glassware Pipette, repeat, tip2.5/5.0 ml,10/25 ml Pipette, tip, barrier, 200ul/1000ul,sterile Pipette, tip, blue, 100-1000 ul Pipette, tip, yellow, 10-100 ul/20-200 Pipette, tip, white, 2-20ul Pipette, transfer, 3ml,non-sterile Pipette, transfer, 3ml,sterile Compress, gauze, anti-septic,6x3cm,sterile Compress, gauze, 10x10cm,non-sterile Bandage, adhesive, 3.0 cm,box/100 Lancet, 2mm,safety, sterile Blood collection tube, neonatal cord blood,sterile Name ofmedicaldevice X X X X X X X X X X X X X Community

level Potential Useat X X X X X X X X X X X Health Center X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X District Hospital Regional/ X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Provincial Hospital 5. Laboratory supply and blood bank commodities 5.2 Diagnostic tests and Laboratory Uninterrupted provision of testing services requires a continuous supply of diagnostics/reagents and the required consumables—for example, specimen transfer devices, lancets, alcohol swabs, and blood collection equipment. This requires accurate forecasting of testing needs, efficient planning and distribution of test kits and consumables, and continuous post-market surveillance to report any quality problems. Certain types of diagnostics will require laboratory equipment/analyzers that must be correctly installed, then maintained and used properly to prevent breakdown. Testing facilities should be clean with adequate room and storage, and due care should be given to temperature and humidity as these factors may affect the reliable functioning of certain test kits, and equipment/analyzers.

Any country considering the selection and use of diagnostics and laboratory technologies should have: • A national laboratory policy and national laboratory strategic plan (1, 2); • A national quality assurance programme including quality control, external quality assessment, equipment maintenance, documentation/recordkeeping, etc. (3,4,5); • A national list of testing services to be provided for each level of the health system (by analyte, and by test format), including use of nationally validated testing algorithms with back-up options, as appropriate (6, 7); • Accurate forecasting to avoid stock-outs of test kits and related consumables. WHO recommends standardized testing strategies1 to maximize the accuracy of test results while minimizing cost. Validated testing algorithms should ideally use the assay with highest sensitivity first, then assays with highest specificity used second and/or third, depending on the required predictive values (99% is desirable). When two or more assays are used, it is essential to use assays with different antigen preparations (components) to minimize the potential for shared false non-reactivity or false reactivity. The following considerations should be taken into account when validating a set of potential testing algorithms, see Table 38.

Table 38. Specific considerations for selection of diagnostics

Parameter Considerations

Performance characteristics Clinical sensitivity Set a minimum acceptable criteria Clinical specificity Set a minimum acceptable criteria Seroconversion sensitivity Important for blood screening Limit of detection/ dynamic range Set a minimum acceptable criteria that relates to a clinically relevant level. Misclassification rate Important for monitoring of disease and/or treatment Inter-reader variability, if subjectively Set a minimum acceptable criteria read format Invalid rate, devices/test results, test Set a minimum acceptable criteria runs Operational characteristics Test format RDTs (immunochromatographic, immunofiltration) Simple (comb formats, agglutination assays) EIAs (manual plate-based EIAs, immunoanalysers) Supplemental assays (Western blot, line immunoassays) Nucleic Acid Testing (qualitative, quantitative) Specimen type Serum/plasma, venous or capillary whole blood, dried blood spot, oral fluid Detection type If HIV; discriminatory detection of HIV-1 and HIV-2 antibodies or combined detection of HIV-1/2 antibodies. If HIV; simultaneous or combined detection of HIV-1 antigen and HIV-1/2 antibodies Subtype detection If HIV; M, N, O subtypes Time to result If RDT; immunochromatographic (less than 30 minutes with fewer steps) or immunofiltration (less than 5 minutes with more steps). If EIA; random access analyser or not? Endpoint stability How long is the result stable? Is longer reading time or shorter reading time desirable? (depends on service delivery model) Ease of use If RDT; depends on a combination of: • nature of specimen collection (fingerstick whole blood by lancet or venous whole blood by venipuncture); • number of steps in the test procedure; • ease of reading the test band, line, spot; • ease of interpretation of testing results; • addition of procedural quality control (band appears when human specimen is added versus band appears when running buffer is added). 1 In this context, a testing strategy generically describes a testing approach for a specific need (for example, transfusion and transplantation screening, surveillance, and/or diagnosis of infection) taking into consideration the presumed prevalence in the population being tested. A testing algorithm describes the combination and sequence of specific assays used within a giventesting strategy. It has been shown that combinations of EIAs or combinations of RDTs or mixed combinations of EIAs and RDTs can provide reliable results. 127 128 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health and available by contacting WHOat [email protected] publications/biosafety/en/Biosafety7.pdf, accessed 22May 2014) Laboratory Biosafety Manual,3rd edition.Geneva: World HealthOrganization; 2004(http://www.who.int/csr/resources/ who.int/publications/2003/9241545453.pdf, accessed 22May 2014). Basic Laboratory Procedure inClinicalBacteriology, 2ndedition.Geneva: World HealthOrganization; 2003 (http://whqlibdoc. medicinedocs/documents/s16537e/s16537e.pdf, accessed 22May 2014). Manual ofBasicTechniques for aHealthLaboratory, 2ndedition.Geneva: World HealthOrganization; 2003 (http://apps.who.int/ publications/2008/9789241596350_eng_low.pdf, accessed 22May 2014). Maintenance manualfor laboratory equipment,2ndedition.Spain:World HealthOrganization; 2008(http://whqlibdoc.who.int/ Programme on HIV/AIDS; 1996(http://www.who.int/diagnostics_laboratory/quality/en/EQAS96.pdf, accessedGuidelines for 22May organizing 2014). national external qualityassessment schemesfor HIVserological testing. Geneva: United Nations Further reading Diagnostics UN BulkProcurement Scheme Through WHO Prequalification ofDiagnostics programme of prequalification ofdiagnostics isavailable ontheWHOwebsite at http://www.who.int/diagnostics_laboratory. to specimens. dossier Specimen not provided inthetest kit Equipment/consumables system Technical testing service delivery models Access to referral laboratory Shelf-life oftest kits compatibility withQCmaterials Availability testing required Degree Parameter Table 38.Specific considerations for selectionofdiagnostics the resource-limited United quality review of the i.e. on through-put skill of In Nations which laboratory found the WHO and addition, test and of WHO performance level Prequalification to staff kit settings. site (UN) meet and website infrastructure of controls required WHO inspection conducting the agencies. individual minimum health Performance at assesses of and but http://www.who.int/diagnostics_laboratory/procurement/purchase/en/index.html commercially of Other general laboratory consumables. Blood collection equipmentfor venous wholeblood. Lancets, alcohol swabs for fingerstick wholeblood. Electricity/generator. Temperature-controlled work space. Refrigeration for storage oftest kitsand/or reconstituted reagents. EIAs if≥40specimensperday peroperator withlaboratory infrastructure. RDTs if≤40specimensperday peroperator withlimited laboratory infrastructure. Particularly importantwhen4thgeneration assays are used. Must benegotiated aspartoftheprocurement contract. See alsonote above onprocedural in-builtqualitycontrol. Some are available butseparate from test kit. Including bothlaboratory andphlebotomy skills. Considerations to Further Diagnostics standards provide the and quality information available for continual operational programme, WHO management diagnostics concerning prequalification assurance characteristics WHO system conducts and the of quality. list laboratory under are are of independent then products which assessed Further eligible technologies the information eligible using and for product procurement impartial panels that for is concerning procurement are made of assessments best biological by through

suited WHO the or is stored at 2°Cto 8°C Perishable items: must be stored at 2°Cto 8°C Perishable items: must be stored at 2°Cto 8°C Perishable items: must be Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Classification b) Bloodgroup serology testing Recommended stationery Recommended stationery Recommended stationery Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Medical Device Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Classification a) Collection Blood Collection, Testing andProcessing transportation Table 39. Essential items for bloodbank:collection, testing andprocessing, clinicaltransfusion, bloodstorage andblood Anti-D bloodgroup reagent (Saline/monoclonal) Anti-B bloodgroup reagent, monoclonal Anti-A bloodgroup reagent, monoclonal Wooden orplastic applicator sticks plastic non-sterile, 3ml Pasteur pipettes withintegral bulb, disposable, glassware Markers, fine point,permanentblack, for Glass slides,25x75mm Description Registers, hard-cover, A4 Labels for bloodbags Blood donorquestionnaires Weighing scale, range 0–150 Kg Tube stripper Tourniquets, arm,adjustable Test tuberacks, 30holes,plastic/wooden Surgical scissors Spring balance, range 250–600gm Sphygmomanometer Artery forceps (Clamp) Test tubes,round bottom, polystyrene, 10ml Surgical plaster roll must bein-builtpreventing re-use) Single bloodcollection bags,CPD-A1 (needle Rapid test for haemoglobinestimation isopropanol Impregnated medicated swabs, chlorhexadine or Gauze swabs, 8-ply, 10x10cm/Cotton swabs other essential medicines) corticosteroid, adrenaline, antihistamine and Emergency medicines(Crystalloids, Blood lancets, sterile, disposable Adhesive plasters, 6x2cm Description Required for Rh Dbloodgrouping Required for ABO bloodgrouping Required for ABObloodgrouping blood grouping For mixingofreagents and bloodsampleswhile For patients' bloodgrouping andcross- matching blood for TTIs For bloodgrouping andscreening ofdonated For labellingonglassware For cross-matching* and patient sample For performing bloodgrouping ondonated blood Indication For donorandpatient records on thebloodunit To includepatient andcross-match information For useduringdonorselection selection For checkingdonors'weight duringdonor patients For holdingsampletubeswith donorsand sample collection For useduringblooddonation andpatient donation For monitoring bloodvolume duringblood selection For measuringbloodpressure duringdonor For useduringblooddonation and patients' bloodsamplesfor bloodgrouping For collecting bloodsamplesfor donation testing 350 mlor450 during donorselection Suitable for estimation ofdonors'haemoglobin For donors'armcleansingbefore blooddonation collection after blooddonation, duringpatients' sample For applyingpressure onthevenepuncture site For managementofdonorreactions selection For haemoglobinestimation duringdonor sample collection For application after blooddonation andpatients' Indication 5. Laboratory supply and blood bank commodities 5.3 Blood bank commodities Considering the significant positive impact of increasing the availability of blood transfusions on maternal health outcomes, Table 39 contains a list of essential items for a blood bank.

Table 39. Essential items for blood bank: blood collection, testing and processing, clinical transfusion, blood storage and blood transportation

Blood Collection, Testing and Processing

a) Collection

Classifi cation Description Indication Consumables: non-perishable Adhesive plasters, 6x2cm For application after blood donation and patients' sample collection Consumables: non-perishable Blood lancets, sterile, disposable For haemoglobin estimation during donor selection Consumables: non-perishable Emergency medicines (Crystalloids, For management of donor reactions corticosteroid, adrenaline, antihistamine and other essential medicines) Consumables: non-perishable Gauze swabs, 8-ply, 10x10cm/Cotton swabs For applying pressure on the venepuncture site after blood donation, during patients' sample collection Consumables: non-perishable Impregnated medicated swabs, chlorhexadine or For donors' arm cleansing before blood donation isopropanol Consumables: non-perishable Rapid test for haemoglobin estimation Suitable for estimation of donors' haemoglobin during donor selection Consumables: non-perishable Single blood collection bags, CPD-A1 (needle 350 ml or 450 ml must be in-built preventing re-use) Consumables: non-perishable Surgical plaster roll

Consumables: non-perishable Test tubes, round bottom, polystyrene, 10 ml For collecting blood samples for donation testing and patients' blood samples for blood grouping

Medical Device Artery forceps (Clamp) For use during blood donation Medical Device Sphygmomanometer For measuring during donor selection Medical Device Spring balance, range 250 – 600 gm For monitoring blood volume during blood donation Medical Device Surgical scissors For use during blood donation and patient sample collection Medical Device Test tube racks, 30 holes, plastic/wooden For holding sample tubes with donors and patients Medical Device Tourniquets, arm, adjustable Medical Device Tube stripper Medical Device Weighing scale, range 0 –150 Kg For checking donors' weight during donor selection Recommended stationery Blood donor questionnaires For use during donor selection Recommended stationery Labels for blood bags To include patient and cross-match information on the blood unit Recommended stationery Registers, hard-cover, A4 For donor and patient records

b) Blood group serology testing

Classifi cation Description Indication Consumables: non-perishable Glass slides, 25x75mm For performing blood grouping on donated blood and patient sample For cross-matching* Consumables: non-perishable Markers, fi ne point, permanent black, for For labelling on glassware glassware Consumables: non-perishable Pasteur pipettes with integral bulb, disposable, For blood grouping and screening of donated plastic non-sterile, 3 ml blood for TTIs For patients' blood grouping and cross- matching Consumables: non-perishable Wooden or plastic applicator sticks For mixing of reagents and blood samples while blood grouping

Perishable items: must be Anti-A blood group reagent, monoclonal Required for ABO blood grouping stored at 2°C to 8°C

Perishable items: must be Anti-B blood group reagent, monoclonal Required for ABO blood grouping stored at 2°C to 8°C

Perishable items: must be Anti-D blood group reagent (Saline/monoclonal) Required for Rh D blood grouping stored at 2°C to 8°C

129 130 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health NOTE: This list ofcommodities islinked withinterventions inthemainmatrix. Recommended stationery Medical Device Medical Device Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Classification b) BloodTransfusion Recommended stationery Recommended stationery stored at 2°Cto 8°C Perishable items: must be stored at 2°Cto 8°C Perishable items: must be stored at 2°Cto 8°C Perishable items: must be Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Classification a) BloodCross-Matching Clinical Transfusion NOTE: This list ofcommodities isrecommended onlyfor theReferral level. stored at 2°Cto 8°C Perishable items: must be stored at 2°Cto 8°C Perishable items: must be stored at 2°Cto 8°C Perishable items: must be stored at 2°Cto 8°C Perishable items: must be Consumables: non-perishable Consumables: non-perishable Classification transportation Table 39. Essential items for bloodbank:collection, testing andprocessing, clinicaltransfusion, bloodstorage andblood c) Screening donated bloodfor transfusion transmissible infections Transfusion request forms Tourniquets, arm,adjustable Surgical scissors wing IV catheter, 23GxД,sterile, disposable, with IV catheter, 22Gx1”,sterile, disposable, withwing wing IV catheter, 20Gx1Д,sterile, disposable, with filter withpore size 170–200 micron Blood administration setwithhave an integral Description Registers, hard-cover, A4 Labels for bloodbags Anti-D bloodgroup reagent (Saline/monoclonal) Anti-B bloodgroup reagent, monoclonal Anti-A bloodgroup reagent, monoclonal Wooden orplastic applicator sticks Test tubes,round bottom, polystyrene, 10ml Test tuberacks, 30holes,plastic/wooden Syringe 5ml,hypo, disposable plastic non-sterile, 3ml Pasteur pipettes withintegral bulb, disposable, Needle, hypo, disposable, 23Gx1”,sterile Needle, hypo, disposable, 21Gx1.5”,sterile Markers, fine point,permanentblack,for glassware Glass slides,25x75mm Description RPR rapid test HIV 1+2rapid tests HCV rapid tests HBsAg rapid tests plastic non-sterile, 3ml Pasteur pipettes withintegral bulb, disposable, glassware Markers, fine point,permanentblack,for Description For requesting bloodtransfusion for apatient sample collection For useduringblooddonation andpatient of vein anddesired rate oftransfusion Used for bloodadministration dependingonsize patients Required for administration ofbloodto the Indication For donorandpatient records on thebloodunit To includepatient andcross-match information Required for RhDbloodgrouping Required for ABObloodgrouping Required for ABObloodgrouping blood grouping For mixingofreagents andbloodsampleswhile and patients' bloodsamplesfor bloodgrouping For collecting bloodsamplesfor donation testing patients For holdingsampletubeswith donorsand For collecting patients' bloodsamples For patients' bloodgrouping andcross- matching blood for TTIs For bloodgrouping andscreening ofdonated For labellingonglassware For cross-matching* and patient sample For performing bloodgrouping ondonated blood Indication syphilis Required for screening ofdonated bloodfor 1+2 Required for screening ofdonated bloodfor HIV Required for screening ofdonated bloodfor HCV HBsAg Required for screening ofdonated bloodfor For patients' bloodgrouping andcross- matching blood for TTIs For bloodgrouping andscreening ofdonated For labellingonglassware Indication 5. Laboratory supply and blood bank commodities Table 39. Essential items for blood bank: blood collection, testing and processing, clinical transfusion, blood storage and blood transportation

Equipment in the Blood Centre

Classifi cation Description Indication Medical Device Autoclaves Medical Device Automated sample processor Medical Device Automatic pipette Medical Device Binocular microscopes Medical Device Blood collection bag weighing balances Medical Device Cell washer centrifuge Medical Device Colorimeters Medical Device Cryoprecipitate bath (40C) Medical Device Donor weighing scale For weighing blood donors Medical Device Double beam balance For weighing blood packs Medical Device Electronic balance For weighing chemicals Medical Device ELISA plate reader Medical Device ELISA plate washers Medical Device Equipment necessary for producing chemically pure and /or pyrogen-free water (e.g. still; deionizer) Medical Device Haematology autoanalyzer with platelet counts Medical Device Haemocue/instrument for Haemoglobin Estimation Medical Device Incubators For laboratory serology tests Medical Device Laboratory bench top centrifuge for separation of samples Medical Device Laboratory thermometers Medical Device Laminar Airfl ow cabinet Medical Device Micro plate shaker Medical Device Oxygen supply equipment (such as cylinder) It covers the administration set (mask) Medical Device pH Meter Medical Device Plasma extractors Medical Device Plasma freezer –300C Medical Device Plasma thawing bath Medical Device Platelet incubator and shaker Medical Device Serologic rotators Medical Device Spectrophotometers Medical Device Sphygmomanometers Medical Device Tube sealers Recommended stationery Blast freezer Recommended stationery Blood bank refrigerator Recommended stationery Blood transportation box Recommended stationery Container for safe disposal of sharps Recommended stationery Deep freezer -80 C Recommended stationery Donor beds/couches Recommended stationery Hot Air ovens Recommended stationery PC with accessories and software Recommended stationery Refrigerated centrifuges Recommended stationery Stop watches/timers Recommended stationery Vehicles for outdoor blood donation sessions Recommended stationery Voltage stabilizers Recommended stationery Water bath

131 132 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health All existing legislation andothernational requirements. efficacy These which definedstorage temperatures andconditions are strictly maintained,monitored andrecorded. depending onnational regulations andinfrastructure. services country availability ofbloodandproducts to meettheneedsof allpatients whorequire transfusion. meet control of • • Blood Provision ofsafe bloodandproducts Blood Checklist ofEssential Items for Collection, Testing andTransfusion of50UnitsWholeBlood Safe bloodandclinicaltransfusion 5.4 Blood Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Consumables: non-perishable Classification Standard Precautions should bebasedonthesestandards. is conducted. Ifnational standards for equipmentrequirements at various level ofbloodtransfusion services are available, thislist NOTE: The list ofequipmentshouldbeadapted to beusedfor thebloodcentres invarious levels inthecountry where assessment Recommended stationery Recommended stationery Recommended stationery Recommended stationery Medical Device Medical Device Medical Device Medical Device Medical Device Classification Equipment intheHospitalBloodStorage Centre andfor BloodTransportation transportation Table 39. Essential items for bloodbank:collection, testing andprocessing, clinicaltransfusion, bloodstorage andblood patients blood and products take place. Suitable infrastructure andfacilities inallcentres inwhich bloodcollection, testing, processing andstorage of processing administration, quality systems, transfusion medicine, blooddonorprogramme andlaboratory testing andblood Adequate number ofqualified,skilledandexperienced personnelinhumanresource management,finance and donations, targets screening transfusion transfusion lists and of should to blood of suffering ensure valid for supplies blood put laboratories the and services results. contributes a provision in from consistent components, blood place should Globally should life-threatening Waste bags,35 L,yellow Waste bags,35 L,blackplastic Sharps containers different sizes) Gloves, latex, disposablefor singleuse(in Description need) Insulated cool box, 10L(capacity dependingon Deep freezer -80C Blood transportation box Blood bankrefrigerator Platelet incubator andshaker Plasma freezer –300C samples Laboratory benchtop centrifuge for separation of Incubators for laboratory serology tests Binocular microscopes Description products should policies, of to be approach safe comply saving adapted blood recognized have blood prepared systems millions appropriate with samples, to conditions, and for quality national use international and blood for of test at therapeutic lives structures throughout quality products. and various policies kits every supports and standards, standards levels and to year, To use. reagents their ensure perform strategies complex The in improves activities based the could standards For disposalofcontaminated swabs For disposalofgeneral waste For safety disposalofsharps For standard precautions Indication blood For temporary storage andtransportation of blood For temporary storage andtransportation of blood For temporary storage andtransportation of For storage ofbloodandreagents blood For temporary storage andtransportation of blood For temporary storage andtransportation of blood For temporary storage andtransportation of blood For temporary storage andtransportation of blood For temporary storage andtransportation of Indication the should their country to medical on safety, also life ensure and functions national be expectancy be should where to quality, stored and adopted they ensure standards, efficiently, surgical take assessment implement in accessibility suitable the and into by procedures. overall blood the to BTS account ensure standards is quality equipment should conducted, transfusion and safety relevant process timely of Every have: and and life in

5. Laboratory supply and blood bank commodities Table 39. Essential items for blood bank: blood collection, testing and processing, clinical transfusion, blood storage and blood Requirements include: transportation • Effective quality system within which all activities are performed in a quality-focused way and are continuously Equipment in the Hospital Blood Storage Centre and for Blood Transportation monitored

Classifi cation Description Indication • Sustainable donor education, motivation, voluntary none remunerated blood donor recruitment and retention Medical Device Binocular microscopes For temporary storage and transportation of programme blood Medical Device Incubators for laboratory serology tests For temporary storage and transportation of • Safe blood collection process, including donor selection and deferral, donor care, notification, counselling and blood referral, and confidentiality Medical Device Laboratory bench top centrifuge for separation of For temporary storage and transportation of samples blood • Testing and processing using the most appropriate and effective methodologies and best laboratory practices Medical Device Plasma freezer –300C For temporary storage and transportation of Efficient inventory management system for optimum blood stocks and minimal wastage blood • Medical Device Platelet incubator and shaker For temporary storage and transportation of Effective blood cold chain for safe storage and distribution of blood and blood products blood • Recommended stationery Blood bank refrigerator For storage of blood and reagents • Information management system encompassing all activities from blood donors to distribution of blood and Recommended stationery Blood transportation box For temporary storage and transportation of blood products to hospitals, and issue and transfusion of blood and blood products to patients blood Recommended stationery Deep freezer -80 C For temporary storage and transportation of • Liaison with hospitals in the implementation of transfusion guidelines and staff training blood Recommended stationery Insulated cool box, 10 L (capacity depending on For temporary storage and transportation of • Participation in national haemovigilance system. need) blood NOTE: The list of equipment should be adapted to be used for the blood centres in various levels in the country where assessment Table 40. Essential Items for Blood Transfusion in Emergency Settings is conducted. If national standards for equipment requirements at various level of blood transfusion services are available, this list should be based on these standards. Usual or Recommended Item Description preferred Remarks quantity Standard Precautions presentation Perishable items: must be stored at 2°C to 8°C Classifi cation Description Indication 1. Anti-A blood group reagent, monoclonal 5 ml vial 1 x 5 ml Required for ABO blood grouping Consumables: non-perishable Gloves, latex, disposable for single use (in For standard precautions different sizes) 2. Anti-B blood group reagent, monoclonal 5 ml vial 1 x 5 ml Consumables: non-perishable Sharps containers For safety disposal of sharps 3. Anti-D blood group reagent (Saline/ 5 ml vial 1 x 5 ml Required for Rh D blood grouping monoclonal) Consumables: non-perishable Waste bags, 35 L, black plastic For disposal of general waste 4. HIV 1+2 rapid tests 100 tests 1 x 100 Required for screening of donated blood for Consumables: non-perishable Waste bags, 35 L, yellow For disposal of contaminated swabs 5. HBsAg rapid tests 100 tests 1 x 100 transfusion- transmissible infections (TTIs), including HIV 1+2, hepatitis B and C, and 6. HCV rapid tests 100 tests 1 x 100 syphilis 7. RPR rapid test 100 tests 1 x 100

Consumables: non-perishable 8. Single blood collection bags, CPD-A1 (needle Pack with 6 9 packs (50-60 350 ml or 450 ml must be in-built preventing re-use) blood collection bags) bags each 9. Blood administration set with have an 50 sets 1 x 50 sets Required for administration of blood to the integral filter with pore size 170–200 micron patients 10. IV catheter, 20 G x1¼”, sterile, disposable, 50 pieces 1 x 50 pieces Used for blood administration depending on with wing size of vein and desired rate of transfusion 11. IV catheter, 22 G x1”, sterile, disposable, with 50 pieces 1 x 50 pieces wing 12. IV catheter, 23 G x¾ ”, sterile, disposable, 50 pieces 1 x 50 pieces with wing 13. Pasteur pipettes with integral bulb, 100 pipettes 2 x 100 • For blood grouping and screening of disposable, plastic non-sterile, 3 ml pipettes donated blood for TTIs • For patients' blood grouping and cross- matching 14. Blood lancets, sterile, disposable 100 1 x 100 For haemoglobin estimation during donor selection 15. Gauze swabs, 8-ply, 10x10cm/Cotton swabs 100 swabs 2 x 100 swabs • For applying pressure on the venepuncture site after blood donation • During patients' sample collection 16. Adhesive plasters, 6x2cm 100 pieces 1 x 100 pieces For application after blood donation and 17. Surgical plaster roll 2 pieces 1 x 2 pieces patients' sample collection 18. Markers, fine point, permanent black, for 10 markers 1 x 10 markers For labelling on glassware glassware 19. Impregnated medicated swabs, 100 pieces 2 x 100 For donors' arm cleansing before blood chlorhexadine or isopropanol donation 20.Test tubes, round bottom, polystyrene, 10 ml 100 tubes 2 x 100 tubes For collecting blood samples for donation testing and patients' blood samples for blood grouping 21. Glass slides, 25x75mm 50 4 x 50 slides • For performing blood grouping on donated blood and patient sample • For cross-matching* 22. Wooden or plastic applicator sticks 200 2 x 200 For mixing of reagents and blood samples while blood grouping

133 134 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health * Insettingswhere tubemethodcannotbeused. . WHOexpert meetingreport onshort,medium,andlongerterm product development prioritiesinHIV-related 7. Guidelinesfor appropriate evaluations ofHIVtesting technologies inAfrica. Geneva: World HealthOrganization Regional Office 6. Laboratory qualitymanagement system training toolkit. Geneva: World HealthOrganization, U.S. Centers for Disease Control and 5. HIVrapid test training package. Geneva: World HealthOrganization; 2005(http://www.who.int/diagnostics_laboratory/4. Guidelinesfor assuring theaccuracy andreliability ofHIVrapid testing: applyingaqualitysystem approach. Geneva: World 3. . Service delivery approaches to HIVtesting andcounselling (HTC): Astrategic policy framework. Geneva: World Health 2. Development ofnational healthlaboratory policy andplan.India:World HealthOrganizations; 2011 (http://www.wpro.who.int/ 1. References 5.5 45. Bloodbankrefrigerator 44. Insulated cool box, 10L 43. Test tuberacks, 30holes,plastic/wooden 42. Tube stripper 41. Artery forceps (Clamp) 40. Springbalance, range 250–600gm 39. Weighing scale, range 0–150 Kg 38. Tourniquets, arm,adjustable 37. Surgical scissors 36. Sphygmomanometer One-off items –ifabove are re-ordered, theseshouldnotberepeated 35. Transfusion request forms 34. Registers, hard-cover, A4 33. Labelsfor bloodbags 32. Blooddonorquestionnaires Recommended stationery 31. Waste bags,35 L,yellow 30. Waste bags,35 L,blackplastic 29. Sharpscontainers other essential medicines) corticosteroid, adrenaline, antihistamine and 28. Emergency medicines(Crystalloids, different sizes) 27. Gloves, latex, disposablefor singleuse(in 26. Rapidtest for haemoglobinestimation 25. Needle, hypo, disposable, 23Gx1”,sterile 24. Needle, hypo, disposable, 21Gx1.5”,sterile 23. Syringe 5ml,hypo, disposable Item Description Table 40. Essential Items for BloodTransfusion inEmergency Settings bitstream/10665/75971/1/9789241504522_eng.pdf, accessed 22May 2014) diagnostics, 6–7 June2012 Geneva, Switzerland. Geneva: World HealthOrganization; 2012 (http://apps.who.int/iris/ who.int/afro/2002/a82959_eng.pdf, accessed 22May 2014). for Africa, U.S. Centers for DiseaseControl andPrevention, Association HealthLaboratories; ofPublic 2002 (http://whqlibdoc. html, accessed 22May 2014). Prevention, theClinicalandLaboratory Standards Institute; 2009(http://www.who.int/ihr/training/laboratory_quality/en/index. documents/guidance/hivrttraining_overview/en/index.html, accessed: 22May 2014). Health Organization; 2005(http://whqlibdoc.who.int/publications/2005/9241593563_eng.pdf, accessed: 22May 2014). Organization; 2012 (http://www.who.int/hiv/pub/vct/htc_framework/en/, accessed 22May 2014). health_technology/documents/docs/Nationalhealthlab2_0F38.pdf, accessed 22May 2014).

20 aroll 20 aroll products the available Depending on products the available Depending on 50 pairs products the available Depending on 100 needles 100 needles 100 syringes presentation preferred Usual or 1 2 5 2 2 2 1 2 2 1 50 5 50 ofeachtype 60 1 roll 1 roll 2 1 2 x50pairs tests For upto 100 1 x100 1 x100 1 x100 Recommended Recommended quantity Remarks For storage ofblood For temporary storage ofdonated blood patients For holdingsampletubeswith donorsand For useduringblooddonation donation For monitoring bloodvolume duringblood selection For checkingdonors'weight duringdonor sample collection For useduringblooddonation andpatient selection For measuringbloodpressure duringdonor patient For requesting bloodtransfusion for a For donorandpatient records information onthebloodunit To includepatient andcross-match For useduringdonorselection For disposalofcontaminated swabs For disposalofgeneral waste For disposalofsharps For managementofdonorreactions For standard precautions haemoglobin duringdonorselection Suitable for estimation ofdonors' For collecting patients' bloodsamples

6. Surgery and Anaesthesia 6. Surgery and Anaesthesia 6.1 Surgery and Anaesthesia As a first estimate, conditions treatable by surgery account for 11% of the global burden of disease(Debas H, Gosselin R, McCord C, et al. 2006). Surgically addressable burden of disease at the first referral level include the following (1): • Injuries (e.g. from road traffic accidents - from which 1.3 million people lose their lives each year, violence, falls, and burns) • Pregnancy related complications - every year over 287,000 women die before, during or after childbirth (complications requiring surgical intervention include haemorrhage, obstructed labour, unsafe abortion, ectopic pregnancy). • Anaesthesia is an integral component of surgical care systems and anaesthesia-related complications have also been cited as a significant cause of maternal deaths • Infection (e.g. wound infections, abscesses, and bone infections) • Acute abdominal conditions (e.g. gastro-intestinal obstruction, perforation and strangulation) • Congenital anomalies (e.g. club foot) • Other surgical conditions

Often surgical procedures cannot be performed or referred to higher level health facilities due to lack of or non- functioning equipment such as oxygen supply and anaesthesia machine (2,3,4). To maximize the effectiveness of district and sub-district health facilities in the management of pregnancy-related complications, injuries, congenital anomalies and prevention of infection, and enable them to meet the MDGs 4, 5, and 6, the following strategies should be implemented:

1. Personnel with appropriate education and training in (5): • Anesthesia and resuscitation • Obstetrics and gynecology • General surgery • Traumatology • Orthopedics 2. Practical skills training and continuing education programmes in the management of essential anesthesia and surgical (emergency, obstetrics, trauma) care, to maintain the quality and safety of care through: • Evaluation of training needs • Coordinated plan for education and training • Educational resources and best practice protocols at the point of care • Monitoring and evaluation of the progress and impact of education and training 3. Appropriate physical facilities for: • Casualty area, operating room, labour room, high dependency area • Continuous oxygen supply • Blood bank and laboratory • Diagnostic imaging • Sterilization • Water, electricity, safe waste disposal and communications 4. Equipment (including basic monitoring) and instruments to meet the needs of district surgical services for minor and major surgical interventions in : • Obstetrics and gynecology surgery • Abdominal surgery • Orthopedic surgery • Common pediatric surgical conditions • Anesthesia • Resuscitation 135 136 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Table 41. Contents ofsurgical instrument sets Surgical Grouping ofcommon surgical instruments by surgical procedure 6.2 • • • • • • • • • 5. The 6. guidance onstrengthening surgical care healthsystems. Itcontains sets canoften beusedfor multipleprocedures. Contents ofeachsurgical instrument setislisted inTable 41. Set content: the suture setwhenepisiotomy isnecessary. The delivery set isusedfor spontanousdelivery to clamp/cut theumbilicalcord anditisalsobeusedincombination with 2. Delivery set Set content: The basicsurgery setisusedfor minorsurgery and/or exploratory ofcomplex wounds. 1. Basicsurgery set Table 41. Contents ofsurgical instrument sets 1 xBowl, stainless steel, 180ml 1 xScissors,Mayo,140mm,curved, blunt/blunt 1 xScissors,Metzembaum,140mm,curved, blunt/blunt 1 xScalpelhandle,no.4 1 xRetractor,Farabeuf,double-ended,120mm,pair 1 xProbe,double-ended,145mm 1 xNeedleholder,Mayo-Hegar,180mm,straight 1 xForceps,dressing &polypus,Cheron,250mm 1 xForceps,tissue,standard,145mm,straight 1 xForceps,tissue holding,Collin,160mm 1 xForceps,dressing,standard,155mm,straight 1 xForceps,artery,Kocher,140mm,straight 6 xForceps, artery, Halsted-Mosquito, 125mm,curved 2 xForceps,tissue seizing,Allis,150mm 4 xClamp,towel,Backhaus,130mm • • • • • • • • Monitoring andEvaluation tool to monitor progress ofimprovement insurgical care systems various levels ofcare Situation analysis tool to assess emergency, anesthesia, obstetrics, pediatrics, trauma andsurgical services at situations andsurgical care, infection control andfor referral to higherlevel healthfacilities. Best practice protocols onanesthesia, obstetrics, common pediatric surgical conditions, trauma, disaster supplies ofmedicines,anaesthesia andsurgical materials andotherconsumables Guidance to infrastructure andsuppliesat various levels ofhealthcare facilities to assure adequate andreliable Essential emergency equipmentgenericlist anesthetic service Education andtraining tools to enablehealthproviders to provide aneffective surgical, obstetrics, trauma and Guidance onorganization andmanagementofdistrict hospital Planning tool to guideincorporation ofdistrict surgical services withinthenational healthplan Policies to ensure qualityandsafety inprovision ofanesthesia, obstetrics, trauma andsurgical care A reliable system for thesupplyof: A qualityassurance system for: WHO Evaluation Supervision Communication Management Patient safety Other consumables Surgical materials Medication, bloodandintravenous fluids instruments Integrated are Management often packed for into Emergency sets related & Essential to the surgical Surgical (6): procedures

(IMEESC) for toolkit which was they developed are required. to provide These 6. Surgery and Anaesthesia Table 41. Contents of surgical instrument sets 1 x Scissors,Mayo,140mm,curved, blunt/blunt 1 x Scissors,gynecological,200mm,curved, blunt/blunt 2 x Forceps,artery,Kocher,140mm,straight

3. Dilatation/Evacuation (D&E) set

The dilatation and evacuation set is used for surgical methods of safe abortion beyond the fi rst trimester. The evacuation reququires electric or manual vacuum aspiration equipment with different sizes of plastic cannulae, ranging from 12 - 16mm in diameter and long forceps. Set content: 1 x Dilators, uterine, tapered, up to 51 mm 1 x Forceps, dressing, ring 1x Forceps, uterine, ovum, Bierer, large 1x Forceps, uterine, ovum, Bierer, small 1x Forceps, uterine, ovum, Sopher, small 1 x Retractor, vaginal, Doyen, 45 x 85 mm 1 x Retractor, vaginal, Auvard, 38 x 80 mm 1 x Curette, postpartum fl exible, large 1 x Forceps, tenaculum, atraumatic 1 x Speculum, vaginal, Graves, wide mouth 1 x Bowl, stainless steel, 180 ml Footnotes: Recommendation: Vacuum aspiration is the recommended technique of surgical abortion for of up to 12 to 14 weeks of gestation. The procedure should not be routinely completed by sharp currettage. Dilation and sharp currettage (D&C), if still practised should be replaced by vacuum aspiration (page.2 in the reference). Dilatation and curettage: Where it is still practised, all possible efforts should be made to replace D&C with vacuum aspiration, to improve the safety and quality of care of women. At sites where vacuum aspiration has yet to be introduced, manegers must ensure that proper painmanagement protocols are followed, and that D&C procedures are performed by well-trained staff under adequate supervision. Reference: Safe abortion second edition, 2012: http://www.who.int/reproductivehealth/publications/unsafe_ abortion/9789241548434/en/

4. Dressing set

The dressing set is used for simple wound dressings, basic instrument donation for medical staff. Set content: 1 x Forceps,artery,Kocher,140mm,str 1 x Forceps,dressing,standard,155mm,str 1 x Scissors,Deaver,140mm,str,s/b

5. Early infant male circumcision set

The early infant male circumcision set is used for male circumcision in ealy infancy, mostly within the fi rst two months of life in case of full-term baby. Three different circumcision devices are existing. The circumcision device should be selected by a surgeon based on his learning technique and experiences accordingly. Set content: One 7.5-cm to 12.5-cm (3-inch to 5-inch) fl exible probe Three small mosquito haemostats, two curved and one straight ( 80 - 125 mm) Small straight scissors, (115 - 140 mm) Desired male circumcision device (Mogen, Gomco or Plastibell) and all appropriate parts Reference; Manual for early infant male circumcision under local anaethesia, 2010: http://www.who.int/hiv/pub/malecircumcision/ manual_infant/en/ Specifi cations and picures of male circumcision devices in Page 42 to 51.

6. Embryotomy set

The set is used for embryotomy (cranioclasy, craniotomy). Set content: 1 x Cranioclast,Braun,420mm 1 x Perforator,Smellie,250mm 1 x Scissors,gynecological,200mm,curved, blunt/blunt 1 x Hook,decapitation,Braun,310mm

7. Examination/suturing, vaginal/cervical set

The set is used for checking and repairing cervical tears and deep vaginal tears. Set content: 1 x Scissors,Mayo,170mm,curved, blunt/blunt 1 x Needle holder,Mayo-Hegar,180mm,straight 2 x Retractor,vaginal,Doyen,45x85mm 1 x Speculum,vaginal,Graves,75x20mm

137 138 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Set content: hysterectomy..), salpingectomy, ectopic pregnancy, andothergynaecological operations. The laparotomy setisusedfor exploratory laparotomy, ceasarean section&related complications (uterin rupture, 9. Laparotomy (gyn/obs) set Set content: contraseptive methods. The intra uterin device (IUD) setisusedfor insertionandremoval ofintra uterin devices through viginaasoneof 8. Intra uterin device (IUD) insertion/removal set Table 41. Contents ofsurgical instrument sets 2 xForceps,dressing &polypus,Cheron,250mm 1 xSpeculum,vaginal,Graves,115x35mm 1 xSpeculum,vaginal,Graves,95x35mm 1 xBowl,stainless steel,600ml 1 xTube suction,Yankauer,270mm 2 xSpatula,abdominal,malleable,270mm 1 xScissors,Mayo,230mm,curved, blunt/blunt 1 xScissors,Mayo,170mm,curved, blunt/blunt 1 xScissors,Metzembaum/Nelson,230mm,curved, blunt/blunt 1 xScissors,Metzembaum/Nelson,180mm,curved, blunt/blunt 1 xScalpelhandle,no.4 1 xRetractor,Farabeuf,double-ended,180mm,pair 1 xRetractor,abdominal,Balfour,3 blades 1 xRetractor,abdominal,Collin,3 blades 1 xNeedleholder,Mayo-Hegar,180mm,straight 1 xForceps,tissue,standard,250mm,straight 1 xForceps,tissue,standard,145mm,straight 2 xForceps,tissue holding,Duval,230mm 1 xForceps,tissue &organ holding,Babcock,200mm 2 xForceps,tissue seizing,Allis,150mm 1 xForceps,uterine, vulsellum,Duplay,280mm,curved 2 xForceps,uterine, haemostatic, Phaneuf,215mm,curved 2 xForceps,intestinal,clamp,Doyen,230mm,curved 1 xForceps,dressing &polypus,Cheron,250mm 1 xForceps,dressing,standard,250mm,straight 1 xForceps,dressing,standard,155mm,straight 1 xForceps,artery,Mixter,230mm 6 xForceps, artery, Halsted-Mosquito, 125mm,curved 2 xForceps,artery,Pean/Rochester,240mm,curved 2 xForceps,artery,Pean/Rochester,200mm,curved 2 xForceps,artery,Kocher,140mm,straight 1 xForceps,artery,Kelly,140mm,curved 4 xClamp,towel,Backhaus,130mm 1 xBasin,kidney, approx. 825ml 1 xBowl, approx. 180ml 1 xScissors, gynaecological, 200mm,curved 1 xSound,uterine, Martin,320mm 1 xForceps,uterine, vulsellum,Duplay,280mm,curved 1 xForceps, artery,Pean/Rochester, 220mm,straight 1 xForceps,dressing &polypus,Cheron,250mm 1 xSpeculum,vaginal, Graves, 115x35mm 1 xSpeculum,vaginal, Graves, 115x35mm 1 xSpeculum,vaginal, Graves, 75 x20mm 6. Surgery and Anaesthesia Table 41. Contents of surgical instrument sets 10. Suture set

The suture set is used in addition to the delivery set for episiotomy, perineum repairs, and/or simple suturing ,complex dressings. It can also be used (Family Planning) for Sub-dermal implants removal if needed. Set content: 1 x Scissors,Deaver,140mm,curved, sharp/blunt 1 x Needle holder,Mayo-Hegar,180mm,straight 1 x Forceps,artery,Kocher,140mm,straight 1 x Scalpel handle,no.4 1 x Forceps,tissue,standard,145mm,straight 1 x Probe,double-ended,145mm

11. Vacuum Aspiration set

The vacuum aspiration set is used for surgical methods of sage abortion up to less than 15 weeks. Vacuum Aspiration requires electric or manual vacuum aspiration equipment with different sizes of plastic cannulae, ranging from 4 - 16mm in diameter. Set content: 1 x Dilators, uterine, Hegar, double-ended, 3-4mm to 17-18mm, stainless steel 1 x Forceps, dressing, ring 1 x Forceps, tenaculum, atraumatic 1 x Speculum, vaginal, Graves, 95 x 35 mm 1 x Bowl, stainless steel, 180 ml Footnotes; Recommendation: Vacuum aspiration is the recommended technique of surgical abortion for pregnancies of up to 12 to 14 weeks of gestation. The procedure should not be routinely completed by sharp currettage. Dilation and sharp currettage (D&C), if still practised should be replaced by vacuum aspiration (page.2 in the reference). Dilatation and curettage: Where it is still practised, all possible efforts should be made to replace D&C with vacuum aspiration, to improve the safety and quality of care of women. At sites where vacuum aspiration has yet to be introduced, manegers must ensure that proper painmanagement protocols are followed, and that D&C procedures are performed by well-trained staff under adequate supervision. Reference: Safe abortion second edition, 2012: http://www.who.int/reproductivehealth/publications/unsafe_ abortion/9789241548434/en/

12. Vasectomy set

The vasectomy set is used for vasectomy as one of contraseptive methods. This method requires also scissors for clipping scrotal hair and disposables for local anaesthesia. Set content: 1 x Bowl, 180ml, stainless steel 4 x Clamp, towel, Jones, 50 mm 4 x Forceps, artery, Kelly, 140 mm,straight, 2 x Forceps, artery, Halsted/Mosquito, 125 mm, curved 2 x Forceps,tissue seizing, Allis, 150 mm 1 x Scalpel handle, no.3 1 x Scissors, 120 mm, curved

13. Vasectomy non-scalpel set

The non-scalpel set is used for vasectomy with non-scalpel technique which requires the extracutaneous ringed forceps, called Ringed clamp, for grasping the vas voth extracutaneously and directly, and Dissecting forceps for puncturing the scrotal skin and spreading the tissues. This method requires also scissors for clipping scrotal hair and disposables for local anaesthesia . Set content: Ringed clamp (inside dimensions of clamp 3.0, 3.5, or 40. mm) Dissecting forceps Straight, scissors Reference: No-Scalpel Vasectomy third edition (http://www.engenderhealth.org/fi les/pubs/family-planning/no-scalpel.pdf) Page 7 to 9.

139 140 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Surgical (Table 42); Although polished finish.The molybdenumgives greater hardness andhelpsmaintainacuttingedge. manufacturing process vary slightlyto getmore sharpness ormore strength. The Surgical stainless steel includeselementsof:chromium, nickel andmolybdenum. easy to cleanandsterilize. Families ofproducts Note: Table 42.Two maintypesofstainless steel steelstainless Surgical Surgical instrument stainless steel 6.3 Stainless steel. the steel, • • • • • • • • • • • • 1. Pressure force instruments andsprings=>martensitic steel 2. Instruments that cutby shearing=>martensitic steel MANGANESE =>0,4 to 2% SILICON =>0,5 to 1% MOLYBDENUM =>0,2 to 1% CHROMIUM =>12to 14% CARBON =>0,1 to 1% They contain: These are quenched,magneticsteels. Martensitic stainless steels them brittle Cannot Gives corrosion andimpactresistance Improves thecutting qualities Gives corrosion resistance Essential alloying element Lowers corrosion resistance Gives hardness andtensile strength fact Cutting forceps Gouge shears Raspatories Curettes Scissors Clamping forceps Threading forceps Needle-holding forceps Surgical towel clamp Gripping forceps Dissecting forceps Haemostatic forceps chromium Most and that stainless be there easier surgical used these gives are to steels for types instruments myriad keep pressure the is are of metal a sharp. of specific steel defined force variations, are its Depending are instruments, scratch made type by well-suited the cutting qualities. The instruments inorder to increase hardness. incorporation The Instruments The proportions must bevery exact. Carbon The steel usedmust bespringyandhighlyimpactresistant. treatment Instruments the first timethey are used. the polishingdetermines thecorrosion resistance. there of out standard resistance stainless steel percentage on of as are gives for the martensitic used it which two makes making made made type EN them steel, of has and main of ISO allows molybdenum of of hardness, a of chromium used MANGANESE =>0,4 to 2% SILICON =>0,5 to 1% NICKEL =>8to 12% MOLYBDENUM =>2to 3% CHROMIUM =>16to 20% They contain: These are non-quenched,non-magneticsteels. Austenitic stainless steels corrosion surgical Gives corrosion andimpactresistance Gives corrosion resistance Essential alloying element higher stainless 7153-1: surgical these categories these the in medical percentage steels steels Surgical instruments: steel while steel, instruments, is resistance. the makes of to have chromium must it stainless applications. same instruments be is to of much up be hardened; they The to carbon undergo the carefully the gives give steel: harder nickel are stainless balance The - corrosion than strong, them martensitic Metallic otherwise a polished; provides complex, than word for corrosion steel and corrosion-resistant, the austenitic ‘surgical’ materials resistance, they pressure composition improves the a rigorous and smooth resistance. quality will austenitic refers stainless – while Part force bend heat the and of to & 1: 6. Surgery and Anaesthesia 3. Instruments that cut by percussion => martensitic steel • Chisel shears For the cutting part, the heat treatment and polishing are the same as for • Osteotomes instruments that cut by shearing. • Gouges For the non cutting part, the heat treatment and polishing are the same as for pressure force instruments. 4. Static function instruments => martensitic or austenitic steel • Autostatic retractors • Long-handled retractors • Valves • Speculums • Dilators 5. Miscellaneous instruments => austenitic steel • Instrument box • Obstetrical hook • Manual drill etc.

Table 43. Standard grades of steel for surgical instruments

Composition of the steel

Families of products Type of steel NICKEL SILICON CARBON CHROMIUM MANGANESE MOLYBDENUM

1. Pressure force instruments & springs Haemostatic forceps Martensitic 0.2 % 13 % 1 % 1 % Dissecting forceps Martensitic 0.2 % 13 % 1 % 1 % Gripping forceps Martensitic 0.2 % 13 % 1 % 1 % Surgical towel clamps Martensitic 0.2 % 13 % 1 % 1 % Needle-holding forceps Martensitic 0.2 % 13 % 1 % 1 % Threading forceps Martensitic 0.2 % 13 % 1 % 1 % 1 % 1 % Clamping forceps Martensitic 0.2 % 13 % 2. Instruments that cut by shearing

Scissors Martensitic 0.4 % 14 % 0.5 % 0.4 % Curettes Martensitic 0.2 % 13 % 1 % 1 % Raspatories Martensitic 0.2 % 13 % 1 % 1 % Gouge shears Martensitic 0.3 % 13 % 1 % 1 % Cutting forceps Martensitic 0.3 % 13 % 1 % 1 % 3. Instruments that cut by percussion

Chisel shears Martensitic 0.5–0.7 % 13–14 % 1 % 1 % 0.5-0.9 % Osteotomes Martensitic 0.5–0.7 % 13–14 % 1 % 1 % 0.5-0.9 % Gouges Martensitic 0.3 % 13 % 1 % 1 % 4. Static function instruments

Autostatic retractors Martensitic 13 % 8-10 % 1 % 2 % Long-handled retractors Austenitic 18 % 10-12 % 1 % 2 % Valves Austenitic 0.3 % 16–18 % 10-12 % 1 % 2 % 2-3 % 8-10 % 1 % 2 % Speculums Austenitic 16–18 % 2-3 % 1 % 2 % Dilators Austenitic 18 % 5. Miscellaneous instruments

Instrument box etc. Austenitic

141 142 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Swaged Suture Sutures threads are madefrom numerous materials andexist invery specificsizes. A numberofdifferent needlesshapes,sizes andthread materials have beendeveloped over itsmillenniaofhistory. them. They are therefore less traumatic for thetissues. Suture nonabsorbable Structure ofthread • • • • • • Suture absorbable(naturally biodegradable inthebody), Type ofthread suture), (atraumatic combination Needle-suture A surgical suture isasterile singleusemedicaldevice usedto holdbodytissues together after aninjuryorsurgery. Surgical sutures 6.4 structures. Sutures absorbable derived from polyglycolic acid. healthy are and the suture tract. » » » » » » » » Multifilament Monofilament - Synthetic (i.e nylon,polypropylene). Natural: (i.e. silk) Synthetic (i.e. polyglycolic acid,polylacticacid) Natural:(i.e. catgut), from » » » » » » » » avoid usely coated to reduce capillarity. easier to handleandto tie, thread madeofseveral braided filaments, have nocapillarity. knot tyingmore difficult, thread madeofonesinglefilament presenting auniquephysical structure, Absorption by hydrolysis. Absorption by enzymatic process, varying resorption time. material beef must needles synthetic the The and be “wick original strong are can sheep polymers, eyeless effect” be sutures enough (catgut) classified needles (capillary such were to or hold on non-absorbable, as attached made action) the polyamide, tissue from basis securely onto that biological of would polyolefines sutures needle the such but characteristics allow flexible as materials threads with organic fluids and attached enough at either polyesters, protein the and absorbability, factory, to thus length absorbable, be called infection knotted. including allowing of fibrin thread, origin such to They (silk). a non-absorbable penetrate smooth as is of must collagen recommended. Most material be junction modern the hypoallergenic derived body and as between sutures well thread along Note: from as 6. Surgery and Anaesthesia Classification of suture thread sizes

The tensile strength and knot-tying properties of a surgical suture material are determined not only by the starting material and structure, but also by the thickness of the thread. Classification of thread size must therefore be precise.

Suture thread sizes are defined by two parralele systems:

The United States Pharmacopeia (U.S.P.), • range from 10-0 (or 10/0) to 5 • Size refers to the diameter of the suture strand and is denoted as zeroes. The more zeroes characterizing a suture size, the smaller the resultant strand diameter (eg, 4-0 is larger than 5-0).

The European Pharmacopia (E.P.) metric, according to decimal system. • range from 0.2 to 7 (this denotes the diameter of the suture strand as a multiple of 0.1 mm.) • Size refers to the diameter of the suture strand and is denoted asa multiple of 0.1 mm • expressed as a DEC number (DEC2 = 0.20 mm) Table 44. Size of non-absorbable and absorbable synthetic sutures

USP EP (metric) Ø in mm

Non-absorbable & absorbable Non-absorbable & absorbable Limit on average diam Min - Max synthetic materials synthetic materials (mm) 10-0 0.2 0.020-0.029 9-0 0.3 0.030-0.039 8-0 0.4 0.040-0.049 7-0 0.5 0.050-0.069 6-0 0.7 0.070-0.099 5-0 1 0.100-0.149 4-0 1.5 0.150-0.199 3-0 2 0.200-0.249 2-0 3 0.300-0.349 0 3.5 0.350-0.399 1 4 0.400-0.499 2 5 0.500-0.599 3 and 4 6 0.600-0.699 5 7 0.700-0.799

Non-needled suture (spooled suture)

Threads for non-swaged needles are supplied in spools and must be threaded on surgical needles with eyes by the user only at the time of use. They are more traumatic when passing through the tissues and increase the risk of accident (including users stick injuries). Consequently they need to be avoided.

Needle-suture combination (atraumatic suture)

Atraumatic sutures are defined as needle-suture combinations. Swaged needles are eyeless needles attached onto sutures threads at the factory, allowing a smooth junction between them in order to reduce tissue trauma. Threads of needle-suture combinations have an average length of 75 cm. Nowdays, atraumatic sutures are widely used.

There is a wide range of needles, they are made of stainless steel. They are defined by their curvature (longitudinal shape), their body (cross section) - point, their length.

143 144 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Examples sides. Integrated Management for Emergency andEssential Surgical Care (IMEESC)toolkit. Geneva: World HealthOrganization;6. 2009 Aidememoire onsurgical andemergency obstetrical care at first referral level. Geneva: World HealthOrganization; 2003 (http:// 5. BelleJ, Cohen H,ShindoN,LimM,Velazquez-Berumen A,Ndihokubwayo JB,CherianMN.Influenza preparedness4. inlow-resource OlogundeR,Vogel JP, CherianMN,SbaitiM,MerialdiM,Yeats3. J, etalAssessment ofcesarean delivery availability in26low- and DVo, MNCherian,SBianchi,LNoël,GLundeg,ATaqdeer, BTJargo,2. MOkello-Nyeko, AKahandaliyanage, OSentumbwe- WHOEmergency &Essential Surgical Care. (http://www.who.int/surgery/en/, accessed 22May 2014). 1. References 6.5 Round-bodied Needle body–point (needle bodyistriangularandhasthethird cuttingedgelocated ontheouter convex curvature oftheneedle) Box 2.Needleshape Box 3.Needlebody–point Sutures ofmusclesandskin. 2. Triangular bodied-Reverse cuttingneedle Sutures ofsofttissues, mucous membranes andvessels. 1. Round-bodied –Taperpoint needle To beavoided (more dangerous thanthecurved needles). 3. Straight needle General surgery, vascular sutures… 2. Curved needle, 3/8 circle Deep sutures, stomatology, gynaecology… 1. Curved needle, 1/2 (=4/8) circle (=half) (http://www.who.int/surgery/publications/imeesc/en/index.html, accessed 22May 2014). www.who.int/surgery/publications/en/Aide-Memoire_surgery.pdf, accessed 22May 2014). settings: alookat oxygen delivery in12African countries. JInfect Dev Ctries.2010 August;4(7):419-424. middle-income countries: across-sectional study. (2014). Am JObstet Gynecol. Anesth ClinRes. April;3(4):207. S Prasad, MWekesa, O Toliva, PKibatala andMMcCunn,Anesthesia capacityin22Low and MiddleIncome Countries. (2012). J Mugisa, AOchroch E,DOkello, JAbdoulie, O.Ayankogbe, OASoyannwo, PHoekman,Bossyn, RSani,MThompson, SMwinga, include:Taper needles taper point gradually needle (needle to a point body whereas is round triangular-bodied and tapers smoothly needles to a have point) cutting & reverse edges cutting along needle three

7. Infection prevention and control 7. Infection prevention and control 7.1 Injection safety With an estimated 25 billion injections administered annually in developing and transitional countries alone, injections are among the most frequently used medical procedures. If delivered unsafely, injections have the potential to contribute to the transmission of bloodborne pathogens with devastating consequences such as disability and death. Unsafe practices and the overuse of injections can cause an estimated 32% of Hepatitis B virus, 40% of Hepatitis C virus and 5% of all new HIV (human immunodeficiency virus) infections every single year (1).

The risk of an unsafe injection is not only associated with the patient but also the health care worker (HCW) administering the injection and the community following dangerous waste disposal practices. In 1999, the World Health Organization (WHO) launched the Safe Injection Global Network (SIGN), an international alliance hoping to achieve the safe and appropriate use of injections on a global scale. The Injection Safety programme comprises of three core technical strategies believed to be necessary to bring about an improvement in injection practice. These include; (2)

1. Behaviour change among patients and healthcare workers to decrease injection overuse and achieve injection safety 2. Availability of necessary and of good quality injection devices and supplies 3. Management of sharps waste

Implementation of these strategies will facilitate • improved patient safety by preventing the reuse of injection equipment or reducing unnecessary injections; • health care worker safety through needle stick injury prevention, provision of Hepatitis B vaccine or post exposure prophylaxis and • community safety via safe sharps waste management.

Despite the simple strategies to improve injection safety, many countries are still facing to address unsafe injections issue: (3) • Poor practices are being targeted such as preventing the reuse of equipment through the introduction of reuse prevention syringes (RUPs) syringes, however many challenges still remain. Injection equipment availability, supply and quality are still key issues that need to be resolved to ensure safer injection practices. • Patient preference or doctor over-prescription of injectable medications means unnecessary injections are still a major issue. It is estimated that over 70% of • injections are unnecessary when oral formulation could have been used as an alternative therapy. • To bring about behaviour change is a well-recognized challenge yet it is essential that these issues and gaps in interventions are addressed to ensure improved injection safety throughout the world. Recent evidence suggests that change is possible. Intervention strategies that target all three core components simultaneously have been shown to have the greatest positive effect on improved injection safety. To ensure rational use of injections and avoid risks of transmission of bloodborne pathogens to patients, healthcare workers and the community at large, WHO recommends to implement the following key steps: (4, 5, 6, 7, 8)

1. Always use one single-use sterile needle and one single-use sterile syringe per patient and per injection, and to reconstitute each unit of injectable medication. 2. Promote oral treatment and limit the number of injections to only those strictly necessary. Use oral rehydration to limit the use of drips. 3. Single-use syringes with a reuse-prevention feature (RUPs) should be considered for therapeutic injections, and auto-disable syringes with attached needles ( Ads) for immunization activities. 4. Ensure adequate supply of good quality and safety injection devices and that all injectable medications are supplied with matching quantities of single-use safety syringes, appropriate diluents and safety boxes/sharp containers according to the bundle principle. 5. Use single-dose vials rather than multi-dose vials. If multi-dose vials must be used, always pierce the septum with a sterile needle and avoid leaving a needle in place in the vial stopper. 6. Collect used needles and syringes in a sharps container according to waste segregation rules. 145 146 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Chemical must emerge dry. the Safe 7.2 Decontamination andSterilization at healthcare facilities method detergent The gloves andheadgearmust beprovided duringthecleaningandreprocessing ofmedicaldevices. cleaning- water of medical bath A collection tubes and teeth, After contamination- they alsogive afalse senseofsecurityto theusers. due anywhere gauges but Disposal maternal birth canal must beeitherdisposableor, ifreused, sterilized usingheat s. the Boiling sterilizers: when usingchemicalsfor maternity units andprimaryhealthcare. carrying infectious units of Bench topsterilizers:Bench cannot becontrolled andthedevices cannotbedriedwithoutcontaminating them. have Medical section. The open trays andplaced inthesterilizer. Somehave builtinvalidation processes. cooled down andeach cycle hasto bemonitored manually. The devices separate not sexually water absence the advantage first cycle plastic to maternal or a (MOU) cleaning, preferably integrity less heating (pressure a chemicals an are devices of devices over step items these lack level disinfectants where agents at is than transmitted automated disinfection designated not aprons), short of the provide chemicals childbirth and of to element and the is 80°C available heat, destroy wrapped and correct there both used cookers) avoid that such properly must these and most medical functionality. prepare disposable for a facilities There hot the washer is for diseases as high therefore or such splashing. area be which to is the require 10 dilution important electricity in and hepatitis and one sterilization. medical sophisticated fitted examination rinsed minutes sterilized such devices integrity level is them should as therefore of disinfector. can cold, wide for sodium filling are vaginal and to the Those the disinfectant healthcare off Automated for cause both devices or B them. step or electricity offered range are be Millennium thoroughly a of medical devices and safe with a 90°C This soft made source found can the of hypochlorite inspected natural in self injury speculae, The Manual C, of patient water are women, reprocessing nylon in can medical for become HIV steam facilities bench are advantage primary systems (such available devices and to exposed to of 1 be Goals deliveries and minute. and and be the brush heating cleaning readily use. good for needles done generating top which as unfit device medical boiling contaminated, vaginal bacterial must set include health cleanliness Protective should in glutaraldehyde to to to sterilizers light Medical either medical is available. for by health up as clean high reprocess will come that never and coating, for the the mucosa use clinics devices and well include personal require pathogens. sterilizers. manually temperatures 10 these WHO, syringes, the delivery water. devices are equipment in devices be especially ventilation. ranging min. as The and the medical contact create replaced used medical and assisted dried a is a however or Some The disinfection protective that disadvantages community devices pair reprocessed in therefore areas peracetic The is suturing from to Antenatal prior crevices a disadvantage they thorough such the devices of with have sink Only and soak devices. before medical childbirth those this domestic resulting emerge hinges, to are as or the temperature mucous trained clothing medical great material, use. stage goal acid) units. a and bowl, by cheap care sterilizing in that visor, process cleaning devices It are a There holding serrated cannot hot increase such must care will in washer with is gloves, Maternal and staff require via 11) 10, (9, that membranes mask, and that devices (such transmission and and be must is is an as temperatures management have are and should with prior can be the them the a much considered have water disinfector edges ultra Caesarean laboratory the apron filling danger as loaded obstetric achieved be pressure be medical prior process running heat. to gloves risk under taken to clean sonic safer. used with and and and and any be to of of of In in 7. Infection prevention and control

Figure 3. Bench top front loading sterilizer Figure 4. Pot sterilizer Dry Heat or Hot Air Sterilizers: These consist of a simple chamber incorporating a heating element and a fan. The advantages of these are that they only require a source of electricity and do not need running water. The disadvantages are that they require a very long cycle time that exceeds 3 hours by the time heat up is included. As with bench top sterilizers, the medical devices are not wrapped and therefore can become contaminated, the devices emerge hot and have to be cooled down and each cycle has to be monitored manually.

Figure 5. Dry Heat sterilizer

Whatever type of sterilizer is used, it is important that the process is validated and that either biological indicators or chemical indicators are routinely used to prove the sterilizing performance.

Documentation requires standard operating procedures (SOP) that everyone carrying out the procedure will follow easily. There must be a register or a logbook kept of medical devices processed and by which method, to ensure patient safety records- Traceability is essential.

Acknowledgement:

Contribution on behalf of the Decontamination Working Group under WHO Patient Safety,

Prof Shaheen Mehtar, Unit for IPC, Div Community Health, Fac Medicine and Health Sciences Stellenbosch Uni, Chair of the Decontamination Working Group under WHO Patient Safety.

Mr Wayne Spencer, Hospital Engineer, Healthcare Facilities Consultants, member of Decontamination Working Group under the WHO Patient Safety.

147 148 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health must and Thermoresistant autoclave catheters) Table 45.Basicsterilization equipmentandotherrelevant equipment Processing 7.3 Sterilization equipment Thermosensitive critical information, they Sterilizer, steam, approx. #capacities,electricwithaccessories Timer, 60min,mechanical Paper sheet,crepe, for sterilization pack Masking tape, for sterilization pack Indicator, TST control, spot&tape Drum, sterilizing #sizes 7. 6. 8. 5. 4. 10. 9. 3. 1. Box 4.Model10Point ManualWashing Procedure: 2.

noncritical Change therinse-water after every batch ofinstruments orwhenitbecomes visiblysoiledorcloudy. sink orbowl for rinsing. Remove Rinse theitem thoroughly withcleanpotablewater usingthewater-jet gunwhennecessary (see point5). Remove supply only. The gunisconnected to theinstrument andheldunderwater duringtheirrigation process. member whocompleted theprocedure. If should besingle-useonly. Record Cleaning materials shouldbesafely disposedofinaccordance withlocalwaste policy. linting clothorby mechanical drying.Analcohol wipecanbeusedto facilitate thedryingprocess. (spray). care and Brush, in thecaseofhollow instruments, to ensure penetration ofchannels. use Fill instruments: be Dismantle parts. have be high-pressure-jet in items the of sterilized to with accordance between been are wipe, sink an of ensure the Brushes please the and must reusable enzymatic the or for or items) device soiled device agitate, washing-up critical open semi-critical drain other single the appropriate by each see be should with item that the steam and by the medical from cleaned guns clean Section items irrigate, use detergent patient blood instrument the item, has the remains be the liquid are only receptacle autoclave manufacturer’s items made (such been heat detergent. devices sink and 5 and or used jet-wash and and (special should other under to resistance or processed must from then as disinfected to kept for facilitate must bowl surgical with be must between cannulated biological nylon the or not dry be Detergents note cleaned sterile and not potable hand-spray instructions subjected surface ideally be using including of the bristles on instruments drain be done regularly the until each and decontamination cleaning resterilized the fluids water be instruments, of any materials used according and fully use. used. the preferred patient the to the and excess to or high-level but should water immerse Thermosensitive item method of must a and in local Detergent predetermined surgical not or case (thermoresistant but cleaning to to surgical at method: they be reused. be policy. dislodge necessarily all the and do in of and cleaned disinfection specifically should times the instruments dilution infection risk not solutions Consideration solution sterilization drapes) for solution Thermoresistant of need to and level critical and be example, infections prevent and between remove connected (12) requiring sterilized before or at used designed between to must to with water the thermosensitive items displace be at and the by should specified be placing channels health-care kept all (critical, each temperature using daily, creation (such isolation. sterilized details each visible semi-critical to to trapped sterile be the clean patient, into or a temperature patient. given as or semi-critical clean, of dirt, cold-water preferably, of tubes a complex facilities). the For by until devices). surgical air aerosol second should taking to unless steam non- staff and, items more Non- the use. and 7.4 Health care waste management 7. Infection prevention and control Health-care waste is a by-product of health care that includes sharps, non-sharps, blood, body parts, chemicals, pharmaceuticals, medical devices and radioactive materials. In order to avoid air and water pollution and the possible transmission of infections by health-care waste, proper health-care waste management should be implemented and promoted in all situations. (13, 14)

Health-care waste management includes the following steps:

1. Segregation of the various categories of waste; 2. Storage and collection; 3. Treatment and disposal; 4. Waste zone.

Segregation

The four major categories of health-care waste recommended for organizing segregation and separate storage, collection and disposal are (WHO 2005): • sharps (needles, scalpels etc.), which may be infections or not; • non-sharps infections waste (anatomical waste, pathological waste, dressings, used syringes, used single-use gloves); • non-sharps non-infections (general) waste (paper, packaging etc.); • hazardous waste (expired drugs, mercury-containing thermometers, laboratory reagents, radioactive waste, insecticides etc.).

Storage and collection

Sharps should be places immediately after use in puncture resistant, fluid impermeable sharps containers which are placed at the site of use and regularly collected for disposal.

Non-sharps infections waste contains (15-401 capacity, with lids) should be collected, emptied, cleaned, disinfected and replaces after each intervention (e.g. in an operating or maternity unite) or twice daily.

Non-sharps non-infections waste (20-601 capacity) should be collected, emptied, cleaned and replaces daily; alternatively, plastic bags may be used inside the containers (MSF 2005).

For the above categories of waste, it is recommended that waste containers are a maximum of 5m from the point of waste generation, in 2 sets for each location, for a minimum 3 types of waste. At least one set of waste containers should be provided per 20 beds in a ward (MSF 2005).

Hazardous waste should be collected and stored in appropriate labelled containers places in a secure location. Radioactive waste should be stored in containers that prevent dispersion, behind lead shielding. (14)

Treatment and disposal

Sharps should be disposed of in a sharps pit (buried drum in small centres or emergency structures, concrete- lined sealed pit in other settings) or autoclave followed by shredding after which they can be buried in a pit or landfill.

Non-sharps infections waste should be buried in a pit fitted with a sealed cover and ventilation pipe, or high- temperature (850 degrees C) incineration. Special arrangements may be needed for disposing of , according to local custom.

149 150 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health a from Non-sharps non-infectious wastenon-infectious Non-sharps for detailsofrange ofprocesses for treating infectious wastes. edition, 2013 from disposal blood such which There ashes andresidues shouldbeburiedinapit. www2.paho.org/hq/dmdocuments/2009/sterilization_manual_2009.pdf, accessed 22May 2014). Sterilization manualfor healthcentres. Washington D.C.: Pan American HealthOrganization; 2009 (http:// (http://whqlibdoc.who.int/publications/2009/9789241547857_eng.pdf, accessed: 22May 2014). Natural Ventilation for Infection Control inHealth-Care Settings.Carnberra: World Health Organization; 2009 pdf, accessed 22May 2014). Geneva: World HealthOrganization; 2011 (http://whqlibdoc.who.int/publications/2011/9789241548182_eng. Replacement ofmercury thermometers andsphygmomanometers inhealthcare, Technical guidance. factsheets/fs361/en/, accessed 22May 2014). Mercury andhealth,fact sheetno. 361. World HealthOrganization; 2013 (http://www.who.int/mediacentre/ mwinjections.pdf, accessed 22May 2014). Geneva: World HealthOrganization; 2006(http://www.who.int/water_sanitation_health/medicalwaste/ WHO Managementofwaste from injectionactivitiesat district level. Guidelinesfor District HealthManagers. Further reading Health-care Waste zone Steam space avoid by care Wastewater other facilities have to bebuilt. containers in infectious plant. should notbeusedfor agricultural purposes, butshouldbeburiedfollowing safe procedures. any point Where in or the should traps. from water table large standard the disinfectant safest health-care groundwater facility incineration a the (more as of Otherwise contamination may There is samples, are health may laboratory) sterilization an be centre limited, pharmaceutical waste of one feasible incinerator covered. several waste, also that waste in hazardous include should drainage waste should (14). centre, used coarse The generation. be for plastic are setting it and (14) source Inallcases,national legislation shouldbefollowed. could non-sharps drainage method disposed kinds should is for waste-disposal have storage collected Small prior be encapsulation, on-site of nearby sands, segregated . is rainwater It sterilization syringes at wastes, used, should the be is a of wastes, to to least quantities be important specific available. incinerated. At hazardous waste hazardous systems health-care gravels in disposal, and avoid septic treated housing from it least the non-infectious 1.5 be and should see and destruction cannot at metres septic contaminating connected should all waste-disposal tank zone of and one surface WHO of sterilization, laboratory the to as to Waste healthcare if medical and be infectious off-site If health-care dedicate with fissured available, setting set should point tank this be between located preferably crops, Safe run-off of containers effluent disposed is or or to and devices waste, of waste sewer tests, not also or management formations), in services returned properly one liquid generation and burial, groundwater. is to zone the soakaway the each from possible, waste be a discharged allow be containers specific prior or hazardous it preferred broader within bottom of located may should which should on-site recycled health-care requires incineration and and safely built effective to to be and it pits according the disposal, autoclave the stored of not is may of be environment. at and poured be Septic disposal into option should fenced in the wasted or laboratory. waste) or the specific least combined supplier. located large be low-cost infiltration operation functioning can settings system a safely infiltration and burned soakaway tank as 30 into to for for be off, be systems. enough from in this metres long-term treatment its a provided waste before specific For has sinks buried sludges should colour-coded with maximum See settings Wastewater should four avoids in with trenches health-care a guidance sewer system a pit WHO, for wastewater. or sterilization water All from drum types treatment be in minimal or infectious toilets. be from per extension environmental open and storage. a and at infiltration system groundwater pit built equipped of 2013 burner. and point least 20 (sharps, should healthcare disposal 5 on should or or wastewater activities, Toxic local beds. the metres and and and/or Where that a 30 with treatment labelled and waste Some if In landfill groundwater managed metres be trench. air wastes new with UNEP, both non-sharps be is The soap treatment methods, pollution pollution from removed different disposal sources. possible

settings such wastes, second sent pits grease health cases, site. drains waste and/ from Grey 2012 (e.g. and the as to or to If

WHO guidelines on Hand Hygiene in Healthcare: First Global Patient Safety Challenge Clean 7. Infection prevention and control Care is Safer Care. Geneva: World Health Organization; 2009 (http://whqlibdoc.who.int/ publications/2009/9789241597906_eng.pdf, accessed 22 May 2014). Standard precautions in Health care. Geneva: World Health Organization; 2007 (http://www.who.int/csr/ resources/publications/EPR_AM2_E7.pdf, accessed 22 May 2014). Mercury in health care, Policy paper. Geneva: World Health Organization; 2005 (http://www.who.int/water_ sanitation_health/medicalwaste/mercurypolpap230506.pdf, accessed 22 May 2014). Infection control. Geneva: World Health Organization; 2004 (http://www.who.int/injection_safety/AM_ InfectionControl_Final.pdf, accessed 22 May 2014). Safe health-care waste management, Policy paper. Geneva: World Health Organization; 2004 (http://www. who.int/water_sanitation_health/medicalwaste/en/hcwmpolicye.pdf, accessed 22 May 2014). Healthcare worker safety, aide-memoire. Geneva: World Health Organization; 2003 (http://www.who.int/ injection_safety/toolbox/docs/en/AM_HCW_Safety.pdf, accessed 22 May 2014). Safe health-care waste management, aide-memoire. Geneva: World Health Organization; 2003 (http://www. who.int/water_sanitation_health/medicalwaste/aidemem.pdf, accessed 22 May 2014). UNEP Compendium of technoloiges for the treatment or destruction of healthcare waste. Nairobi: United Nations Environment Programme; 2012. (http://www.unep.org/ietc/Portals/136/News/Publication%20of%20 Healthcare%20Waste%20compendium%20of%20technologies/Compendium_Technologies_for_Treatment_ Destruction_of_Healthcare_Waste_2012.pdf, accessed 22 May 2014).

7.5 References 1. WHO Aide memoire on injection safety. Geneva: World Health Organization (http://www.who.int/injection_safety/ about/country/en/AMENG.pdf, accessed 22 May 2014). 2. WHO Best Practices for injections and Related Procedures Toolkit. Geneva: World Health Organization; 2010 (http:// www.who.int/injection_safety/toolbox/9789241599252/en/index.html, accessed 22 May 2014). 3. WHO Guiding principles to ensure injection device security. Geneva: World Health Organization; 2003 (http://www. who.int/entity/injection_safety/toolbox/docs/en/Guiding_Principle_Inj.pdf, accessed 22 May 2014). 4. WHO-UNICEF-UNFPA Joint statement on the use of auto-disable syringes in immunization services. Geneva: World Health Organization, United Nations Children’s Fund, United Nations Population Fund; 1999 (http://www.who.int/ entity/injection_safety/toolbox/en/Bundling.pdf, accessed 22 May 2014). 5. Safe Injection Global Network: Advocacy Booklet. Geneva: World Health Organization; 2011 (http://www.who.int/injection_safety/sign/advocacy_booklet/en/index.html, accessed 22 May 2014). 6. Safe Management of Wastes from Health-Care Activities. Geneva: World Health Organization; 1999 (http://www.who. int/entity/injection_safety/toolbox/docs/en/waste_management.pdf, accessed 22 May 2014) 7. A Guide for the Quality Assurance of Single Use Injection Equipment. Geneva: World Health Organization; 2003 (http://www.who.int/entity/injection_safety/toolbox/docs/en/InjEquQualityGuiden.pdf, accessed 22 May 2014). 8. Safety of Mass Immunization Campaigns. Geneva: World Health Organization; 2002 (http://www.who.int/entity/ injection_safety/toolbox/en/AM_SafetyCampaigns.pdf, accessed 22 May 2014). 9. Pan American Health Organization. Sterilization Manual for Health Centers. Washington, D.C.: PAHO; 2009. (http://pdf. usaid.gov/pdf_docs/PNADT378.pdf, accessed 22 May 2014). 10. Best Practice in D&S Canada Best Practice Guidelines for Cleaning, Disinfection and Sterilization in Health Authorities. BC Ministry of Health; 2011 (http://www.health.gov.bc.ca/library/publications/year/2011/Best-practice-guidelines- cleaning.pdf, accessed 22 May 2014). 11. Health Estates. Decontamination in General Dental Practices DHSSPS General Dental Services Quality Improvement Scheme Technical Guidance. 2007. (http://www.dhsspsni.gov.uk/gdp_dg_2007_-_decontamination_guidance_ nov_2007.pdf, accessed 22 May 2014). 12. Interagency list of essential medical devices for reproductive health. Geneva: World Health Organization, John Snow Inc., PATH, Population Action International, United Nations Population Fund and World Bank; 2008 (http://apps.who. int/medicinedocs/documents/s16440e/s16440e.pdf, accessed 22 May 2014). 13. WHO health-care waste web site. (http://www.who.int/topics/medical_waste/en/, accessed 22 May 2014). 14. Safe management of wastes from health-care activities, second edition. Geneva: World Health Organization; 2013 (http://apps.who.int/iris/bitstream/10665/85349/1/9789241548564_eng.pdf , accessed 22 May 2014)

151 152 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health consider Generally, Modern While Figure 6.Progressive Regulatory Framework The 8.1 Regulations for Medicaldevices 8. the level framework shouldbepresumed to beincorporated in themediumandhighest level ones(Figure 6). knowledge individual framework, for issues Post-market convergence Global treatments. (see As throughout theirlife-cycle and(4)priority ofprocurement. We not have any interest intheviewpoint ofstandards. the audit frameworks foundation. However Supporting/Monitoring categorized Softwares… IVD, pointed regulatory conceptual can cost regulations Contraceptive Reference). management ofmedicaldevices Technical notesregulation and process, the Device-specific Harmonization recognize Medical of implemented regulations on manufactu on regulations implemented should benoted also that the possible on effect the availabilitymedical a devices due to burden of Date: Figure 13. Progressive RegulatoryFramework

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In the next, we need the conceptual understanding of key topics for medical devices. 8. Technical notes regulation and management of medical devices

Quality Assurance

Traditionally, GMP (Good Manufacturing Practice) is using to ensure the product quality in the manufacturing and testing process for Pharmaceuticals and Medical Devices. For example, the importer of Pharmaceuticals needs to assure the product quality by Laboratory testing with the sampling of each batch. Now we should require QMS (Quality management System) as ISO 13485 instead of GMP for Medical Devices. Generally medical devices consist of many parts including lots of raw materials. We can recognize one lot of medical device as sterilization lot, however this lot can’t be recognized as a single quality product. The different concept is ‘Management System’ from ‘Good Practice’. ISO 13485 doesn’t show any practical procedure or criteria, because they shall be established by an organization throughout the lifecycle of a medical device including the design and development, production, storage and distribution, installation and servicing of medical devices, and the design, development, and provision of associated activities. So regulators need to trust a medical device manufacturer with their audit results.

‘Risk’-based concept for Essential Principles

All kinds of regulation may be established with ‘Risk-based’ concept. GHTF founding members have 4 classes as Low, Low-Moderate, Moderate-High and High (Table 46).

Table 46. Risk-based Classifications for Medical Devices in Different Jurisdictions

Risk GHTF USA Europe Japan Canada Australia

Low A I I I I I Low-Mod B II IIa II II IIa Mod-High C II IIb III III IIb High D III III IV IV III

However ISO 14971 shows the definition of ‘Risk’ is ‘combination of the probability of occurrence of harm and the severity of that harm’. Customarily, a classification system of this type is referred to as a ‘risk-based classification scheme’ but this is a misnomer since the rules take account only of the hazard presented by a particular device and not the probability harm will occur. So GHTF guidance uses Class A, B, C, D instead of digits (1<2<3<4). This classification requires more and detailed (not higher) information in Essential Principles of medical devices from A to D with their hazard. For example, GHTF guidance Rule 17 shows class C on condoms, because the hazard associated with unwanted pregnancy if caused by mechanical failure of the device is significant. So the manufacturer of condom needs to comply with all kinds of technical standards for safety, performance and quality of their condom in R&D process. Regulator will audit and evaluate the manufacturer’s QMS and application for approval or certification. Also post-market regulations are established with ‘risk-based’ concept. However condom shall be distributed /spread easily in the standing point to safeguard the public health. This purpose doesn’t require Class C distribution practice.

In the conclusion, Pre or Post-market may require different class for some medical devices.

153 154 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health In medical devices are following theimportofmedicaltreatment ineachjurisdiction’s history. traditionally, had by has devices & Human Nomenclature/Coding System continued Control The 6. 5. 4. 3. 2. 1. Device Nomenclature) includingsixexisting nomenclatures; the may The these different concepts ofnomenclature systems. very devices, system, our ‘Ophthalmic need Event Codes. We needto understand theimportance ofCoding System intheGlobalCommunication. 52:00 Medicaldevices --QualitymanagementMedicaldevice nomenclature data structure ISO 15225:2010 Medical devices --Application ofriskmanagement to medicaldevices ISO 14971:2007 Medical devices --Quality managementsystems --Requirements for regulatory purposes ISO 13485:2003 Qualitymanagementsystems --Fundamentalsandvocabulary ISO 9000:2005 Box 5.ISOStandards (http://www.iso.org/iso/home/standards.htm) Nomenklatur, order the UMDNS Universal MedicalDevice Nomenclature System Developed by ECRI NKKN NorskKlassifisering Koding &Nomenklatur, Norwegian Nomenclature JFMDA JapaneseMedicalDevice Nomenclature ISO 9999Technical Aidsfor DisabledPersons Classification EDMA European Diagnostic Manufacturers Association invitro diagnostic product classification and DrugAdministration (FDA) USA CNMD Classification Namesfor MedicalDevices andinVitro Diagnostic Products. 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Technical notes regulation and management of medical devices Box 6. GHTF Documents All GHTF guidance is available in International Medical Device Regulators Forum (IMDRF) website (http://www.imdrf.org/documents/documents.asp) GHTF/SC/N4 Definition and Glossary of Terms Used in GHTF Documents GHTF/AHWG-GRM/N1 The GHTF Regulatory Model GHTF/AHWG-UDI/N2 Unique Device Identification (UDI) System for Medical Devices GHTF/SG1/N71 Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ GHTF/SG1/N55 Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer GHTF/SG1/N78 Principles of Conformity Assessment for Medical Devices GHTF/SG1/N77 Principles of Medical Devices Classification GHTF/SG1/N68 Essential Principles of Safety and Performance of Medical Devices GHTF/SG1/N63 Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices GHTF/SG1/N44 Role of Standards in the Assessment of Medical Devices GHTF/SG1/N70 Label and Instructions for Use for Medical Devices GHTF/SG1/N65 Registration of Manufacturers and other Parties and Listing of Medical Devices GHTF/SG2/N54 Global Guidance for Adverse Event Reporting for Medical Devices GHTF/SG2/N33 Timing of Adverse Event Reports GHTF/SG2/N32 Universal Data Set for Manufacturer Adverse Event Reports GHTF/SG2/N36 Manufacturer’s Trend Reporting of Adverse Events GHTF/SG2/N57 Content of Field Safety Notices GHTF/SG2/N31 Proposal for Reporting of Use Errors with Medical Devices by their Manufacturer or Authorized Representative GHTF/SG2/N68 Summary of Current Requirements for Where to Send Adverse Event Reports GHTF/SG2/N09 Global Medical Devices Competent Authority Report GHTF/SG2/N79 National Competent Authority Report Exchange Criteria and Report Form GHTF/SG3/N15 Implementation of risk management principles and activities within a Quality Management System GHTF/SG3/N17 Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers GHTF/SG3/N18 Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N19 Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange GHTF/SG3/N99 Quality Management Systems - Process Validation Guidance GHTF/SG4/N28 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 1: General Requirements GHTF/SG4/N30 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy GHTF/SG4/N33 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 3: Regulatory Audit Reports GHTF/SG4/N83 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 4: Multiple Site Auditing GHTF/SG4/N84 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 5: Audits of Manufacturer Control of Suppliers GHTF/SG5/N1 Clinical Evidence - Key Definitions and Concepts GHTF/SG5/N2 Clinical Evaluation GHTF/SG5/N3 Clinical Investigations GHTF/SG5/N4 Post-Market Clinical Follow-Up Studies GHTF/SG5/N5 Reportable Events During Pre-Market Clinical Investigations GHTF/SG5/N6 Clinical Evidence for IVD medical devices - Key Definitions and Concepts GHTF/SG5/N7 Scientific Validity Determination and Performance Evaluation Clinical Evidence for IVD medical devices - Scientific Validity Determination and Performance Evaluation GHTF/SG5/N8 Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices

155 156 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Definitions Such information may appearonthedevice itself, onpackaging orasinstructions for use. safety Promotion, ClinicalResearch, Innovation andEducation Center, Tohoku University Hospital(CRIETO). The following chartdisplays thesymbols withtheirdefinitions(Table 43). • • Selected ISO15223 andEN980MedicalDevice Symbols ISO &ENStandards: Symbols usedinMedicaldevice label Labelling: Information suppliedby themanufacturer: means‘Labelling’. The Labelsandinstructions for useofmedicaldevices 8.2 This Acknowledgments: Lay person:individualthat doesnothave formal training inarelevant fieldordiscipline. User: theperson,eitherprofessional orlay, who usesamedicaldevice. The patient may betheuser. service asreflected inthespecifications, instructions andinformation provided by themanufacturer. use: for Instructions packaging ofeachunit,oronthepackaging ofmultipledevices. Intended use / purpose: device’s intended purposeandproper useandofany precautions to betaken. Label: description, intended purposeandproper useofthemedicaldevice, butexcluding shippingdocuments. EN 980,Graphical symbols for useinthelabellingofmedicaldevices be supplied ISO 15223, Medical Devices -Symbols to beusedwithmedicaldevices label,labellingandinformation to primary note and written, was 2) (1, the performance purpose label, contributed printed, instructions information of related or labelling The by graphic objective Mr information for Tom(omichi) is provided use, to information intent identify and by to any of the the NAKAZAKI, the the either other user, manufacturer medical manufacturer information appearing professional Visiting device to regarding on that and Professor, inform or the 4) (3, lay, its is related medical manufacturer, or the the other Department use device to device of identification, person, a user product, and itself, of as of communicate Development appropriate. the process or technical medical on the or Table 43. Medical devices - symbols with their definitions 8. Technical notes regulation and management of medical devices

Symbol Used for Symbol Used for

Use by Do not reuse YYYY-MM-DD or YYYY-MM

Batch code Serial number

Date of manufacture Sterile

Sterilized using ethylene oxide Sterilized using irradiation

Sterilized using steam or dry heat Catalog number

Caution, consult accompanying Sterilized using aseptic processing documents technique

Authorized representative in the Manufacturer European Community

Contains sufficient for < n > tests For IVD Performance Evaluation only

In vitro diagnostic medical device Upper limit of temperature

Lower limit of temperature Temperature limitation

Consult instructions for use Biological risks

Control Negative control

Positive control Graphic symbols

157 158 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health e.g.: 19G=0.042 Inches–1.067 mm e.g.: 21G=0.032 Inches-0.819 mm e.g.: 25G=0.020 Inches-0.514 mm not take into account thickness ofthewall, soitwillnotindicate theinternal diameter. Another and suture wires. Itisabbreviated Ggorg. asG,Ga, Note: 1 mm=0.0394 Inchor0.0394’’ 1 Inch=25.4mm use: of Field Definition: Synonym: use: of Field Definition: SYSTEM Synonym: GAUGE WIRE Ggorg =G,Ga, Gauge IRON STUBS THE The different units(symbols) usedto express outsidediameter (O.D.) inmedicaldevices are listed below: Units The Systems usedto specifytheoutsidediameter for medicaldevices Unitsandbiomaterials usedfor medicaldevices 8.3 its inventor) inFrench speakingcountries. The 30G, corresponding respectively: 4mmto 0.3 mm to In a standard in1884. or of Inch =Inor’’ millimetres) medical, catheters, diameter millimetres Stubs Iron Wire Gauge higher The system; Birminghamwire gauge inFrench «pouce »

Unitusedto express theoutsidediameter (O.D.: Outer Ø)ofguidesfor catheters gauge/mm Unit is this Guidesfor catheters IVshortcatheters, needles,scalpveins of tubes the (Reference metal wire gauge which the gauge, & French scale wire, drains. correspondence indicates the strip, made system system It smaller is and the abbreviated to or is (also outside conversion French gauge tube is used the may known products. outside to vary, diameter as specify table FG, Fr or F. or Fr FG, as due system diameter. the The the to between (O.D.: Birmingham wire gauge) Stubs figures outside is commonly Outer It The system is fractional being also gauge diameter Ø) abbreviated was of rounded used gives the and/or the of to product, hypodermic the first measure off is decimal outside as in wire used CH or Ch or CH conversion in gauge the a to diameter, inches needles, range, specify outside (for recognized from from and Charrière, catheters thickness diameter but metric inches 8G does as to Table 47. Sterile single-use hypodermic needles: equivalence Gauge / mm and colour coding 8. Technical notes regulation and management of medical devices for identification (EN-ISO 6009)(3, 5, 6)

Size in Gauge Nominal O.D. in mm Colour code

29 G 0.3 mm - 27 G 0.4 mm Grey 26 G 0.45 mm Brown 25 G 0.5 mm Orange 23 G 0.6 mm Blue 22 G 0.7 mm Black 21 G 0.8 mm Dark green 20 G 0.9 mm Yellow 19 G 1.0 mm Cream 18 G 1.2 mm Pink 17 G 1.5 mm Red-violet 16 G 1.6 mm White 15 G 1.8 mm Grey-blue 14 G 2.1 mm Light green 13 G 2.4 mm -

Table 48. Sterile, single-use intravascular catheters: equivalence Gauge / mm and colour coding for identification (EN ISO 10555)(3, 4, 5)

Size in Gauge Nominal O.D. in mm Colour code

26 G 0.6 mm Violet 24 G 0.7 mm Yellow 22 G 0.8;0.9 mm Blue 20 G 1.0;1.1 mm Pink 18 G 1.2;1.3 mm Green 17 G 1.4;1.5 mm White 16 G 1.6;1.7;1.8 mm Grey 14 G 1.9;2.0;2.1;2.2 mm Orange

159 160 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health e.g.: 14FG =CH144.7 mm(0.184 Inch) e.g.: 8FG =CH082.7 mm(0.105 Inch) 1FG =CH01 =⅓ mm but doesnottake into account thickness ofthewall, soitwillnotindicate theinternal diameter. e.g.: CH14=14FG =4.7 mm(0.184 Inch) e.g.: CH08=8FG =2.7 mm(0.105 Inch) CH01 =1FG =⅓mm to The to Charrière =CHorCh Note: Somemanufacturers offer catheters inInches use: of Field Definition: Synonym: use: of Field Definition: SYSTEM GAUGE Synonym: FRENCH OR French gauge=FG,FrorF SCALE FRENCH THE ⅓mm ⅓mm smaller French gauge, French size French size, Charrière

Unit Unit is Tubes anddrains Exploratory catheters, tubesanddrains the which which French indicates indicates size, the the the larger outside outside is the diameter diameter outside (O.D.: (O.D.: diameter. Outer Outer The Ø) Ø) French of of the the product, product, size gives each each the outside unit unit corresponds corresponds diameter, GENERAL NOTE: 8. Technical notes regulation and management of medical devices

An increasing French size corresponds to a larger outside diameter catheter. This is contrary to needle-gauge size, where an increasing gauge corresponds to a smaller diameter catheter.

Figure 7. Equivalence Charrière / mm Catheters and drains Endotracheal tubes

NB: OD = Outer Ø, ID = Inner Ø

Biomaterials

Biomaterials are materials (synthetic and natural; solid and sometimes liquid) that are used in medical devices or in contact with biological systems.

Polymers

A polymer is a large molecule (macromolecule) composed of repeating structural units (building block of a polymer chain). These sub-units are typically connected by covalentchemical bonds*. Although the term polymer is sometimes taken to refer to plastics, it actually encompasses a large class of compounds comprising both natural and synthetic materials with a wide variety of properties.

*A chemical bond is an attraction between atoms that allows the formation of chemical substances that contain two or more atoms. *A covalent bond is a form of chemical bonding that is characterized by the sharing of pairs of electrons between atoms.

Major Polymer Classifications/Categories: • Thermoplastic • Thermoset • Elastomer (or rubber) • Thermoplastic elastomer (TEP)

161 162 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health Medical Society the finishproduct asalotofthemare intended for implantinginthehumanbodyfor afairly extended period. standardized namingconventions; theACS andIUPAC conventions are similarbutnotidentical. Table 49. Common MedicalDevices Polymers –Glossary A Medical Devices Polymers precedent nomenclature: Polymer used SI NR Latex TPU PVC PUR PTFE PSU PP POM PMMA PLA PGA PET LDPE HDPE PE PES PC PA 6/6 orNylon6/6 FEP EVA ABS Acronym large polymers range devices (ACS) or of popular (7) are polymer polymers

and referred usage the types There are International to subject rather are by are used a Silicone elastomer Natural rubber(elastomer) (anelastic polymer) Natural latex rubber;particularly for non-vulcanized rubber Thermoplastic Polyurethane Polyvinyl chloride Cross-linked Polyurethane Polytetrafluoroethylene Polysulfone Polypropylene Polyoxymethylene, Polyacetal Poly(methyl methacrylate) Polylactic acid Polyglycolide orPolyglycolic acid Poly(ethylene tetraphthalate) Low densitypolyethylene High densitypolyethylene Polyethylene Polyether sulfone Polycarbonate Polyamide 6/6 orNylon6/6 Fluorinated ethyl polypropylene Ethylene vinyl acetate Acrylonitrile butadienestyrene Polymer type common multiple than to in strict Union the a standardized field conventions or selection of trivial of Pure Medical name. criteria and for naming devices. The Applied naming and trivial convention. strong Most polymer Chemistry name regulations of them is Both substances. assigned (IUPAC) are the from thermoplastic American (8) based the Many

have raw on material commonly polymers. proposed Chemical historical to

8.4 Textiles used for linen and clothing in health-care facilities 8. Technical notes regulation and management of medical devices Protection from infection and safety for patients and healthcare workers are major concerns.

Occupational Safety and Health Administration (OSHA)(10) is a division of the Department of Labor and was established in 1971 to save lives, prevent injury, and protect workers’ health. OSHA recommends that appropriate *protectiveclothing must be worn to form an effective *barrier when an employee has a potential for exposure on the job (OSHA, 1989). The type of clothing and linen needed depends upon the occupational task and the degree of potential exposure. If the clothes are potentially soiled from blood or other potentially infectious materials, protective clothing must be worn to prevent the employees underlying clothing from contamination. Fluid-resistant clothing must be worn when workers could become contaminated through splashing or spraying of blood or other potentially infectious materials. Because a larger volume of blood and other potentially infectious materials are associated with the work of the healthcare workers, a specific protective type of barrier clothing is needed. * Personal Protective Equipment: “specialized clothing or equipment worn by an employee for protection against infectious materials”(OSHA)(11) * Barrier material: a material that minimizes or retards the penetration of microorganisms, particulates and fluids. (12, 13)

Linen and clothing for medical applications are subject to regulations, governed by a large range of norms/ standards (EN/ISO) (14, 15) according to level of expected protection.

Linen and Clothing used in healthcare facilities: patient bed sheet, patient gowns, lab coats, surgical suits, surgical gowns, surgical drapes, isolation gowns, coveralls, caps, face masks, shoes covers, boots covers.

Linen and clothing used for patients and healthcare workers can be manufactured from either single-use fabrics or multiple use fabrics

The characteristics of single-use fabrics or multiple use fabrics are dependent on fiber type, and expected level of barrier performance bacteria and liquid barrier performances of the products

Reusable fabrics can be used over 50 times after laundering and sterilization; whereas, single-use fabrics are used only once before being discarded.

There are several factors to consider in determining the most appropriate textile to use in healthcare facilities. These will vary according to procedure and local priorities and are likely to include: • The type of procedure and the assessed level of risk involved • A priority of properties desired, for example: wet and dry bacterial barrier properties, fluid resistance, liquid absorption, strength etc. • Disposable or reusable • Processing requirements, for example: ability to be sterilized, rinse finishes in laundry • Cost • Expected life

Single-use nonwoven textiles

Nonwovens are principally produced in three stages: web formation, bonding and finishing treatments. Nonwoven manufacturing starts by the arrangement of fibers in a sheet or web. The fibers can be staple fibers or filaments extruded from molten polymer granules. Basic methods are used to form a web, and nonwovens are usually referred to by one of these methods: drylaid; spunlaid; wetlaid.

Nonwoven can be made of natural materials such as cotton, linen, wood pulp, and paper, or man-made materials such as polyester, polypropylene, polyimide, and polytetrafluoroethylene (PTFE).

Spunbond nonwoven: fabric made of different fibers: polypropylene (PP), polyethylene (PE) etc. • Nonwoven textiles for basic protection • Lightweight, breathable fabric, which consists of continuous filament, with good tensile strength and elongation. • Standard fabric, low-cost solution for protecting workers 163 164 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health finish. Note: (e.g., blood,bodyfluids). nature protection 100% polyester. Note: made of100%cotton andare more absorbentthanfabrics madeonlyof100%polyester. Cotton cellulose polymers. As repellent finish. durability Spunbonded Meltblown Spunbonded (SMS) nonwoven: A Polyester andcotton blend Polyester Polyester Cotton Cotton Woven Reusable woven textiles • • • • • • Meltblown nonwoven:fabric madeofvery highdensityweb ofpolypropylene fibers with aplainweave Spunbond comprising for that fiber. Different typesexist: SMMS–SMMMSaccording to expected level ofprotection. Reusable together to form aweb in arepeated interlocking pattern. to of to environment polyester, ifthegarmentbecomes contaminated, stains willbecome difficultto remove through laundering. fabric polyester the wick Strong anddurable, yet offer outstanding comfort, breathability, softness, andwearability Lightweight andresistant to tears andpunctures Fluid andparticulate barrier. Nonwoven textiles for highprotection Meltblowns often are usedashigh-degree filter mediafor air, liquidandparticles. Nonwoven textiles for highprotection general linen it Polyester/cotton Cotton is structure of is material: is the non-polar with and a cotton linen is a from layer of durable overview, natural a layers perspiration are that fabrics synthetic clothing. healthcare a and polyester polyester very and is fabric allows becomes with and, fiber. of clothing and can wicking durable reusable spunbond constructed fabrics One for fiber, therefore, good staple The workers be or fibers and seepage moisture are of treated uncomfortable problem which properties due tensile can cotton length the woven often .Fabrics polypropylene, against to does be reasons from is and by the strength away made usually treated associated blend fiber. surgical chemicals not penetration strength of yarns containing bacterial cotton. attract from The is of if fiber a by the their and cotton, made transparent gowns polymer chemicals with the of meltblown (65%-35%) for wearer elongation, water. penetration In combined the when a of body, antimicrobial addition, cotton polyester, polyester and natural fibers. fabric structure The perspires. cotton white drapes for due use polypropylene, content hydrophobicity properties antimicrobial meltblown Polyester or because made and to or and for or synthetic linen are lack of cotton finishing transmission. off-white linen The cotton of cotton is made and of high of the is polyester and of layer and hydrogen a the clothing fibers and finishing most comfort hydrophobic blend density fiber of and of color. clothing polyester hydrophobic consists polyester a by or In cotton/polyester common spunbond is are fibers Linen adding are addition, filaments of composed bonding and from is stronger polypropylene splashed of its blend by would and fiber, can cotton continuous ineffectiveness a fabric characteristic adding water-repellent the polypropylene. that clothing in create woven which of than not comparison with hydrophilic fibers are type over blend a be a fabrics fabrics liquids means water- woven fibers, fabric micro made used 90% able and or of in New generation of woven fabrics 8. Technical notes regulation and management of medical devices

Microfilament fabrics

The yarn in microfilament fabrics is made of fine, continuous polyester filaments. Conductive carbon fibers are generally also woven into the material to guarantee permanent antistatic qualities. These fabrics are highly resistant to tearing and rubbing and release practically no particles when used. Because of the fluorocarbon component, the materials are fluid-repellent, which means that high-quality materials can be reprocessed up to 80 times.

Laminates

A trilaminate (three-layer construction) is a membrane sandwiched between an upper and lower layer. Selecting suitable surface materials produces liquid-absorbing or repellent effects as desired. The membranes can be designed to prevent bacteria or viruses from penetrating together with liquids. The membrane is not a barrier for water vapor molecules. Human perspiration can therefore escape in the form of moisture vapor, thus maintaining natural thermoregulation.

Furthermore, trilaminates are impervious to liquids even under high pressure and absorb high volumes of fluid on the surface and are therefore used in surgical areas (high performance)(16).

General note:

The discussion continues about single-use, disposable materials versus reusable fabrics for linen and clothing in healthcare facility.

Protection from infection and safety for patients and healthcare professionals are major concerns. Cost, regulations and the environment are also concerns for healthcare facility administrators.

Multiple factors must be weighed when making a decision to purchase linen and clothing for healthcare professionals and patients including: • Required level of barrier protection from fluids, particulates and micro-organisms to reduce risk of infections. • Material breathability and garment construction for physical comfort and ability to remain focused during medical/surgical procedures. • Appropriate and safe disposal and proper waste management for minimal impact on the environment. Over the last two decades, many studies have been conducted comparing the advantages and disadvantages of woven and non-woven materials used for linen and clothing in healthcare facility.

The need for improving the level of protection has increased with the rise in infectious diseases. This need is greater in countries where economic factors come in to play and seriously inhibit good healthcare and infection control practices.

Useful links

• Association for the Advancement of Medical Instrumentation (AAMI). Arlington: Association for the Advancement of Medical Instrumentation (http://www.aami.org/, accessed 22 May 2014) • American Society for Testing Materials (ASTM). West Conshohocken: American Society for Testing Materials (http:// www.astm.org/, accessed 22 May 2014) • International Organization for Standardization (ISO). Geneva: International Organization for Standardization (http:// www.iso.org/iso/home/standards.htm, accessed 22 May 2014) • Committee for European Normalisation (CEN). Brussels: Committee for European Normalisation (http://www.cen.eu/ cen/Sectors/Sectors/Healthcare/Pages/default.aspx, accessed 22 May 2014) • American College of Surgeons (ACS) Committee on the Operating Room Environment (CORE). Chicago: American College of Surgeons (http://www.facs.org/, accessed 22 May 2014) • Association of peri Operative Registered Nurses (AORN) . Denver: Association of peri Operative Registered Nurses (http://www.aorn.org/, accessed 22 May 2014)

165 166 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health supply chain management, workshop management andstaff development. equipment to ensure itcontributes most effectively to patient care: MEM • • • • • • • • • • • • • This includesbothengineeringandmanagerialskillsto: Medical What ismedicalequipmentmanagement? Medical What ismedicalequipment? HealthTechnology Management 8.5 Medical equipmentexcludes implantable, disposableorsingle-use medicaldevices and used specific Decommission theequipmentanddisposeofitproperly Manage themaintenance program, includingpreventive andcorrective maintenance Manage theequipmentinventory program andinformation abouttheequipment Support thesafe andeffective operation oftheequipment Train themaintenance team to service itproperly Train theequipmentusersto operate itsafely andeffectively Oversee theincoming inspection,installation andcommissioning oftheequipment Procure theequipmentandmanagedelivery logistics Negotiate theterms oftheservice contract, and for training for maintenance staff Select appropriate maintenance materials such asspare parts Select appropriate modelswiththerightaccessories andconsumables Allocate appropriate fundsto them Assess theequipmentneedsandplanfor themeffectively decommissioning either activities purposes equipment equipment alone require of or is management diagnosis in a — combination subset skills and repair Maintenance activities Figure 8:TheMedicalEquipmentManagementLife Cycle making. information tosupportinformeddecision- ensuring theinventoryprovidesuseful inventory inHTMandtheimportance illustrate theroleofanaccurate,detailed Furthermore, thedocumentisintendedto the dataincludedintheseinventories. about thedifferenttypesofinventoryand The readerwillbenefitfromlearning to understandthetopicingreaterdetail. within thehealth-carefi technology inventoryforpeopleworking provide anoverviewofhealth-care The purposeofthisdocumentisto 2 Purpose Source: LenelAetal.(2005)(1) Figure 1.Health-caretechnologymanagementcycle and safety Operation and and and disposal Decommissioning of medical expertise (MEM) usually treatment with development Training andskill encompasses any devices managed eld and who wish in of accessory, medical disease that assessment Planning and • Monitor and • Monitor • Create by evaluate awareness require clinical equipment, or all consumable, importance itplaysinallfacetsofHTM. discussed inordertoemphasizethe inventory ineachstepofthecycleis (Figure 1).Theroleofanequipment different activitieswithintheHTMcycle inventory servesasaninputtothemany the endofHTMprocess.Rather, maintaining anaccurateinventoryisnot It isimportanttounderstandthat rehabilitation activities commissioning Installation and calibration, engineers. financial fi Budgeting and nancing performed or following other Medical maintenance, and logistics Procurement selection assessment and Technology management, (18) H eia eietcnclsre 9 WHO Medicaldevicetechnicalseries piece across equipment disease (17) of . the medical repair, or life purchasing injury; is user cycle used equipment. it training, for can of and the the be Why is medical equipment management important? 8. Technical notes regulation and management of medical devices

Medical equipment management is essential to prolong the useful lifespan of the equipment and make good use of scarce resources. Without an effective MEM system in place, costly equipment expenditures have a very low return on investment.

The Swiss Centre for International Health found that equipment lost 30% of its value before even being place in service when it was procured improperly, or more sophisticated than necessary. Once put in to service, improper use and inadequate maintenance (both preventive and corrective) devalued it even further – until it was worth only 10% of the initial financial investment (19).

Who is involved in medical equipment management?

MEM activities are typically led by a medical engineer (sometimes called a clinical or biomedical engineer1), with support from a team of medical engineering professionals of varying skill levels. These professionals may be craftspeople, technicians or technologists who are responsible for medical equipment maintenance and support the MEM activities.

Depending on the size of the health facility and the structure of the health system, this team may work within a larger department such as the ‘facilities’, ‘maintenance’ or ‘hospital engineering’ department, or they may exist as their own department called ‘medical’, ‘clinical’ or ‘biomedical’ engineering.

Regardless of the structure, the team will need to interact with a variety of stakeholders, both within their health facility and external to it, to perform the MEM activities:

Figure 9. Clinical Engineer Interactions with Stakeholders for MEM Activities (20)

Vendors Nurses Doctors

Allied Hospital Health Administration Professionals

Cost Third Party and CLINICAL Patient Payors Economics ENGINEER Efficacy, Safety Power, Cabling Maintenance,

Leasing Safety Hospital Agencies Environment

Regulation Clinical Agencies Research

Input from the medical engineering team is essential during the whole MEM process.

1 Biomedical engineers belong to Unit Group 2149 “Engineering Professionals Not Elsewhere Classified” under the International Standard Classification of Occupations produced by the International Labour Organization. From this classification: “It should be noted that, while they are appropriately classified in this unit group with other engineering professionals, biomedical engineers are considered to be an integral part of the health workforce alongside those occupations classified in Sub-major Group 22: Health Professionals, and others classified in a number of other unit groups in Major Group 2: Professionals.” The full classification can be found at http://www.ilo.org/wcmsp5/groups/public/--- dgreports/---dcomm/---publ/documents/publication/wcms_172572.pdf (accessed 17 October 2013) 167 168 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health discussion of wa.exe?A0=HTA) onHealthTechnology Assessment. wa.exe?A0=MED-DEVICES) org/scripts/wa.exe?A0=EHEALTH) various wa.exe?A0=INFRATECH) healthcare technology management(whichincludesMEM)system for: To Managing The • • • • • • • • • • • • • • • The What resources are available for healthtechnology management? considerations for solicitation andprovision include: that and resources for: Clinical Medical SurplusRecovery –goodpractice resources (CHAUSA) MAKING ITWORK: AToolkit for MedicalEquipmentDonations to Low-Resource Settings(THET) Resource centre (HUMATEM) How to ManagetheFinances ofyour Healthcare Technology ManagementTeam How to Organize theMaintenance ofyour Healthcare Technology How to Operate your Healthcare Technology Effectively and Safely How to Procure andCommission your Healthcare Technology How to PlanandBudgetfor Healthcare Technology How to Organize aSystem ofHealthcare Technology Management Computerized Maintenance ManagementSystem Maintenance Inventory Management Donation Procurement Process Resource Guide Needs Assessment join WHO’s ‘How improve may issues a rely global To medical groups Engineering Medical Manage’ MEM significantly of common discussion topics systems equipment Device Series (ACCE) related is concern on Technical to the on for on them. ensure donations MEM, Healthcare Internet providing regulatory to on on medical Further Series clinical the please e-health, Discussion best can a Technology provides resources issues devices, engineering forum visit use be the the particularly is and for MED-DEVICES group guidance made please that INFRATECH Series global the and complement created of visit HTA health provides medical on challenging networking the MEM website website website by technology EHEALTH equipment WHO, guidance activities the and for (http://listserv.paho.org/scripts/ (http://listserv.paho.org/scripts/ (http://listserv.paho.org/scripts/ WHO PAHO low-resource website exchange management. that on investment. Medical setting and can (http://listserv.paho. American be of device up used health information To These and join to donations: running Colleage facilities develop include further on a 8.6 References 8. Technical notes regulation and management of medical devices 1. The International Medical Device Regulators Forum (IMDRF) (http://www.imdrf.org/, accessed 22 May 2014) 2. Label and Instructions for Use for Medical Devices. GHTF/SG1/N70:2011. Tokyo: Global Harmonization Task Force; 2011 (http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n70-2011-label-instruction-use-medical- devices-110916.pdf, accessed 22 May 2014) 3. International Organization for Standardization (ISO). Geneva: International Organization for Standardization (http:// www.iso.org/iso/home/standards.htm, accessed 22 May 2014) 4. Medical devices. Directive 93/42/EEC. Brussels : European Commission - European standards (EN) ; 1993 (http:// ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm, accessed 22 May 2014) 5. Medical devices. Directive 93/42/EEC. Brussels : European Commission - European standards (EN) ; 1993 (http:// ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm, accessed 22 May 2014) 6. Committee for European Normalisation (CEN). Brussels: Committee for European Normalisation (http://www.cen.eu/ cen/Sectors/Sectors/Healthcare/Pages/default.aspx, accessed 22 May 2014) 7. American Chemical Society (ACS). Wachington, DC: American Chemical Society (http://www.acs.org/content/acs/ en.html, accessed 22 May 2014) 8. International Union of Pure and Applied Chemistry (IUPAC). Reseach Triangle Park: International Union of Pure and Applied CHemistry (http://www.iupac.org, accessed 22 May 2014) 10. Occupational Safety and Health Administration (OSHA). Washington, DC: United States Department of Labor (http:// www.osha.gov/, accessed 22 May 2014) 11. Personal Protective Equipment. Washington, DC: OSHA United States Department of Labor; 2003 (http://www.osha. gov/Publications/osha3151.pdf, accessed 22 May 2014) 12. Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. ANSI/AAMI PB70:2003. Arlington: Association for the Advancement of Medical Instrumentation; 2003 (http:// marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/pb700310preview.pdf, accessed 22 may 2014) 13. Selection and use of protective apparel and surgical drapes in Health Care Facilities AAMI TIR11. Arlington: Association for the Advancement of Medical Instrumentation; 2005 (http://marketplace.aami. org/eseries/scriptcontent/docs/Preview%20Files/TIR110511preview.pdf, accessed 22 May 2014) 14. Personal protective equipment. Directive 89/686/EEC. Brussels: European Commission - European standards (EN) ;1989 (http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/personal-protective- equipment/index_en.htm, accessed 22 May 2014) 15. Guidelines on the application of Council Directive 89/686/EEC of 21 DECEMBER 1989 on the approximation of the laws of the member states relating to Personal Protective Equipment. Version12 April 2010. Brussels: European Commission - European standards (EN) ; 2010 (http://ec.europa.eu/enterprise/sectors/mechanical/files/ppe/ppe- guidelines_en.pdf, accessed 22 May 2014) 16. EN 13795:2012 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels 17. WHO Medical Device Technical Series. Geneva: World Health Organization; 2011 (http://www.who.int/medical_devices/ management_use/en/, accessed 22 May 2014) 18. How To Manage Series for Healthcare Technology Guide 1: How to Organize a System of Healthcare Technology Management. East Sussex: Ziken International Ltd; 2005 (http://www.healthpartners-int.co.uk/our_expertise/ HCTGuide1.pdf, accessed 22 May 2014) 19. Technical discussions: The role of medical devices and equipment in contemporary health care systems and services. Cairo: Regional Office for Eastern Mediterranean, World Health Organization; 2007 (http://gis.emro.who. int/HealthSystemObservatory/PDF/TechnicalandDiscussionPapers/The%20role%20of%20medical%20devices%20 and%20equipment%20in.pdf, accessed 22 May 2014) 20. Dyro J. Clinical Engineering Handbook. Elsevier; 2004.

169 170 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health for Education the published programmes there Equipment as accessed 22May 2014). Organization; 2006(http://www.who.int/reproductivehealth/publications/family_planning/9241595132/en/index.html, Reproductive choices andfamily planningfor peoplelivingwith HIV: counselling tool. Geneva: World Health reproductivehealth/publications/family_planning/9780978856304/en/, accessed 22May 2014). Hopkins Bloomberg Health/Center School ofPublic for Communication Programs; 2011 (http://www.who.int/ Family planning:aglobalhandbookfor providers 2011. Geneva: World HealthOrganization andJohns Further reading Health Healthcounselling, education andpromotion 9.2 Optimal 9.1 Building services equipment If 9. services furniture shouldbestocked continually for theproper functioningofthemedicalarea intervention sources Some considered. and example, interventions; Some chain, however, shouldbedesignedaround national programmes. other training equipment. the • • • • • • • • • • Box 7. Topics for health counselling, education and promotion in family planning and reproductive health possible, medical example, role use Bereavement assessment Counselling for post-abortion Counselling for infertile couples Counselling for gender-basedviolence Counselling for breast examination Management ofmentalhealthdisorders Prevention ofsexually transmitted infections Nutritional management(undernutrition,obesity, micronutrient deficiencies) Sexual andreproductive education: prevention andfollow-up ofriskfactors Information oncontraceptive methods nutrition Other healthproducts must of general counselling, (1). of of of implementation the the on several a energy, hats, health-care for devices be patient’s services. supplies continuous must standard cleaning for counselling services a communication towels continuous example, guidelines water be education and in relatives Equipment accomplished precautions area, have facilities and previous vocational of and not to bednets medical kangaroo different laundry, medical for effort listed complement in and and should situations health lists guidelines promotion such training in devices to can emergency in clothing, gases could supply care the provide the be counselling as be previous hand with equipped the wraps, health-care be used for for requires should specifications are part security, the health them reproductive, varying hygiene patient to very and optimal of be to prevent tables proper in with workers the optimize reviewed neonatal important facilities levels the waste and transportation immunization sterilization may function according planning health-care malaria, the of maternal, and management, be (2). the complexity. provision resuscitation before issues professional used

of clinical Health of thermal to medical and the to supply implementation facility newborn the across in of the entire pathology products practice the Health level supplies care stationary may devices referral chain help (see the proper medical of of and require counselling continuum health-care for Boxes newborns of and for that (1). facilities, should level child health the practice supplies of implementing logistics. unit. are mannequins

these 2–6). patient’s should health not be Adequacy workers may of may a facility. of

and evaluated. pharmacy additional WHO care, classified The involve, also priority priority require family. office such cold and and and has For be of

Clinical management of rape survivors: developing protocols for use with refugees and internally displaced persons. 9. Other health products Revised edition. Geneva: World Health Organization; 2004 (http://whqlibdoc.who.int/publications/2004/924159263X. pdf, accessed 22 May 2014).

Counselling for maternal and newborn health care: a handbook for building skills. Geneva: World Health Organization; 2013 (http://apps.who.int/iris/bitstream/10665/44016/1/9789241547628_eng.pdf, accessed 22 May 2014).

Box 8. Topics for health counselling, education and promotion in pregnancy • Prevention of sexually transmitted infections • Nutritional management (undernutrition, obesity, micronutrient deficiencies) • Interventions for smoking cessation during pregnancy • Counselling on birth and emergency preparedness • Counselling on post-abortion • Bereavement assessment • Management of mental health disorders • Counselling of gender-based violence

Further reading Counselling for maternal and newborn health care: a handbook for building skills. Geneva: World Health Organization; 2013 (http://apps.who.int/iris/bitstream/10665/44016/1/9789241547628_eng.pdf, accessed 22 May 2014).

Safe abortion: technical and policy guidance for health systems. Second edition. Geneva: World Health Organization; 2012 (http://apps.who.int/iris/bitstream/10665/70914/1/9789241548434_eng.pdf, accessed 22 May 2014).

Box 9. Topics for health counselling, education and promotion in postnatal mothers • Support for breastfeeding • Advice in family planning • Management of postpartum depression • Prevention of sexually transmitted infections • Nutritional management (undernutrition, obesity, micronutrient deficiencies) • Counselling for gender-based violence • Bereavement assessment • Advice in family planning • Sexual and reproductive education • Management of mental health disorders

Further reading Counselling for maternal and newborn health care: a handbook for building skills. Geneva: World Health Organization; 2013 (http://apps.who.int/iris/bitstream/10665/44016/1/9789241547628_eng.pdf, accessed 22 May 2014).

171 172 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health (http://www.who.int/maternal_child_adolescent/documents/child_hospital_care/en/index.html, accessed 22May 2014). Pocket bookofhospitalcare for children: guidelinesfor themanagementofcommon illnesses, second edition2013 2013 (http://apps.who.int/iris/bitstream/10665/44016/1/9789241547628_eng.pdf, accessed 22May 2014). Counselling for maternal andnewborn health care: ahandbookfor buildingskills.Geneva: World HealthOrganization; Further reading whqlibdoc.who.int/hq/2009/WHO_FCH_CAH_09.02_eng.pdf, accessed 22May 2014). Home visitsfor thenewborn child:astrategy to improve survival. Geneva: World HealthOrganization; 2009(http:// May 2014). 2012 (http://www.who.int/maternal_child_adolescent/documents/caring_for_newborn/en/index.html, accessed 22 Caring for thenewborn at home:atraining course for community healthworkers. Geneva: World HealthOrganization; 2013 (http://apps.who.int/iris/bitstream/10665/44016/1/9789241547628_eng.pdf, accessed 22May 2014). Counselling for maternal andnewborn healthcare: ahandbookfor buildingskills.Geneva: World HealthOrganization; Further reading • • • • • • Box 10. Topics for health counselling, education and promotion for postnatal babies (newborns) • • • • • • • • • • Box 11.Topics for healthcounselling, education andpromotion ininfancy andchildhood Toys andplay therapy Human immunodeficiency virus(HIV)counselling Counselling onfamily planningandreproductive health Advise ofimmunization status ofmotherandchildren Identification ofemergency signs Teaching motherto treat localinfections at home Teaching motherto give oral drugsat home Assessment ofbreastfeeding andsupplementaryfeeding programme Detection ofabnormalstate ofnutrition(obesity, undernutrition) Monitoring ofearlychildhooddevelopment Birth registration Newborn stimulation andplay Promotion andprovision ofhygienic cord andskincare Detection ofabnormalstate ofnutrition(obesity, undernutrition) promotion andsupportfor earlyinitiation ofandexclusive breastfeeding Promotion delayed bathing) and provision of thermal care (immediate drying, warming, skin-to-skin – kangaroo mother care,

9.3 References 9. Other health products 1. Lenel A, Temple-Bird C, Kawohl W, Kaur M. How to organize a system of healthcare technology management. Geneva: World Health Organization; 2005 (http://www.who.int/management/organize_system_%20healthcare.pdf, accessed 22 May 2014). 2. Standard precautions in health care. Geneva: World Health Organization; 2007 (http://www.who.int/csr/resources/ publications/EPR_AM2_E7.pdf, accessed 22 May 2014).

173 174 Interagency list of medical devices for essential interventions 2014 for reproductive, maternal, newborn and child health

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health

ISBN 978 92 4 156502 8