Systematic Review of Needs for Medical Devices for Ageing Populations Medical Ageing for Needs for Devices of Review Systematic

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Systematic review of needs for medical devices for ageing populations medical ageing for needs for devices of review Systematic

Systematic review of needs for medical devices for ageing populations

Commissioned to the Australian Safety and Efﬁ cacy Register of New Interventional Procedures – Surgical (ASERNIP-S) by the World Health Organization (WHO)

Department of Essential Medicines and Health Products World Health Organization 20 Avenue Appia ISBN 978 92 4 150922 0 CH-1211 Geneva 27 Switzerland Tel: +41 22 791 21 11 E-mail: [email protected] http://www.who.int/medical_devices/en/ WHO Library Cataloguing-in-Publication Data Systematic review of needs for medical devices for ageing populations: commissioned to the Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S) by the World Health Organization (WHO). 1.Equipment and Supplies – supply and distribution. 2.Health Services for the Aged. 3.Self-Help Devices – supply and distribution. 4.Appropriate Technology. 5.Secondary Prevention. 6.Rehabilitation. 7.Aged. 8.Review. I.World Health Organization.

ISBN 978 92 4 150922 0 (NLM classification: WT 26)

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Printed in Switzerland Cover photo, bottom left: ©Jessie George/HelpAge International Layout: Inís Communication – www.iniscommunication.com Systematic review of needs for medical devices for ageing populations

Commissioned to the Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S) by the World Health Organization (WHO)

2015 ii 2015 Systematic review of needs for medical devices for ageing populations Wendy Babidge; ASERNIP-S Research Manager, Merrîcc Edgar-Hughes; ASERNIP-S SeniorResearcher, The ASERNIP-S review group included: ASERNIP-S SurgicalDirector, GuyMaddern;ASERNIP-S Director, Garçon,Alex Ross, WHO Centre for HealthinDevelopment, Kobe, Japan. ofChapal Khasnabis,support FrancisMoussy, Yukiko Nakatani, WHO, Geneva, Switzerland, andLoic This reportwasproduced underthe overall direction of Adriana Velazquez-Berumen, andthe technical devices for olderpeoplefor five mainhealthconditionsand19specifictopics. this project was to produce a report in the form of a systematic review for WHO on needs for medical Funding for this project was provided of Health, by the Japanese Ministry Labour and Welfare. The aim of ProceduresInterventional –Surgical(ASERNIP-S)group oftheRoyal Australasian CollegeofSurgeons. and wasprepared authorshipofthe undertheprimary Australian Safety andEfficacyRegisterofNew This reporthasbeendeveloped ofaproject aspart fundedby the World HealthOrganization(WHO) for theirguidanceinpreparing thisreport. Michael Goggin, HarshKanhere, GuyRees, Richard Ruffin, MichaelSchultz, DanSpernatandDavid Walsh In addition tothereview group, ASERNIP-S would like toacknowledge Peter Bardy, Boundy, Karyn Arlene Vogan. and Chadbourne Alun Cameron; and ASERNIP-S researchers Robyn Lambert, Meegan Vandepeer, Yasoba Atukorale, Jennifer Acknowledgements Table of contents

ACKNOWLEDGEMENTS II

ABBREVIATIONS 1

OVERVIEW 2

1. INTRODUCTION ...... 4

1.1 THE GLOBAL AND REGIONAL CHALLENGE OF AN AGEING POPULATION 4 1.2 AGE-RELATED DISEASE IN THE WESTERN PACIFIC REGION ...... 5 Table 1 Estimates of death by cause, Western Pacific Region, 2008 ...... 5 Table 2 Major contributions to projected disability-adjusted life-years (DALYs), Western Pacific Region, 2008 6 1.3 DEFINING OLD AGE ...... 7 1.4 AGEING AND DISEASE ...... 7

2. METHODS ...... 9

2.1 POPULATION 9 2.2 MEDICAL DEVICES 9 2.3 INTERVENTION ...... 10 2.4 COMPARATOR AND OUTCOME ...... 10 2.5 LITERATURE SEARCH 10 2.6 SEARCH STRATEGY 11 2.7 ADDITIONAL SEARCH CRITERIA AND FILTERS ...... 11 2.8 STUDY INCLUSION CRITERIA AND PRESENTATION OF RESULTS 12 2.9 CATEGORIES OF MEDICAL DEVICES 13 2.10 SUPPLEMENTARY RESOURCES 13

3. CARDIOVASCULAR DISEASES 15

3.1 INTRODUCTION ...... 15 3.2 ISCHAEMIC HEART DISEASE ...... 15 Introduction ...... 15 Table 3 Mortality due to cardiovascular disease, worldwide and Western Pacific Region, 2008 ...... 15 Methodology 16 Results ...... 16 Table 4 Ischaemic heart disease – key studies 17 Table 5 Ischaemic heart disease – devices identified for prevention, diagnosis and treatment 18 3.3 CEREBROVASCULAR DISEASE ...... 19 Introduction ...... 19 Methodology 19 Results ...... 19 Table 6 Cerebrovascular disease – key studies ...... 20 Table 7 Cerebrovascular disease – devices identified for diagnosis and treatment ...... 21 3.4 HYPERTENSIVE HEART DISEASE 22 Introduction ...... 22 Methodology 22 Results ...... 23 3.5 CONCLUSION 23 Table 8 Hypertensive heart diseases – key studies 24 Table 9 Hypertensive heart diseases – devices identified for prevention, diagnosis and treatment ...... 24

iii iv 2015 Systematic review of needs for medical devices for ageing populations 4.. MALIGNANTNEOPLASMS 4.5 STOMACH CANCER 4.1 INTRODUCTION 4.2 CANCER OF 4.2 CANCER THE MOUTH AND OROPHARYNX 4.7 LYMPHOMA 4.3 OESOPHAGEAL CANCER 4.4 CANCER OF 4.4 CANCER THE LUNG, TRACHEA AND BRONCHUS 4.6 LIVERCANCER 4.9 COLON AND RECTUMCANCER 4.8 BREASTCANCER 4.10 PROSTATE CANCER Results Results Results Results Introduction Results Results Results Results Methodology Introduction Methodology Introduction Methodology Introduction Methodology Methodology Introduction Methodology Introduction Methodology Introduction Methodology Introduction Table 14Oesophagealcancer–key studies Table andmouthcancer–devices 13Oropharyngeal identified for prevention, diagnosisandtreatment Table andmouthcancer–key 12Oropharyngeal studies Table 17Lung, tracheaandbronchus cancer–devices identified for diagnosisandtreatment Table 16Lung, tracheaandbronchus cancer–key studies Table 15Oesophagealcancer–devices identified for diagnosisandtreatment Table duetocancer, 11Mortality worldwide and Western PacificRegion Region Pacific Western and worldwide cancer, Table of 10Incidence Table 26Colorectal cancer–key studies Table 25Breast cancer–devices identified for diagnosisand treatment Table 24Breast cancer–key studies Table 23Lymphoma –devices identified for diagnosisandtreatment Table 22Lymphoma –key studies Table 21Liver cancer–devices identified for diagnosisandtreatment Table 20Liver cancer–key studies Table 19Stomachcancer–devices identified for prevention, diagnosisandtreatment Table 18Stomachcancer–key studies ......

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28 30 30 48 47 34 34 40 40 37 37 37 37 43 42 56 56 51 50 28 28 30 30 47 47 33 33 36 36 42 42 55 55 50 50 58 29 35 45 32 38 35 41 53 49 31 38 57 41 44 48 52 Introduction ...... 58 Table 27 Colorectal cancer – devices identified for prevention, diagnosis and treatment ...... 58 Methodology 59 Results ...... 59 Table 28 Prostate cancer – key studies 60 Table 29 Prostate cancer – devices identified for diagnosis and treatment 61 4.11 CONCLUSION ...... 62

5. RESPIRATORY DISEASES 69

5.1 INTRODUCTION ...... 69 5.2 CHRONIC OBSTRUCTIVE PULMONARY DISEASE 69 Introduction ...... 69 Methodology 69 Results ...... 70 Table 30 Chronic obstructive pulmonary disease – key studies 70 Table 31 Chronic obstructive pulmonary disease – devices identified for diagnosis and treatment 71 5.3 CONCLUSION 72

6. SENSE ORGAN DISEASES 74

6.1 INTRODUCTION ...... 74 6.2 OPHTHALMIC DISEASES 75 6.2.1 Glaucoma 75 Table 32 Glaucoma – key studies 76 Table 33 Glaucoma – devices identified for prevention, diagnosis and treatment 77 6.2.2 Cataracts ...... 78 Table 34 Cataracts – key studies 79 Table 35 Cataracts – devices identified for diagnosis and treatment ...... 80 6.2.3 Refractive errors ...... 81 Table 36 Refractive errors – key studies ...... 82 Table 37 Refractive errors – devices identified for diagnosis and treatment 83 6.2.4 Macular degeneration 84 Table 38 Macular degeneration – key studies 85 Table 39 Macular degeneration – devices identified for prevention, diagnosis and treatment 85 6.3 OTIC DISEASES ...... 86 6.3.1 Adult-onset hearing loss 86 Table 40 Hearing loss – key studies 88 Table 41 Hearing loss – devices identified for diagnosis and treatment ...... 88 6.4 CONCLUSION 90

7. NEUROPSYCHIATRIC CONDITIONS ...... 94

7.1 INTRODUCTION ...... 94 7.2 ALZHEIMER’S DISEASE AND VASCULAR DEMENTIA 94 Introduction ...... 94 Methodology 94 Results ...... 95 Table 42 Alzheimer’s disease – key studies 95 7.3 CONCLUSION 96 Table 43 Alzheimer’s disease – devices identified for diagnosis and treatment 96

8. DISCUSSION ...... 98

8.1 METHODS ...... 98 8.2 USE OF SUPPLEMENTARY RESOURCES 98 v vi 2015 Systematic review of needs for medical devices for ageing populations ANNEX 1: DESIGNATIONS OFLEVELSEVIDENCE ACCORDING TO TYPE OFRESEARCHQUESTION 8.7 CONCLUSIONS 8.6 FUTURERESEARCH AREAS 8.5 DEVICES ASSOCIATED WITH OLDERPEOPLE 8.4 PREVENTIVEDEVICES 8.3 OVERALL RESULTS DEVICES OFINCLUDEDMEDICAL .

104 102 102 101 100 99 Abbreviations

ASERNIP-S Australian Safety and Efficacy Registry of New Interventional Procedures – Surgical

COPD chronic obstructive pulmonary disease

CT computed tomography

DALY disability-adjusted life-year

MeSH medical subject heading

MRI magnetic resonance imaging

NHMRC Australian National Health and Medical Research Council

PET positron-emission tomography

PICO population, intervention, comparator and outcome

TNM tumour–node–metastasis

WHO World Health Organization

1 2 2015 Systematic review of needs for medical devices for ageing populations least oneof the following areas:search strategy, completion. Modificationshave beenmadeinat more areas the timefor inorder its toshorten systematic review andsowaslimited inoneor usedfor this report wasarapidThe methodology Global Harmonization Task Force. according to the definitions presented by the all identified medicaldevices were categorized beyond thescopeofthisreport. Where possible, efficacy andcost–effectiveness ofeachdevice was each device. Detailedinformation onthesafety, widely betweenquality ofthisinformation vary provided whenavailable, although thevolume and safety and effectiveness information hasalso been preventive, diagnosticortherapeutic. Broad clinical devices categorized intermsofwhetherthey are The results have beenusedtocreate listsof of medicaldevices neededby olderpeople. This report provides aliterature-based review • • • • • identified: conditions, with19 associatedsub-topics, were in the Western Pacific Region. Five mainhealth older people(definedasaged60–79 years) loss ofdisability-adjustedlife-years (DALYs) for the five healthconditionsthatcausethegreatest The clinicalfocus ofthisreporthasbeendefinedas devices. These factorsimpedeequitableaccesstomedical expensive ormay notbeavailable inallcountries. elderly people, althoughthesedevices may be medical devices are available thatmay benefit tothisdemographic.health care services Many to placeadditional burdens on theprovision of world, thepopulationisrapidly ageing. This islikely Western PacificRegion, ofthe asinmostparts Across the World HealthOrganization(WHO) Overview neuropsychiatric conditions. sense organdiseases; diseases; respiratory malignant neoplasms; cardiovascular diseases; in theresearch andpublicationfocus ofcertain independent searches reflects the differences to studytype. This variabilitybetween the19 and lymphoma; these topics were not limited example cancersofthemouthandoropharynx, Other topicswere lesshighly represented, for quality and relevance ofthe pool ofliterature. publications) were applied toincrease theoverall high-quality levels ofevidence andmore recent diseases. Inthese cases, criteria(limitingto for exampletopicsrelated tocardiovascular topics were highly represented intheliterature, 1535 have beenincludedinthisreport. Some retrievedOf the3278articles inthesearches, should beaware ofthelimitationsthisreview. the literature may be required. such,As readers understanding ofthistopic, abroader analysis of agreement with WHO. For amore comprehensive following therequirements ofthespecific review, in high-resource settings, andthere isanassumption are generally usedin locationsofmedium-or devices reportedinthe peer-reviewed literature established. This may reflect thefactthatmedical of thesestandard pieces ofequipmentbeingwell included studies; thisisprobably related tothe use monitors, were usually notreportedinthe tables, anaesthesiamachinesandphysiological as scalpelsandothersurgicalinstruments, surgical identified infrequently. Basicmedicaldevices, such diagnostics, especially invitro diagnostics, were and many conditions, butotherdevices, suchas were commonly identified across many studies resonance imaging scanners and endoscopes, bias. Somemedical devices, suchasmagnetic specialties, level andshows acertain ofpublication clinical questionsasked. These limitswere applied been adhered tomainly by restricting thespecific a fullsystematicreview. These limitationshave findings ofarapid review whencompared with amendments donotsignificantly alterthe overall and dataanalysis. Itisconsidered thatthese inclusion criteria, assessmentofstudyquality that these basic devices are readily available and health problems in ageing populations within the highly diffused across all jurisdictions. Western Pacific Region, and the way in which they are treated, will be highly varied because the Care was taken not to overinterpret search region includes a large number of countries over results, and information was provided as identified a wide area. The majority of studies were done from the source publications. Some devices were in high-resource settings, and no studies provided explained in detail in terms of their use and clinical information on devices and outcomes specifically utility, but other devices were described very related to low-resource countries. There is a lack briefly; some devices were described in a generic of studies reporting on the clinical outcomes of manner but others according to their trade basic or essential devices associated with service name. It is likely that for each example identified, delivery, perhaps because the utility of these has a number of alternatives are available in addition been established through historical experience. to the specific devices that were mentioned, and the results of this report are not intended to be Clinical issues of safety and effectiveness are likely a comprehensive list. In many cases, the specific to be cross-jurisdictional. Cost-effectiveness for use of a medical device, how and why it was used, each device would be procedure-based where and its clinical significance were not clear from relevant and would likely vary from country to the information provided in the published study. country, and will be the focus of future research. Many studies report a range of similar types of The basic elements of service delivery would devices, including tests used during the course of remain similar, although the availability and cost of the study. In many cases, there may be a range different parts of the service could vary widely and of options of devices for a specific indication. The be dependent on current skills and infrastructure clinical application of the information from these in each country. It is intended that this report will studies in a real-world context may not always be inform future research, with the aim of improving clear, and a specific comment on the comparative access to devices of elderly people across the safety and effectiveness of the alternative devices different countries of the Western Pacific Region. was not possible. To achieve effective clinical management of any Although the list of topics was based on the top five health condition, all aspects of the management causes of losses of DALYs for older people in the pathway must be considered. The true clinical Western Pacific Region, regionality has not been a effectiveness of an individual device or intervention constraint in the search methodology; therefore, can be established only within the framework of the outcomes of searches reported here may be preventive, diagnostic and therapeutic strategies. broadly applicable to any country. The specific

3 4 2015 Systematic review of needs for medical devices for ageing populations decisions, adetailed mapping oftheneedfor Pacific Region. To prepare a foundation for future research regarding thisinitiative inthe Western of Health, Labourand Welfare, WHO hasbegun from With financialsupport theJapanese Ministry remain healthy, active andindependent for longer. people agedover 60years) toenablethem a lower costfor ageingpopulations(definedas to appropriate medicalandassistive devices at initiative to facilitate the development and access Consequently, WHO hasestablishedanew delivery. devices play asacrucialcomponentofhealthcare WHO recognizesrole theimportant thatmedical medical products andtechnologies. Furthermore, to ensure theimproved access, qualityanduseof Organization (WHO)planfor 2008–2013(1)is A strategicobjective ofthe World Health 1. Introduction devices and thus improving access of elderly the aimof determining the need for medical willinformthat thisreport future research, with review ofneededmedicaldevices. Itisintended isaliterature-basedThis initialreport systematic clinically appropriate manner. created toensure thatthesedevices are usedina Western PacificRegionwillbestrengthened or and assistive devices for ageingpopulationsinthe costs. Finally, centres of excellence for medical suitable technologiestoproduce devices atlower to facilitatethedevelopment andtransfer of identified asessential, butnotcurrently available, develop preferred product profiles for devices be available. The initialwork willallow WHO to will bedefined, especially for devices thatmay not resource settings, needsofprioritycore devices these devices. For low-income countriesandlow- the availabilityto ascertain and affordability of level will beconductedatacountry-by-country of thispopulation. research Further andsurveys needs for diagnosisand treatment of the diseases be conducted. This willdeterminethetechnological medical devices for olderpeopleintheregion isto WHO region. It is estimated that approximately is expectedtobefasterthaninalmostany other of populationageinginthe Western PacificRegion compared withdevelopedrate countries(2). The experience acceleratedratesofpopulationageing countries across theworld are expectedto rates. and declining fertility at birth Developing as aconsequenceofincreased life expectancy 60 years orover. The globalpopulationisageing that approximately oneinninepeopleisaged older isgrowing worldwide. Current datasuggest The proportion ofthepopulationclassified as POPULATION OF ANAGEING CHALLENGE 1.1 THE GLOBAL AND REGIONAL has increased withthereduction in maternal preponderance of women in the aged population every 100women over theageof60years. The Pacific Regionthere are approximately 90men for overrepresentation ofwomen. Inthe Western The agedpopulationisalsocharacterizedby an diseasesandcerebrovascularheart diseases(5). from infectious diseasestomalignantneoplasms, common causesofdeathinJapan have shifted highest life expectancy. Consequently, themost of thepopulationinJapan, whichhastheworld’s ratesandthelongevitycombination oflow birth 13% ofthepopulation(4). This isattributed toa people undertheageof15years only accountfor 65 years accountfor 23%ofthepopulationwhile pronounced,particularly aspeopleover theageof In Japan, thechallengeofpopulation ageingis New Zealand(3). a process thattookover 50years in Australia and Guinea isexpectedtodoubleinlessthan30years, Lao People’s DemocraticRepublicand Papua New population agedover 60years inCambodia, the 65 years ofageby 2050. The proportion ofthe 23% ofthe Western Pacificpopulationwillbe over Pacific Region. people toneededdevices across the Western mortality and drop in overall fertility rates, which 84% of estimated all-cause mortality and 76% means that a greater number of women reach of all projected disability-adjusted life years older age (3). (DALYs) (6,7). People over the age of 60 years accounted for 82% of all mortality due to

1.2 AGE-RELATED DISEASE IN THE noncommunicable diseases. Introduction 1. WESTERN PACIFIC REGION The leading causes of mortality in the Western Global improvements in medical care, the ageing Pacific Region are represented in Table 1. of the population and increased provision of public Communicable, maternal, perinatal, and nutritional health interventions such as vaccinations have conditions accounted for 8% of all-cause mortality, caused changes in the types of disease that affect injuries accounted for 8% of all-cause mortality, populations. In the past, infectious diseases were and noncommunicable diseases accounted for 82% the primary causes of mortality; now, the primary of all-cause mortality. Only causes that account causes of global mortality are noncommunicable for more than 10% of all mortality are included diseases such as cardiovascular disease and in Table 1. Table 2 includes the major causes (10% neoplastic disease. In 2012, it was estimated or more) of projected DALYs for 2008 in the that approximately half of the global burden of Western Pacific Region. The largest proportion disease was attributable to noncommunicable of mortality due to noncommunicable diseases diseases. In the Western Pacific Region in 2012, occurred in people over the age of 60 years. noncommunicable diseases accounted for

Table 1 Estimates of death by cause,a Western Pacific Region, 2012 (published in 2014) (7)

Cause of mortality All ages Age > 60 years: total Age > 60 years vs estimated deaths all ages: estimated Total estimated All causes of deaths (%) deaths mortality (%) All causes 12 960 505 NA 9 933 496 77 Noncommunicable diseases 10 896 059 84 8 981 580 82 Cardiovascular disease 5 371 830 41 4 688 555 87 Malignant neoplasms 2 900 829 22 2 131 683 73 Cerebrovascular disease 2 703 356 21 2 375 306 88 Ischaemic heart disease 1 831 039 14 1 597 367 87 Respiratory diseases 1 302 109 10 1 220 781 94 a Major causes of death; figures numbers should not sum.

5 6 2015 Systematic review of needs for medical devices for ageing populations sex, urban andindoorairpollution, andunsafe physical inactivity, tobacco use, alcoholuse, unsafe body massindex, low fruitandvegetable intake, majority of all deaths from lungcancer. High women, and tobaccouseisassociatedwiththe due tocanceramongbothmenand mortality defined. Lungcanceristheleadingcauseof cancersitesremainfactors for certain poorly Risk factorsfor specificcancersvary, andrisk leading causeofcardiovascular deaths(9). these risk factors, highbloodpressure is the or obese, and low fruit and vegetable intake. Of blood glucose, physical inactivity, beingoverweight high bloodpressure,factors: highcholesterol, high associated with at least one of the following risk 57% ofdeathsfrom cardiovascular diseaseare and cerebrovascular disease. Approximately cardiovascular diseaseare ischaemic heart The leadingconditionsthatbringaboutdeathfrom osteoporosis andseborrhoeic keratosis (8). related maculardegeneration, osteoarthritis, Alzheimer’s disease, Parkinson’s disease, age- complications, cancer, benignprostatic hyperplasia, including atherosclerosis, hypertension, diabetic conditions are strongly associatedwithageing, factor for age-related diseases, and some health men thanfor women. isanon-modifiablerisk Age ratesarebut cancermortality much higherfor both menandwomen aged60years andover, in account for alargeproportion ofmortality Cardiovascular diseaseandmalignantneoplasms NA: notapplicable. 2012Region, (6) (DALYs), life-years Table to 2Major contributions projected disability-adjusted Western Pacific Injuries Cerebrovascular disease Communicable diseases Malignant neoplasms Cardiovascular disease Noncommunicable diseases All causes Cause ofDALY Total estimated 112 302635 376 359807 496 817257 54 682868 55 121610 65 774588 74 241072 DALYs All ages All causesof DALYs (%) NA 11 11 13 15 23 76 factors such as poornutrition, physical inactivity, later inlife; the prevalence and distributionofrisk lifestyle factorsplay inthedevelopment ofdisease There isincreasing recognition oftherole that wide area andatdifferent stagesof development. accounts for a large number of countries over a they are treated, are highly varied, astheregion Western PacificRegion, andtheway inwhich health problems inageingpopulations withinthe of life andchoiceoravailability oftreatment. The always present (10), andthismay affect thequality is thatinolderpatientscomorbidityalmost across thepopulation. consideration Another these conditionsmay becomemore prevalent traditional modesofliving, theriskfactorsfor choices.dietary from societiesdepart more As are associatedwithmodernlifestyle and Many riskfactorsfor theconditionsofinterest loss live inlow- andmiddle-income countries(3). majority ofpeopleaffected by visionorhearing experience severe hearinglossordeafness. The those people, 10%willbecomeblindand25% vision lossand26%experiencehearingloss. Of of peopleaged60years orover experience in olderage. Inthe Western PacificRegion, 44% Vision andhearingproblems are alsomore likely responsible from for 18%ofmortality cancer(9). infection infection andHelicobacterpylori are viral hepatitis, liver flukes, humanpapillomavirus to 35%ofallcancermortality. Infections suchas health care injectionsare riskfactorsattributing Age > 60 years: total estimated DALYs 191 851690 213 449156 11 727900 41 084201 40 188854 80 421955 9 869564 all ages: estimated Age > 60 years vs DALYs (%) 21 75 15 54 72 51 43 tobacco use and high alcohol consumption varies the ageing population, such as atherosclerosis considerably between countries in the Western and cancers (13). The relationship between Pacific Region. the aetiology of age-related diseases and the physiological processes that underpin ageing is 1.3 DEFINING OLD AGE not well understood. The process of ageing, like There is no clear, universally accepted definition all biological processes, is regulated by molecular of “elderly” or “aged”. The concept of ageing signalling pathways and genetic transcription factors. There is a research focus on identifying

encompasses chronological age, changes in Introduction 1. social roles, and changes in physical, mental and familial aspects to ageing and longevity, including functional capabilities. The age at which someone specific genetic mutations that may confer a is considered elderly varies between countries longer lifespan and slow the onset of age-related and is often associated with the age at which a disease (14). person becomes eligible for pension schemes The development of age-related diseases reflects or retirement: this is usually between 60 and 65 the cumulative effect of the ageing process as years (11). Ageing is a diffuse biological process well as the impact of lifestyle and environmental that can be described as the accumulation of factors over many years. Strategies to lower the deleterious changes in cells and tissues that risk of developing many age-related diseases may occur with advancing age. Defining old age is be focused on modifying lifestyle or environmental challenging as its onset is not defined by a single factors, the early initiation of which may help to physiological phenomenon and its manifestation promote healthy ageing. varies across individuals. The process of ageing involves physical, physiological and social changes REFERENCES and is considered by many to be a stage of life in 1. Medium-term strategic plan 2008–2013 – interim which a person’s functional, mental and physical assessment. Geneva: World Health Organization; capacity decline (2). Old age is also associated 2009 (http://www.who.int/about/resources_planning/ with an increased propensity to disability and MTSP_20082013_interim_assessment.pdf, accessed disease as a consequence of the cumulative 19 February 2014). 2. Ageing in the twenty-first century: a celebration and a effect of a range of deleterious changes in the challenge. New York: United Nations Population Fund body. Although chronological age is the common (UNFPA) and HelpAge International; 2012 (http:// basis for determining old age by governments, www.unfpa.org/public/home/publications/pid/11584, demographers and researchers, it may not be accessed 19 February 2014). equivalent with an individual’s biological age (12). 3. Ageing in the Western Pacific Region. Manila: World Health Organization Regional Office for the Western An increase in a person’s chronological age does Pacific; 2012 (http://www.wpro.who.int/world_health_ not necessarily lead to ill health. day/2012/WHD2012INFORMATION/en/index.html, accessed 19 February 2014). The United Nations applies 60 years as the cut- 4. Japan. Manila: World Health Organization Regional off for older people, so the health conditions that Office for the Western Pacific, 2010. (http://hiip.wpro. are the subject of this project were identified by who.int/portal/countryprofiles/Japan.aspx, accessed 6 March 2015). examining the top five causes of loss of DALYs in 5. Public health policy and approach for noncommunicable people aged 60–79 years in the Western Pacific disease prevention and control in Japan: a case study. Region. Kobe: World Health Organization Centre for Health Development; 2005 (http://www.who.int/kobe_centre/ 1.4 AGEING AND DISEASE ageing/ahp_vol6_ncd.pdf, accessed 19 February 2014). 6. Global burden of disease 2012 summary tables. Geneva: Damage at the cellular level that is attributed World Health Organization; 2014 (http://www.who.int/ to the process of ageing has been linked to the healthinfo/global_burden_disease/estimates/en/index2. pathology of certain diseases associated with html, accessed 6 March 2015).

7 8 2015 Systematic review of needs for medical devices for ageing populations 10. 9. 8. 7. 2008;337:149–50. and diseaseprevention for the 21st century. BMJ. TF, CasselC, etal. Newmodelofhealthpromotion Butler RN, MillerRA, D, Perry BA, Carnes Williams 2014). report_full.pdf, accessed19February healthinfo/global_burden_disease/GlobalHealthRisks_ Health Organization; 2009(http://www.who.int/ attributable toselectedmajorrisks. Geneva: World andburden ofdisease mortality Global healthrisks: 2012;181:1142–6. related diseases by slowing down JPathol. aging. Am Blagosklonny MV. Prospective treatmentofage- html, accessed6March2015). healthinfo/global_burden_disease/estimates/en/index1. Health Organization; 2014(http://www.who.int/ tables.Causes ofdeath2012summary Geneva: World 14. 13. 12. 11. 2010;464:504–12. Kenyon CJ. The geneticsofageing. Nature. aging.organismal Mech Aging Dev. 2008;129:467–74. Jeyapalan JC, SedivyJM. Cellularsenescence and 2014). ageingdefnolder/en/index.html, accessed19February 2012 MDS project. Geneva: World HealthOrganization; in definitionofanolderperson for the Africa working proposed person: Definition ofanolderorelderly the Englishdefinition. JSocHist. 1979;12:416–28. Roebuck J. When doesoldagebegin? The evolution of (http://www.who.int/healthinfo/survey/ 2. Methods

This project was requested by WHO to inform ––prostate a consultation process on the need for medical ––lymphoma devices in the ageing population in the Western ––breast Pacific Region. The work was focused on five ––stomach main health conditions and 19 specific topics. The ––liver methodology in this report is not comprehensive. ––oesophagus Rather, this is a rapid systematic review in which ––mouth and oropharynx the methodology has been limited in one or more • respiratory diseases: areas in line with the requirements of the report. ––chronic obstructive pulmonary disease 2. Methods 2. Thus, modifications have been made in at least one (COPD) of the following areas: search strategy, inclusion • sense organ diseases: criteria, assessment of study quality, data analysis, ––glaucoma and limitations pertaining to the questions of the ––cataracts review. It is considered that these amendments ––refractive errors do not significantly alter the overall findings of the ––adult-onset hearing loss rapid review when compared with a full systematic ––macular degeneration review. • neuropsychiatric conditions: ––Alzheimer’s disease and other dementias. This rapid review is a limited evidence-based assessment based on a restricted systematic Therefore, there were 19 groups of populations search of studies published in the peer-reviewed associated with the above topics, broadly grouped literature on the specific review topic. As a result, within five major health conditions. this rapid review may be used to inform certain questions on the topic. For a more comprehensive 2.2 MEDICAL DEVICES understanding of the topic, a broader analysis of Medical devices are required in all aspects of the literature may be required. As such, readers clinical practice, and many are the focus of a should be aware of the limitations of this review. substantial commitment in terms of research and The project methodology was arranged with development worldwide. Effective medical devices reference to the population, intervention, are needed in the management of many chronic comparator and outcome (PICO) criteria (1,2). health conditions and, if selected, purchased and used appropriately, may be instrumental in 2.1 POPULATION addressing the priority health care needs of a The populations of interest were defined through population. Medical devices are also a source of the health conditions that were the top five causes cost to health care systems, however, and their for loss of DALYs in 2010 for older people (aged regulation and assessment require a significant 60–79 years) in the Western Pacific Region: investment of time and resources. The utility of a particular device to a specific population is • cardiovascular diseases: influenced by a number of factors, including: ––ischaemic heart disease ––cerebrovascular disease • the priority health care needs of the population, ––hypertensive heart disease which may be informed by population health • malignant neoplasms: issues or by broader policy commitments; ––trachea, bronchus and lungs • the level of public health infrastructure available ––colon and rectum in the country, which may vary widely between 9 10 2015 Systematic review of needs for medical devices for ageing populations are definedas: Medical devices are essentialfor patientcare and diagnostic machinesto simpleimplements. of medicalequipment, from highly sophisticated The term “medical device” covers abroad range diseases. neuropsychiatric conditions and senseorgan malignant neoplasms, conditions, respiratory population, includingcardiovascular diseases, several health conditions that affect the ageing in theprevention, diagnosisandtreatment of of thisproject istoidentifymedicaldevices used address themare many andcomplex. The focus and identifying the medical devices needed to involved insettingpriorityhealthcare areas settings needstobeconsidered. The factors their applicability tolow- ormedium-resource and testedinhigh-resource settings, andhence New medicaldevices are frequently developed or homeandself-care devices (3). such astowards minimally invasive technologies priorities toaccommodatetheagedpopulation, changes, there may also be shifts in research diseases. theintendedtreatment population As such ascardiovascular diseaseandneoplastic to prevent, diagnose and treat chronic diseases need associatedwiththeglobalburden ofdisease population alsochange. There isnow agrowing ages, thepriorityhealthcare areas ofthe highly context-specific.As theglobalpopulation Thus, medicaldevice theneedfor is aparticular • • • • machine, appliance, implant, reagent for invitro …any instrument, apparatus, implement, device manufacturer. market, andotherissuesofrelevance tothe issuesandeaseofaccesstothe regulatory of thedevice; the skillandexperiencelevel oftheenduser purchase costandongoing costs); the costofmedicaldevice (including technologies; devices andcomplementary the availability ofresources topurchase needed areas; different towns orbetween ruralandurban indexing isfrequently updated. databases (includingMedline andothers)its engine, mainly becauseitaccessesarange of searchnih.gov/pubmed) wasusedastheprimary relevant literature. PubMed(http://www.ncbi.nlm. A systematicapproach wastaken toidentify 2.5 LITERATURE SEARCH topics underinvestigation. widely betweenvary the different conditions and have beendefined. Thesecriteria would probably devices, nospecific comparatorandoutcome As theaimofthisproject istoinform onneeded 2.4 COMPARATOR AND OUTCOME • • • “needed devices”.The devices were categorized as: forThe intervention thisproject isdefinedas 2.3 INTERVENTION therapeutic. diagnostic preventive • • • • • • • purpose(s) of: human beings for one or more of thespecific to be used, alone or in combination, for related article, intended by the manufacturer use, software, materialorothersimilar in itsintendedfunctionby suchmeans(4,5). the humanbody, butwhichmay beassisted immunological ormetabolicmeans, inoron intendedactionby pharmacological,primary human bodyandwhichdoesnotachieve its examination ofspecimensderived from the providing information by meansofinvitro disinfection ofmedicaldevices; control ofconception; orsustaininglife; supporting process; of theanatomysupport orof a physiological investigation, replacement, modification, or of orcompensationfor aninjury; diagnosis, monitoring, treatment, alleviation or alleviation ofdisease; diagnosis, prevention, monitoring, treatment 2.6 SEARCH STRATEGY #31 treatment* The searches were undertaken in two steps. A #32 prevention core search strategy was developed to identify #33 monitoring non-disease-specific devices used for the #34 screening prevention, diagnosis and treatment of older people. A wide range of Medical Subject Heading #35 rehabilitat* (MeSH) terms and keywords were used. This #36 alleviat* strategy was consistently applied to each of the #37 #23 OR #24 OR #25 OR #26 OR #27 OR 19 topics and was built as follows: #28 OR #29 OR #30 OR #31 OR #32 OR #33 OR #34 OR #35 OR #36 #38 #7 AND #22 AND #37 #1 aged [MeSH terms] #2 health services for the aged [MeSH terms] 2. Methods 2. #3 aged For each of the 19 separate topics, a range of #4 senior keyword and MeSH terms were used to create a disease- or condition-specific search that was #5 elderly applied to the above core strategy. The specific #6 geriatric search strategy used for each of the 19 conditions #7 #1 OR #2 OR #3 OR #4 OR #5 OR #6 is provided in the relevant section of this report. #8 equipment and supplies [MeSH terms] Using this methodology we identified a range #9 assistive devices [MeSH terms] of devices associated with the older population, #10 surgical instruments [MeSH terms] focused on each of the 19 topics of interest. #11 device* #12 aid* 2.7 ADDITIONAL SEARCH CRITERIA #13 equipment AND FILTERS #14 armamentarium In order to focus the literature search results to #15 appliance* the most relevant and high-quality literature, a #16 instrument* small number of additional criteria were applied to the initial search results: #17 apparatus #18 good* • languages: ––limit to English language only #19 implement* • publication date: #20 material* ––limit to the past five years #21 machine* ––limit to the past 10 years #22 #8 OR #9 OR #10 OR #11 OR #12 OR #13 • publication type: OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 OR #20 OR #21 ––limit to randomized controlled trials #23 diagnosis [MeSH terms] ––limit to systematic reviews.

#24 rehabilitation [MeSH terms] These criteria were applied to individual topics #25 primary prevention [MeSH terms] following the initial consideration of preliminary #26 secondary prevention [MeSH terms] search results. The specific criteria used for each #27 after treatment [MeSH terms] topic are given in the relevant sections.

#28 therapeutics [MeSH terms] No specific ages were used in the search terms #29 diagnos* or in any additional search criteria. The population #30 therap* is primarily defined through the 19 conditions and topics, which have been identified as being

11 12 2015 Systematic review of needs for medical devices for ageing populations • to theapplication oftheselevels ofevidence: 1) (see Annex Research Council(NHMRC)levels ofevidence to the Australian National Health and Medical according totheirdesign. This wasdoneaccording Where possible, studies were categorized study outcomes. or designasthere wasnoqualitative evaluation of No studies were excludedbased on study quality to adevice inthetitleorabstract)wasrecorded. references relevant totheproject (thatis, referred investigation were excluded. The number of studies ofnorelevance totheconditionunder number ofstudiesidentified ineachsearch.Any The results for each topic describethe total PRESENTATION OFRESULTS 2.8 STUDY INCLUSIONCRITERIA AND search have beenhighlighted. population identified asa result oftheliterature associated more commonly withthespecificaged age-specific manner; however, any specific devices associated witheachtopicinabroad ornon- as not to inadvertently exclude relevant studies The search termswere deliberately kept broad so associated witholderpeople(aged60–79years). • studies was “not abletobedetermined”. Pacific Region, the evidence hierarchy ofthese may between the countriesinthe vary Western for each device, andthefactthatthisstandard required toestablishthereference standard standard. Duetothesignificantclinicalinput need touseanappropriate andvalidreference outcomes:to be classified aslevel II, these trials Randomized controlled trials ofdiagnostic applicable” tothesestudytypes. practice guidelines. Evidencehierarchy was “not exception alsoincludedevidence-based clinical on randomizedcontrolled trial evidence). This I level ofevidence (systematicreview based literature reviews could not be allocated a level non-randomized controlled trialdata:these systematic methodology, orthatmay comprise that didnotexplicitly reporttheuseofa Literature reviews orclinicalpracticeguidelines (6,7). There were two exceptions were provided asexamples; tradenameswere trade namesofspecifically marketed products Devices were listedinagenericmannerand same clinicalobjective were grouped together. was identified. Where relevant, devices withthe is notcitedaccording tothestudyfrom where it undertaken toinform thistable, and each device search. full text reviewA of each study was not title andabstractofallrelevant studiesfrom the of alldevices identified through asearch ofthe The secondtableincludesacomprehensive list identified study. informed through a review of the full text of the randomized controlled trial). This firsttableis information regarding the comparator arm in a have beenwithinthestudyfocus (for example, devicesthe studyandany thatmay secondary device orprocedurethe primary associatedwith a level ofevidence. The firsttablealsoprovides Where possible, thesestudieswere designated relevantand interventions tothetopicofinterest. representative information ofthemaindevices the literature review as providing themost a descriptionofkey studiesidentified through main healthcondition. The firsttableprovides Two levels ofresults are provided for each the level of detail, range of devices and nature of literature identified; for this reason, disparitiesin are intendedtoreflect thecharacteristics ofthe device specifications were mentioned. Thetables specifictradenames or but inothercasesvery wereor interventions describedinbroad terms, as provided. Insomeinstancesmedicaldevices potential misinterpretation oftheinformation provided intheliterature inorder toavoid in thetablesisreflective ofthelevel ofdetail The level ofdetailregarding devices presented a device’s safety, efficacyorcost-effectiveness. devices; norshoulditbetaken asanindicationof interpreted asanexhaustive listofallmarketed service. The tabulatedinformation shouldnotbe different from, otherdevices available for thesame these devices were similarto, orsignificantly unclear withoutsubsequentresearch whether provided when identified intheliterature asitwas descriptive data provided across and between for categorization purposes where these were topics are observable. identified as being reported distinctly from other medical devices. The term “consumable” indicates The complete bibliography of the results for each that the device will be depleted or “consumed” topic was recorded using Endnote X4 (1988–2010 after use. An example of a consumable is a single- Thompson Reuters). use syringe. Procedures, interventions and tests (such as questionnaires) that did not explicitly 2.9 CATEGORIES OF MEDICAL DEVICES report the use of a defined medical device are Where possible, the identified devices were discussed narratively. categorized using the following nomenclature as informed by the Global Harmonization Task Force The term “appliance” was used to describe definition of a medical device: devices such as ultrasound machines. The term

indicates that the device is comprised of several Methods 2. • appliance (a large instrument for a particular components such as probes, processing units and purpose or use with associated console, consoles (display units). The term also indicates accessories, attachment and consumables); that consumables such as a gel may be involved in • instrument (a mechanical tool or implement, the operation of the device. When specified in the for example surgical instrument); primary literature, the components of the device • implant (a device used for repairing or replacing of interest may also be listed. part of the body, including medication or radioactive material inserted into tissue for 2.10 SUPPLEMENTARY RESOURCES sustained therapy); • prosthesis (a device, either external or The results of the literature search were implanted, that substitutes for or supplements considered from a clinical perspective in order a missing or defective part of the body); to establish the role of each device within the • material (an inert substance used for repairing overall management of a specific condition. In or replacing part of the body); certain cases, clinical practice guidelines were • apparatus (a group or combination of used to confirm these issues (http://bestpractice. instruments, machinery, tools, materials, etc., bmj.com/best-practice/welcome.html). The use of having a particular function or intended for a supplementary resources is clearly explained in the specific use); methods and results of each topic where relevant. • in vitro diagnostic (a medical device intended to perform tests out of the body for diagnostic REFERENCES purposes); 1. Counsell C. Formulating questions and locating primary studies for inclusion in systematic reviews. Ann Intern • software (the programs used to direct Med. 1997;127:380–87. the operation of a computer, as well as 2. Higgins JPT, Green S. Cochrane handbook for documentation giving instructions on how to systematic reviews of interventions, 5.1.0 edn. London: use them); The Cochrane Collaboration; 2011. (http://handbook. • other (devices which do not fit to any of the cochrane.org, accessed 19 February 2014). 3. Priority medical devices. Geneva: World Health above categories. Techniques or procedures Organization; 2010 (http://www.who.int/medical_ which play a key role in the provision of services devices/access/en/index.html, accessed 19 February for the condition, but have no explicit medical 2014). device associated with them have been provided 4. Medical device regulations: global overview and guiding under this category for comprehensiveness) (5). principles. Geneva: World Health Organization; 2003 (http://www.who.int/medical_devices/publications/en/ MD_Regulations.pdf, accessed 19 February 2014). For clarity and comprehensiveness, the terms “consumable”, “chart” and “aid” were also used

13 14 2015 Systematic review of needs for medical devices for ageing populations 5. 2014). documents/doc-ghtf-sg1.asp, accessed 19 February Regulator’s Forum; 2011(http://www.imdrf.org/ medical device.term Medical Device International Global Harmonisation Task Force. Definition of the 6. 7. Canberra, ACT:National HealthandMedicalResearch ofguidelines.recommendation for developers forNHMRC levels ofevidence and grades Med ResMethodol. 2009;9:34–42. toincludetopicsotherthantreatment.hierarchy BMC Merlin T, Weston A, Tooher R. Extendinganevidence 2014). grades.pdf, accessed19February file/guidelines/stage_2_consultation_levels_and_ Council; 2009(http://www.nhmrc.gov.au/_files_nhmrc/ 3. Cardiovascular diseases

3.1 INTRODUCTION of the mortality. In terms of overall mortality, Cardiovascular disease is a broad term cerebrovascular disease is overrepresented in encompassing diseases of the heart and blood the Western Pacific Region compared with rates vessels (1). These diseases commonly also involve worldwide. the brain and kidney. The underlying aetiologies are varied and include congenital diseases, 3.2 ISCHAEMIC HEART DISEASE inflammatory diseases, rheumatic diseases, Introduction atherosclerosis, cardiac functional insufficiencies Ischaemic heart disease, or myocardial ischaemia, and disease of other body systems. Atherosclerosis is characterized by reduced blood supply to the is the major cause for ischaemic heart disease. heart muscle, usually due to coronary artery Hypertension and atherosclerosis are the leading disease. As a consequence of reduced blood causes for cerebrovascular disease. Hypertensive supply, the heart muscle may become damaged, diseases are often associated with pathology commonly resulting in heart attack and death (3). of kidney function. In general, multiple organs diseases The risk of developing ischaemic heart disease and systems are involved with cardiovascular Cardiovascular 3. increases with age, smoking, high cholesterol pathologies. level, diabetes and high blood pressure. It is more The WHO estimated global burden of death common in men and people with close relatives due to cardiovascular disease in 2012, both with ischaemic heart disease (4). Although worldwide and in the Western Pacific Region, is ischaemic heart disease usually develops over summarized in Table 3. Of the burden of disease several decades, clinical complications such as caused by cardiovascular disease, heart attack heart attack and stroke are mainly observed in and stroke account for a significant proportion middle-aged and elderly people (5).

Table 3 Mortality due to cardiovascular disease, worldwide and Western Pacific Region, 2008a (2)

Cause of death Worldwide Western Pacific Region Percentage of worldwide death from Total (millions) Percentage Total Percentage cardiovascular diseases of deaths (millions) of deaths attributable to Western (%) (%) Pacific Region (%) All deaths 55.86 NA 12.96 NA 23 All cardiovascular disease 17.52 31 5.37 41 31 Rheumatic heart disease 0.34 1 0.08 1 23 Hypertensive heart 1.14 2 0.30 2 26 disease Ischaemic heart disease 7.36 13 1.83 14 25 Cerebrovascular disease 6.67 12 2.70 21 41 Inflammatory heart 0.47 1 0.07 1 15 diseases Other cardiovascular 1.54 3 0.39 3 25 diseases

NA: not applicable. a Percentages calculated from raw data and rounded.

15 16 2015 Systematic review of needs for medical devices for ageing populations attributed to ischaemic heart disease(2). attributed toischaemicheart of totaldeathsinthe Western PacificRegion were attributable tothedisease. More specifically, 14% disease,heart with 13% of total deaths that year 7.4 millionpeopleworldwide had ischaemic and is a chief health concern worldwide. In 2012, indevelopeda majorcauseofmortality countries cause ofdeathfor allcardiovascular diseases. Itis diseaseisthemostcommon Ischaemic heart related tosomeprocedures. conducted onlinetoconfirmthesurgicaldevices and systematicreviews. searching was Additional language andpublishedwithinthepastfive years filters were applied tothesearch English results: treatment disease. ofischaemicheart The following that couldbeusedintheprevention, diagnosisor incorporating textandMeSHtoidentifydevices An apriorisearch wasdeveloped strategy Methodology #9 #8 #7 #6 #5 #4 #3 #2 #1 (#8) AND #1 (#8) AND #7 (((((#2) OR#3)#4) #5) OR#6) myocardial ischaemia myocardial ischemia disease ischaemic heart disease ischemic heart disease[MeSH terms] artery coronary myocardial ischaemia [MeSHterms] OR (alleviat*)) (monitoring) OR(screening) OR(rehabilitat*) (therap*) OR(treatment*) OR(prevention) OR (therapeutics [MeSHterms])OR(diagnos*) OR (aftertreatment [MeSHterms])OR preventionOR (secondary [MeSHterms]) preventionterms]) OR(primary [MeSHterms]) [MeSH terms])OR(rehabilitation [MeSH (material*) OR(machine*)) AND ((diagnosis (apparatus) OR(good*) OR(implement*) OR (appliance*) OR(instrument*) (aid*) OR(equipment)(armamentarium) instruments [MeSHterms])OR(device*) OR (assistive devices [MeSHterms])OR(surgical ((equipment andsupplies[MeSHterms])OR (senior) OR(elderly) OR(geriatric)) AND for theaged[MeSHterms])OR(aged) ((aged [MeSHterms])OR(healthservices Other therapeutic procedures identified inthe grafting andcardiac resynchronization therapy. included angioplasty, bypass artery coronary for thetreatmentdisease ofischaemicheart The maintherapeutic procedures identified pressure. included bloodtestsandassessmentof screening disease methodsfor ischaemicheart preventive mechanisminfuture years. Additional before symptomsarisemay prove tobeapowerful diseasethrough ischaemic heart genetechnology categorized as “preventive” becauseidentifying and diagnosis, respectively. The test for LRP6was troponin-T, whichmay berelevant for screening two testsfor geneticmarkers, LRP6andcardiac therapeutic procedures. The search identified diagnostic machinesandprocedures aswell as A review oftheliterature identified a focus on review ofallincludedstudies(Table 5). devices wasobtainedthrough titleandabstract summarized in Table broader listofidentified A 4. of thekey studiesretrieved for fulltextreview are treatment disease. of ischaemic heart The details reported theuseofadevice for thediagnosisor abstract screen, 88 studies were identified that yielded 269 results.The strategy On the title and Results therapy andcardiogoniometry. revascularization, thrombectomy, reperfusion search revascularization, includedcoronary hybrid Table 4 Ischaemic heart disease – key studies

Study Level of Primary focus Secondary focusa evidence Bavry et al 2008 (6) I Embolic protection device Thrombectomy Reperfusion Revascularization Percutaneous coronary intervention Catheter thrombus aspiration Mechanical thrombectomy Syringe Saline jet Rotating catheter Occlusive balloon Guide-wire Biondi-Zoccai et al I Drug-eluting stent Cardiac surgery 2008 (7) Bare-metal stent Balloon angioplasty Coronary artery bypass grafting Restenosis Surgical revascularization Coronary angiography Byrne et al 2009 IV Drug-eluting stent Restenosis (8) Bare-metal stent diseases Drug-eluting stent 3. Cardiovascular Cardiovascular 3. CYPHER™ drug-eluting stent Taxus paclitaxel-eluting stent angiography Cine-angiogram balloon Balloon angioplasty Palmaz–Schatz stent Percutaneous coronary intervention Revascularization Stirolimus-eluting stent Chander et al 2008 IV Electrocardiographically CT coronary angiography (9) gated Rb PET 64-slice scanner Contrast-enhanced CT Nuclear imaging ventriculography Echocardiography Cardiac MRI Contrast ventriculography Discovery STRx PET/CT system equipped with integrated lutetium yttrium orthosilicate crystal PET component and 64-slice CT component CT topogram Suyker and Borst I Coronary connector Anastomotic connector 2008 (10) device Angiography Multi-detector CT MRI anastomotic device Anastomotic connector Graft thrombosis Proximal anastomosis devices: Symmetry™, SJM prox-II, CorLink™ PAS-Port®, Spyder® Distal anastomosis devices: MVP-4000/6000, C-Port®, Converge Coupler™, SJM distal 2.5 mm, SJM distal Easyload, automated anastomotic distal device Thavapalachandran IV Heart failure Implantable cardioverter defibrillator device et al 2009 (11) Cardiac resynchronization therapy by biventricular pacing electrocardiogram

CT: computed tomography; MRI: magnetic resonance imaging; PET: positron-emission tomography. a Proprietary marks have been included where this information was readily identified through source material.

17 18 2015 Systematic review of needs for medical devices for ageing populations b a IVD: invitrodiagnostic; PET: positron-emission tomography. treatment and diagnosis prevention, for identified –devices disease heart Table 5Ischaemic rapamycin-eluting coated bioactive; polymer-free titanium-nitride oxide- Stents: drug-eluting; bare-metal; Wire Impella® recover pump balloonpump Intra-aortic Implantable cardiodefibrillator therapy device Cardiac resynchronization ultrasound catheter 40 MHzintravascular glue Cyanoacrylate Impella® device TandemHeart™ system Embolic protection device Ventricular assistdevice Balloon catheter Treatment X-ray machine Intravascular ultrasound 64-slice system Computed tomography PET system Cine-angiograph Electrocardiogram machine Echocardiogram machine Cardiac troponin Diagnosis LRP6 gene Prevention Device May beimplantable orextracorporeal. have wasreadily identified marks beenincludedwherethisinformation throughsourcematerial. Proprietary a b b b Implant Consumable appliance Implant/ Implant Implant Consumable Consumable Implant Consumable Consumable Appliance Appliance Appliance Appliance Appliance Appliance Appliance IVD IVD Description Instrument appliance Implant/ appliance Implant/ Mesh tubeusedtoopenarteries Stainless-steel pinusedinsurgery from catheterintoascendingaorta Pulls bloodfrom leftventricle through inletarea neartipandexpelsblood tachycardia risk ofsudden cardiac deathduetoventricular fibrillationand ventricular Small battery-powered electricalimpulsegeneratorimplantedinpatientsat Treatment for congestive failure heart causedby dilatedcardiomyopathy Thin tubeusedinultrasound Medical adhesive to perform life-saving procedures angioplasty by relieving heart’s pumpingfunctionandproviding timeneeded Ventricular assistdevice thathelpspatienttolerateprocedures suchas procedure Captures andremoves debristhatbecomesdislodgedduringinterventional Empty andcollapsed balloon onendovascular guide-wire ofangiographyPart procedure Uses penetratingelectromagnetic radiationtovisualizeanatomicalstructures. miniaturized ultrasoundprobe attachedtodistalendofcatheter usingspecially designedcatheterwith Medical imagingmethodology intravenously injectedcontrastagents cross-sectional imagesofspecificareas ofbody,e.g. theheart. May involve Medical imagingmodalityusingcomputer-processed X-rays togenerate body, e.g. intheheart tracers togeneratethree-dimensional imagesofmetabolicprocesses within Nuclear medicineimagingmodalityusingpositron-emitting radionuclide obtained afterinjectingpatientwithnon-toxic radio-opaquemedium Motion-picture recording ofbloodvessel ofcardiovascular orportion system device externaltobody detected by electrodes attachedtooutersurfaceofskinandrecorded by Transthoracic interpretation over ofelectrical activityofheart periodoftime, diseases known heart Diagnosis, managementandfollow-up ofpatientswithany suspectedor Biomarker failure testingindiagnosisofheart marker testing Encodes memberoflow-density lipoprotein receptor genefamily ingenetic Function Increases myocardial oxygen perfusionand increases cardiac output tobypass leftventricle and pumpsitbackintofemoral artery Extracorporeal assistdevice circulatory thatdrainsbloodfrom leftatrium failing heart deviceMechanical circulatory orcompletely thatpartially replaces function of 3.3 CEREBROVASCULAR DISEASE #2 cerebrovascular disorders (MeSH terms)

Introduction #3 cerebrovascular disorders Cerebrovascular disease is a cardiovascular disease #4 cerebrovascular disease that incorporates a number of conditions caused #5 stroke by problems with blood vessels in the brain. The #6 transient ischaemic attack most common cerebrovascular diseases include #7 transient ischemic attack ischaemic stroke, transient ischaemic attack, #8 subarachnoid haemorrhage subarachnoid haemorrhage, intracranial aneurysm #9 intracranial aneurysm and vascular dementia (covered under Alzheimer’s #10 #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR disease) (12). Some of the more common risk #8 OR #9 factors for developing cerebrovascular disease #11 #10 AND #1 include smoking, high blood pressure, diabetes, high cholesterol level, obesity and age.

Cerebrovascular disease is the second most Following review of the search results, resources common cause of death from cardiovascular consulted included clinical practice guidelines (13) disease. In 2012, 6.7 million people worldwide and the Best Practice website of the BMJ Evidence diseases Centre (14). had cerebrovascular disease, and it accounted for Cardiovascular 3. 12% of total deaths. A similar trend is observed Results in the Western Pacific Region, with 21% of total The strategy yielded 250 results. On the title and deaths in the region attributed to cerebrovascular abstract screen, 77 studies were identified that disease (2). reported the use of a device for the prevention, Ischaemic stroke is the main cause of death and diagnosis or treatment of cerebrovascular disease. disability from cerebrovascular disease. The details of the key studies retrieved for full text review are summarized in Table 6. A broader Methodology list of identified devices was obtained through An a priori search strategy was developed title and abstract review of all included studies incorporating text and MeSH terms to identify (Table 7). devices that could be used in the prevention, diagnosis or treatment of cerebrovascular disease. The results of the search identified a number The following filters were applied to the search of devices for the diagnosis and treatment of results: English language and published within the cerebrovascular disease. It should be noted, past five years and systematic reviews. however, that although no devices for the prevention of cerebrovascular disease were #1 ((aged [MeSH terms]) OR (health services identified, the management and prevention of for the aged [MeSH terms]) OR (aged) OR extracranial carotid disease and hypertensive (senior) OR (elderly) OR (geriatric)) AND ((equipment and supplies [MeSH terms]) OR and ischaemic heart disease may be considered (assistive devices [MeSH terms]) OR (surgical preventive measures for cerebrovascular disease. instruments [MeSH terms]) OR (device*) OR (aid*) OR (equipment) OR (armamentarium) OR (appliance*) OR (instrument*) OR Treatments for stroke or transient ischaemic (apparatus) OR (good*) OR (implement*) attack included carotid endarterectomy, carotid OR (material*) OR (machine*)) AND ((diagnosis [MeSH terms]) OR (rehabilitation stenting, endovascular mechanical clot disruption, [MeSH terms]) OR (primary prevention endovascular thrombectomy, surgical intervention [MeSH terms]) OR (secondary prevention and medical management. Treatments for cerebral [MeSH terms]) OR (after treatment [MeSH terms]) OR (therapeutics [MeSH terms]) OR aneurysm included endovascular coil treatment (diagnos*) OR (therap*) OR (treatment*) OR and surgical clipping, with the aim of excluding the (prevention) OR (monitoring) OR (screening) OR (rehabilitat*) OR (alleviat*)) aneurysm from intracranial circulation. 19 20 2015 Systematic review of needs for medical devices for ageing populations a CT: computedtomography; MRI: magneticresonanceimaging; ND: notable tobedetermined; SPECT, singlephoton-emissioncomputedtomography. –key studies disease Table 6Cerebrovascular White etal2010(21) (20) Ottomeyer etal2012 etal2012(19) Nagy Fraser etal2011(18) Brinjikji etal2009(17) Study Aqel etal2009(16) Argawal et al 2012 (15) Proprietary marks have wasreadily identified marks beenincludedwherethisinformation throughsourcematerial. Proprietary evidence Level of ND ND IV IV IV IV I Bridging ofveins Diathermy Burr holes Mini-craniectomy snare) Penumbra™, Phenox®, Amplatz GooseNeck® Endovascular mechanical therapy (AngioJet®, therapy Intravenous thrombolysis withintra-arterial therapyIntra-arterial Intravenous thrombolysis Thrombo-obliteration Gamma-knife radiosurgery Balloon-assisted liquidembolization Endoluminal flow-diversion withstent Craniotomy andresection Shunt low-flow bypass graftfor high-or Saphenous vein orradialartery embolization Intracranial bypass and subsequentcoil Radiographic/nuclear perfusionscans Stump pressure measurements Doppler ultrasonography Balloon testocclusionwithangiography Vascular plugs Primary focus Primary Micro-catheters, coil Guiding sheaths Guiding catheters Detachable coil Two-dimensional digitalsubtractionangiography Stent Stent placementofintroducer catheter Transcatheter closure coilembolization a Cannula aspiration Subdural drain None subtraction angiography Magnetic resonance digital MRI Stereotactic catheterangiography Software for doseplanning None Angiogram Sheaths Stent Guiding catheter Balloon Balloon remodelling Doppler ultrasound SPECT Electrocardiogram Blood pressure monitor Cerebral angiogram Pretreatment shunt Secondary focus Secondary Table 7 Cerebrovascular disease – devices identified for diagnosis and treatment

Devicea Description Function Diagnosis MRI system Appliance Medical imaging modality using magnetic fields and radiowaves to visualize anatomy, in particular soft tissue, organs and muscle. Characterizes aneurysm properties; evaluates extent of damage from stroke; diagnoses aneurysm and stroke. Functional MRI has applications in assessing level of rehabilitation following stroke. Techniques include functional MRI, contrast-enhanced MRI, 3 tesla MRI, diffusion-weighted MRI and magnetic resonance angiography CT system Appliance Medical imaging modality using computer-processed X-rays to generate cross-sectional images of body. May involve intravenously injected contrast agents. Characterizes aneurysm properties; evaluates extent of damage from stroke or transient ischaemic attack. May also be used for CT angiography SPECT system Appliance Medical imaging modality using gamma rays to generate three- dimensional images of anatomical and functional processes in body. Characterizes aneurysm properties. Also evaluates extent of damage from stroke or transient ischaemic attack Tests:b serum electrolytes; clotting IVD Diagnosis of SAH profile; full blood count; troponin I Electrocardiogram machine Appliance Diagnosis of SAH diseases Lumbar-puncture needleb Instrument Diagnosis of SAH and cerebral aneurysm

Treatment Cardiovascular 3. MRI system Appliance Contrast-enhanced magnetic resonance angiography for planning surgical approaches, and diagnosis of aneurysm and SAH X-ray machine Appliance Uses penetrating electromagnetic radiation to visualize anatomical structures. Used for angiography procedures with contrast agent CT system Appliance Medical imaging modality using computer-processed X-rays to generate cross-sectional images of body. May involve intravenously injected contrast agents. Used in CT angiography Intra-arterial cerebral catheter Consumable Angiography that characterizes aneurysmal remnant Syringe Consumable Administration of contrast agents Inflatable balloon Instrument Balloon test occlusion angiography Ultrasound Appliance Diagnosis and treatment planning Electrocardiogram machine Appliance Evaluation of patient’s status Blood pressure monitor Appliance Diagnosis, treatment planning and risk assessment Stump pressure monitor Appliance Evaluation of treatment (carotid occlusion) Serum BNP and inflammatory markers IVD Prognostic factor: BNP levels are associated with functional (IL-6, CRP, fibrinogen tests) test outcome after ischaemic stroke. May also be used to predict mortality Shunt Instrument Carotid endarterectomy (revascularization therapy), embolizing procedures, surgical procedures Clamp Instrument Carotid endarterectomy (revascularization therapy) Patches: autologous; bovine; Dacron Material Patch angioplasty and carotid endarterectomy Closed-suction drain Instrument Carotid endarterectomy (revascularization therapy) Stents: balloon-expandable; Implant Carotid stenting (revascularization therapy), embolization of self-expanding intracranial aneurysm Guide-wire Consumable Carotid stenting (revascularization therapy) Catheter Consumable Carotid stenting and mechanical clot disruption using angioplasty, intravenous thrombolysis, embolization of intracranial aneurysm Antibiotic-impregnated catheter Consumable Treatment of SAH Sheath Consumable Delivery of stents Continues… 21 22 2015 Systematic review of needs for medical devices for ageing populations and deathfrom highbloodpressure (23). disease hasbecomethe leading causeofillness aresult ofthesefactors,As hypertensive heart combined withcholesterol depositsinthevessels. increase attackandstroke therisk ofheart when to thickening ofthebloodvessel walls, whichcan arteries. Similarly, highbloodpressure also leads to pumpharder duetothehighpressure inthe muscle tothicken isrequired becausetheheart chronic highbloodpressure causestheheart thickening muscle. oftheheart Characteristically, disease,artery chestpain(angina), failure heart and (hypertension). These problems includecoronary that occurduetohighbloodpressure diseasesare problemsHypertensive heart Introduction 3.4 HYPERTENSIVE HEART DISEASE b a imaging; SAH: haemorrhage; subarachnoid SPECT, singlephoton-emissioncomputedtomography. BNP: peptide; natriuretic brain CRP: C-reactive protein; CT: computedtomography; IL-6: interleukin-6; IVD: invitrodiagnostic; MRI: magneticresonance Device Gamma knife bypass machine artery Coronary Cannula Subdural drain Diathermy unit Drill Autologous tissue Vascular plug Clip bare-platinum Coils: detachable; Cerecyte®; realityVirtual system Robot Hypobaric oxygen therapy unit GooseNeck® snare AngioJet®;Phenox®; Amplatz Clot-retrieval systems: Penumbra®; Balloon Identified via search of Best Practice database. Identified via search ofBestPractice have wasreadily identified marks beenincludedwherethisinformation throughsourcematerial. Proprietary a Appliance Appliance Instrument Instrument Instrument Appliance Material Instrument Consumable Consumable Appliance Appliance Appliance Instrument Instrument Description Treatment ofarteriovenous malformations (radiosurgery) Stabilization ofSAH Drainage ofsubduralhaematoma Treatment ofsubduralhaematoma Treatment ofsubduralhaematoma Creation ofburr holesintreatment ofsubduralhaematoma Embolization ofgiantintracranialaneurysm Embolization ofintracranialaneurysm Open surgicalclippingofintracranialaneurysm Embolization ofintracranialaneurysm Rehabilitation following stroke Rehabilitation andlower-limb movement following stroke Treatment ofstroke following cardiac surgery arteries) Endovascular thrombectomy (revascularization ofintracranial aneurysm balloon-remodelling procedures for embolizationofintracranial Carotid stentingandmechanicalclotdisruptionusingangioplasty, Function within thepastfive years andsystematic reviews. search results:English language and published disease. The following filters were applied tothe diagnosis ortreatment ofhypertensive heart devices thatcouldbeusedintheprevention, incorporating text and MeSH terms to identify An apriorisearch wasdeveloped strategy Methodology disease. (2). of totaldeathsattributedtohypertensive heart inthe observed Western PacificRegion, with2% 2% oftotaldeathsinthatyear. similartrend is A hypertensive disease, heart anditwasthecauseof disease. In2012, 1.1millionpeopleworldwide had common causeofdeathfrom cardiovascular disease isthethird most Hypertensive heart #1 ((aged [MeSH terms]) OR (health services After reading the study titles and abstracts, for the aged [MeSH terms]) OR (aged) OR studies were excluded if they did not include (senior) OR (elderly) OR (geriatric)) AND the targeted population or had not specified ((equipment and supplies [MeSH terms]) OR (assistive devices [MeSH terms]) OR (surgical devices in the abstract. Among the excluded 113 instruments [MeSH terms]) OR (device*) OR studies, 11 studies focused only on ischaemic (aid*) OR (equipment) OR (armamentarium) OR (appliance*) OR (instrument*) OR heart disease and another seven focused only (apparatus) OR (good*) OR (implement*) OR on cerebrovascular diseases. Hypertensive renal (material*) OR (machine*)) AND ((diagnosis [MeSH terms]) OR (rehabilitation [MeSH diseases were included in the search results, terms]) OR (primary prevention [MeSH terms]) although the identified literature focused OR (secondary prevention [MeSH terms]) OR (after treatment [MeSH terms]) OR predominantly on the cardiac consequences of (therapeutics [MeSH terms]) OR (diagnos*) OR hypertension, which include heart failure and (therap*) OR (treatment*) OR (prevention) OR (monitoring) OR (screening) OR (rehabilitat*) cardiomyopathy. The preventive, diagnostic and OR (alleviat*)) therapeutic devices related to ischaemic heart #2 hypertension [MeSH terms], cardiac output, disease and cerebrovascular disease are discussed high [MeSH terms] OR cardiomegaly [MeSH separately in this report. terms] OR cardiomyopathies [MeSH terms] OR heart aneurysm [MeSH terms] OR heart The search identified preventive, diagnostic and

failure [MeSH terms] OR heart rupture [MeSH diseases terms] OR diseases, heart valve [MeSH terms] treatment modalities for hypertensive heart

OR cardiac hypertrophy [MeSH terms] disease. Cardiovascular 3. #3 heart* OR cardi* In addition to the medical devices listed in Table 9, #4 hypertens* OR pressure a number of cardiovascular risk assessment tools #5 #3 AND #4 were identified, including the Framingham Heart #6 #2 OR #5 Study Model, the Cardiovascular Life Expectancy #7 #1 AND #6 Model, the United Kingdom Prospective Diabetes #8 #1 AND #6 Filters: systematic reviews, Study Model and the Symptoms Causes Output published in the past five years, English Resources Effects Model, which are often used in the diagnosis of hypertensive heart disease (24).

Results 3.5 CONCLUSION The strategy yielded 186 results. On the title and The searches identified devices related to the abstract screen, 67 studies were identified that diagnosis and treatment of ischaemic heart reported the use of a device for the prevention, disease, cerebrovascular disease and hypertensive diagnosis or treatment of hypertensive heart heart disease. No specific screening methods disease. The details of the key studies retrieved were identified, although genetic marker testing for full text review are summarized in Table 8. A may be used in screening for hereditary factors broader list of identified devices was obtained associated with an increased risk of cardiovascular through title and abstract review of all included conditions. Prevention is usually associated with studies (Table 9). lifestyle-modification devices. Risk assessment tools are used in the early identification of potential complications.

23 24 2015 Systematic review of needs for medical devices for ageing populations Table 9Hypertensive diseases heart – devices identified for prevention, diagnosisand treatment a CRT: cardiacresynchronizationtherapy; CT: computedtomography; ICD: ND: defibrillator; implantable cardioverter notable tobedetermined. –key studies diseases heart Table 8Hypertensive MRI system INR bloodtest cardiography Doppler cardiac ultrasoundsystem acoustic echocardiography Duplexultrasound; echocardiography; pocket-sized echocardiograms; three-dimensional Ultrasound machinesandtheirmodes: Electrocardiogram machine Haemodynamic monitoringsystem Diagnosis Biofeedback device Prevention Device Study et al2009(11) Thavapalachandran 2010 (27) Dickstein etal (26) Raphael etal2012 (24) Padwal etal2009 Alexis 2009(25) Proprietary marks have wasreadily identified marks beenincludedwherethisinformation throughsourcematerial. Proprietary a evidence Level of ND ND lll l l pacemaker, biventricular pacemaker with pacemaker (CRT-P), permanent CRT withdefibrillator(CRT-D), CRT Implantable cardiac devices: ICD, (including ICD) (conventional andCRT), defibrillator Implantable cardiac devices: pacemaker music device, UsualCare device RESPeRATE (InterCure Ltd), Interactive Lifestyle-modification devices: Resources–Effects model model, Symptoms–Causes–Output– Kingdom Prospective DiabetesStudy life expectancymodel, United StudyModel,Heart cardiovascular Risk-assessment tools: Framingham Sphygmomanometer Primary focus Primary Appliance IVD test Appliance Appliance Implant Appliance Description a function organs andmuscle. Measures heart, cardiac vasculature and radiowaves tovisualizeanatomy, softtissue, inparticular Medical imagingmodalityusingmagnetic fields and assesses riskfor cerebrovascular disease Monitors effects ofwarfarin(anticoagulationtherapy) and monitoring anddiagnosisofcardiac pathology Views cardiac anatomy andassessescardiac functioninthe Monitors anddiagnosescardiac pathology Implantable cardiac pressure monitoringdevice blood pressure Improves cardiac performance by assistingmaintenanceof Function Electrocardiography ll), pulsative device assist device, continuous-flow device (HeartMate ablation, biventricular stimulation, leftventricular therapy combiningCRT, atrioventricular node Electrocardiography, echocardiography, hybrid pressure monitor Grab It!(Datatrend Software), standard blood radioisotope renal scan angiography, CTangiography, captopril-enhanced Doppler sonography, magneticresonance Screening for renal vasculardisease: (duplex) test, captopril suppression test saline loadingtests, fludrocortisone suppression concentration, plasmaaldosterone concentration, Screening for hyperaldosteronism: plasmarenin and triglycerides, urinealbumin cholesterol, low-density lipoprotein cholesterol total cholesterol andhigh-densitylipoprotein creatinine), fastingbloodglucose, fastingserum IVD: (potassium, bloodchemistry sodium, scintigraphy, nuclear imaging tomography, iodine-131metaiodobenzylguanidine echocardiography, electrocardiography, computed sphygmomanometer, manometer blood pressure monitor, stethoscope, Global riskassessmenttool, ambulatory Cuff, stethoscope, charts observation Secondary focus Secondary Devicea Description Function CT system Appliance Medical imaging modality using computer-processed X-rays to generate cross-sectional images of body. May involve intravenously injected contrast agents. Measures heart and cardiac vasculature function X-ray machine Appliance Uses penetrating electromagnetic radiation to visualize anatomical structures. Measures heart and major cardiac vasculature Electro-anatomical mapping system (EnSite Appliance Rapid, high-density atrial mapping. Cardiac chambers are NavX™) mapped during rhythm of interest, and patterns of atrial activation are analysed to identify wavefronts of electric propagation 20-pole penta-array catheter Consumable Rapid, high-density atrial mapping. Part of electro-anatomical mapping system Treatment Endoscope Instrument Assists endoscopic submucosal dissection External ventricular support device: HeartNet; Implant Management of cardiac aneurism, hypertrophy and CorCap cardiomegaly Implantable cardioverter-defibrillator Implant Detects cardiac arrhythmia and corrects by delivering jolt of electricity

Cardiac resynchronization therapy device Implant Resynchronizes contractions of heart’s ventricles by diseases delivering electrical impulses to heart muscle 3. Cardiovascular Cardiovascular 3. Ventricular assist device and left ventricular Implant/ Assists maintenance of ventricular output assist deviceb Appliance

Dual chamber implantable defibrillator Implant Implantable defibrillator Intra-aortic balloon pump Instrument Increases myocardial oxygen perfusion and cardiac output Contractility modulation pulse generator Implant Increases cardiac contraction by improving function of cardiomyocytes Biventricular pacemaker Implant Controls abnormal heart rhythm. Can pace both septal and lateral walls of left ventricle Permanent pacemaker Implant Controls abnormal heart rhythm Prosthetic heart valves (e.g. Freedom Solo, Prosthesis Aortic valve replacement procedure Carpentier-Edwards) Sorin Bicarbon bileaflet Prosthesis Valvuloplasty MitraClip Implant Percutaneous mitral valve repair device Kalangos ring, De Vega semicircular rings Implant Annuloplasty Annuloplasty ring, semi-rigid ring, rigid ring Implant Valve repair in management of mitral regurgitation Coapsys device Implant Decreases chronic ischaemic mitral regurgitation by geometrically reshaping mitral valve Mitral contour system (Carillon system) Implant Implanted into coronary venous system to enable tension of mitral ring in order to improve coaptation of leaflets Mobile respiratory spirometric device Appliance Monitors respiratory capability Embolic protection system Consumable Angioplasty procedure Blood gas analyser Instrument Monitors ventilation and acidosis Aortic cross-clamp Instrument Clamps aorta and separates systemic circulation from outflow of heart Electrocautery Instrument Cuts and cauterizes tissue and blood vessels Snare Instrument Assists marking of mucosa at tumour Oral gastric tube Instrument Nasogastric decompression during surgery Cyanoacrylate glue Consumable Prevents postoperative sternal wound infections Radiation-absorbing drape Consumable Shield for protection

Continues… 25 26 2015 Systematic review of needs for medical devices for ageing populations aneurysms, cardiomegaly and cardiac hypertrophy. cardiac valve pathologies, cardiomyopathies, result from malignant hypertension, suchas and cardiac functional insufficiencies thatcould cardiac diseasesincludeatherosclerotic diseases cardiovascular or renal inorigin. Associated toanotherdisease,or secondary commonly diseasemayHypertensive heart beidiopathic andtreatment options. these services devices andconsumablesare involved in providing vascular stenosis. Numerous otherassisting as drug-elutingstents, may beusedtoresolve and devices for removing bloodclots. Stents, such endovascular ofemboliccoilandstents, delivery conditions, including cathetersandguide-wires for identified for thetreatment ofcerebrovascular sudden cardiac death. Numerous devices were used toassistventricular functionandtoprevent cardiac resynchronization therapy devices may be devices suchasimplantabledefibrillatorand strategies for management. Implantablecardiac reconstruction procedures are the mainsurgical diagnoses. Bypassgrafting procedures andvascular biomarker testshave beenusedfor differential apparatus identified. Inaddition, several invitro tomography (PET)are themaindiagnostic tomography (CT)and positron-emission echocardiography, X-ray, sonography, computed morphology. Electrocardiography, Holtermonitor, by testing cardiovascular functionality and atherosclerosis. These diseases are diagnosed dueto orcerebralof acoronary artery disease are commonly causedby stenosis diseaseandcerebrovascularIschaemic heart b a CT, computedtomography; INR: ratio; normalized international IVD: invitrodiagnostic; MRI: magneticresonanceimaging. Clip Gauze Ligature Suture Device May beimplantable orextracorporeal. have wasreadily identified marks been included wherethisinformation throughsourcematerial. Proprietary a Consumable Consumable Consumable Consumable Description valve implantation. Numerous ringsandmechanical corrected by valve reconstruction orprosthetic to monitor blood pressure. Valve is pathology as thesphygmomanometer are commonly used hypertensive diseases. heart Manometers such electro-anatomical mapping inthediagnosisof imaging (MRI), nuclear cardiac imagingand search identified theuseofmagnetic resonance diagnosis ofatherosclerotic diseases, theliterature 5. 4. 3. 2. 1. REFERENCES and pacemakers. range of implantabledevices suchas valves, stents and improve healthoutcomesincludeabroad vascular ruptures. Devices toprevent failure heart are implantedfor theprevention ofcardiac and or biologicalvalves are used. devices Support Surgery Surgery Surgery Surgery Function In addition tothemodalitiesidentified inthe

Global burden of disease 2012 summary tables.Global burden of disease 2012 summary Geneva: Circulation. 1999;100:1481–92. Association and the College of Cardiology.American for healthcare professionals from the Heart American a statement assessment equations:multiple-risk-factor Fuster V. by ofcardiovascular useof risk Assessment SM,Grundy R, Pasternak GreenlandP, SmithS, Jr, 24th edn. Philadelphia, PA:Elsevier Saunders; 2011. and vascular biology.Goldman’s In: Cecil medicine, Hansson GK, Hamsten A. Atherosclerosis, thrombosis, htmll, accessed6March2015). healthinfo/global_burden_disease/estimates/en/index2. World HealthOrganization; 2014(http://www.who.int/ html, accessed6March2015). healthinfo/global_burden_disease/estimates/en/index1. Health Organization; 2014(http://www.who.int/ tables.Causes ofdeath2012summary Geneva: World 2014). resources/atlas/en/, accessed19February 2011 (http://www.who.int/cardiovascular_diseases/ and control. Geneva: World HealthOrganization; Global atlasoncardiovascular diseaseprevention 6. Bavry AA, Kumbhani DJ, Bhatt DL. Role of adjunctive 17. Brinjikji W, Cloft HJ, Kallmes DF. Difficult aneurysms for thrombectomy and embolic protection devices in acute endovascular treatment: overwide or undertall? AJNR myocardial infarction: a comprehensive meta-analysis Am J Neuroradiol. 2009;30:1513–17. of randomized trials. Eur Heart J. 2008;29:2989–3001. 18. Fraser JF, Smith MJ, Patsalides A, Riina HA, Gobin YP, 7. Biondi-Zoccai GG, Lotrionte M, Moretti C, Meliga E, Stieg PE. Principles in case-based aneurysm treatment: Agostoni P, Valgimigli M, et al. A collaborative systematic approaching complex lesions excluded by International review and meta-analysis on 1278 patients undergoing Subarachnoid Aneurysm Trial (ISAT) criteria. World percutaneous drug-eluting stenting for unprotected Neurosurg. 2011;75:462–75. left main coronary artery disease. Am Heart J. 19. Nagy G, Major O, Rowe JG, Radatz MW, Hodgson 2008;155:274–83. TJ, Coley SC, et al. Stereotactic radiosurgery for 8. Byrne RA, Iijima R, Mehilli J, Pinieck S, Bruskina O, arteriovenous malformations located in deep critical Schomig A, et al. Durability of antirestenotic efficacy regions. Neurosurgery. 2012;70:1458–71. in drug-eluting stents with and without permanent 20. Ottomeyer C, Zeller J, Fesl G, Holtmannspotter M, polymer. JACC Cardiovasc Interv. 2009;2:291–9. Opherk C, Bender A, et al. Multimodal recanalization 9. Chander A, Brenner M, Lautamaki R, Voicu C, Merrill J, therapy in acute basilar artery occlusion: long- Bengel FM. Comparison of measures of left ventricular term functional outcome and quality of life. Stroke. function from electrocardiographically gated 82Rb PET 2012;43:2130–35. with contrast-enhanced CT ventriculography: a hybrid 21. White M, Mathieson CS, Campbell E, Lindsay KW, PET/CT analysis. J Nucl Med. 2008;49:1643–50. Murray L. Treatment of chronic subdural haematomas: 10. Suyker WJ, Borst C. Coronary connector devices: a retrospective comparison of minicraniectomy versus

analysis of 1,469 anastomoses in 1,216 patients. Ann burrhole drainage. Br J Neurosurg. 2010;24:257–60. diseases Thorac Surg. 2008;85:1828–36.

22. BMJ Evidence Centre. Subarachnoid haemorrhage. Cardiovascular 3. 11. Thavapalachandran S, Leong DP, Stiles MK, John B, London: BMJ Publishing Group; 2012 Dimitri H, Lau DH, et al. Evidence-based management 23. U.S. National Library of Medicine. Hypertensive heart of heart failure in clinical practice: a review of device- disease. Bethesda, MD: National Institutes of Health; based therapy use. Intern Med J. 2009;39:669–75. 2013 (http://www.nlm.nih.gov/medlineplus/ency/ 12. What are cerebrovascular diseases? London: NHS article/000163.htm, accessed 19 February 2014). Choices; 2011 (http://www.nhs.uk/conditions/ 24. Padwal RS, Hemmelgarn BR, Khan NA, Grover S, Cerebrovascular-disease/Pages/Definition.aspx, McKay DW, Wilson T, et al. The 2009 Canadian accessed 19 February 2014). Hypertension Education Program recommendations 13. Stroke: diagnosis and initial management of acute for the management of hypertension. Part 1 – blood stroke and transient ischaemic attack (TIA). London: pressure measurement, diagnosis and assessment of National Institute for Health and Clinical Excellence; risk. Can J Cardiol. 2009;25:279–86. 2008. 25. Alexis O. Providing best practice in manual blood 14. Best Practice. London: BMJ Publishing Group; 2012 pressure measurement. Br J Nurs. 2009;18:410–15. (http://bestpractice.bmj.com/best-practice/welcome. 26. Raphael CE, Whinnett ZI, Davies JE, Fontana M, Ferenczi html, accessed 19 February 2014). EA, Manisty CH, et al. Quantifying the paradoxical 15. Agarwal S, Bajaj NS, Kumbhani DJ, Tuzcu EM, effect of higher systolic blood pressure on mortality in Kapadia SR. Meta-analysis of transcatheter closure chronic heart failure. Heart. 2009;95:56–62. versus medical therapy for patent foramen ovale in 27. Dickstein K, Vardas PE, Auricchio A, Daubert JC, Linde prevention of recurrent neurological events after C, McMurray J, et al. 2010 Focused update of ESC presumed paradoxical embolism. JACC Cardiovasc guidelines on device therapy in heart failure: an update Interv. 2012;5:777–89. of the 2008 ESC Guidelines fo7r the diagnosis and 16. Aqel R, Dorfman TA. The brain first or the heart: treatment of acute and chronic heart failure and the the approach to revascularizing severe co-existing 2007 ESC Guidelines for cardiac and resynchronization carotid and coronary artery disease. Clin Cardiol. therapy. Developed with the special contribution of 2009;32:418–25. the Heart Failure Association and the European Heart Rhythm Association. Europace. 2010;12:1526–36.

27 28 2015 Systematic review of needs for medical devices for ageing populations Incidence of cancer, worldwide and Western Pacific Region (3) Region Pacific Western and worldwide cancer, of Table 10 Incidence of many cancers; thiscouldbeduetothe is anon-modifiableriskfactor for thedevelopment The incidenceofcancerriseswithage, andageing cause ofdeathduetocancer(1). system todistant sites; metastasesare the major orlymphaticand metastasizeviathecirculatory inherited. Cancerous cellsmay invade localtissue environmental factors, orthemutation may be to theDNAofacellmay ariseasaresult of characterized by unchecked proliferation. Damage over time. Physiologically, cancerous cellsare number ofmutations thathave accumulated may betheresult ofasinglemutation oragreater cell’s lifecycle. Malignantneoplasms, orcancers, of amutation inacell’s DNAthatdisruptsthe Malignant neoplasmsare generally theproduct 4.1 INTRODUCTION 4. Malignantneoplasms Type ofcancer Other pharynx Brain, system nervous Larynx Pancreas Kidney Lip, oral cavity Leukaemia Non-Hodgkin’s lymphoma Bladder Oesophagus Liver Stomach Colorectum Prostate Lung Breast skin cancer All cancers, excludingnon-melanoma 14 067894 Worldwide 1 360602 1 094916 1 824 701 1 671149 142 387 256 213 156 877 337 872 337 860 300 373 351 965 385 741 429 793 455 784 782 451 951 594 Number ofcases from 2012(3). Globocan database and are based on estimates Table 11. datawere obtainedfromAll theonline in the Western PacificRegionissummarizedin with variousmalignantneoplasmsworldwide and summarized in Table 10. associated The mortality worldwide andinthe Western PacificRegionare The incidencesofvariousmalignantneoplasms majority ofworld duetothesecancers. mortality world’s liver andstomachcancersfor the for alargeproportion (more than50%)ofthe to cancer. The Western PacificRegionaccounts breast are the five leading causes of death due Cancer ofthelung, stomach, liver, colorectum and estimated deathsin2012were duetocancer(2). ageing. Inthe Western PacificRegion, 22%ofall as the underlying biological processes involved in accumulation ofenvironmental riskfactorsaswell Western Pacific 4 543359 459 958 153 167 838 978 329 762 113 015 254 572 500 506 571 139 Region 19 241 82 184 29 647 98 473 47 524 95 087 84 401 91 294 reported in Western reported Pacific Region(%) Worldwide cases 34 14 46 20 32 14 32 19 33 29 16 27 22 21 56 64 60 Type of cancer Number of cases Worldwide cases reported in Western Pacific Region (%) Melanoma of skin 232 130 27 772 12 Gallbladder 178 101 81 549 46 Nasopharynx 86 691 45 726 53 Multiple myeloma 114 251 20 932 18 Testis 55 266 5 819 11 Thyroid 298 102 101 489 34 Hodgkin’s lymphoma 65 950 5 066 8

Table 11 Mortality due to cancer, worldwide and Western Pacific Region (3)

Type of cancer Number of deaths Worldwide deaths reported in Western Worldwide Western Pacific Region Pacific Region (%) All cancers, excluding non- 8 201 575 2 978 084 36 melanoma skin cancer Lung 1 589 925 747 920 47 Stomach 723 073 409 897 57 Liver 745 533 476 692 64 Colorectal 693 933 224 808 32 Breast 521 907 85 837 16 Oesophagus 400 169 219 296 55 4. Malignant neoplasms 4. Cervix uteri 265 672 43 220 16 Pancreas 330 391 108 444 33 Prostate 307 481 45 977 15 Leukaemia 265 471 76 977 29 Non-Hodgkin’s lymphoma 199 670 47 335 24 Brain, nervous system 189 382 59 984 32 Bladder 165 084 39 606 24 Ovary 151 917 26 163 17 Lip, oral cavity 145 353 22 068 15 Kidney 143 406 38 951 27 Gallbladder 142 823 68 486 48 Other pharynx 96 105 12 048 13 Larynx 83 376 15 778 19 Corpus uteri 76 160 22 776 30 Multiple myeloma 80 019 15 689 20 Nasopharynx 50 831 26 763 53 Melanoma of skin 55 488 9 802 18 Thyroid 39 771 10 469 26 Hodgkin’s lymphoma 25 469 1 801 7 Testis 10 351 1 264 12 29 30 2015 Systematic review of needs for medical devices for ageing populations controlled trialsandsystematicreviews. within thepastfive years andrandomized search results:English languageandpublished cancer. The following filters were applied tothe diagnosis ortreatment ofmouthandoropharyngeal devices thatcouldbeusedintheprevention, incorporating text and MeSH terms to identify An apriorisearch wasdeveloped strategy Methodology programmesin theplanningofintervention (6). Health Programme toassessriskfactorsandassist consumption. WHO has established a Global Oral may befocused onreducing smokingandalcohol south-central Asia andIndia. Preventive strategies countries, highincidenceratesin withparticularly cancervariessubstantiallyoropharyngeal between (3).other pharynx The incidenceoforalcavity and oral cavity and0.5per100000for cancersofthe was 0.9per100000for cancersofthelipor standardized worldwide rateofcancerin2012 countries than developed countries than women andismore common indeveloping The incidenceoforalcancerishigherinmen 40–60 years) (5). is commonly reportedinyounger patients(aged tumours, oforopharyngeal the aetiology which human papilloma virushasbeenimplicatedin betel nut isalsoariskfactor. Infection withthe are tobaccoandalcoholconsumption. Chewing factors for cancerofthemouthandoropharynx are distinct neoplastic entities. The major risk tongue gum/gingiva, hard palate, retromolar trigone or arising from any region oftheoralcavity:the lip, wall.posterior pharyngeal Mouthcanceris soft palate, uvula, tonsillarpillar, tonsilorlateral regionthe base ofthetongue, oftheoropharynx: cancer is cancer arising fromOropharyngeal any Introduction OROPHARYNX 4.2 CANCEROF THE MOUTH AND (4). cancers Mouthandoropharyngeal . The age- (6). The as well astherapeutic procedures. Laserablation screening and diagnostic machines and procedures, A review oftheliterature identified a focus on studies (Table 13). through titleandabstractreview ofallincluded broader listofidentified devicesA wasobtained for fulltextreview are summarizedin Table 12. cancer. The detailsofthekey studiesretrieved diagnosis ortreatment ofmouthandoropharyngeal reported the use of a device for the prevention, abstract screen, 86 studies were identified that yielded 183 results.The strategy On the title and Results clinical practiceguidelines(7). The results ofthesearch were supplementedwith #13 #12 #11 #10 #9 #8 #7 #6 #5 #4 #3 #2 #1 #12 AND #1 #12 AND #8 OR#9#10#11 #2 OR#3#4#5#6#7 cancer* AND oropharyn* tumor* AND oropharyn* tumour* AND oropharyn* andneoplasm* oropharyn* neoplasms(MeSH) oropharynx cancer* mouth AND tumour* mouth AND tumor* mouth AND neoplasm* mouth AND mouth neoplasm(MeSHterms) OR (rehabilitat*) OR(alleviat*)) (prevention) OR(monitoring)(screening) (diagnos*) OR(therap*) OR(treatment*) OR terms]) OR(therapeutics [MeSHterms])OR [MeSH terms])OR(aftertreatment [MeSH prevention[MeSH terms])OR(secondary prevention[MeSH terms])OR(primary ((diagnosis [MeSHterms])OR(rehabilitation OR (material*)(machine*)) AND (apparatus) OR(good*) OR(implement*) OR (appliance*) OR(instrument*) (aid*) OR(equipment)(armamentarium) instruments [MeSHterms])OR(device*) OR (assistive devices [MeSHterms])OR(surgical ((equipment andsupplies[MeSHterms])OR (senior) OR(elderly) OR(geriatric)) AND for theaged[MeSHterms])OR(aged) ((aged [MeSHterms])OR(healthservices of precancerous conditions such as oral excision and chemotherapy. Clinical advice leukoplakia may be considered to be a preventive indicates that specific tools such as oropharyngeal procedure (8). Broader preventive strategies retraction systems and transoral carbon dioxide were aimed at the control of risk factors such as lasers are used to access the primary tumour smoking and high levels of alcohol consumption. during surgery (G Rees, Queen Elizabeth Hospital, Human papilloma virus has been implicated in the Adelaide, Australia, personal communication, aetiology of oropharyngeal cancers, and future 29 January 2013). Transoral robotic resection preventive strategies may focus on this risk factor. is currently used in clinical practice in some countries where the device is available. A large The search strategy identified a number of devices range of devices used in reconstruction following used to visualize lesions in screening examinations resection and treatment of radiotherapy-induced performed by a dentist or physician (Table 13). complications was identified, including speaking Cancers of the mouth and oropharynx are rare, valves (Table 13). however, and a large proportion of patients present with advanced or metastatic disease. The search identified one study indicating that high Histological analysis of biopsy samples is the epidermal growth factor receptor expression and definitive diagnosis of mouth and oropharyngeal other molecular markers in tumour samples may cancer, and the search identified several biopsy assist in identifying patients who would benefit devices. from accelerated radiotherapy (9); this novel test has been identified as a horizon-scanning The main therapeutic interventions identified technology. included radiotherapy, brachytherapy, surgical

Table 12 Oropharyngeal and mouth cancer – key studies

Study Level of Primary focusa Secondary focus evidence 4. Malignant neoplasms 4. Arden et al 1999 (10) IV Three-dimensional bendable Solid screws mandibular reconstruction plates Drill Skin graft Radiotherapy: external beam Brachytherapy Hyperfractionation radiotherapy Balevi et al 2007 (11) NA VELscope® None Deo et al 2005 (12) II Harmonic scalpel (ultrasonic Electrocautery dissection) Silk ligatures Coagulation shears Skin staplers Sponges Drains Herberer et al 2011 (13) IV Dental implants Ablative therapy Mucke et al 2010 (14) IV Surgery CT imaging MRI Skeletal scintigraphic surveys Sonography Gastroscopy Bronchoscopy X-ray Continues…

31 32 2015 Systematic review of needs for medical devices for ageing populations treatment and diagnosis prevention, for identified –devices cancer mouth and Table 13 Oropharyngeal a CT: computedtomography; MRI: magneticresonanceimaging; NA: notapplicable. Device Study Sweeny etal2011(15) White-light imagingunit Diagnosis Er:YAG laser Prevention Narrow-band imagingunit CO Handheld autofluorescence unit Biopsy needle Handheld tissuereflectance unit Fibre-optic spectrometer Depth-sensitive oralspectroscope Forceps Ultrasound CT system MRI scanner Gastroscope Bronchoscope X-ray machine PET system Medical linearaccelerator Treatment Collimator Catheter Interstitial radioactive seed Surgical System®) Robotic surgical system(da Vinci Proprietary marks have wasreadily identified marks been includedwherethisinformation throughsourcematerial. Proprietary 2 laser a evidence Level of IV Appliance Description Instrument Appliance Instrument Instrument Instrument Instrument Instrument Instrument Instrument Appliance Appliance Appliance Instrument Instrument Appliance Appliance Appliance Appliance Consumable Material Appliance Primary focus Primary and tissuereflectance) (combination autofluorescence Handheld detectiondevice Ablates lesions(oralleukoplakia) Function carcinomas Improves visualizationinscreening anddetectionofsquamouscell Ablates lesions(oralleukoplakia) Oral cancerscreening/detection ofsquamouscellcarcinomas Oral cancerscreening Takes tissuesamplesfor screening anddiagnosis Oral cancerscreening Oral cancerscreening Oral cancerscreening Biopsy procedures Guides biopsyprocedures and staging contrast agents. Provides imagesofareas ofbodytoassist in diagnosis cross-sectional imagesofbody. May involve intravenously injected Medical imagingmodalityusingcomputer-processed X-rays togenerate images ofareas ofbodytoassistindiagnosisandstaging visualize anatomy, softtissue, inparticular organsandmuscle. Provides Medical imagingmodalityusingmagneticfields andradiowaves to Helps tovisualizeoralcavity Helps tovisualizeoralcavity structures for diagnosisandstagingofcancer Uses penetratingelectromagnetic radiationtovisualize anatomical staging (nuclear imagingtechnique) within body. Provides imagesofareas ofbodytoassistindiagnosisand tracers togeneratethree-dimensional imagesofmetabolicprocesses Nuclear medicineimagingmodalityusingpositron-emitting radionuclide hyperfractionation and externalbeamradiotherapy Generates radiationinradiotherapy procedures, including Delivers radiotherapy inintensity-modulatedradiotherapy Delivers brachytherapy Required todeliver brachytherapy Robotic surgery for treatmentRobotic surgery ofmalignantheadandneck lesions a Depth-sensitive oralspectroscopy Fibre-optic spectrometers Tissue reflectance (handheld) Biopsy White-light visualization focus Secondary Devicea Description Function

CO2 laser Appliance Treatment of radiation-induced mucositis Surgical resection procedures Retractor Instrument Surgical resection procedures Three-dimensional bendable Implant Reconstruction in oral cavity/oropharyngeal carcinoma mandibular reconstruction plate Solid screw Consumable Reconstruction in oral cavity/oropharyngeal carcinoma Drill Appliance Reconstruction in oral cavity/oropharyngeal carcinoma Obturator Implant Reconstruction in oral cavity/oropharyngeal carcinoma Intubating laryngeal mask airway Instrument Intubation in patients scheduled for oral surgery tracheal tube Endonasal endoscope Instrument Minimally invasive treatment of pituitary adenomas Therabite mechanical jaw Appliance Improves mandibular mobility after composite resection mobilization system LigaSure™ vessel sealing system Instrument Seals vessels in lobectomy of parotid gland Harmonic scalpel system Instrument Ultrasonic dissection Electrocautery unit Instrument Cautery dissection Silk ligature Consumable Surgical procedures Coagulation shears Instrument Surgical procedures Sponge Consumable Surgical procedures Skin stapler Instrument Surgical procedures Drain Instrument Surgical procedures Dental implant Implant Reconstruction in head/neck cancer Face pad Consumable Application of pressure to face after parotid surgery Bipolar diathermy system Appliance Homeostasis in surgical procedures 4. Malignant neoplasms 4. Syringe Consumable Administers anaesthesia Patient-controlled analgesia unit Appliance Delivers pain-relieving medicine following surgery Intubation tube Consumable Intubation in patients scheduled for oral surgery Gelclair® Material Pain relief of oral mucositis Nasal cannula Instrument Treatment of radiation-induced xerostomia Bedside humidifier Appliance Treatment of radiation-induced xerostomia Indwelling tracheo-oesophageal Implant Voice restoration following total laryngectomy speaking valve Gastrostomy tube Consumable Nutritional delivery device postoperatively

CT: computed tomography; Er:YAG: erbium-doped yttrium aluminium garnet; MRI: magnetic resonance imaging; PET, positron-emission tomography. a Proprietary marks have been included where this information was readily identified through source material.

4.3 OESOPHAGEAL CANCER disease and family history of cancer. Environmental factors such as tobacco use, heavy consumption Introduction of alcohol, consumption of hot drinks, exposure Cancer of the oesophagus is associated with to certain chemicals (such as nitrosamines, a wide range of conditions and risk factors, acetaldehyde, mycotoxins and polycyclic aromatic including gastro-oesophageal reflux disease, hydrocarbons), nutritional deficiencies, poor oral human papilloma virus infection, Plummer–Vinson health, achalasia and low socioeconomic status are syndrome, tylosis, Howel-Evans syndrome, coeliac also risk factors (16). 33 34 2015 Systematic review of needs for medical devices for ageing populations systematic reviews. yearsandrandomizedcontrolled trialsand five English languageandpublishedwithinthepast following filters were applied tothesearch results: diagnosis ortreatment ofstomachcancer. The devices thatcouldbeusedintheprevention, incorporating text and MeSH terms to identify An apriorisearch wasdeveloped strategy Methodology reported from China(17). half of the cases of squamous cell carcinoma are oesophageal cancerincidenceworldwide. Nearly carcinoma represents approximately 90%oftotal histological typesofthedisease. Squamouscell cell carcinoma and adenocarcinoma are the major 100 000in Australia to12.5inChina(3). Squamous varies between countries, for examplefrom 3.5per cause ofcancer-related deaths. The incidence cancer worldwide andtheseventh mostcommon Oesophageal canceristheninthmostcommon #10 #9 #8 #7 #6 #5 #4 #3 #2 #1 oesophag* AND cancer* oesophag* AND cancer* esophag* AND tumour* oesophag* AND tumour* esophag* AND tumor* oesophag* AND tumor* esophag* AND neoplasm* oesophagi* AND neoplasm* esophag* AND esophageal neoplasms[MeSHterms] OR (rehabilitat*) OR(alleviat*)) (prevention) OR(monitoring)(screening) (diagnos*) OR(therap*) OR(treatment*) OR terms]) OR(therapeutics [MeSHterms])OR [MeSH terms])OR(aftertreatment [MeSH prevention[MeSH terms])OR(secondary prevention[MeSH terms])OR(primary ((diagnosis [MeSHterms])OR(rehabilitation OR (material*)(machine*)) AND (apparatus) OR(good*) OR(implement*) OR (appliance*) OR(instrument*) (aid*) OR(equipment)(armamentarium) instruments [MeSHterms])OR(device*) OR (assistive devices [MeSHterms])OR(surgical ((equipment andsupplies[MeSHterms])OR (senior) OR(elderly) OR(geriatric)) AND for theaged[MeSHterms])OR(aged) ((aged [MeSHterms])OR(healthservices required for severe dysphagiaor reflux (25). managed usingstents, andenteralfeeding may be (24). Complicationsofadvanceddiseasemay be chemotherapy and varioustypesofradiotherapy and oesophagogastrostomy (25), togetherwith cancer istreated withradicaloesophagectomy for Barrett’s oesophagus. oesophageal Advanced techniques endoscopic mucosal resection andablation Early stagesofthecancerare managed by diagnosis (20,21). identified thatthesetestsmay have a role in tomography, althoughsupplemental investigation did notidentifyMRIandopticalcoherence searchof oesophagealcancerdiagnosis(19). The PET/CT scanningisrecommended for alltypes staging anddifferential diagnosis; for example, number ofimagingdevices may assistwithdisease chromoendoscopy andvideoendoscopy (18).A designs were identified, includingthose for oesophageal cancer. varietyofendoscope A commonly useddiagnosisprocedure for Oesophagogastroduodenoscopy isthemost helpful inidentifyingpatientsprone tothedisease. suggested thatscreening for H. may pylori be tests were identified; however, theliterature No preventive modalitiesorinvitro diagnostic diagnosis andtreatment ofoesophagealcancer. The search identified devices related tothe (Table 15). title andabstractreview ofallincludedstudies list ofidentified devices wasobtainedthrough review are summarizedin Table 14. broader A details ofthekey studiesretrieved for fulltext diagnosis ortreatment ofoesophagealcancer. The reported the use of a device for the prevention, abstract screen, 15 studies were identified that yielded45results.The strategy Onthetitleand Results #13 #12 #11 #1 AND #11 #1 AND #11 #1 AND #8 OR#9#10 #2 OR#3#4#5#6#7 (22), includingradiofrequency ablation Table 14 Oesophageal cancer – key studies

Study Level of Primary focusa Secondary focus evidence Kranzfelder et al 2009 l Diagnosis of tumour staging and Gastric tube, stapler, needles (26) potential systemic diseases, including F-deoxyglucose PET, PET/CT scan, Procedures: Ivor Lewis procedure, transhiatal endoscope (oesophagoscopy, oesophagectomy panendoscopy, bronchoscopy, laparoscopy), endoscopic ultrasound, CT, echocardiography, electrocardiography, sonography, endosonography, X-ray Shen et al 2012 (27) II Imaging, including PET/CT, PET/ Procedure: hand/video-assisted thoracoscopic CT/X-ray (e.g. GE Discovery® LS4 oesophagectomy, Ivor Lewis oesophagectomy, PET/CT), ring detectors (attachment double-lumen endotracheal intubation to PET) Muto et al 2010 (18) ll Endoscopic imaging Lugol chromoendoscopy, narrow-band imaging filters, endoscope (e.g. GIF-Q240Z), video- Narrow-band imaging endoscope system (e.g. EVIS Lucera®) White light imaging Procedures: endoscopic mucosal resection Bergman et al 2011 ll Endoscopic radiofrequency ablation White-light endoscopy, chemoendoscopy, (28) Lugol’s chromoendoscopy, CT endoscope (e.g. Electrode, balloon (e.g. HALO90 and 360 Olympus GIF-H260), endoscopes (Lucera™ HALO ) systems), mechanical radial ultrasonic Catheters, catheter balloon gastrovideoscope (e.g. Olympus GF-UM2000), biopsy forceps Procedure: fundoplication Blomberg et al 2010 ll Stents/SEMS: anti-reflux stent, anti- X-ray (fluoroscopic monitoring), guide-wire (29) reflux valve/sleeve; conventional (e.g. Savary-Gilliard wire), endoscope, balloon SEMS (e.g. Ultraflex®, Wallstent®) dilator

CT: computed tomography; PET, positron-emission tomography; SEMS: self-expandable metallic stent. a Proprietary marks have been included where this information was readily identified through source material.

Table 15 Oesophageal cancer – devices identified for diagnosis and treatment Malignant neoplasms 4.

Devicea Description Function Diagnosis Endoscope Instrument Examination of oesophagus for screening and diagnosis Conventional white-light imaging Video-assisted thoracoscope Narrow-band imaging endoscope Instrument Endoscopic diagnostic imaging technique using light of specific blue and green wavelengths to enhance detail of certain aspects of surface mucosa Ultrasound (endoscopic ultrasound) Appliance Guides fine-needle aspiration and biopsy in cancer diagnosis PET system Appliance Nuclear medicine imaging modality using positron-emitting radionuclide tracers to generate three-dimensional images of metabolic processes within body CT system Appliance Medical imaging modality using computer-processed X-rays to generate cross-sectional images of body. May involve intravenously injected contrast agents PET/CT system Appliance Medical imaging modality combining metabolic activity with anatomical location Treatment Endoscope Instrument Visualizes endoscopic submucosal dissection Radiofrequency ablator Appliance Focal ablation of areas of Barrett’s oesophagus Laser and photodynamic therapy Appliance Provides very high-intensity light to allow ablation and scarring machine Multipolar electrocoagulator machine Appliance Endoscopic ablation of oesophageal mucosa Continues… 35 36 2015 Systematic review of needs for medical devices for ageing populations Australia, New Zealandandmany countriesin are reportedto have peaked inNorth America, risk. Lungcancerincidenceratesamong males pneumonia are alsoassociatedwithanincreased diseases ofthelungsuchastuberculosis and oflungcancer andpre-existing family history A carcinogens suchasasbestos andairpollution. exposure toradon gas, andindustrial orchemical factors for thedevelopment oflungcancerinclude lung cancer is tobacco smoking. Environmental risk metastasize the more aggressive, having ahigherpropensity to non-small celllungcancer. Smallcelllungcanceris is categorized aseithersmallcelllungcanceror most commoncancersworldwide. Lungcancer Cancers ofthelung, tracheaandbronchus are the Introduction AND BRONCHUS 4.4 CANCEROF THE LUNG, TRACHEA a CT: computedtomography; PET: positron-emissiontomography. Device Argon plasmacoagulationmachine Cryoablation machine Cryoablation Radiofrequency machine stent stent (Z-Stent®); double-layered; Niti-S (e.g. Ultraflex®, Wallstent®); anti-reflux Stents: self-expandablemetallicstent Anti-reflux valve Electrocautery Guide-wire Snare Nasogastric tube Stapler Provox HME®) Heat andmoisture exchanger(e.g. Gauze Suture Clip Ligature Proprietary marks have wasreadily identified marks beenincludedwherethisinformation throughsourcematerial. Proprietary a (30). The predominant causalfactorfor Description Appliance Appliance Appliance Implant Implant Instrument Consumable Consumable Consumable Instrument Instrument Consumable Consumable Consumable Consumable Function Controls bleedingfrom lesionsingastrointestinal certain tract Low temperature usedtotreat/ablate dysfunctionaltissue Ablates dysfunctionaltissue manage dysphagia Management ofanastomoticleakageafteroesophagectomy to Prevents gastro-oesophageal reflux following stentinsertion Marking/cutting ofmucosa attumour Part ofcatheterusedtodeployPart stents Marking ofmucosa attumour Assistance to surgery andnasogastricdecompression Assistance tosurgery Oesophagogastric anastomosisafteroesophagealcancerresection ventilation Prevents mucosa ofrespiratory duringmechanically drying Surgical procedures Surgical procedures Surgical procedures Surgical procedures estimated inmiddle andwestern Africa (31) . America andeastern Asia, low while very ratesare in central, easternandsouthernEurope, North throughout theworld:high ratesare observed lung cancer reflects trends in smoking prevalence frequently thanwomen (3). of The epidemiology to be148per100 000, withmenaffected more for peopleaged60years orover isestimated age-standardized rateoflungcancerworldwide the mostcommoncauseofcancermortality. The new casesoflungcancerandwas By 2008there were anestimated1.61 million 31% in1980toapproximately 50%in2002(30). a proportion oflungcancersworldwide rose from lung cancersdiagnosedindeveloping countriesas Japan andChina. Overall thepercentage ofnew many southernandeasternEuropean countries, have beenincreasing orhave beguntoplateauin subsequently declined. Incontrast, incidencerates north-western Europe during the 1980s, and have Methodology Results An a priori search strategy was developed The strategy yielded 181 results. On the title and incorporating text and MeSH terms to identify abstract screen, 52 studies were identified that devices that could be used in the prevention, reported the use of a device for the prevention, diagnosis or treatment of lung, trachea and diagnosis or treatment of lung, trachea or bronchus cancer. The following filters were bronchus cancer. The details of the key studies applied to the search results: English language and retrieved for full text review are summarized in published within the past five years and randomized Table 16. These studies were then used to inform controlled trials and systematic reviews. the list of devices presented in Table 17.

#1 ((aged [MeSH terms]) OR (health services A review of the included studies identified a focus for the aged [MeSH terms]) OR (aged) OR on diagnosis and treatment. The search did not (senior) OR (elderly) OR (geriatric)) AND ((equipment and supplies [MeSH terms]) OR identify any devices for the prevention of lung (assistive devices [MeSH terms]) OR (surgical cancer. Screening using X-ray and sputum cytology instruments [MeSH terms]) OR (device*) OR (aid*) OR (equipment) OR (armamentarium) in the general population or with scanning in high- OR (appliance*) OR (instrument*) OR risk patients does not appear to be supported (apparatus) OR (good*) OR (implement*) OR (material*) OR (machine*)) AND (31–33). ((diagnosis [MeSH terms]) OR (rehabilitation [MeSH terms]) OR (primary prevention The search identified a range of devices used in [MeSH terms]) OR (secondary prevention the diagnosis and staging of lung cancer, including [MeSH terms]) OR (after treatment [MeSH terms]) OR (therapeutics [MeSH terms]) OR imaging devices and devices to obtain a tissue (diagnos*) OR (therap*) OR (treatment*) OR sample for pathology (Table 17). Treatment (prevention) OR (monitoring) OR (screening) OR (rehabilitat*) OR (alleviat*)) options include surgical resection (lobectomy), #2 neoplasm, tracheal [MeSH terms] chemotherapy and radiotherapy. Ablative #3 trachea* AND tumor* technologies and video-assisted thorascopic surgery were identified as emerging therapies for #4 trachea* AND neoplasm*

lung cancer. Malignant neoplasms 4. #5 trachea* AND tumour* #6 trachea* AND cancer* The search also identified a range of sealant #7 #2 OR #3 OR #4 OR #5 OR #6 materials and devices for the reduction of alveolar #8 bronchial neoplasms [MeSH terms] air leak following pulmonary resection. #9 bronchia* AND neoplasm* #10 bronchia* AND tumor* 4.5 STOMACH CANCER #11 bronchia* AND tumour* Introduction #12 bronchia* AND cancer* Gastric cancer is the second most common cancer #13 #8 OR #9 OR #10 OR #11 OR #12 of the gastrointestinal system and the fourth most #14 lung neoplasms [MeSH terms] prevalent cancer worldwide. Although there is #15 lung AND neoplasm* no definitive cause, H. pylori infection, smoking, #16 lung AND tumor* age over 50 years, unbalanced diet and excessive #17 lung AND tumour* salt intake (more than 10 g/day) are risk factors. #18 lung AND cancer* Family history of stomach cancer, including familial #19 #14 OR #15 OR #16 OR #17 OR #18 adenomatous polyposis and hereditary non- #20 #7 OR #13 OR #19 polyposis colorectal cancer, also predisposes to #21 #20 AND #1 the disease (41).

37 38 2015 Systematic review of needs for medical devices for ageing populations Lung, trachea and bronchus cancer – devices identified for diagnosis and treatment and diagnosis for identified –devices cancer bronchus and Table 17 trachea Lung, a CT: computedtomography; PET: positron-emissiontomography. –key studies cancer bronchus and Table 16 trachea Lung, electromagnetic tracking needle) field generator, fiducialmarkers and computer workstation, electromagnetic Electromagnetic needlesystem(including Coaxial lungbiopsyneedle Flexible fibre-optic bronchoscope Biopsy needle Helical CTsystem Diagnosis Device Study (40) Miyamoto etal2010 Hetzel etal2012(39) Han etal2010(38) Grand etal2011(37) (36) Cerfolio etal2008 (35) Carrafiello etal2012 Brunelli etal2010(5) Proprietary marks have wasreadily identified marks beenincludedwherethisinformation throughsourcematerial. Proprietary a evidence Level of II II II II II II II haemostat absorbable topicalcollagen Integran®: sheettype Rigid tube Flexible bronchoscope Cryoprobe Abdominal compression Electromagnetic needlesystem Heimlich valve Microwave ablation Radiofrequency ablation pressure monitoringdevice Air leakandintrapleural Primary focus Primary Appliance Instrument Instrument Instrument Appliance Description a yield Guides biopsyfor correct positioning andmaximum diagnostic Biopsy oflungmass Visualizes lungstructures Takes tissuesamplefor pathology injected contrastagents. Usedfor screening anddiagnosis generate cross-sectional imagesofbody. May involve intravenously Medical imagingmodalityusingcomputer-processed X-rays to Function Stapler Fibrin glue sheet TachoComb: bioabsorbablepolyglycolic acidmesh Forceps body frame Vacuum cushionaloneorwithinstereotactic Stereotactic bodyradiationtherapy cyclesignalmonitoringsystem Respiratory Four-dimensional CTsimulation withvacuumcushion Coaxial lungbiopsyneedle High-speed CT Single-detector row scanner CT fluoroscopy Chest radiograph Chest retractor Forceps Needles Epidural equipment PET CT function Pulmonary Water sealdevice CT fluoroscopy Thoracic multidetector row CT CT Biopsy needle Staplers Chest drain X-ray Secondary focus Secondary Devicea Description Function Forceps Instrument Takes tissue sample for pathology Brush Instrument Takes tissue sample for pathology Biopsy needles: Tru-cut-type; modified Instrument Takes tissue sample for pathology Menghini-type needle Cryoprobe Instrument Takes tissue sample for pathology (cryobiopsy) Endobronchial ultrasound system Appliance Assists in navigation in biopsy Mediastinoscope Instrument Collects tissue or fluid from lungs PET system Appliance Nuclear medicine imaging modality using positron-emitting radionuclide tracers to generate three-dimensional images of metabolic processes within body. Provides guidance in lung biopsy Spirometer Instrument Measures flow and volume of exhaled air Radial ultrasonic probe Instrument Assists accurate insertion of bronchoscope Suction catheter Instrument Bronchoscopic tissue sampling X-ray machine Appliance Uses penetrating electromagnetic radiation to visualize anatomical structures. Used for distinguishing pathological tissue from normal tissue; diagnosis of lung cancer; pretreatment, intraoperative monitoring, follow-up and screening MRI system Appliance Medical imaging modality using magnetic fields and radiowaves to visualize anatomy, in particular soft tissue, organs and muscle. Provides images of lung tissues Electrocardiogram machine Appliance Electrocardiographic assessment of patients. Treatment Sealants: BioGlue®; Vivostat®; TachoSil®; Consumable Reduces alveolar air leak after pulmonary resection TachoComb®; bioabsorbable polyglycolic acid mesh sheet; fibrin glue; Integran® (sheet type absorbable topical collagen haemostat) Microelectronic mechanical system sensor Appliance Reduces alveolar air leak after pulmonary resection 4. Malignant neoplasms 4. Digital continuous recording system Appliance Monitors air leak Radiofrequency ablation system (including Appliance Ablates lung tumours probe, radiofrequency generator and temperature-monitoring probe) Microwave ablation system (including Appliance Ablates lung tumours microwave generator, microwave antennae and saline perfusion system) Transcutaneous electrical nerve- Appliance Treats pain after thoracotomy stimulation unit

Radiotherapy machine (medical linear Appliance Generates radiation for radiotherapy treatments accelerator)

Immobilization system Instrument Immobilizes patient during stereotactic body radiation therapy

Ventilator Appliance Supports postoperative lung function and during thoracoabdominal oesophagectomy Chest retractor Instrument Pulmonary resection Stapler Instrument Surgical procedures Stents: silicone; metal; covered; uncovered Implant Treats obstruction in thyroid cancer that has invaded larynx or trachea Syringe Consumable Administers pharmacological agents Intercostal drain Instrument Drains lungs following interventional procedure

CT: computed tomography; MRI: magnetic resonance imaging; PET, positron-emission tomography. a Proprietary marks have been included where this information was readily identified through source material.

39 40 2015 Systematic review of needs for medical devices for ageing populations systematic reviews. five years andrandomized controlled trialsand English languageandpublishedwithinthepast following filters were applied tothesearch results: diagnosis ortreatment ofstomachcancer. The devices thatcouldbeusedintheprevention, incorporating text and MeSH terms to identify An apriorisearch wasdeveloped strategy Methodology screenings. which canbeachieved through regular cancer preventionSecondary relies onearly detection, which seekstocontrol aetiologicaldeterminants. prevention is essentially behavioural modification, prevention. andsecondary into primary Primary Prevention ofgastriccancercanbebroadly divided and 9.8per100000women (3). rates are ineastern Asia:24.0 per100000men advanced stage. The highestestimatedmortality only 15–20%becauseitismostly diagnosedatan Overall ofstomachcanceris the5-year survival cancer isnearly twiceashighinmenthanwomen. occur indeveloping countries. The riskofstomach the totalcancerincidence. More than70%ofcases cancer were estimatedin2012, amounting7%of Approximately 1millionnew casesofgastric #3 #2 #1 stomach AND neoplasm* stomach AND stomach neoplasms[MeSHterms] OR (rehabilitat*) OR(alleviat*)) (prevention) OR(monitoring)(screening) (diagnos*) OR(therap*) OR(treatment*) OR terms]) OR(therapeutics [MeSHterms])OR [MeSH terms])OR(aftertreatment [MeSH prevention[MeSH terms])OR(secondary prevention[MeSH terms])OR(primary ((diagnosis [MeSHterms])OR(rehabilitation OR (material*)(machine*)) AND (apparatus) OR(good*) OR(implement*) OR (appliance*) OR(instrument*) OR (aid*) OR(equipment)(armamentarium) instruments [MeSHterms])OR(device*) OR (assistive devices [MeSHterms])OR(surgical ((equipment andsupplies[MeSHterms])OR (senior) OR(elderly) OR(geriatric)) AND for theaged[MeSHterms])OR(aged) ((aged [MeSHterms])OR(healthservices imaging, andinvitro histopathology tests. identified several diagnosticprocedures, including searchat highriskofgastriccancer(43). The vitro diagnosticsinearly identificationofpatients gastrin-17 markers appears to beemergingin pylori strategies for precancerous infections suchasH. cancer. Endoscopeswere identified asscreening prevention, diagnosisandtreatment ofgastric The search identified devices related tothe (Table 19). title andabstractreview ofallincludedstudies list ofidentified devices wasobtainedthrough review are summarizedin Table 18. broader A details ofthekey studiesretrieved for fulltext diagnosis or treatment of colorectal cancer. The reported the use of a device for the prevention, abstract screen, 18 studies were identified that yielded70results.The strategy Onthetitleand Results the management. Chemotherapy and radiotherapy are alsousedin for malignant gastricoutletobstruction. placement are commonly usedtreatments endoscopically. Gastrojejunostomy andstent through openlaparotomy, laparoscopically or The main therapeutic procedures were undertaken #13 #12 #11 #10 #9 #8 #7 #6 #5 #4 (42). Serological testing of pepsinogens and five years, English trails, systematicreviews, publishedin the past #1 AND #11Filters: randomizedcontrolled #11 #1 AND #8 OR#9#10 #2 OR#3#4#5#6#7 cancer* gastr* AND tumour* gastr* AND tumor* gastr* AND neoplasm* gastr* AND cancer* stomach AND tumour* stomach AND tumor* stomach AND Table 18 Stomach cancer – key studies

Study Level of Primary focusa Secondary focusa evidence Wilhelm et al 2011 II Dissection techniques Sutures (44) Ultrasonic dissector (e.g. Harmonic Ligatures Wave®) Gauzes Clips Electrocautery Kim et al 2010 (45) ll Stents Endoscope (e.g. Olympus® GIF-H260, Covered self-expanding metallic stents GIF-2T240) Uncovered self-expanding metallic stents X-ray for fluoroscopy Guide-wire Tatsumi et al 2012 ll Dissection techniques Knives (insulated tipped knife, needle knife) (42) Water-jet videoendoscope Disposable attachment (e.g. Olympus® Conventional videoendoscope D-201–11804) Forceps, coagrasper (e.g. Olympus® FD-410LR) Coagulation systems (e.g. Intelligent™ Cut and Coagulation 200) Diathermy devices Mechanical pump (e.g. Olympus® OFP-2), J-scope (e.g. EVIS™ GIF-Q260J) Kiyotoki et al 2010 ll Imaging Light source (e.g. CV-260SL) (46) Narrow-band imaging Forceps Indigocarmine chromoendoscopy Knifes Electrocautery with tip of high-frequency snare (e.g. SD-5L-1s) Light microscopy (e.g. BX41) Imaging tools such as DP2-BSW software a Proprietary marks have been included where this information was readily identified through source material. 4. Malignant neoplasms 4. Table 19 Stomach cancer – devices identified for prevention, diagnosis and treatment

Devicea Description Function Prevention Endoscope Instrument Endoscopic biopsy for H. pylori diagnosis pH monitoring systems (e.g. BRAVO™ Instrument Assists diagnosis of gastro-oesophageal reflux disease and catheterless) regulation of gastric acid Diagnosis Endoscopes: 2-way and 4-way angulation Instrument Screening and diagnosis of gastric cancer. Imaging and contrast endoscopes; magnifying endoscopy with material assists viewing of lesions narrow-band imaging; indigocarmine chromoendoscopy Ultrasound (endoscopic ultrasound) Appliance Guides fine-needle aspiration and biopsy in cancer diagnosis CT system Appliance Medical imaging modality using computer-processed X-rays to generate cross-sectional images of body. May involve intravenously injected contrast agents PET system Appliance Nuclear medicine imaging modality using positron-emitting radionuclide tracers to generate three-dimensional images of metabolic processes within human body Treatment Endoscope Instrument Assists surgical procedures such as endoscopic submucosal dissection, insertion and deployment of stents etc. Water-jet videoendoscope Small-calibre endoscope Ultrasonic dissectorb (Harmonic Instrument Marks and cuts mucosa at tumour Wave®) Continues… 41 42 2015 Systematic review of needs for medical devices for ageing populations worldwide. The incidence of hepatocellular the seventh mostcommoncancer inwomen is thefifthmostcommon cancerinmenand Cancer reportsthathepatocellular carcinoma The International Agency for Research on liver (47). cases, hepatocellularcarcinoma occursinanormal liver, may becomemalignant. Inlessthan10%of hepatocellular adenoma, abenigntumourofthe with hepatocellularcarcinoma. Lesscommonly, non-alcoholic fattyliver diseaseisalsoassociated Cirrhosis of the liver as a result of alcoholic and associated withhepatocellularcarcinoma. B andCare causesofchronic liver disease disease andcirrhosis oftheliver. Viral hepatitis commonly occursinpatientswithchronic liver Liver cancer, orhepatocellularcarcinoma, most Introduction 4.6 LIVERCANCER b a CT: computedtomography; PET, positron-emissiontomography; SEMS: self-expandable metallicstent. Device Gauze Ligature Suture Knife (insulated tippedknife) Snare Stapler Vessel-sealing systems(e.g. LigaSure™) Electrocautery mask) masks(e.g.Laryngeal LMAProSeal™ Oral gastrictube Nasogastric tube plug) Vascular plugs(e.g. Amplatz™ vascular Clips (e.g. NiTiHandCAC™ 30) guiding catheter Catheters: Soft-VU®catheter; angled Coil (interlockdetachablecoil) Guide-wire anti-reflux stent Stents: covered anduncovered SEMS; The device consists of a generator andshear-likeThe deviceconsistsofagenerator connectedviaaplug-inlinkingcable andisactivatedby hand. instrument have wasreadily identified marks beenincludedwherethisinformation throughsourcematerial. Proprietary a Consumable Consumable Consumable Instrument Instrument Instrument Instrument Instrument Instrument Instrument Instrument Instrument Consumable Consumable Consumable Consumable Implant Description Surgical procedures Surgical procedures Surgical procedures Assists endoscopicsubmucosal dissection Marks mucosa attumour Oesophagogastric anastomosisaftergastriccancerresection Ligates andsealsvessels Marks andcutsmucosa attumour andanaesthesia Assists surgery Nasogastric decompression duringsurgery Nasogastric decompression duringsurgery peptic ulcerationfollowing radiotherapy Transcatheter vessel occlusioninprevention ofradiation-induced Anastomotic clipsandcompression devices Provides assistancefor surgicalprocedures Embolizes gastroduodenal artery ofstentsinmanagementbowelGuides insertion obstruction malignant gastricoutletobstruction Management ofanastomoticleakageaftergastrectomy and Function incorporating text and MeSH terms to identify An apriorisearch wasdeveloped strategy Methodology foodstuffs contaminatedwithaflatoxin B chronic hepatitisBinfection andconsumptionof In high-riskareas themajorriskfactorsare distribution ofriskfactorswithinthepopulation. according toregionpatterns ofincidencevary and incidence increases withage, althoughage-specific occurs more commonly in men thanwomen. The Polynesia and western Africa, Melanesia, Micronesia and including easternandsouth-eastern Asia, middle carcinoma casesoccurindeveloping countries, people the incidenceisashigh15casesper100 000 people, of the world butin some parts 100 000 incidence hasbeenreportedasthree casesper carcinoma varies greatly:in western countries the (47). Approximately 85%ofhepatocellular (3). Overall, hepatocellularcarcinoma 1 (48). devices that could be used in the prevention, diagnosis or treatment of liver cancer. The details diagnosis or treatment of liver cancer. The of the key studies retrieved for full text review following filters were applied to the search results: are summarized in Table 20. A broader list of English language and published within the past identified devices was obtained through title and 10 years and randomized controlled trials and abstract review of all included studies (Table 20). systematic reviews. The search identified several devices for the #1 ((aged [MeSH terms]) OR (health services diagnosis and treatment of liver cancer. The search for the aged [MeSH terms]) OR (aged) OR did not identify any devices for the prevention of (senior) OR (elderly) OR (geriatric)) AND ((equipment and supplies [MeSH terms]) OR liver cancer. Broader review indicated that control (assistive devices [MeSH terms]) OR (surgical of risk factors, primarily chronic liver disease, is instruments [MeSH terms]) OR (device*) OR (aid*) OR (equipment) OR (armamentarium) the key focus for preventive strategies. OR (appliance*) OR (instrument*) OR (apparatus) OR (good*) OR (implement*) Preventive strategies focus on the association OR (material*) OR (machine*)) AND between chronic liver disease and hepatocellular ((diagnosis [MeSH terms]) OR (rehabilitation [MeSH terms]) OR (primary prevention carcinoma; strategies include vaccination against [MeSH terms]) OR (secondary prevention hepatitis B and programmes to stop transmission [MeSH terms]) OR (after treatment [MeSH terms]) OR (therapeutics [MeSH terms]) OR of hepatitis B and C (47). Clinical signs of (diagnos*) OR (therap*) OR (treatment*) OR hepatocellular carcinoma include abdominal pain, (prevention) OR (monitoring) OR (screening) OR (rehabilitat*) OR (alleviat*)) jaundice, abdominal distension, leg oedema and weight loss; many patients are asymptomatic, #2 liver neoplasms [MeSH terms] however, and are diagnosed during a screening #3 liver AND neoplasm* ultrasound (49). #4 liver AND tumor* #5 liver AND tumour* Surveillance screening may be indicated in patients with cirrhosis and consists of abdominal #6 liver AND cancer* ultrasound and serum alpha-fetoprotein. Screening #7 hepatic AND neoplasm* Malignant neoplasms 4. for and treatment of underlying viral infections #8 hepatic AND tumor* that lead to cirrhosis may also be appropriate. #9 hepatic AND tumour* The search also identified a study indicating the #10 hepatic AND cancer* G/G polymorphism in the EGF gene as a predictive #11 #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR factor in the risk for hepatocellular carcinoma in #8 OR #9 OR #10 patients with chronic hepatitis C. The clinical utility #12 #11 AND #1 of this biomarker and a test for it are unknown.

Treatment strategies for liver cancer are based on Following a search of PubMed, supplementary the stage of disease, the number and size of lesions, resources were consulted to inform the broader and the patient’s comorbidities and liver function. clinical context of screening, diagnosis and Treatments identified include liver transplantation, treatment of liver cancer. Resources consulted surgical resection, radiotherapy, systemic therapy, included, but were not limited to, the Best Practice ablative therapies and minimally invasive therapies. database of the BMJ Evidence Centre (49) and A large number of devices used in hepatic clinical practice guidelines (47). resection, transarterial chemoembolization and percutaneous embolizing procedures were identified (Table 21). These devices appear to Results encompass established instruments, machines and The strategy yielded 187 results. On the title and materials for treatment, as well as more emerging abstract screen, 109 studies were identified that alternative devices. reported the use of a device for the prevention, 43 44 2015 Systematic review of needs for medical devices for ageing populations Liver cancer –key studies cancer Table Liver 20 introduced ornewly emerging. to beaprocedure thatisonthehorizonofbeing less establishedablative therapy andisconsidered (47).alternative tosurgery Microwave ablationisa that radiofrequency ablationisanovel, butradical, hepatocellular carcinoma. The literature indicated microwave ablationdevices for thetreatment of The search identified radiofrequency ablationand (54) Hendlisz etal2010 2005 (53) Smyrniotis etal (52) Shibata etal2009 Liu etal2010(51) 2007 (50) Campagnacci etal Study evidence Level of II II II II II Y-resin microspheres Scalpel system Radiofrequency ablation microwave ablation Ultrasound-guided vessel device electrothermal bipolar LigaSure™ Primary focus Primary a Catheters SPEC PET Lung shunts Coils Intraoperative ultrasonography Computed portography MRI CT Argon-beam coagulation Clamps Biopsy needle Abdominal ultrasound Dynamic controlled CT Gelatin spongeparticles Coeliac angiography Catheter portographyArterial Peristaltic pump Thermocouple device CT Ultrasound guidance Electrocautical equipment Thermal monitoringneedles Thermal monitoringsystem Gadolinium-enhanced MRI Contrast-enhanced CT Contrast-enhanced ultrasound Ultrasound Clamps Electrocautical instruments Fluid drains MRI CT Intraoperative ultrasound Dissecting sealers Ultrasonic dissectors Ultrasonic shears focus Secondary selected patients(Table 21). as implantabledevices relative topalliationin systemic therapy. The search alsoidentified stents percutaneous interventions, radiotherapy and advanced ormetastaticdiseaseinclude Palliative treatments inpatientswithlocally Study Level of Primary focusa Secondary focus evidence Torzilli et al 2008 II Monopolar floating ball Intraoperative ultrasound (55) (TissueLink™) Contrast-enhanced intraoperative ultrasonography Fibrin glue Electrocautery equipment Suction drains Fisher et al 2011 II TachoSil® adhesive Argon-beam coagulation (56) Vascular clips Ligatures Sutures Malagari et al 2010 II Drug-eluting beads Angiography (57) Catheters Dudeck et al 2011 II Standard pushable coils Fibered interlock detachable coils (58) Micro-catheters Introducer sheaths Sofue et al 2011 (59) II Multi-detector row CT with arterial portography helical CT CT with hepatic arteriography

CT: computed tomography; MRI: magnetic resonance imaging; PET: positron-emission tomography; SPECT, single photon-emission computed tomography. a Proprietary marks have been included where this information was readily identified through source material.

Table 21 Liver cancer – devices identified for diagnosis and treatment

Devicea Description Function Diagnosis Viral hepatitis panelb IVD Determines viral cause of chronic liver disease

Full blood countb IVD Checks for microcytic anaemia and/or thrombocytopenia Malignant neoplasms 4. Liver function testb IVD Measures severity of disease; assesses suitability for liver resection Prothrombin time, INRb IVD Measures function of liver; assesses candidacy for liver resection Alpha-fetoprotein testb IVD Ordered following abnormal liver ultrasound EGF genotype G/G assay IVD Assesses risk for hepatocellular carcinoma Ultrasound Appliance May be contrast-enhanced. Guides biopsy and resection procedures MRI system Appliance Medical imaging modality using magnetic fields and radiowaves to visualize anatomy, in particular soft tissue, organs and muscle. Distinguishes pathological and normal tissues for preoperative imaging and confirmation of diagnosis CT system Appliance Medical imaging modality using computer-processed X-rays to generate cross-sectional images of body. May involve intravenously injected contrast agents. Preoperative imaging and diagnosis of patients; evaluates, detects, diagnoses and sizes hepatic lesions Automatic power injector Instrument Administration of contrast material Computed portography unit Appliance Establishes patency of vein; diagnosis of liver cancer Arterial portography unit Appliance Establishes patency of the vein. Catheter Consumable Computed portography and arterial portography procedures Biopsy needle Instrument Biopsy procedures Treatment LigaSure™ electrothermal bipolar Instrument Hepatic resection for division of parenchyma vessel sealer Ultrasonic shears Instrument Hepatic resection for division of parenchyma Continues… 45 46 2015 Systematic review of needs for medical devices for ageing populations Device Angiography sheath Introducer system Guide-wires Lung shunt Coil micro-catheters Catheters: reverse catheters; Duodenoscope system Delivery uncovered Stents: metal; plastic; covered/ CT system radiotherapy machine) Collimators (intensity-modulated Medical linearaccelerator 500 μm; 500–710μm PVA particles: 250–355μm; 355– Multi-hole needle microspheres; drug-elutingbeads Beads/microspheres: Y-resin Peristaltic pump system Cool-tip radiofrequency ablation Thermal monitoringneedle monitoring probe Thermocouple thermal Cool-shaft antennae Ultrasound Microwave ablationprobe Rubber tape Suction drain Suture Argon-beam coagulator Fibrin glue TachoSil® Vascular stapler Scalpel Clamps: various unit Electrocautery Bifocal forceps TissueLink™ dissectingsealer Ultrasonic dissector Hydrodissection hydrojet a Instrument Instrument Consumable Instrument Consumable Consumable Instrument Instrument Implant Appliance Appliance Appliance Materials Instrument Materials Appliance Appliance Instrument Instrument Instrument Appliance Appliance Consumable Instrument Consumable Appliance Consumable Consumable Instrument Instrument Instrument Instrument Instrument Instrument Instrument Instrument Description Establishes access to portal veinEstablishes access toportal Introduces guide-wire Percutaneous embolizationprocedures Occlusion ofhepaticcirculation duringembolization Embolization procedures and facilitateangiography Deliver embolizationmaterialsandtracerstoachieve vein accesstoportal Endoscopic retrograde cholangiopancreatography –endoscopicdrainage Stent placement Palliative treatment obstruction for malignantbiliary conformal radiotherapy Obtains imagesfor treatment simulations withthree-dimensional Delivers radiotherapy inintensity-modulated radiotherapy Generates radiationinradiotherapy procedures Embolization agents Injection ofsterileethanolinembolizingprocedures Delivers localhigh-doseradiationorchemotherapy Maintains tiptemperature of20–25°Cinablative procedures Radiofrequency ablationofhepaticmetastases Controls temperature inablative procedures Controls temperature inablative procedures Controls temperature inablative procedures Guides ablative procedures. Ablates hepaticlesions triadusingtourniquettechnique Clamps portal Controls bilirubinlevels Ligation ofvessels Hepatic resection for control ofresidual bleeding capillary Achieves haemostasisasliver surfacesealant patch coatedwithhumanfibrinogenandthrombin) Applied toresection surfacestoachieve haemostasis(absorbablesurgical Hepatic resection Hepatic resection inflow Hepatic resection for crushingofliver parenchyma andcontrol ofliver Incision ofGlissoncapsule ofliver for liverSurgery transaction Hepatic resection for divisionofparenchyma Hepatic resection for divisionofparenchyma Hepatic resection for divisionofparenchyma Function Devicea Description Function Gelatin sponge Consumable Controls flow of target artery during embolization procedure Vascular plug Instrument Transcatheter embolization procedures Mechanically detachable long Consumable Occlusion of gastroduodenal artery before selective internal radiotherapy micro-coil Pushable coil Consumable Occlusion of gastroduodenal artery before selective internal radiotherapy or for other occlusive procedures

CT, computed tomography; INR: international normalized ratio; IVD: in vitro diagnostic; MRI, magnetic resonance imaging. a Proprietary marks have been included where this information was readily identified through source material. b Identified by supplementary searches.

4.7 LYMPHOMA Infective organisms, including H. pylori, human T-lymphotrophic virus type I and human Introduction herpesvirus 8, have also been identified as risk Lymphoma is a term that includes lympho factors for the development of lymphoma (60). proliferative malignant diseases originating from T- and B-cells in the lymphatic system. It is The estimated global incidence in 2012 was 5.0 usually considered to be Hodgkin’s lymphoma or per 100 000 people (age-standardized rate) for non-Hodgkin’s lymphoma (60). Non-Hodgkin’s non-Hodgkin’s lymphoma and 0.9 per 100 000 for lymphoma encompasses a heterogeneous group Hodgkin’s lymphoma. The Western Pacific Region of malignancies. The heterogeneity of lymphomas accounted for 22% of new cases of non-Hodgkin’s is due to the various lymphocyte types present lymphoma and 8% of new cases of Hodgkin’s in the body (61). Classification of non-Hodgkin’s lymphoma in 2012 (3). lymphoma is carried out according to the cell lineage of the lymphocyte (T- or B-cell); B-cell Methodology An a priori search strategy was developed

lymphoma is the most common type. Hodgkin’s Malignant neoplasms 4. lymphoma is a histopathologically distinct incorporating text and MeSH terms to identify lymphoma characterized by the presence of devices that could be used in the prevention, Hodgkin or Reed–Sternberg cells; this form of diagnosis or treatment of lymphoma. The following lymphoma is rare and manifests predominantly in filters were applied to the search results: English young adulthood and advanced age (60). language and published within the past 10 years and randomized controlled trials and systematic The aetiology of Hodgkin’s and non-Hodgkin’s reviews. lymphoma is complex and not fully understood. Non-Hodgkin’s lymphoma is linked to viruses, #1 ((aged [MeSH terms]) OR (health services bacteria and autoimmune disorders. In Hodgkin’s for the aged [MeSH terms]) OR (aged) OR (senior) OR (elderly) OR (geriatric)) AND lymphoma, immune deficiency and infection ((equipment and supplies [MeSH terms]) OR with the Epstein–Barr virus are established risk (assistive devices [MeSH terms]) OR (surgical instruments [MeSH terms]) OR (device*) OR factors. The following have been associated with (aid*) OR (equipment) OR (armamentarium) an increased risk of both Hodgkin’s and non- OR (appliance*) OR (instrument*) OR (apparatus) OR (good*) OR (implement*) OR Hodgkin’s lymphoma: (material*) OR (machine*)) AND ((diagnosis [MeSH terms]) OR (rehabilitation [MeSH • immunosuppression therapy terms]) OR (primary prevention [MeSH terms]) • human immunodeficiency virus (HIV) infection OR (secondary prevention [MeSH terms]) OR (after treatment [MeSH terms]) OR • congenital immunodeficiency (therapeutics [MeSH terms]) OR (diagnos*) OR • autoimmune diseases. (therap*) OR (treatment*) OR (prevention) OR (monitoring) OR (screening) OR (rehabilitat*) OR (alleviat*))

47 48 2015 Systematic review of needs for medical devices for ageing populations Lymphoma –key studies Table Lymphoma 22 from immunohistochemical, flow-cytometric studies, tissuebiopsy andcellmarkers obtained physical examination, testing, laboratory imaging Diagnosis isacomplexprocess basedonhistory, preventive devices orstrategieswere identified. for thediagnosisandtreatment oflymphoma. No The search identified alimited number ofdevices abstract review ofallincludedstudies(Table 23). identified devices wasobtainedthrough titleand are summarizedin Table 22. broader listof A of thekey studiesretrieved for fulltextreview diagnosis ortreatment oflymphoma. The details reported the use of a device for the prevention, abstract screen, 88 studies were identified that yielded 131 results.The strategy On the title and Results lymphoma were alsoconsulted(60). Relevant clinical practice guidelines regarding Study (64) Anselmo etal2004 (63) Liang etal2007 Ott etal2010(62) #6 #5 #4 #3 #2 #5 AND #1 #5 AND #1 OR#2#3#4#5 lymphoma* non-hodgkin AND lymphoma* hodgkin AND lymphoma [MeSHterms] evidence Level of II II II Primary focus Primary Radiotherapy Chemotherapy Fine-needle biopsy Magnum® automatedbiopsygun biopsy, 18-gaugeand21-gaugeneedles Ultrasound-guided percutaneous spleen markers, includingCD5, CD10, BCL2, BCL6 Immunohistochemistry: expression levels of a Adjunct treatments includetheadministrationof Adjunct transplant andautologous stemcelltransplant. chemotherapy, radiotherapy, bonemarrow a rangeoftreatment protocols, whichinclude (Table 23). Treatment for lymphoma consistsof and stagingoflymphoma wasalsoidentified A rangeofimagingdevices usedintheevaluation involvement haematopathologists(61). ofexpert of lymphoma are challengingandmay require the indicated thatthediagnosisandcharacterization andgeneticassays.cytometry Broader review also techniques suchasimmunohistochemistry, flow identified. Thesecanbeinvestigated usingseveral value inthediagnosisoflymphoma were also (Table 23). Several biomarkers withprognostic for obtainingabiopsysamplewere identified definitive method for diagnosis, andseveral devices infections may alsoberelevant. resected surgically. Treatments for concomitant and antimicrobial factors. Isolated lesions may be growth factors, systemprophylaxis centralnervous Pathological evaluation oftissuesamplesisthe lymphoma. protocol isbasedonthehistologicalsubtypeof for treatmentimportant becausethetreatment and cytogenetictesting. diagnosisis Accurate Electrocardiogram evaluation Bilateral bonemarrow biopsy Ultrasound examinationofliver andspleen Chest, abdominalandpelvicCT Chest X-ray Blood analysis Physical examination Surgical pathology CT Sonographic examination Immunohistochemistry without rituximab CHOP chemotherapy therapy withor Secondary focus Secondary Study Level of Primary focusa Secondary focus evidence Faber et al 2006 II Stem cell transplant Central venous lines (65) COBE® Spectra blood separators Chemotherapy Ice-Cube 1810 appliance Graft reinfusion Temperature-controlled tanks Immunofluorescence flow cytometry assay Garcia Vicente et al IV PET/CT with F-deoxyglucose PET/CT 2012 (66) van Heeckeren et al II High-dose chemotherapy Baseline: blood count, lymphocyte subset 2006 (67) analysis including CD4+ and CD8+ CliniMACS® device T-lymphocytes (CD3+ cells), B-lymphocytes (CD19+ cells) and NK cells (CD16/CD56+ CD3) Immunofluorescent flow cytometry: FACSCaliburTM flow cytometer

CHOP: cyclophosphamide, hydroxydaunorubicin, oncovin, prednisone; CT: computed tomography; PET: positron-emission tomography. a Proprietary marks have been included where this information was readily identified through source material.

Table 23 Lymphoma – devices identified for diagnosis and treatment

Devicea Description Function Diagnosis PET system Appliance Nuclear medicine imaging modality using positron-emitting radionuclide tracers to generate three-dimensional images of metabolic processes within human body. Detects recurrence of lymphoma and used in staging of lymphoma. Techniques include F-deoxyglucose PET MRI system Appliance Medical imaging modality using magnetic fields and radiowaves to visualize anatomy, in particular soft tissue, organs and muscle. Detects recurrence of lymphoma and stages lymphoma 4. Malignant neoplasms 4. X-ray machine Appliance Uses penetrating electromagnetic radiation to visualize anatomical structures. Detects recurrence of lymphoma and stages lymphoma CT system Appliance Medical imaging modality using computer-processed X-rays to generate cross-sectional images of body. May involve intravenously injected contrast agents. Detects recurrence of lymphoma and stages lymphoma Ultrasound Appliance Diagnosis of lymphoma Electrocardiogram machine Appliance Cardiological assessment of patient suitability for chemotherapy/ radiotherapy Biopsy needle Instrument Biopsy procedures Biopsy gun Instrument Biopsy procedures FACSCalibur™ (flow cytometer) Appliance Analyses immunofluorescent flow cytometry sample Tests: full blood count; blood smear; IVD Assesses organ function in diagnosis and treatment planning basic metabolic; liver function; lactate dehydrogenase; erythrocyte sedimentation rateb BCL6 gene assay IVD Clarifies relationship between primary mediastinal B-cell lymphoma and other non-thymic diffuse large-cell lymphomas Immunohistochemical expression test IVD Tests for cell surface markers, e.g. CD5, CD10, BCL2, BCL6, HLA-DR for use in prognostic assessment FISH assay IVD Tests for bcl-2 protein, a potential biological prognostic marker in intermediate and high-grade non-Hodgkin’s lymphoma Treatment Catheters: Hickman catheter; Consumable Deliver chemotherapy peritoneal catheter; Portacath Continues… 49 50 2015 Systematic review of needs for medical devices for ageing populations with selective oestrogen receptor modulators of developing breast cancerincludetreatment strategies inwomen identified tobeatahighrisk women aged50years orover (72). Preventive age, and the majority of new diagnoses are in developing breast cancerincreases withadvancing with anelevated riskofbreast cancer. The riskof levels ofendogenoussexhormonesare correlated • defined as follows: the breast (68). Diagnosisofbreast cancermay be Breast cancerisamalignancythatoriginatesin Introduction 4.8 BREASTCANCER b a PET: positron-emissiontomography. CT: computedtomography; FISH: fluorescenceinsitu hybridization; HLA: humanleukocyte antigen; IVD: invitrodiagnostic; MRI: magneticresonanceimaging; tumours, withevidence suggestingthatincreased ofbreastalso beenimplicatedintheaetiology risk ofbreast and ovarian cancer. Oestrogen has and gene mutations (ineitherofthegenesBRCA1 invasiveprimary breast cancers, includingBRCA Many genetic factors have been associated with • • Device system CliniMACS® CD34cell-separation Mouthwash helium–neonlaser Low-energy Collimator Medical linearaccelerator Flow cytometer Temperature-controlled tank Medical freezer COBE® Spectrabloodseparator Identified via supplementary searches. Identified viasupplementary have wasreadily identified marks been includedwherethisinformation throughsourcematerial. Proprietary nodes (71). spread beyond thebreast andipsilaterallymph Metastatic breast canceristhathas has spread tosurrounding breast tissues(70). invasivePrimary breast canceristhat situ andlobularcarcinoma insitu)(69). and lobulesofthebreast (ductalcarcinoma in Breast carcinoma insituisconfinedtothe ducts ),BRCA2 whichconfer anelevated lifetime a Appliance Consumable Appliance Appliance Appliance Appliance Appliance Appliance Appliance Description Separates cells Treatment oforalmucositis afterradiotherapy Treatment ofradiation-induced oralmucositis Delivers radiotherapy inintensity-modulatedradiotherapy Generates radiationinradiotherapy procedures Autologous peripheralstemcelltransplant Autologous peripheralstemcelltransplant(cryopreservation) Autologous peripheralstemcelltransplant Autologous peripheralstemcelltransplant Function following filters were applied tothesearch results: diagnosis ortreatment ofbreast cancer. The devices thatcouldbe usedintheprevention, incorporating text and MeSH terms to identify An apriorisearch wasdeveloped strategy Methodology developed countries(3). in more developed countriescompared with more favourable outcomesfor women survival between countries islesspronounced dueto Variation duetobreast inmortality cancer other screening devices indeveloping countries. due toreduced accesstomammography and women);than 40per100 000 thisislikely tobe countries thereportedincidenceislower (less women),than 80per100 000 whileindeveloping reported incidenceofbreast cancerishigh(more in 2012(3). Inmore developed countriesthe 1.6 millionnew breast cancerswere diagnosed Agency for Research onCancerestimatesthat among women worldwide. The International and themostfrequent causeofdeathfrom cancer world. Itisthemostfrequent canceramongwomen disease inboththedeveloped anddeveloping Globally, breast cancerisacommonneoplastic than 1%ofallbreast cancers. (3). Malebreast cancerisrare, accountingfor less and prophylactic mastectomy oroophorectomy English language and published within the past Queen Elizabeth Hospital, Adelaide, Australia, five years and randomized controlled trials and personal communication, 3 January 2013). systematic reviews. The search identified several devices involved #1 ((aged [MeSH terms]) OR (health services in screening for breast cancer. Clinical advice for the aged [MeSH terms]) OR (aged) OR indicates that X-ray mammography units are the (senior) OR (elderly) OR (geriatric)) AND ((equipment and supplies [MeSH terms]) OR main screening devices in women of advanced age (assistive devices [MeSH terms]) OR (surgical (over 70 years) (P Walsh, Queen Elizabeth Hospital, instruments [MeSH terms]) OR (device*) OR (aid*) OR (equipment) OR (armamentarium) Adelaide, Australia, personal communication, 3 OR (appliance*) OR (instrument*) OR January 2013). Patients undergoing mammography (apparatus) OR (good*) OR (implement*) OR (material*) OR (machine*)) AND may have plain or contrast-enhanced ((diagnosis [MeSH terms]) OR (rehabilitation mammography. Three-dimensional tomosynthesis [MeSH terms]) OR (primary prevention [MeSH terms]) OR (secondary prevention mammography may also be available; this technique [MeSH terms]) OR (after treatment [MeSH appears to be investigational (73). Ultrasound and terms]) OR (therapeutics [MeSH terms]) OR MRI were identified as being important in the (diagnos*) OR (therap*) OR (treatment*) OR (prevention) OR (monitoring) OR (screening) diagnosis of women under the age of 50 years, as OR (rehabilitat*) OR (alleviat*)) these technologies are more effective in detecting #2 breast neoplasms [MeSH terms] cancers in denser breast tissue, although the #3 breast AND neoplasm* proportion of older women with dense breasts is #4 breast AND tumor* unknown (74). #5 breast AND tumour* Although screening initiatives may vary between #6 breast AND cancer* countries, there is evidence to suggest that #7 #2 OR #3 OR #4 OR #5 OR #6 mammograms undertaken every 1–2 years in #8 #7 AND #1 women aged 40–70 years may reduce breast cancer-related mortality (75). The search identified

a range of studies focused on initiatives to recruit Malignant neoplasms 4. Results women to screening programmes or to encourage The strategy yielded 251 results. On the title and adherence. abstract screen, 167 studies were identified that reported the use of a device for the prevention, Definitive diagnosis is made by histological analysis diagnosis or treatment of breast cancer. The details of biopsy samples, and a number of devices used of the key studies retrieved for full text review in biopsy procedures were identified in the search. are summarized in Table 24. A broader list of Core biopsy, fine-needle aspiration and cytological identified devices was obtained through title and puncture have different applications in the diagnosis abstract review of all included studies (Table 25). of breast cancer, and a patient may require more than one kind of biopsy (Table 25). Several devices The search strategy identified several devices for used in the preoperative assessment of sentinel the prevention, diagnosis and treatment of breast node involvement for biopsy were also identified cancer. Preventive strategies vary according to (Table 25). an individual’s risk of developing breast cancer. Genetic tests for BRAC1 and BRAC2 mutations have Both MRI and CT are used in the staging of a role in determining the level of risk to a patient. disease and planning of treatment. In the planning For patients at high risk of developing breast of treatment, testing for the hormone receptor cancer, various preventive strategies, including status, human epidermal growth factor receptor 2 chemoprevention, prophylactic mastectomy and (HER2) gene status and genetic profile (Oncotype prophylactic oophorectomy, may be employed. In DX® assay) of the tumour may occur (Table 25) women over 70 years of age, genetic screening for to assist in patient selection for chemotherapy. BRCA1 and BRCA2 is less appropriate (P Walsh, 51 52 2015 Systematic review of needs for medical devices for ageing populations Breast cancer –key studies cancer Table Breast 24 radiotherapy aftertheinitialsurgery. patients whoare not able to return for additional than traditionalradiotherapy andmay benefit treatmentdevice isassociatedwithshorter times personal communication, 2013). 3January This Hospital,Elizabeth Adelaide, Australia,Queen as an emerging therapeutic option (P Walsh, intraoperative radiotherapy systemwasidentified intraoperative radiotherapy; ofthese, thetargeted skin-sparing helicaltomotherapy andtargeted three-dimensional conformal radiotherapy, search, includingintensity-modulatedradiotherapy, Several radiotherapy devices were identified inthe characteristics suchashormonereceptor status. stage ofthedisease, comorbiditiesandtumour breast cancer. Treatment approach isbasedonthe endocrine therapies are offered topatientswith care. Surgery, radiotherapy, chemotherapy and treatment ofthecancerandinpostoperative of breast cancerinclude those used in the Therapeutic devices identified for thetreatment Berg etal2011(76) Study (80) Kerrou etal2011 (79) Iovino etal2012 (78) Godoy etal2012 (77) Canavese etal2009 evidence Level of ND ND IV II II electrical energy, handpiece, blade) Harmonic scalpel(generatordelivering Facilitating apparatus (arm movement) Gamma-ray detectingprobe Lymphatic dye mapping Lymphoscintigraphy PEM andMRI MRI Positron-emission mammography (PEM) focus Primary Hand-held gamma-ray detectioncamera a and tissuegluestoavoid postoperative seroma. pleural effusion(inadvancedmetastaticdisease), and related devices for thetreatment ofmalignant prostheses for breast reconstruction, procedures identified (Table 25). Otherdevices identified were devices for guidanceinresection were also for thetreatment oflymphoedema. Additionally, lymphoedema. The search identified several devices of lymph nodes, whichcanresult inpostoperative for breastSurgery cancer may include dissection communication, 2013). 3January Hospital,Elizabeth Adelaide, Australia,personal patients withadvanceddisease(P Walsh, Queen used inapalliative mannertocontrol cancerin management ofbreast cancerismostlikely tobe indicated thattherole ofablative devices inthe breast cancer. Discussionwithaclinicalexpert not currently established for the treatment of Ablative devices identified by thesearch are Secondary focus Secondary Ligations Scissors equipment Electrocautery Fibrin sealant Suction drain Conventional scalpel Lymphoscintigraphy Active exercise Compression garment Compression bandage Compression sleeve Mammography Mammography andultrasonography and bluedye Dual detectionusingradioactive colloids Lymphoscintigraphy Study Level of Primary focusa Secondary focus evidence Klimberg et al 2011 II Laser ablation: interstitial laser Ultrasound guidance (81) photocoagulation at time of lumpectomy Stereotactic biopsy Radiofrequency ablation MRI Ultrasound guidance Percutaneous biopsy Krekel et al 2011 II Ultrasound guidance Wire localization (82) Palpation guidance Radio-occult localization Medved et al 2011 ND High-spectral and spatial resolution MRI with None (83) or without contrast X-ray mammography Nelson et al 2009 IV MammoSite® breast brachytherapy catheter Whole-breast irradiation (84)

MRI: magnetic resonance imaging; ND: not able to be determined. a Proprietary marks have been included where this information was readily identified through source material.

Table 25 Breast cancer – devices identified for diagnosis and treatment

Devicea Description Function Prevention Genetic testing for BRCA mutation IVD Establishes risk of developing breast cancer Diagnosis Oncotype DX® assay IVD Informs patient selection for breast cancer treatments Hormone receptor assay IVD Guides treatment in known breast cancer HER2 status assay IVD Guides treatment in known breast cancer

X-ray mammography system Appliance Screens for breast cancer, mammographic detection of breast cancer. Malignant neoplasms 4. Also used with contrast materials to produce mammograms Three-dimensional Tomosynthesis Appliance Screens for breast cancer. Mammogram produced displays tissue as mammography system three-dimensional image MRI system Appliance Medical imaging modality using magnetic fields and radiowaves to visualize anatomy, in particular soft tissue, organs and muscle. Used to distinguish pathological tissue from normal tissue PET system Appliance Nuclear medicine imaging modality using positron-emitting radionuclide tracers to generate three-dimensional images of metabolic processes within human body. Used to distinguish pathological tissue from normal tissue (PET). Also used in positron- emission mammography Suction tubeb Instrument Collects fluid in ductal lavage or nipple-aspiration procedure Catheterb Consumable Collects fluid in ductal lavage or nipple-aspiration procedure from nipple: screening for breast cancer

Computer-aided detection software Software Used with mammography machines to interpret results system Syringe Consumable Used to collect milk duct cells for analysis in fine-needle aspiration Biopsy needles: various gauges Instruments Collect cells under image guidance during biopsy Ultrasound machine Appliance Guides biopsy procedures including fine-needle aspiration and cytological puncture. Produces sonogram that assists in differentiating pathological tissue from normal tissue. Guides sentinel node biopsy with injection of dye CT system Appliance Medical imaging modality using computer-processed X-rays to generate cross-sectional images of body. May involve intravenously injected contrast agents. Used to obtain cross-sectional pictures

Continues… 53 54 2015 Systematic review of needs for medical devices for ageing populations Device X-ray machine system Near-infrared laserbreast imaging Medical linearaccelerator Treatment Collimator Applicator system Patient-immobilization device Shielding devices Helical tomotherapy system CT scanner MammoSite® Radiation Therapy System Laser Radiofrequency energy delivery probeRadiofrequency delivery energy Radiofrequency generator Ultrasound: MarginProbe® Temperature-monitoring probe Gamma probe Continuous-infusion pumpsystem device Intravenous patient-controlled analgesia piece, electricalgeneratorandblade) Harmonic scalpel(consistingofhand Scalpel Suction drain Fibrin sealant Electrocautery deviceElectrocautery Scissors Ligature Clip Short stretchShort bandage Compression sleeve Compression garment Hoist Ga-As laser Cellu-M50 LPGSystem Hydrogel dressing Meplix® Litedressings a Description Appliance Appliance Appliance Appliance Appliance Instrument Instrument Appliance Appliance Instrument Appliance Appliance Appliance Appliance Instrument Instrument Appliance Appliance Instrument Instrument Implement Consumable Instrument Instrument Consumable Consumable Consumable Consumable Consumable Apparatus Appliance Appliance Consumable Consumable Function pathological tissuefrom normaltissue structures. Guidesstereotactic breast biopsy. Distinguishes Uses penetratingelectromagnetic radiationtovisualizeanatomical CT lasermammography procedures Generates radiationinradiotherapy procedures intraoperative radiotherapy Delivers radiotherapy inintensity-modulatedradiotherapy and Delivers intraoperative radiotherapy radiotherapy treatment Moulded device assistinginmaintainingpatient’s positioningin Protect healthy tissuesfrom radiation Delivers helicaltomotherapy conformal radiotherapy Obtains imagesfor treatment simulations withthree-dimensional Delivers temporary radiationseedtositeoflumpectomyDelivers temporary Photocoagulation techniqueusedtoobtainsurgicalmargins Delivers radiofrequency tolesions, energy causingtissuenecrosis Generates radiofrequency for useinablative energy procedures margins insurgicalprocedures Guides ablative procedures andsurgicalprocedures. Assesses Monitors tissuetemperatures duringablative procedures Detects sentinellymph nodesintraoperatively Delivers pain-relieving medicationpostoperatively Delivers pain-relieving medicationpostoperatively Cavitation, dissectionsurgery coaptation andcuttinginaxillary Surgical procedures dissection) (axillary Surgical procedures Surgery for breastSurgery cancertoprevent seroma formation Surgical dissectionandhaemostasis Surgical procedures Surgical procedures Surgical procedures Compression treatment oflymphoedema Compression treatment oflymphoedema Compression treatment oflymphoedema Facilitate limbmovement postoperatively Low-level lasertherapy totreat post-mastectomy lymphoedema Delivers mechanicalmassagefor tissuemobilization Treats radiotherapy-induced moistskindesquamation Treats inwomen whohave erythema received radiationtherapy Devicea Description Function Topical purified honey ointment Consumable Treats radiation burn Long-pulsed dye laser Appliance Treats radiodermatitis Intense-pulsed light laser Appliance Treats radiodermatitis Hand-held gamma-camera Instrument Preoperative imaging in sentinel node biopsy Syringe Consumable Delivers dye for lymphoscintography procedures and sentinel node biopsy procedures. Dyes may include blue dye and radioactive colloid Breast implant Implants Breast reconstruction Plastic cup Instrument Breast volume and shape Plastic cast Instrument Assess breast volume and shape Three-dimensional laser scanner Appliance Assess breast volume and shape Ultrasound system Appliance Guides resection of breast cancer. Guides injection of radiopharmaceuticals (radio-guided occult lesion localization) X-ray system Appliance Guides biopsy (wire localization technique). Guides injection of radiopharmaceuticals (radio-guided occult lesion localization) Needle Instrument Administers wire in wire localization of breast biopsy or resection procedures Wire Consumable Guides breast biopsy or resection (wire-localization technique), placed via needle under X-ray guidance Syringe Consumable Delivers radiopharmaceuticals (radio-guided occult lesion localization) Thoracostomy tube Instrument Delivers agents for pleurodesis in palliative care of patients with malignant pleural effusion (metastatic breast cancer) Fotona Fidelis Plus II (Er:YAG laser) Appliance Laser surgery and biostimulation as treatment for osteonecrosis of the jaw (women receiving bisphosphonates) Transcutaneous electrical nerve Appliance During mastectomy stimulation unit

Antimicrobial-coated sutures Consumable Wound closure Malignant neoplasms 4. Needle Consumable Delivers local anaesthetic instellate ganglion block, performed under ultrasound, CT or fluoroscopic guidance

CT: computed tomography; Er:YAG: erbium-doped yttrium aluminium garnet; IVD: in vitro diagnostic; MRI, magnetic resonance imaging; PET, positron- emission tomography. a Proprietary marks have been included where this information was readily identified through source material.

4.9 COLON AND RECTUM CANCER (20.3 per 100 000 males, 11.7 per 100 000 females), and the lower rates are in middle Africa (3.8 per Introduction 100 000 males, 3.9 per 100 000 females). The Colorectal cancer, also known as large bowel 5-year survival rate after diagnosis of colorectal cancer, is the third most common cancer in the cancer is about 45%, and 50–60% of patients world. Approximately 60% of cases occur in the eventually develop metastases (85,86). industrial countries. The lowest incidences are reported from Africa (except southern Africa) and Although there is no definitive cause for the south-central Asia and are intermediate in Latin disease, approximately 20% of patients diagnosed America. The disease is more common in men with colorectal cancer have a familial association. than women. Genetic abnormalities such as Lynch syndrome, hereditary non-polyposis colorectal cancer, familial Bowel cancer is the fifth most common cause of adenomatous polyposis syndromes and MYH- deaths related to cancer (3). The highest estimated associated polyposis can lead to familial colorectal mortality rates are in central and eastern Europe 55 56 2015 Systematic review of needs for medical devices for ageing populations systematic reviews. five years andrandomizedcontrolled trialsand English languageandpublishedwithinthepast following filters were applied tothesearch results: diagnosis or treatment of colorectal cancer. The devices thatcouldbeusedintheprevention, incorporating text and MeSH terms to identify An apriorisearch wasdeveloped strategy Methodology or Crohn’s disease(89–91). more common in patients with ulcerative colitis consumption ofalcohol lifestyle,sedentary smokingandexcessive high-fat diet, inadequatefibre intake), obesity, diabetes mellitus, unbalanceddiet(e.g. red meat, with riskfactorssuchasprevious colonicpolyps, malignancy #14 #13 #12 #11 #10 #9 #8 #7 #6 #5 #4 #3 #2 #1 #7 OR#13 #8 OR#9#10#11 #12 cancer* rect* AND tumour* rect* AND tumor* rect* AND neoplasm* rect* AND neoplasm, rectum [MeSHterms] #2 OR#3#4#5#6 cancer* colon* AND tumour* colon* AND tumor* colon* AND neoplasm* colon* AND colonic neoplasms[MeSHterms] OR (rehabilitat*) OR(alleviat*)) (prevention) OR(monitoring)(screening) (diagnos*) OR(therap*) OR(treatment*) OR terms]) OR(therapeutics [MeSHterms])OR [MeSH terms])OR(aftertreatment [MeSH prevention[MeSH terms])OR(secondary prevention[MeSH terms])OR(primary ((diagnosis [MeSHterms])OR(rehabilitation OR (material*)(machine*)) AND (apparatus) OR(good*) OR(implement*) OR (appliance*) OR(instrument*) (aid*) OR(equipment)(armamentarium) instruments [MeSHterms])OR(device*) OR (assistive devices [MeSHterms])OR(surgical ((equipment andsupplies[MeSHterms])OR (senior) OR(elderly) OR(geriatric)) AND for theaged[MeSHterms])OR(aged) ((aged [MeSHterms])OR(healthservices (87). The disease is also associated (88). Colorectal cancer is occult bloodtests–Guaiacandimmunochemical. this purpose(92). The search identified two faecal been recommended by theEuropean Unionfor test for men and women aged 50–74 years has economies. For instance, thefaecaloccultblood colorectal cancerisunderway inmany advanced A population-basedscreening programme for diagnosis andtreatment ofcolorectal cancer. The search identified devices related toscreening, (Table 27). title andabstractreview ofallincludedstudies list ofidentified devices wasobtainedthrough review are summarizedin Table 26. broader A details ofthekey studiesretrieved for fulltext diagnosis or treatment of colorectal cancer. The reported the use of a device for the prevention, abstract screen, 34 studies were identified that yielded 191 results.The strategy On the title and Results identify metastases. Two- and three-dimensional imaging may beusedtoconfirmthediagnosisand narrow-band imaging andautofluorescence abdomen andpelvis, endorectal ultrasound, X-ray following bariumenema, CTofthechest, The cancerisconfirmed by biopsyexamination. to thetumour–node–metastasis(TNM)staging. Severity ofthediseaseisaddressed according as identified searches. through supplementary liver functiontest identifies metastasestotheliver, test reconfirms thediagnosisofcancer(93).A from cancerous tissue. Carcinoembryonic antigen of anaemia, whichmay beassociatedwithbleeding staging. fullbloodcountconfirmsthediagnosis A In vitro testsare usedindiagnosisanddisease increasingly beingused. this assay. Endoscopicscreening methodsare also not produce studiesthatspecifically highlighted to beusefulinthescreening, butthesearch did Biomarker testingsuchastheM2-PKtestappeared #16 #15 five years, English trails, systematicreviews, publishedin the past #1 AND #14Filters: randomizedcontrolled #14 #1 AND CT colonography and cone-beam CT are used assist with surgery. Colonic stents, specifically in patients where endoscopy is contraindicated self-expanding metallic stents, are used in the or cannot be completed. Magnetic resonance prevention and management of obstruction. volumetry and colonography are helpful in The search identified covered and uncovered monitoring disease progression. PET was not types of self-expanding metallic stent. Park and identified by the literature search, but it may be colleagues implanted a sodium hyaluronate-based used in the diagnosis (94). bioresorbable membrane with similar intentions (95). Additionally, Serra-Aracil and colleagues used The management of the condition depends on the a mesh in the prevention of parastomal hernia stage of disease and the underlying comorbidities. following colostomy (96). Surgical management includes resection of the cancerous bowel and reanastomosis. The resection In anal sphincter preservation following surgery, can be performed as an open laparotomy or ultrasonically activated scalpels and monopolar through laparoscopy. Ideally the resection is electrocautery shovels have been used (97). carried out as a single stage and is curative. Stapling devices such as the Ethicon Proximate Alternatively, the surgery may be performed in two ILS and Autosuture Premium Plus CEEA are or more stages due to underlying comorbidities. used specifically to prevent anastomotic leaks. Colostomy is the initial stage of the resection to Supplementary searches using clinical practice clear the obstruction; intestinal waste is collected guidelines identified implant radiotherapy and in a colostomy bag. brachytherapy as additional techniques used in management that were not identified through the Numerous devices are implanted to prevent results of the systematic literature review (98). complications of colorectal cancer and to

Table 26 Colorectal cancer – key studies 4. Malignant neoplasms 4.

Study Level of Primary focusa Secondary focus evidence Kuiper et al 2011 (99) II Endoscopy: endoscopic trimodal Light source, red–green–blue filters, imaging (e.g. Olympus® Evis charge-coupled devices Lucera) – high-resolution endoscopy; autofluorescence imaging; narrow- band imaging; standard resolution video colonoscopy

Adler et al 2009 (100) II Endoscopy: narrow-band imaging by High-definition television, snare, forceps wide-angle colonoscope

Tribonias et al 2010 II Endoscopy: chromoendoscopy; narrow- Forceps, gold probe, snare, (101) band imaging; high-definition imaging polypectomy snare, video processor, high-definition screen

Park et al 2010 (102) II Stents: covered and uncovered self- Polytetrafluoroethylene membrane, expanding metallic stents CT, X-ray (fluoroscopy), guide-wire, endoscope, stent-delivery catheter, balloon dilator

Zhou et al 2008 (97) II Instruments: electrocautery shovel; Electrocautery, knife scalpel (ultrasonically activated scalpel)

Lee et al 2009 (103) II Imaging: CT; MRI; ultrasound machine Knife, clamps, scalpel, suture, electrocautery Staplers: curved cutter stapler (e.g. contour); lineal stapler (e.g. DST series® TA®); disposable staple cartridge

CT: computed tomography; MRI: magnetic resonance imaging. a Proprietary marks have been included where this information was readily identified through source material. 57 58 2015 Systematic review of needs for medical devices for ageing populations aetiology ofprostateaetiology canceris unknown. high-fat A of glandularoriginsituated intheprostate. The Prostate cancerisdefinedasamalignanttumour Introduction 4.10 PROSTATE CANCER a CT: computedtomography; IVD: invitrodiagnostic; MRI: magneticresonanceimaging; SEMS: self-expandable metallicstent. treatment and diagnosis prevention, for identified –devices cancer Table 27 Colorectal Device Mesh Shovel Scalpel stapler Staplers: e.g. linearstapler, cutter curved Transanal tube Bioresorbable membranes Stent: e.g. covered anduncovered SEMS Treatment Magnetic resonance colonography Magnetic resonance volumetry MRI system: diffusion-weighted imaging Cone-beam CTsystem CT colonography system MRI three-dimensional navigation, i-scan) Extensions toendoscope(e.g. cap, hood, autofluorescence imagingendoscope Retroscope®; narrow-band imaging; double-balloon endoscope; Third Eye® definition wide-angleendoscope; high-resolution endoscope; high- definition television endoscope; Flexible endoscopes: white-lighthigh- Diagnosis Immunochemical faecaloccultbloodtest Guaiac-based faecaloccultbloodtest Faecal occultbloodtest Prevention Proprietary marks have wasreadily identified marks beenincludedwherethisinformation throughsourcematerial. Proprietary a Description Implant Instrument Instrument Instrument Instrument Implant Implant Appliance Appliance Appliance Appliance Appliance Appliance Instrument Instrument IVD IVD IVD Function Prevents parastomalherniaaftercolostomy rectal cancer Provides assistancetoanalsphincter-preservation procedures in rectal cancer Provides assistancetoanalsphincter-preservation procedures in rectal cancers Secures distalrectum duringlow anteriorresection inmidtolow Prevents andreduces anastomoticleakage (e.g.surgery sodiumhyaluronate-based bioresorbable membrane) Reduces adhesive intestinalobstructionaftercolorectal cancer Manages bowel obstruction Detects colorectal lesions with preoperative chemoradiotherapy Predicts treatment outcomesoflocally advancedrectal cancers with preoperative chemoradiotherapy Predicts treatment outcomesoflocally advancedrectal cancers to visualizeanatomy, softtissue, inparticular organsandmuscle. Medical imagingmodalityusingmagneticfields andradiowaves dimensions, andrectal andbladder volume Measures interfractionalchangesinrectal movement and differentiation ofcolorectal lesions is contraindicatedorcannotbecompleted, indetectionand injected contrastagents. Usedinpatientswhomcolonoscopy generate cross-sectional imagesofbody. May involve intravenously Medical imagingmodalityusingcomputer-processed X-rays to Provides additional retrograde view todetectpolyps behindfolds techniques Enhances imagingcapability ofendoscopesandendoscopic by biopsiescollectedduringprocedure Diagnosis ofcolorectal cancerby examinationofbowel lumenand Screens for colorectal cancer Screens for colorectal cancer Screens for colorectal cancer worldwide in2012(3). The diseasepredominantly in men, with1.1millionnew casesregistered is thesecondmostfrequently diagnosedcancer developing prostate cancer(104). Prostate cancer associated with an increase in the relative risk of ofprostatediet andafamily cancerare history affects older men, with the age-standardized rate of #5 prostate AND tumour* prostate cancer increasing from 67.0 per 100 000 #6 prostate AND cancer* in men aged 55-59 years to 136.4 per 100 000 in #7 #2 OR #3 OR #4 OR #5 OR #6 men aged 60-64 years; beyond 64 years, the age- standardized rate continues to increase to 386.9 #8 #7 AND #1 per 100 000 in men aged 75 years or older (3). Results The majority of cases of prostate cancer are The search strategy yielded 245 results. On reported in developed countries, where the the title and abstract screen, 133 studies were practice of early detection is more prevalent than identified that reported the use of a device for in developing countries. Although the incidence the prevention, diagnosis or treatment of prostate of prostate cancer varies widely according to cancer. The details of the key studies retrieved geography, there is less variation in the mortality for full text review are summarized in Table 28. rates, with similar numbers of deaths reported A broader list of identified devices was obtained from prostate cancer in developed and developing through title and abstract review of all included countries (3). Most prostate cancer is slow- studies (Table 29). growing, and there is evidence to suggest that 60–70% of older men have histological prostate The search did not identify any devices for the cancer; however, prostate cancer is diagnosed in prevention of prostate cancer. Devices for the only 15–20% of men during their lifetime (105). screening, diagnosis and treatment of prostate cancer were identified. A review of the literature Methodology identified a focus on early detection in men at high An a priori search strategy was developed risk of developing prostate cancer as opposed to incorporating text and MeSH terms to identify broad-spectrum screening programmes. Large devices that could be used in the prevention, screening studies have suggested that population- diagnosis or treatment of prostate cancer. The based screening is not appropriate because the 4. Malignant neoplasms 4. following filters were applied to the search results: risk of overdiagnosis is high and reductions in English language and published within the past mortality appear modest, particularly in the five years and randomized controlled trials and short term (less than 6 years of follow-up) (105). systematic reviews. The optimal age and screening interval for early detection are yet to be established. #1 ((aged [MeSH terms]) OR (health services for the aged [MeSH terms]) OR (aged) OR Established screening methods for prostate cancer (senior) OR (elderly) OR (geriatric)) AND ((equipment and supplies [MeSH terms]) OR include a prostate-specific antigen test and a digital (assistive devices [MeSH terms]) OR (surgical rectal examination; the results of these are used to instruments [MeSH terms]) OR (device*) OR (aid*) OR (equipment) OR (armamentarium) evaluate the need for biopsy. A panel of kallikrein OR (appliance*) OR (instrument*) OR markers (total prostate-specific antigen, free (apparatus) OR (good*) OR (implement*) prostate-specific antigen, intact prostate-specific OR (material*) OR (machine*)) AND ((diagnosis [MeSH terms]) OR (rehabilitation antigen, kallikrein-related peptidase 2) has been [MeSH terms]) OR (primary prevention proposed as a supplementary test to determine [MeSH terms]) OR (secondary prevention [MeSH terms]) OR (after treatment [MeSH the necessity of biopsy (106). Definitive diagnosis terms]) OR (therapeutics [MeSH terms]) OR of prostate cancer is based on histopathological (diagnos*) OR (therap*) OR (treatment*) OR (prevention) OR (monitoring) OR (screening) analysis of biopsy samples. The search identified OR (rehabilitat*) OR (alleviat*)) transrectal ultrasound as the primary guidance #2 prostate neoplasms [MeSH terms] method for biopsy, and clinical input indicated that #3 prostate AND neoplasm* samples should be obtained from the entire gland. #4 prostate AND tumor* Broader searches identified an epigenetic assay

59 60 2015 Systematic review of needs for medical devices for ageing populations Prostate cancer –key studies cancer Table Prostate 28 were alsoidentified. Several devices ofunknown anaesthesia anddrainagefollowing theprocedure search results. Devices for theadministration of System isonerobotic device identified within the morbidity following surgery. The da Vinci Surgical of theseisassociatedwithdifferent patternsof laparoscopic or robot-assisted procedure; each Radical prostatectomy isperformed asanopen, prostatectomy, radiotherapy andbrachytherapy. the treatment ofprostate cancerare radical The maintherapeutic strategiesidentified for urethral stricture. be usedifspecificindicationsare present, suchas cystoscopy were identified asdevices thatmay advanced disease(Table 29). Endoscopy and different treatment optionsortoindicatelocally be used in the assessment of patient suitability for be used. Several invitro diagnostictestsmay also progression ofthedisease, multiple devices may several purposesand, dependingonthesuspected scanning. Eachimagingdevice may beusedfor prostate cancer, includingCT, MRI, PETandnuclear and tests thatcan be usedin the stagingof The results alsoidentified several imagingdevices of prostate cancer. being underinvestigation for useinthediagnosis investigational. The search alsoidentified MRIas biopsy samples(107). This assay appears tobe for detectingprostate cancerinfalse-negative Study (111) etal2009 Giberti (110) Davis etal2009 (109) Chin etal2012 (108) Catto etal2011 evidence Level of IV IV II II Primary focus Primary slings) (synthetic orbiologicalmixed Suburethral slingpositioning Vacuum erection device Cryoablation Cryotherapy High-intensity frequency ultrasound Focal ablative therapies a pharmacological therapies. includes vacuumdevices, penileimplantsand therapies. For erectile dysfunction, treatment bulking agentsappear tobethemostestablished of incontinence, sphincters, artificial slingsand erectile dysfunction(Table 29). For thetreatment prostatectomy, includingincontinenceand for thetreatment ofcomplicationsfollowing The search alsoidentified several devices devices thatare notyet established. focused ultrasoundwereenergy identified as devices includingcryotherapyAblative andhigh- radiotherapy andneoadjuvanthormonetherapy. a combinationofradicalprostatectomy, adjuvant multimodal treatment may beused. This includes In somecasesofaggressive, high-riskdisease, radioactive seeds. systems, imagingdevices (ultrasound, CT, MRI)and associated withbrachytherapy includeddelivery machines andimmobilizationdevices. Devices deprivation. Devices involved includeradiotherapy delivered withorwithoutconcomitantandrogen radiotherapy andexternal-beamradiotherapy, is conformal radiotherapy, intensity-modulated Radiotherapy, includingthree-dimensional (Table 29). the robotic cameraholderandCavemap device state ofestablishmentwere identified, including Periurethral balloons, flexible urethral cystoscopy Implantable devices, injection ofbulkingagents Extracorporeal magneticinnervation Electrical stimulation None Radiotherapy equipment Focused radiotherapy Brachytherapy Secondary focus Secondary Study Level of Primary focusa Secondary focus evidence Kollmeier and NA Brachytherapy: permanent interstitial Intraoperative imaging guidance in brachytherapy Zelefsky 2011 (112) radioactive seed or temporary interstitial iridium-192 Transrectal ultrasound guidance Afterloading catheters Intraoperative CT and MRI Immobilization ramps Lebeau et al 2011 IV Robotic-assisted laparoscopic None (113) prostatectomy (da Vinci® Surgical System) Sciarra et al 2011 NA (non- Multiparametric MRI Anatomic T2-weighted imaging (114) systematic literature Magnetic resonance spectroscopic imaging review) Dynamic contrast-enhanced MRI Diffusion-weighted imaging

CT: computed tomography; MRI: magnetic resonance imaging; NA: not applicable. a Proprietary marks have been included where this information was readily identified through source material.

Table 29 Prostate cancer – devices identified for diagnosis and treatment Devicea Description Function Diagnosis PSA level test IVD Screens men aged > 50 years. Used in combination with digital rectal examination Four-K kallikrein panelb IVD Reduces unnecessary biopsy in men with elevated total PSA Epigenetic assayb IVD Detects malignant disease in patients with false-negative biopsies (determines methylation status of GSTP1, APC and RASSF1) Renal function testsb IVD Abnormal renal function is indicative of more locally advanced disease Testosterone level testb IVD Considered in men for androgen deprivation

Liver function testb IVD Baseline in patients considering androgen-deprivation therapy Malignant neoplasms 4. Full blood countb IVD Tests for symptomatic anaemia Ultrasound Appliance Guides biopsy procedures Biopsy needles Instrument Biopsy of prostate gland MRI system (computer workstation, Appliance Medical imaging modality using magnetic fields and radiowaves software, separate control room) to visualize anatomy, in particular soft tissue, organs and muscle. Various MRI techniques are used, including: multiparametric, dynamic contrast enhancement, anatomic T2-weighted, diffusion-weighted and spectroscopic imaging PET system Appliance Nuclear medicine imaging modality using positron-emitting radionuclide tracers to generate three-dimensional images of metabolic processes within human body. Detects focal lesions CT system Appliance Medical imaging modality using computer-processed X-rays to generate cross-sectional images of body. May involve intravenously injected contrast agents. Evaluates prostate size and assesses regional lymph nodes X-ray machine Appliance Uses penetrating electromagnetic radiation to visualize anatomical structures. Checks for osseous metastasis Nuclear scanner Appliance Scans for bone metastases in patients with intermediate- and high- risk prostate cancer Endoscope Instrument Used in planning of treatment approach Flexible urethral cytoscope Instrument Excludes possible urethral stricture or bladder neck contracture Treatment Medical linear accelerator Appliance Generates radiation in radiotherapy procedures Collimator Appliance Delivers radiotherapy in intensity-modulated radiotherapy Interstitial radioactive seed Material Delivers brachytherapy Continues… 61 62 2015 Systematic review of needs for medical devices for ageing populations strategies may be context-specific; for example, developing cancer, such as smoking. Preventive factors thatmay increase anindividual’s riskof tended tobefocused onmodifiablelifestyle diseases were not identified. Preventive strategies Overall, devices for theprevention ofneoplastic diseases wasidentified. prevention, diagnosisortreatment ofneoplastic rangeofdevices thatare usedcommonly inthe A each diseasetoinform theresults ofthereview. project. Independentsearches were conducted on Nine neoplasticdiseaseswere investigated inthis 4.11 CONCLUSION b a CT: computedtomography; IVD: invitrodiagnostic; MRI: magneticresonance imaging; PET: positron-emissiontomography; PSA: prostate-specificantigen. Device Penile implant Vacuum erection system Surgical mesh Bone-anchoring system Bone screw mixed Suburethral slings: synthetic; biological; Periurethral balloon Bulking agent Electrical stimulation unit sphincter Artificial Barbed polyglyconate sutures TachoSil® Robotic cameraholder Drain Needle thermocouple monitoringprobes) cryoprobes, ultrasoundmachineand system(consistingof Cryoablation Burdizzo clamp High-intensity focused ultrasoundprobe Da Vinci SurgicalSystem® Hyaluronic acid Immobilization ramp Afterloading catheter Information obtained via supplementary searches. obtainedviasupplementary Information have wasreadily identified marks beenincludedwherethisinformation throughsourcematerial. Proprietary a Implant Implant Implant Instrument Consumable Material Instrument Materials Appliance Implant Consumable Consumable Instrument Instrument Instrument Appliance Instrument Instrument Appliance Material Instrument Consumable Description Treatment oferectile dysfunctionfollowing prostatectomy sling positioning) Treatment ofincontinencefollowing prostatectomy(suburethral sling positioning) Treatment ofincontinencefollowing prostatectomy(suburethral sling positioning) Treatment ofincontinencefollowing prostatectomy (suburethral sling positioning) Treatment ofincontinencefollowing prostatectomy (suburethral Treatment ofincontinencefollowing prostatectomy Treatment ofincontinencefollowing prostatectomy Treatment ofincontinencefollowing prostatectomy Treatment ofincontinencefollowing prostatectomy Treatment ofincontinencefollowing prostatectomy Anastomosis inrobot-assisted prostatectomy toreduce urineleak retropubic prostatectomy withpelviclymphadenectomy Prevents lymphocele development afterextraperitoneal radical Endoscopic prostatectomy Drainage inlaparoscopic prostatectomy procedures Delivers anaesthesia Treatment ofprostate cancer Androgen-deprivation therapy, clampablationoftestes Treatment ofprostate cancer Robot-assisted prostatectomy (decreases toxicity from radiation) Increases distancebetween prostate andanteriorrectal wall Minimizes lower-extremity movement duringtreatment Delivers radioactive ofbrachytherapy materialsaspart Function physical examinationsand imagingdevices such tools identified includeinvitro diagnostic tests, in order toallow early treatment. Screening that may leadtocancerasearly aspossible The aimistoidentifycancer or abnormalities diseaseinasymptomaticpeople.of aparticular Screening for cancer involves lookingfor early signs may control thisriskfactorfor gastriccancer. identification ofH. infection pylori andirradiation prevalence ofviralhepatitisishigh. Similarly, early preventive measures incountrieswhere the liver disease, vaccinationsmay beconsidered because liver cancer isassociatedwithchronic as mammograms. Overall, the search indicated Devices used in surgery include ultrasound that large-scale screening programmes were not dissection devices, robotic systems and other supported for neoplastic disease of most sites; surgical equipment such as scalpels. Surgery notable exceptions included screening for breast requires an operating theatre equipped with cancer, prostate cancer and colorectal cancer. procedure- and anaesthesia-related devices. Conflicting arguments regarding screening for lung Numerous disposables and chemicals are used in cancer were identified. The searches also revealed sterilization and disinfection. a research focus on web- and print-based media The searches identified a large number of aimed at increasing awareness of and participation radiotherapy techniques for the treatment of in screening programmes for breast and prostate cancers. As with most interventions associated cancer. with diagnosis and management of neoplastic The diagnosis of neoplastic disease is a sequential disease, the type of radiotherapy used is process, and a large number of diagnostic devices determined by the site and stage of cancer and were identified. Biopsy samples may be taken the patient’s comorbidities and choice. Variations either before or after imaging studies; however, and improvements in standard radiotherapy histological analysis of a biopsy specimen is the machines appear to focus on the targeted delivery definitive method of diagnosis for all cancers of radiation to precisely located lesions. Imaging investigated. Devices used to obtain a biopsy devices are important for treatment planning, and specimen are many and varied. The choice of computer programs and software are necessary biopsy instruments and method is dependent on for calculating dose delivery. the site of suspected cancer and the accessibility Minimally invasive therapies appeared to be of the lesion. Multiple biopsy specimens and hence an area of research focus, and ablative devices methods may be required in a single patient. identified were considered to be emerging. No information was identified regarding the Minimally invasive therapies, including ablative specific pathology equipment required for cancer devices, were generally not considered curative Malignant neoplasms 4. diagnosis. treatments but were occasionally indicated in The searches identified that imaging technologies control of metastatic disease and palliation or in are central to patient management in oncology. The the management of early stages of oesophageal literature indicates that multiple imaging devices cancer. are required for patient diagnosis and treatment The choice of medical device used in the diagnosis planning. Most imaging devices identified consist of and treatment of the cancers investigated will equipment, computer workstations and computer depend on the patient’s presentation, the clinician’s software. Interpretation of the results requires preference and experience, and the comparative skill and training. safety and effectiveness of each device. It is also The approach to treating neoplastic disease is clear that the choice of device will be informed based on a combination of histological analysis by its suitability as described by the crucial “4 As” of biopsy specimens, imaging studies and in some of availability, accessibility, appropriateness and cases in vitro diagnostic tests. Decision-making affordability, issues that vary substantially both is also guided by the patient’s presentation, across and within jurisdictions (115). There will be preferences and comorbidities. Surgical resection differences in the accessibility of medical devices or dissection, with or without chemotherapy between urban and rural settings and between and/or radiotherapy, were the main therapeutic facilities in similar areas. The relative availability options identified. of medical devices within a jurisdiction will have downstream effects on the overall approach to neoplastic disease; in settings with low access to 63 64 2015 Systematic review of needs for medical devices for ageing populations 10. 9. 8. 7. 6. 5. 4. 3. 2. 1. REFERENCES them. andmaterialstorunservice support as well asappropriate infrastructure, financial tooperatethemorinterpretexperts theresults, of themedicaldevices identified require trained thus have apoorer prognosis. Additionally, many enter treatment atlaterstagesinthediseaseand diagnostic toolsorscreening devices, patientsmay

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5.1 INTRODUCTION predicted that COPD will rank fifth in burden of Chronic respiratory diseases are chronic diseases disease worldwide by 2020 (4). of the airways and other structures of the lung. The disease is preventable, with the primary Some of the most common are COPD, asthma, cause being tobacco smoking (1). The more occupational lung diseases and pulmonary tobacco consumed and years spent smoking, the hypertension. Common risk factors include tobacco higher the risk of developing COPD. The disease use, poor nutrition, frequent lower respiratory is progressive and is related to an abnormal infections during childhood, and environmental air inflammatory response of the lung to noxious pollution (indoor, outdoor, occupational) (1). particles or gases (4). Other causes of COPD In 2012, a total of 4.0 million deaths worldwide include occupational exposures to toxins or were attributed to respiratory diseases, with irritants, air pollution, genetic factors, age and 3.1 million of these attributed to COPD. Specifically autoimmune disease. in the Western Pacific Region for people aged 60 years and older, a total of 1.2 million deaths Methodology were attributed to respiratory diseases, of which An a priori search strategy was developed 1.0 million deaths were from COPD (2). incorporating text and MeSH terms to identify devices that could be used in the prevention, 5.2 CHRONIC OBSTRUCTIVE diagnosis or treatment of COPD. The following PULMONARY DISEASE filters were applied: English language and published within the past five years and randomized Introduction controlled trials and systematic reviews. Chronic obstructive pulmonary disease is a lung disease resulting in reduced lung function and #1 ((aged [MeSH terms]) OR (health services for the aged [MeSH terms]) OR (aged) OR poor quality of life (3). It is characterized by an (senior) OR (elderly) OR (geriatric)) AND airflow limitation that is not fully reversible, ((equipment and supplies [MeSH terms]) OR (assistive devices [MeSH terms]) OR (surgical chronic and worsening dyspnoea, cough and instruments [MeSH terms]) OR (device*) OR sputum production (4). The COPD diagnosis now (aid*) OR (equipment) OR (armamentarium) diseases 5. Respiratory 5. includes chronic bronchitis and emphysema, with OR (appliance*) OR (instrument*) OR (apparatus) OR (good*) OR (implement*) these terms no longer being used to describe OR (material*) OR (machine*)) AND specific conditions(1) . The disease presents with ((diagnosis [MeSH terms]) OR (rehabilitation [MeSH terms]) OR (primary prevention chronic inflammation, increased numbers of [MeSH terms]) OR (secondary prevention specific inflammatory cell types in different parts [MeSH terms]) OR (after treatment [MeSH terms]) OR (therapeutics [MeSH terms]) OR of the lung, and structural changes resulting from (diagnos*) OR (therap*) OR (treatment*) OR repeated injury and repair (4). In general, the (prevention) OR (monitoring) OR (screening) OR (rehabilitat*) OR (alleviat*)) inflammatory and structural changes in the airways become worse with disease severity and continue #2 chronic obstructive respiratory disease even when causative factors have been removed. #3 chronic obstructive airway disease #4 chronic obstructive lung disease Chronic obstructive pulmonary disease affects 6% #5 chronic obstructive pulmonary disease of the general population and is a leading cause of death globally (5). In 2012, more than 3 million #6 pulmonary disease, chronic obstructive [MeSH terms] people worldwide died of COPD (1). The disease #7 (#2 OR #3 OR #4 OR #5 OR #6) is the fourth leading cause of chronic morbidity and mortality in the United States of America. It is #8 (#1 AND #7) 69 70 2015 Systematic review of needs for medical devices for ageing populations Chronic obstructive pulmonary disease –key studies disease pulmonary obstructive Table Chronic 30 involvesOnline spirometry connectinga is now available to use through telemedicine. A number ofstudiesindicatedthatthespirometer or sputumsample. tests, echocardiogram, peakflow test, orphlegm diagnosis may bemadewithchestX-ray, blood involves the use of a spirometer, definitive initialscreening for COPD primarily Although CT scanners, electrocardiograms andspirometers. included pulseoximeters, bodyplethysmographs, bloodgasanalysis.arterial Diagnosticdevices functiontestsand COPD includedpulmonary Established screening methodsidentified for anddiagnostictests. surgical interventions therapeutic equipmentandaids, therapeutic A review oftheliterature identified a focus on available in Table 31. title andabstractreview ofallincludedstudies, is broader listofidentified devices, obtainedthrough the detailsofwhichare summarizedin Table 30. A Key studieswere retrieved for fulltextreview, mention ofdevices for theprevention ofCOPD. of COPD; however, thesearch didnotfindany of adevice for thediagnosis, screening ortreatment screen, 75studieswere identified totheuse report and systematicreviews. Onthetitleandabstract largely ofrandomizedcontrolled trialevidence yielded179studies,The strategy comprised Results (7) Filosso etal2010 2009 (6) Ambrosino etal Study evidence Level of II I moderate COPD in patientswith lungcancer primary after lobectomy for air-leak monitoring Evaluation ofdigital stage COPD Evaluation ofend- Primary focus Primary a Secondary focus Secondary radiogram systematic lymphadenectomy, chestdrainages, chestroentgenogram, fifth intercostal spacethoracotomy, staplers, sealants(TachoSil™), Plus), medicalelectricequipment(PALM), chestX-ray, posterolateral III), digitalcontinuous air-leak recording system(Drentech® Simple drainage device, traditionalchest-drainagesystem(Argyle Thora-Seal tents, glues, lungsealants, one-way valve (Heimlichvalve), compact Chest tube, drainagesystem, lobectomy, fissureless surgery, pleural reduction, nebulizer, tracheotomy transcutaneous electricalstimulation, biologicallungvolume endotracheal intubation, rehabilitation, pulmonary neuromuscular mask, facemask, controlled oxygen therapy, mechanicalventilation, bullectomy, lungvolume-reduction surgery, lungtransplantation, nasal Non-invasive positive-pressure ventilation, invasive ventilation, required ofthethorax. insurgery search, from apart devices thatwould normally be specifically totheseprocedures were found inthe and lungtransplantation. Nodevices related bullectomy, lungvolume-reduction surgery forsurgical interventions late-stagedisease: The results identified three maintherapeutic lung functionorslowing diseaseprogression. and exercising thelungs, withtheaimofimproving common thefocus offacilitatingphysical exercise to treatment. Mostofthesedevices have in all identified thesearch in alternative as approaches mobile phones, pedometers andharmonicaswere For example, acupuncture, exercise machines, with clinicalapplications ofnon-medicaldevices. conventional devices were alsoidentified, together systems, inhalersandventilators. Someless Conventional therapeutic devices includedoxygen telemedicine. diagnostic devices thatmay beadjustedfor usein This hasimplicationsfor anumber ofsimilar opiniononline.diagnosis oraccesstoexpert home. mayThis technology alsoallow for remote evaluation by enablingpatientstobemonitored at such as the spirometer facilitates ongoing clinical withestablisheddevicesof thisnew technology health care professional for assessment. The use electronically forwarding thetestresults toa or mobilephone, blowing intothedevice, and specialized form of spirometer to acomputer a Study Level of Primary focusa Secondary focusa evidence

Storre et al 2009 IV Non-invasive Pressure-limited non-invasive positive ventilation, volume-limited (8) ventilation non-invasive positive-pressure ventilation, ventilatory circuit, pneumotachograph (Ventrak-Respiratory Monitoring System), ventilator, PV 403 ventilator, oronasal mask (Mirage™ Full Face Mask), short tube, T-connector, Combi-Stopper (Braun), lung-function parameters (Masterlab-Compact), blood gas analyser (AVL OMNI), hand-held portable pulse oximeter (NPB-40)

Lareau and I Inhalers Pulmonary rehabilitation, lung volume-reduction surgery, lung Hodder 2012 (3) transplantation, compressor-driven nebulizer, handheld inhalers, pressured-metered dose inhalers, dry-powder inhalers, soft-mist inhalers

Masa et al 2011 II Spirometer (VMax Conventional spirometer, online spirometer, hand-held spirometer, (9) 20) reference spirometer, computer with spirometer software (VMax™ SensorMedic), second computer and software (VNC® Free Edition), webcam (Logitech Quickcam USB), webcam software (Microsoft Netmeeting), bacterial filter

Strickland et al IV Long-term oxygen Home concentrator, portable concentrator, compressed oxygen, 2009 (10) therapy: Helios, liquid oxygen, oxygen concentrator, continuous-flow oxygen, HomeFill, FreeStyle compressed oxygen cylinder, liquid oxygen canister, liquid oxygen and compressed system (Helios), compressed oxygen cylinder system filled oxygen cylinder from home concentrator (HomeFill), portable battery-powered systems concentrator (FreeStyle™)

COPD: chronic obstructive pulmonary disease; RCT: randomized controlled trial. a Proprietary marks have been included where this information was readily identified through source material.

Table 31 Chronic obstructive pulmonary disease – devices identified for diagnosis and treatment

Devicea Description Function Diagnosis Pulse oximeter Appliance Monitors saturation of haemoglobin X-ray machine Appliance Provides images to assist with diagnosis of COPD Plethysmograph Appliance Measures changes in lung volume

Blood gas analyser Appliance Measures PaO2, PaCO2 and acidity (pH). SaO2 can also be determined

Electrocardiogram Appliance Records heart’s electrical activity diseases 5. Respiratory 5. Spirometer Instrument Measures volume of air inspired and expired by lungs. Pocket version is also available Treatment Cylinder concentrator Apparatus Oxygen therapy Oxygen systems: Helios, Homefill, Apparatus Oxygen therapy Freestyle™, compressed oxygen cylinder system, standard home oxygen system Continuous-flow oxygen system Apparatus Supplies oxygen constantly, irrespective of whether patient is inhaling or exhaling Accu02 Apparatus Conserves oxygen Liquid oxygen portable device Apparatus Provides liquid oxygen therapy in portable form Portable oxygen concentrator Apparatus Provides oxygen therapy at substantially higher concentrations of oxygen than levels of ambient air, in portable form Oxygen tank Apparatus Stores oxygen for provision of oxygen therapy Oxygen mask and helmet Apparatus Transfers oxygen from storage tank to lungs Oxygen flow regulator Apparatus Automatically continuously regulates delivery of oxygen quantity to patient while constantly acquiring saturation value Continues… 71 72 2015 Systematic review of needs for medical devices for ageing populations and more invasive for interventions respiratory identified were oxygen therapy and ventilation, and pulseoximeters. Therapeutic interventions machines, plethysmographs, bloodgasanalysers used inthediagnosisofCOPDincludeX-ray main screening device isaspirometer. Devices anddiagnostictests.surgical interventions The therapeutic equipmentandaids, therapeutic The literature reviewed identified a focus on exposure toenvironmental toxins orpollutants. include cessationofsmokingandavoiding developing COPD. Preventive measures may Tobacco smokingincreases therisk of treatment ofthisdisease. search identified devices usedinthediagnosisand The project therefore focused onCOPD, andthe for lessthan2%ofalldeathsintheregion (2). diseasesaccounted asthma andotherrespiratory for more than8%ofalldeathsintheregion, and Western PacificRegionin2012, COPDaccounted were responsible for 10%ofalldeathsinthe It is estimated that chronic disease respiratory 5.3 CONCLUSION a disease;COPD: pulmonary PaCO chronicobstructive Device Transdermal tulobuterol patch Chest-drainage system Negative-pressure ventilator (iron lung) Humidifier vest therapy High-frequency chest-walloscillation: Chest tube vestThorax support Nebulizer (intubation) invasive positive-pressure ventilation pressure ventilation (usingfacemask); Ventilators: non-invasive positive- mist inhaler; metered-dose inhaler handheld inhalerdevices; Respimatsoft- Novoliser®,Genuair®, Turbuhaler®); (Breezehaler®, Handihaler®, Diskus®, Inhalers: inhaler dry-powder Proprietary marks have wasreadily identified marks beenincludedwherethisinformation throughsourcematerial. Proprietary a Apparatus Apparatus Appliance Appliance Apparatus Instrument Apparatus Appliance Appliance Apparatus Description 2 : carbondioxide tension; PaO Administers bronchodilator collections withinpleuralcavities Treats pneumothorax, haemothorax, empyema andother or work ofbreathing exceedspatient’s ability Enables patienttobreathe ifnormalmuscle control hasbeenlost Increases humidityinroom orlargerarea Clears airway Removes air, fluidorpusfrom intrathoracicspace Prevents sternum instabilityaftercardiac surgery Administers medicationinform ofmistinhaledintolungs Mechanically moves breathable airintoandoutoflungs Delivers medicationtolungs Function 6. 5. 4. 3. 2. 1. REFERENCES disease following failure ofprevious treatment. areinterventions generally usedinend-stage andlungtransplantation.surgery These aggressive failure suchasbullectomy, lungvolume-reduction 2 : arterial oxygen tension;: SaO arterial Alergol Pol.Alergol 2009;77:173–9. disease. Pneumonol pulmonary chronic obstructive Ambrosino N, M, Gherardi N. Carpene Endstage J. 2006;27:833–52. Fukuchi Y, et al. Increasing COPD awareness. Eur Respir Zielinski J, Bednarek M, GoreckaD, Viegi G, HurdSS, CareMed.Respir Crit 2007;176:532–55. GOLD executive disease: summary. J pulmonary Am management, andprevention ofchronicobstructive P,Calverley etal. for thediagnosis, Globalstrategy Rabe KF, HurdS, Anzueto A, PJ, Barnes BuistSA, Pract.Nurse 2012;24:113–20. disease patients. pulmonary J obstructive Am Acad Lareau SC, Hodder R. Teaching inhaler use in chronic html, accessed6March2015). healthinfo/global_burden_disease/estimates/en/index1. Health Organization; 2014(http://www.who.int/ tables.Causes ofdeath2012summary Geneva: World 2014). February www.who.int/respiratory/copd/en/, accessed 19 Geneva: World HealthOrganization; 2013 (http:// disease(COPD). pulmonary Chronic obstructive 2 : arterial oxyhaemoglobin saturation. : arterial 7. Filosso PL, Ruffini E, Solidoro P, Molinatti M, Bruna MC, 9. Masa JF, Gonzalez MT, Pereira R, Mota M, Riesco JA, Oliaro A. Digital air leak monitoring after lobectomy for Corral J, et al. Validity of spirometry performed online. primary lung cancer in patients with moderate COPD: Eur Respir J. 2011;37:911–18. can a fast-tracking algorithm reduce postoperative 10. Strickland SL, Hogan TM, Hogan RG, Sohal HS, costs and complications? J Cardiovasc Surg (Torino). McKenzie WN, Petroski GF. A randomized multi- 2010;51:429–33. arm repeated-measures prospective study of several 8. Storre JH, Bohm P, Dreher M, Windisch W. Clinical modalities of portable oxygen delivery during impact of leak compensation during non-invasive assessment of functional exercise capacity. Respir Care. ventilation. Respir Med. 2009;103:1477–83. 2009;54:344–9. diseases 5. Respiratory 5.

73 74 2015 Systematic review of needs for medical devices for ageing populations people over theageof65years, insomeinstances hearing loss affects asignificantproportion of presentation ofoticdiseases, andadult-onset tinnitus andvertigo. Hearinglossis acommon manifesting asearache, hearingloss, otorrhoea, of theexternal, middle and innerearcommonly Otic diseasesencompassarangeofdisorders (18%) are undetermined. less contributory. largeproportion ofcauses A such asglaucomaandmaculardegeneration, being impairment worldwide, withothereye diseases, and cataractsare theleadingcausesofvisual From thisfigure, itisclearthat refractive errors causes ofvisualimpairmentare shown inFigure 1. surroundings, climateandnutrition (1). Global developing countries anddifferences insocial in due toinadequateophthalmicservices developing countries thandeveloped countries there isgreater prevalence ofblindnessin Eye diseasesoccurthroughout theworld, but and environmental factors. of corticosteroids, previous intraocularsurgery smoking, obesity, diabetesmellitus, long-termuse physical and age-related changestotheeye, predisposition, gender, race, systemicfactors, also contribute to eye disease, including genetic related changestotheeye. Otherfactorsmay the light-sensitive cellsinthemaculaandage- and intothesubretinal space, deteriorationof of abnormalbloodvessels underthemacula lens,optical qualityofthecrystalline growth damage totheopticnerve, degradationofthe of theseeye diseasesare variedandmay include and refractive errors. The underlying aetiologies include glaucoma, cataracts, maculardegeneration Ophthalmic diseasesare specifictothe eye. These otic diseaseswere identified for investigation. information.sensory ophthalmicand Age-related system responsibleof the nervous for processing system,encompasses diseases of the sensory a part Sense organdiseaseisabroad termthat 6.1 INTRODUCTION 6. Senseorgandiseases Organization, 2012(WHO/NMP/PBD/12.01). Source: GlobalDataon 2010.Visual Impairments Geneva: World Health degeneration; RE: errors. refractive DR: diabeticretinopathy; CO: opacities; corneal AMD: age-relatedmacular glaucoma tendstoappear suddenly andismore a slow andinsidiousonset, whereas angle-closure open-angleglaucomaischaracterizedby Primary open-angle glaucoma and angle-closure glaucoma. There are two maintypesofglaucoma:primary of visionandincreased intraocularpressure (3). head disease, associatedwithaprogressive loss disease is traditionally considered an optic nerve the affected eye may result ifleftuntreated. The isdamagedinsuchawaynerve thatblindnessin optic impairment andblindnessworldwide (2). The and isoneoftheleadingcausessevere visual Glaucoma isachronic progressive eye disease Introduction 6.2.1 Glaucoma 6.2 OPHTHALMICDISEASES Global causes of visual impairment visual of causes 1Global Figure may decrease hearingquality. signalsthrough theeartobrain or auditory deleteriously affecting thetransductionofsound ofhearinglossisvaried,aetiology asanything leading tosevere hearinglossordeafness. The undetermined cataract 33% 1 8% glaucoma 2% 1% trachoma, AMD childhood, DR, CO, 42% RE acute. Most forms of glaucoma progress without #2 glaucoma [MeSH terms] clinical symptoms and often advance to a severe #3 glaucoma stage before the patient is aware of the disease (2). #4 (#2 OR #3) Treatment aims to prevent further loss of vision: usually vision lost in glaucoma cannot be restored. #5 (#4 AND #1)

Risk factors for glaucoma include those that are Results limited to the onset of the disease and those that The strategy yielded 220 studies that comprised are associated with progressive worsening in the a range of evidence, including systematic reviews, already established disease. Notably, age, genetic randomized controlled trials, non-randomized predisposition, gender, race and systemic reasons comparative evidence, case series and non- are risk factors for the disease (4). systematic clinical reviews. On the title and Glaucoma is found in approximately 2% of the abstract screen, 128 studies were identified to population aged 40 years and above. It is estimated report the use of a device for the prevention, that more than 70 million people worldwide are diagnosis or treatment of glaucoma. The full text affected by the disease (3). More specifically, in of seven key studies (Table 32) and a review of people of European descent over 40 years of age, clinical practice guidelines were retrieved and the prevalence of primary open-angle glaucoma is used to inform the list of needed devices and to approximately 1.5–3% (5) and the prevalence of provide additional clinical context (Table 33). angle-closure glaucoma is reported to be 0.4% (6). A review of the literature identified medical devices and procedures for the diagnosis and Methodology treatment of glaucoma; no devices were identified An a priori search strategy was developed for the prevention of glaucoma. incorporating text and MeSH terms to identify devices that could be used in the prevention, Angle-closure glaucoma is a leading cause of diagnosis or treatment of glaucoma. The following blindness worldwide and is potentially preventable filters were applied: English language and published (7). There was a suggestion in the literature that within the past 10 years and randomized everyone aged 40 years or older undergoing an controlled trials and systematic reviews. eye examination, either routinely or for a specific reason, should be screened for angle-closure glaucoma to prevent unnecessary blindness (8). #1 ((aged [MeSH terms]) OR (health services diseases for the aged [MeSH terms]) OR (aged) OR Definitive diagnosis of glaucoma may be made (senior) OR (elderly) OR (geriatric)) AND Sense organ 6. ((equipment and supplies [MeSH terms]) OR using a number of tests. Ophthalmoscopy is used (assistive devices [MeSH terms]) OR (surgical as a primary test for glaucoma (9). Other tests instruments [MeSH terms]) OR (device*) OR (aid*) OR (equipment) OR (armamentarium) include visual field testing and gonioscopy (9). OR (appliance*) OR (instrument*) OR (apparatus) OR (good*) OR (implement*) OR (material*) OR (machine*)) AND ((diagnosis [MeSH terms]) OR (rehabilitation [MeSH terms]) OR (primary prevention [MeSH terms]) OR (secondary prevention [MeSH terms]) OR (after treatment [MeSH terms]) OR (therapeutics [MeSH terms]) OR (diagnos*) OR (therap*) OR (treatment*) OR (prevention) OR (monitoring) OR (screening) OR (rehabilitat*) OR (alleviat*)) 75 76 2015 Systematic review of needs for medical devices for ageing populations Glaucoma –key studies Table 32 Glaucoma 2011 (14) Staffieri etal (13) Pablo etal2010 2009 (12) Ivandic etal 2003 (11) D’Eliseo etal 2011 (10) Bollinger etal Study evidence Level of IV IV IV II II Primary focus Primary Telemedicine (GDx) Scanning laserpolarimetry Tomograph Heidelberg Retina irradiation Low-intensity laser phacoemulsification Combined deepsclerectomy implant Deep sclerectomy with implant Fluocinolone acetonide Secondary focus Secondary Nidek 3-Dxstereodisc camera Stereoscopic opticdiscphotographs Central cornealthicknessmeasurement Intraocular pressure measurement Humphrey 24–2SITA (Zeiss) visualfield analyser Computerized visualfield testing Visual acuitystandard logMARBailey-Lovie visualacuitychart Pachmate DGH55 Tonopen XL Autorefractor Kerameter Short-wavelength automatedperimetry Standard automatedperimetry Central cornealultrasonicpachymetry Intraocular pressure measurement Slit lamp Biomicroscope Red-free fundusphotography Fundoscopy Optical coherence tomography fibreRetinal nerve layer photography Photographic evaluation head ofopticnerve Biomicroscope andslitlamp Ophthalmoscope Tenon nylon 10–0suture Nylon 10–0throws Triangular drainagedevice Vannas scissors Step diamondknife Dumontforceps 6–0 prolene superiorrectus bridlesuture Goldman applanation tonometer Gonioscopy Biomicroscopy Best corrected visualacuitytest Stegmann’s viscocanalostomy Trabeculectomy phacoemulsification Snellen chart 8–0 polypropylene suture Vitrectomy Glaucoma-drainage device Study Level of Primary focus Secondary focus evidence Toth et al 2007 IV Scanning laser polarimetry Optic nerve head photography (2) (GDx-VCC) Scanning laser tomography Matrix Frequency Doubling Scanning laser polarimetry Technology Frequency-doubling technology Variable corneal compensator Goldmann applanation tonometer Slit lamp Goniolens Humphrey visual field analyser Standard visual acuity testing 90-dioptre non-contact aspheric lens Diurnal intraocular pressure curve Central corneal thickness measurement Optic nerve head evaluation Standard automated visual field testing Vizzeri et al IV Heidelberg Retina 78-dioptre lens 2009 (15) Tomograph Confocal scanning laser ophthalmoscopy

NA: not applicable. a Proprietary marks have been included where this information was readily identified through source material.

Table 33 Glaucoma – devices identified for prevention, diagnosis and treatment

Device Description Function Prevention Bailey-Lovie chart Chart Measures visual acuity Autorefractor/keratometer Appliance Assesses refractive status Pachymeter Appliance Measures central corneal thickness Stereoscopic camera Appliance Visualization of optic disc Visual field analyser: Humphrey analyser; Appliance Measures visual field matrix frequency-doubling instrument Diagnosis Snellen eye chart Chart Measures visual acuity Tonometer: Goldmann application; Appliance Assesses intraocular pressure Pascal dynamic contour; Reichart Ocular Response Analyser Biometer Appliance Measures axial length and corneal curvature Pachymeter Appliance Measures central corneal thickness

Scanning laser polarimetry (GDx) Appliance Measures thickness of retinal nerve fibre layer diseases

Heidelberg Retina Tomograph Appliance Visualization of optic nerve head Sense organ 6. Pentacam Apparatus Visualization of anterior chamber depth Slit-lamp biomicroscope Appliance Examination of eye Fundus camera Apparatus Viewing of eye, including fundus Goniolens Apparatus Identification of angle closure Tomograph Appliance Examination of retina, measures retina thickness and identifies lesions Treatment Lasers: argon laser; Nd:YAG laser Appliance Reduces intraocular pressure through laser trabeculoplasty and laser iridotomy Glaucoma-draining implant Implant Reduces intraocular pressure

ND:YAG: neodymium-doped yttrium aluminium garnet. 77 78 2015 Systematic review of needs for medical devices for ageing populations controlled trialsandsystematic reviews. within thepastfive years andrandomized filters were applied: Englishlanguageandpublished diagnosis or treatment of cataracts. The following devices thatcouldbeusedintheprevention, incorporating text and MeSH terms to identify An apriorisearch wasdeveloped strategy Methodology do nothave accesstotreatment (17). affects agreater number ofpeople, many ofwhom countries, thedisease beginsatanearlierageand of cataractsduetoenvironmental factors. Inthese developing countries, there isahigherprevalence There are regional variationsindiseaseaetiology. In previous (16). intraocular surgery mellitus, long-term use ofcorticosteroids and development ofcataractsare smoking, diabetes The mostcommonriskfactorslinked withthe resumption ofregular activitiesofdaily living(16). successful, leadingtotherestoration ofvisionand and physical function. istypically highly Surgery cataracts may experienceasteadydeclineinvisual cataracts 20 millionpeople)in2010beingattributedto 51% ofallcasesblindness(approximately cause ofblindnessworldwide, withanestimated lead tolossofvision(16). Cataractsare theleading progressive opacificationofthe eye, whichcan lens,optical qualityofthecrystalline resulting in Cataracts are definedasthedegradationof Introduction 6.2.2 Cataracts (17). Leftuntreated, patientswith examination isconductedtolookfor cloudy using a number of eye tests. direct physicalA Definitive diagnosis ofcataractsmay be made identified. for thediagnosisandtreatment ofcataractswere but anumber ofmedicaldevices andprocedures The search didnotyieldany preventive devices, relevant tocataracts (18). were alsoconsultedtoidentify additional devices 35). clinicalpracticeguidelines Supplementary and abstractreview ofallincludedstudies(Table of identified devices wasobtainedthrough title review are summarized in Table 34. broader list A details ofthekey studiesretrieved for fulltext for thediagnosisortreatment ofcataracts. The were identified theuseofadevice to report On thetitleandabstractscreen, 130studies largely ofrandomizedcontrolled trialevidence. yielded217studies,The strategy comprised Results lens implant. the clouded eye lens and replacing it with a plastic cataracts istheonly effectiveSurgery treatment for glare-vision testorslit-lampexamination. examination, measurement ofintraocular pressure, areas onthelens. This may involve adilatedfundus #5 #4 #3 #2 #1 #1 AND #4 #1 AND #2 OR#3 cataract cataract [MeSHterms] OR (screening) OR(rehabilitat*) OR(alleviat*)) (treatment*) OR(prevention) OR(monitoring) [MeSH terms])OR(diagnos*)(therap*) OR treatment [MeSHterms])OR(therapeutics prevention(secondary [MeSHterms])OR(after preventionOR (primary [MeSHterms])OR terms]) OR(rehabilitation [MeSHterms]) OR (machine*)) AND ((diagnosis[MeSH OR (good*) OR(implement*)(material*) (appliance*) OR(instrument*)(apparatus) OR (equipment)(armamentarium) [MeSH terms])OR(device*) OR(aid*) devices [MeSHterms])OR(surgicalinstruments and supplies[MeSHterms])OR(assistive OR (elderly) OR(geriatric)) AND ((equipment the aged[MeSHterms])OR(aged)(senior) for ((aged [MeSHterms])OR(healthservices (19). The procedure involves removing Table 34 Cataracts – key studies

Study Level of Primary focus Secondary focus evidence Barsam et al 2008 II Phacoemulsification devices Ophthalmic viscosurgical device (20) Slit-lamp examination Dilated fundoscopy Visual acuity Optical coherence tomography Coelho et al 2009 II Nd:YAG laser Visual acuity testing (21) Slit-lamp examination Applanation tonometry Keratometry Axial length measurements Anterior chamber depth measurements Slit-lamp biomicroscopy 2.75 mm knife Phacoemulsification Fundus examination Dell et al 2011 (22) II Ocular hydrogel bandages Intraocular lenses Collagen corneal shield Fernandez de Castro II Phacoemulsification Snellen chart et al 2008 (23) devices, including handheld Intraocular pressure measurement attachment Slit-lamp examination Dilated fundus examination Ferreira and Almeida II Refraction Snellen chart 2012 (24) Slit-lamp examination Goldmann applanation tonometer Dilated fundoscopy Partial coherence interferometer Pentacam Mendez degree gauge and axis marker Phacoemulsification Injector/inserter Viscosurgical device Wavefront abberometer systems Intraocular lenses Gangwani et al 2011 II Intraocular lens Partial coherence interferometry (25) Intraocular lenses Ophthalmic viscosurgical devices Phacoemulsification

Slit-lamp evaluation diseases

Snellen chart Sense organ 6. Autorefraction measures Anterior chamber depth measures Intraocular pressure measures Retinal examination Nd:YAG laser Martinez Palmer et II Intraocular lenses Diamond knife al 2008 (26) Phacoemulsification Intraocular lens delivery systems Refractor Intraocular pressure measurement Slit-lamp examination Fundus examination Partial coherence tomography Continues… 79 80 2015 Systematic review of needs for medical devices for ageing populations Nd:YAG – aluminiumgarnet. Neodymium-dopedyttrium treatment and diagnosis for identified –devices Table 35 Cataracts Nd: YAG – aluminiumgarnet. Neodymium-dopedyttrium Degree gaugeandaxismarker Ophthalmic viscosurgicaldevice bandages; collagencornealshield Bandages/shields: ocularhydrogel Lasers: Nd:YAG attachments Phacoemulsification andassociated 2.75 mm diamondknife systems Intraocular lensdelivery Intraocular lens Spectacles Treatment Wavefront abberometer system Keratometer/ophthalmometer Snellen eye chart interferometer; ultrasound Biometers: coherence partial Optical coherence tomographer Pentacam Fundus camera Refractor direct ophthalmoscope Scopes: slit-lampbiomicroscope; Tonometer Visual field analyser 1 Chart retinopathy studychart; CSV-1000E Charts: early treatment diabetic Diagnosis Device Study (27) Swamy etal2009 evidence Level of IV Direct ophthalmoscopy Slit-lamp biomicroscopy tonometer Perkins applanation field unit Humphrey automatedvisual CSV-1000E 1 Chart retinopathy studychart Early treatment diabetic focus Primary Instrument Material Consumable Appliance Instrument Instrument Instrument Implant Aid Instrument Instrument Chart Appliance Appliance Apparatus Apparatus Instrument Instrument Instrument Appliance Chart Description Marks implantationaxis Fills anteriorchamberduringlens implantation Provides wound protection andpain relief postoperatively Capsulotomy ortopreoperatively openanteriorcapsule removal Attachments includesonicoscillationstoincrease efficiencyofcataract Removal oflensmaterialusingultrasonic, fluidicandvacuumpower. Delivers cornealincision Assists inlensimplantation Restores vision Improves visualacuity autorefractometer andtopographer Identification ofcornealandinternalaberrations whencombinedwith astigmatism Measures of anteriorsurfaceofcorneatoassessextent curvature Measures visualacuity Measures axiallength, anteriorchamberdepthandsurfacecurvature Measures retinal depth Obtains keratometry values Examination ofeye, includingfundus Measures refractive error Examines eye Assesses intraocularpressure Assesses visualfield Measures monocularandbinocular visualacuity, andcontrastsensitivity Refractor Spectacles focus Secondary 6.2.3 Refractive errors #1 ((aged [MeSH terms]) OR (health services for the aged [MeSH terms]) OR (aged) OR Introduction (senior) OR (elderly) OR (geriatric)) AND Refractive error is a condition of the eye that ((equipment and supplies [MeSH terms]) OR (assistive devices [MeSH terms]) OR (surgical leads to inaccurate focusing of parallel light rays at instruments [MeSH terms]) OR (device*) OR the fovea. It is a common cause of impaired visual (aid*) OR (equipment) OR (armamentarium) OR (appliance*) OR (instrument*) OR acuity. Refractive errors are classified as spherical (apparatus) OR (good*) OR (implement*) OR and cylindrical errors. Myopia (near-sightedness) (material*) OR (machine*)) AND ((diagnosis [MeSH terms]) OR (rehabilitation [MeSH and hyperopia (far-sightedness) are spherical terms]) OR (primary prevention [MeSH terms]) errors. In these circumstances, parallel rays of OR (secondary prevention [MeSH terms]) OR (after treatment [MeSH terms]) OR light focus anteriorly (myopia) or posteriorly (therapeutics [MeSH terms]) OR (diagnos*) OR (hyperopia) to the fovea, resulting in blurry vision. (therap*) OR (treatment*) OR (prevention) OR Astigmatism and presbyopia are cylindrical errors. (monitoring) OR (screening) OR (rehabilitat*) OR (alleviat*)) Astigmatism is caused by the irregular shape #2 error, refractive [MeSH terms] OR refractive of the cornea and/or lens. Presbyopia is age- error* OR myopia OR hyperopia OR related vision impairment where the eye shows a astigmatism OR presbyopia OR aniseikonia OR anisometropia progressively diminished ability to focus on near objects. In addition, different refractory errors #3 #1 AND #2 and magnifications between the two eyes lead to #4 #1 AND #2 anisometropia and aniseikonia (28).

In the Western Pacific Region, WHO estimates Results that less than 1% of all DALYs in 2012 were due The strategy yielded 142 results. On the title to refractive errors (29). It is estimated that vision and abstract screen, 35 studies were identified impairment resulting from uncorrected refractive that reported the use of a device for diagnosis errors affected 1–4% of the world’s population in or management of refractive errors. The details 2012. The prevalence of uncorrected refractive of the key studies retrieved for full text review errors is greatest in people over 50 years of age are summarized in Table 36. A broader list of (30). identified devices was obtained through title and abstract review of all included studies (Table 37).

Methodology None of the devices was related to screening or An a priori search strategy was developed prevention of refractive errors in elderly people. incorporating text and MeSH terms to identify devices that could be used in the prevention, People with blurred vision, double vision, eye diagnosis or treatment of refractive errors. The strain or eye discomfort are examined to identify following filters were applied to the search results: potential causes for symptoms. Spectacles and diseases

English language and published within the past contact lenses provide sufficient aid for many Sense organ 6. five years and randomized controlled trials and people. Contact lenses can be for long-term or systematic reviews. short-term use. Disposable contact lenses, which have been designed for short-term use, have the additional benefit of increased cleanliness and sterility compared with reusable contact lenses. To minimize the risk of eye infections, extraocular contact lenses are cleaned with special cleaning solutions. Supplementary searches using clinical practice guidelines identified phoropters, trial lenses and trial frames for the correction of

81 82 2015 Systematic review of needs for medical devices for ageing populations a –key studies errors Table 36 Refractive corrected by eitherchangingtheshape ofthe refractive surgery. The refractive errors are Severe refractive errors may bemanagedby review (31). through theresults ofthesystematicliterature refractive errors, whichwere notidentified Hjortdal 2012(36) Hjortdal Ivarsen and (35) Barisic etal2010 (34) Chan etal2008 (33) Choi etal2009 OHTAS 2009(32) Study Proprietary marks have wasreadily identified marks beenincludedwherethisinformation throughsourcematerial. Proprietary evidence Level of II II II II I ultrasound; pachymetry Imaging: TMS-1 cornealtopography; Multifocal) Intraocular lens(e.g. Tecnis® IntraLase™, StarS4IR™) Femtosecond lasers(e.g. lenses (e.g. IQ) Acrysof® Adapt™); asphericintraocular (e.g. Akreoslenses AO™, Akreos aberration-free intraocular Intraocular lenses: spherical posterior chamberlenses Implantable); iris-fixatedlenses; intraocular lens(e.g. Collamer® Intraocular lenses: phakic Primary focus Primary a performed withthehelpofablationtechniques. (Table 36). Remodellingofthecorneacanbe Several typesofintraocularlenseswere identified to effectively changethepower ofthenaturallens. procedures, or by implanting an intraocular lens cornea using corneal incision, surface or flap Secondary focus Secondary Keratometry Wavefront aberrations spectacles Optical analysis software (e.g. Zemax™EE) Bandage contactlens Cutting heads Schwind Supratome Excimer laserphotoablation Knife PHACO machines(e.g. Infiniti®, Alcon®, Signature®) Special multifocal lenses(bifocal andprogressive) Spectacles Software (SPSSversion 11.0) Mechanical keratome (Hansatome) Aberrometer Excimer laserreticle Pachymetry Software (e.g. SPSSversion 13.0) Pupillometer (Colvard®) Luminometer Snellen visualacuitychart system(e.g.Lens insertion SystemInserter) Sofport® Diamond knife irrigation/aspiration system Wavefront analysis (WaveScan WaveFront™) Visual capacity analyser Biometry Specular photomicroscopy Corneal topography Corneal pachymetry Contact lenses Spectacles Snellen chart Claw CustomCornea® Laser systems: VISX CustomVue™ and Alcon a Table 37 Refractive errors – devices identified for diagnosis and treatment

Devicea Description Function Diagnosis Refractor Instrument Measures refractive error Disparity vectographic apparatus: Appliance Measures stereoacuity vectographic Titmus; random dot stereotests; Howard–Dolman Vision contrast test system (e.g. Appliance Tests vision contrast Vistech® VCTS 6500) Tonometers: applanation tonometer; Appliance Assesses intraocular pressure measurements or direct Perkins applanation tonometer; transcorneal measurement of intraocular pressure Goldmann applanation tonometer; Pascal dynamic contour tonometer; applanation resonance tonometer

Ultrasound Appliance Measures various dimensions of eye and its components and their interrelationships Ultrasound pachymeter Instrument Measures thickness of cornea in glaucoma, in suspected hypertension or before refractive surgery Stray-light meter Instrument Measures stray light Optical coherence tomograph Appliance Analyses anterior segment and its thickness Visual field analyser Appliance Assesses visual field Ocular response analyser Appliance Assesses biomechanical properties of corneal tissue Functional vision analyser Appliance Tests vision Aberrometer (ANIDEK® OPD) Instrument Measures refractive aberrations Ophthalmoscope Instrument Examination of eye Cameras: fundus camera; Scheimpflug Apparatus Views and photographs eye photography (Pentacam) Partial coherence interferometer Appliance Measures various dimensions of eye and its components and their interrelationships

iVIS® Suite Software Assesses pupil, anterior segment elevations, true shapes, asphericity and critical surgical dimensions iTrace® Software Management/education software for patients with unsatisfactory vision Poco® Software Quantifies results from retroillumination photographs CustomVue® Software Used in laser ablation system Treatment Spectacles Aid Improves visual acuity

Contact lenses: silicone hydrogel lens; Aid Improves visual acuity diseases disposable contact lens 6. Sense organ 6. Intraocular lenses: monofocal and Implant Surgical correction of refractive errors multifocal lenses; aspheric and spherical lenses; phakic lens Hessburg-Barron suction trephine Instrument Aids keratotomy and keratoplasty procedures Laser Appliance Ablative reconstruction of curvature of cornea Femtosecond laser Appliance Creates flap during bladeless LASIK Perspex ring Implant Physical alteration of shape of cornea Bandage Consumable Provides wound protection and pain relief postoperatively

LASIK: laser-assisted in situ Keratomileusis. a Proprietary marks have been included where this information was readily identified through source material.

83 84 2015 Systematic review of needs for medical devices for ageing populations systematic reviews. 10 years and randomized controlled trialsand English languageandpublishedwithinthepast degeneration. The following filters were applied: diagnosis ortreatment ofage-related macular devices thatcouldbeusedintheprevention, incorporating text and MeSH terms to identify An apriorisearch wasdeveloped strategy Methodology and 50%ofallblindness(39). degeneration toberesponsible for between 3% Pacific Regionhave estimatedage-related macular Studies conductedincountriesofthe Western than 82%ofallblindpeopleare agedover 50 years. ageing of the population with prevalence increasing substantially withthe leading causeofcentralblindnessorlow vision, countries, age-related maculardegenerationisthe In theelderly populationofindustrialized include cigarette smokingandobesity(37). macular degeneration. Modifiableriskfactors have beenimplicatedincausingage-related A variety of genetic and environmental factors lead tocompletevisualloss(37). resulting visualdeterioration, infurther whichmay space, leadingtorapid damagetothemaculaand grow underthemaculaandintosubretinal wet form occurswhenabnormalbloodvessels vision oftheaffected eye. The more insidious the macula, leadingtoagradualblurinthecentral from thedeteriorationoflight-sensitive cellsin related maculardegeneration. form resultsThe dry by centralvisionloss. There are two forms ofage- Age-related maculardegenerationischaracterized Introduction 6.2.4 Maculardegeneration (37,38). Globally, more Results also usedinthescreening ofmaculardegeneration. (Table 39). Blueoryellow is automatedperimetry be usedinthescreening ofmaculardegeneration 65 years andolder(41). may number ofcharts A 40–64 years and every 1–2years for peopleaged recommended every 2–4 years for people aged formula such asthe Age-Related Eye DiseaseStudy smoking cessationandnutritional supplements degeneration. Proven preventive strategiesinclude the prevention, diagnosisandtreatment ofmacular The search identified several strategy devices for (Table 39). title andabstractreview ofallincludedstudies list ofidentified devices wasobtainedthrough text review are summarizedin Table 38. broader A The detailsofthekey studiesretrieved for full treatment ofage-related maculardegeneration. use ofadevice for theprevention, diagnosisor screen, 45studieswere identified to the report systematic reviews. Onthetitleandabstract comparative evidence, caseseriesandnon- randomized controlled trials, non-randomized range ofevidence, includingsystematicreviews, yielded 110studiescomprisinga The strategy #5 #4 #3 #2 #1 #1 AND #4 #1 AND #2 OR#3 age related maculardegeneration age related maculardegeneration[MeSHterms] OR (alleviat*)) (monitoring) OR(screening) OR(rehabilitat*) (therap*) OR(treatment*) OR(prevention) OR (therapeutics [MeSHterms])OR(diagnos*) OR (aftertreatment [MeSHterms])OR preventionOR (secondary [MeSHterms]) preventionterms]) OR(primary [MeSHterms]) [MeSH terms])OR(rehabilitation [MeSH (material*) OR(machine*)) AND ((diagnosis (apparatus) OR(good*) OR(implement*) OR (appliance*) OR(instrument*) (aid*) OR(equipment)(armamentarium) instruments [MeSHterms])OR(device*) OR (assistive devices [MeSHterms])OR(surgical ((equipment andsupplies[MeSHterms])OR (senior) OR(elderly) OR(geriatric)) AND for theaged[MeSHterms])OR(aged) ((aged [MeSHterms])OR(healthservices (40). Regulardilatedeye examinationsare A definitive diagnosis of macular degeneration types of angiography are also used to diagnose may be made using a number of tests. Optical macular degeneration: fluorescein angiography coherence tomography is used to confirm the and indocyanine angiography. Angiography involves presence of subretinal and intraretinal fluid. Two injection of dye into the vein and the use of X-ray

Table 38 Macular degeneration – key studies

Study Level of Primary focus Secondary focus evidence Brown et al 2011 IV Implantable miniature telescope None (44) Christoforidis et al NA Diagnostic and therapeutic None 2011 (37) options Culham et al 2004 IV Electronic head-mounted low- Early treatment diabetic retinopathy study chart (45) vision devices Bailey-Lovie near word and word charts Pelli-Robson chart Karnon et al 2008 I Screening programme Amsler grid (46) Slit-lamp Argon laser Transpapillary thermo-therapy Laser photocoagulation Fluorescein angiography Koss et al 2009 (47) II Rheopheresis treatment system Early treatment diabetic retinopathy study chart Neelam et al 2009 IV Slit-lamp biomicroscopy None (48) Fundus photography Nowak et al 2012 IV Photodynamic therapy Snellen chart (38) Transpapillary thermo-therapy Intraocular pressure measurement Slit-lamp examination Fundoscopy Fluorescein angiography Optical coherence tomography Parodi et al 2004 II Prismatic correction spectacles Early treatment diabetic retinopathy study chart (49) Schmitz-Valckenberg IV Fundus camera None et al 2008 (50) Confocal scanning laser ophthalmoscope

NA: not applicable. diseases

Table 39 Macular degeneration – devices identified for prevention, diagnosis and treatment Sense organ 6.

Device Description Function Prevention Amsler grid Chart Monitors central visual field Perimeter Appliance Detects early changes in age-related macular degeneration Diagnosis Charts: Snellen chart; early treatment Chart Measures visual acuity and contrast sensitivity diabetic retinopathy study chart; Bailey-Lovie near word/word chart; Pelli- Robson chart Tonometer Instrument Assesses intraocular pressure Slit-lamp biomicroscope Instrument Examination of eye Continues… 85 86 2015 Systematic review of needs for medical devices for ageing populations clinical practice guidelines(43). literature search butwere identified through plus verteporfin were notidentified through the photocoagulation and photodynamic therapy growth factorinhibitors, thermallaser intravitreal injection with vascular endothelial dose antioxidant andmineralsupplementation, treatment maculardegeneration. for dry High- identified through the search as anexperimental to filterthebloodand reduce itsviscositywas in the macula. Double-filtration plasmapheresis with theaimofcontrolling blood vessel growth was identified treatment, inthesearch asaprimary disease, sight(42). andpreserving Lasertreatment immediate maculardegenerationtoadvanced is aimedatreducing therateofprogression of ofdiseaseatpresentation.on the category It Treatment for maculardegenerationisdependent choroidal circulation. angiography provides adetailedrepresentation of abnormal vascularprocesses, whileindocyanine allows for theidentificationandlocalizationof based imagingtechniques. Fluorescein angiography Rheopheresis treatment system Laser Implantable miniature telescope Low-vision filter Prismatic correction spectacles hardware/software) circuit television andadaptive computer Electronic visualaid(includingclosed- electronic head-mountabledevice Visual aids: magnifyingglass; telescope; Treatment Angiogram Angiograph Optical coherence tomographer Fundus camera Confocal scanninglaserophthalmoscope Device Appliance Appliance Implant Aid Aid Aid Aid Appliance Appliance Appliance Apparatus Instrument Description Filters outrheologically relevant plasmaproteins Destroys orsealsoffnew bloodvessels toprevent leakage Improves vision preferred by patient. May protect from ultraviolet further damage Reduces short-wavelength lightandreduces glare. Identifies light preferred retinal loci Stabilizes oculomotorfunctiontopromote betterfunctionof computer monitor Projects magnified imageonvideomonitor, television screen or Improves visualfunctionby decreasing viewing distanceoftarget indocyanine angiography Images bloodvessels. Usedinfluorescein angiography and treatment option Determination oflesionmorphology. Helpsdecipherbest lesions Examination ofretina, measures retina thicknessandidentifies Views eye, includingfundus Examination ofeye Function hearing loss isnormally treated through the of repairing this type of damage, sensorineural and isgenerally permanent. there isnowayAs brain (neural). This may becongenital oracquired pathwayor tothenerve from theinnerearto damage to the hair cells of the cochlea (sensory) type ofhearinglossandoccurswhere there is Sensorineural hearinglossisthemostcommon ear andthentothebraincanaffect hearingquality. the externaleartomiddle eartotheinner that interferes withthemovement ofsoundfrom ofhearinglossisvaried,The aetiology asanything and depression (54). loss isstrongly associatedwithfunctionaldecline 80% inpeopleagedover 80years (53). Hearing (51,52). This prevalence increases tomore than aged over 65years hashearingimpairment age. Itisestimatedthat25–60%ofthepopulation Hearing lossbecomesincreasingly commonwith Introduction 6.3.1 Adult-onset hearingloss 6.3 OTIC DISEASES amplification of sound through various means. #2 presbycusis [MeSH terms] Conductive hearing loss is a condition where #3 presbycusis sound is not conducted properly through the #4 adult onset hearing loss external auditory canal, the tympanic membrane (eardrum) or the ossicular chain (bones of the #5 hearing loss [MeSH terms] ear) to the oval window of the cochlea. Impacted #6 #2 OR #3 OR # 4 OR #5 cerumen (earwax) within the external ear canal #7 #1 AND #6 is the most common cause of conductive hearing loss and can affect up to one in three older adults Results (55). As the causes of conductive hearing loss The strategy yielded 151 results. The majority of are generally mechanical in nature, treatment is studies were randomized clinical trials, although a often surgical. Mixed hearing loss occurs when number of systematic reviews were also retrieved. there are impediments to both conductive and On the title and abstract screen, 135 studies were sensorineural pathways. identified to report the use of a device for the Age-related hearing loss (presbycusis) is generally prevention, diagnosis or treatment of hearing loss. bilateral, gradual and progressive (53). It is normally The details of the key studies retrieved for full sensorineural in nature as a result of damage to text review are summarized in Table 40. A broader cochlea hair cells. Many factors may contribute to list of identified devices was obtained through presbycusis, including genetic factors, exposure title and abstract review of all included studies to loud noise or ototoxic agents, a history of (Table 41). inner ear infections, and systemic diseases such as A broad range of procedures, interventions and diabetes (53). devices was identified to prevent, diagnose, aid and treat various forms of hearing loss. The literature Methodology search also identified the use of hearing-protection An a priori search strategy was developed devices as workplace safety equipment to reduce incorporating text and MeSH terms to identify damage to the ear, together with educational devices that could be used in the prevention, programmes to promote their use and improve diagnosis or treatment of hearing loss. The compliance. following filters were applied to the search results: English language and published within the past Due to the slow and progressive nature of 10 years and randomized controlled trials and presbycusis, many older people may not be aware systematic reviews. that they have a hearing problem. Consequently, screening of elderly people may provide a useful #1 ((aged [MeSH terms]) OR (health services tool in identifying hearing loss in this population for the aged [MeSH terms]) OR (aged) OR (senior) OR (elderly) OR (geriatric)) AND (52,53,56,57). The literature search identified a diseases ((equipment and supplies [MeSH terms]) OR wide range of screening strategies. Two common Sense organ 6. (assistive devices [MeSH terms]) OR (surgical approaches include the AudioScope (a handheld instruments [MeSH terms]) OR (device*) OR (aid*) OR (equipment) OR (armamentarium) combined audiometric device and otoscope) OR (appliance*) OR (instrument*) OR and Hearing Handicap Inventory for the (apparatus) OR (good*) OR (implement*) OR (material*) OR (machine*)) AND ((diagnosis Elderly – Screening version (a self-administered [MeSH terms]) OR (rehabilitation [MeSH questionnaire). Further audiology tests identified terms]) OR (primary prevention [MeSH terms]) OR (secondary prevention [MeSH terms]) included the Bench–Kowal–Bamford sentence OR (after treatment [MeSH terms]) OR scores for sentence perception, the Speech (therapeutics [MeSH terms]) OR (diagnos*) OR (therap*) OR (treatment*) OR (prevention) OR Perception in Noise tests and the Glasgow Hearing (monitoring) OR (screening) OR (rehabilitat*) Aid Benefit Profile to measure the subjective OR (alleviat*)) benefit of hearing aids.

87 88 2015 Systematic review of needs for medical devices for ageing populations Hearing loss – devices identified for diagnosis and treatment and diagnosis for identified –devices loss Table 41 Hearing a HHIE: for theElderly. HandicapInventory Hearing –key studies loss Table Hearing 40 listening devices canbeusedinassociationwith able toafford thecostofhearingaids. Assistive patients whomay notbenefitfrom ormay notbe Assistive listeningdevices may beoffered to clear how thiswas provided. Enhancement programme), althoughitwasnot of thehearingaid(ListeningandCommunication that assisted the user in aspects offitting anduse audiologist. Specificsoftware wasalsoidentified and forums andtelephoneconsultationswithan educational initiatives includedonlineprogrammes successful useofexternalhearingaids. These that aimedtoimprove thefittingandcontinued Questionnaires andprogrammes were identified 2007 (51) Yueh andShekelle (53) Chou etal2011 (58) Balkany etal2007 Device Study Otoscope Diagnosis Tone-emitting otoscope Proprietary marks have wasreadily identified marks beenincludedwherethisinformation throughsourcematerial. Proprietary a evidence Level of II I I therapy Screening, diagnosisand Screening devices andtests Freedom™) Cochlear implant(Nucleus Primary focus Primary Description Instrument Instrument a Function Visualization of external auditory canalandtympanicmembrane Visualization ofexternalauditory Combined otoscopeandaudiometer for identificationofhearing loss in therepair ofthetympanicmembrane. One with effusion. Nospecificdevices were identified be usedinthetreatment ofpersistentotitismedia tube placedthrough thetympanicmembranecan initially through systemicmedication. ventilation A infections andfluidbuild-upare likely tobetreated squeezable bottlewithaspecially designedtip. Ear the patient, for exampleusing70%alcoholfrom a accomplished by aclinicianormay bedoneby Removal ofimpactedcerumen(earwax)canbe home. improve aperson’s audiovisual stimuli intheirown doorbells, televisions andsmoke detectorsto household technologies such as telephones, Cochlear implant telephones anddoor-knock systems) Assistive listeningdevices (e.g. amplifiers, headphones, visual Hearing aids Speech-reception threshold Pure-tone audiometry AudioScope HHIE Single-question screening andscreening questionnaires Whispered voice, fingerrubandwatch-ticktest Hearing aiduse HHIE otoscope device) AudioScope (handheldcombinationaudiometricand recognition test Comparison withNucleusContour(CNC)word- Sound-treated booth sentence recognition Audiometer andaudiogramsfor pure-tone, word and Hearing-in-noise test(HINT)-Q focus Secondary Devicea Description Function Audiometer Instrument Identification of hearing loss; an audiogram is the graphical and associated representation of the results. Tests that can be undertaken include software pure-tone audiometry, air–bone gap audiometry, azimuth audiometry (where sound source is angled), impedance audiometry (to determine status of tympanic membrane) and otoacoustic emission testing (detection of spontaneous or stimulated sounds produced from middle ear). Statistical algorithms (Fast Fourier Transform techniques with F-test and Fourier Linear Combiner) were identified to measure auditory steady-state response, an auditory evoked potential elicited with modulated tones to predict hearing sensitivity in patients of all ages CT system Appliance Provides imaging information before implantation of devices such as cochlear implant, or provides additional information for diagnosis of conductive hearing loss Treatment Linear analogue external hearing aid Aid Provides amplification for hearing loss Digital hearing aids, e.g. Siemens Aid Provides amplification for hearing loss Artis 2 SP behind-the-ear hearing aids, digital hearing aid with phase- preserving and non-phase-preserving amplification, binaural broadband digital hearing instruments Trainable hearing aid Aid Provides real-world preferred hearing aid gain Automatic-volume-control hearing Aid Provides amplification for hearing loss aid Wide-dynamic-range compression Aid Compensates for loudness sensitivity hearing aids Open-mould behind-the-ear hearing Aid Improves ventilation aid Hearing aid anti-cardioid directivity Aid/software Improves speech recognition when originating behind the user pattern (current options include omnidirectional and conventional adaptive directional aids) Ventilation tube Implant Treatment of persistent otitis media with effusion Modified Politzer device Instrument Naturally opens blocked eustachian tube with air High-fidelity personal sound player Other Provides acoustic stimulus modified according to the patient’s with earphones audiometric profile for reducing effects of tinnitus RetroX® Implant Auditory implant of external ear for patients without occlusion of external auditory canal Custom-made electrical stimulator Instrument Provides transcutaneous electrical stimulation for treatment of tinnitus (shown not to be effective) Hyperbaric chamber Appliance Hyperbaric oxygen therapy for sudden sensorineural hearing loss Squeezable bottle with specially Instrument Removal of cerumen (earwax) to reduce impaction, using 70% designed tip isopropyl alcohol

Needle and syringe Consumable Trans- or intra-tympanic steroid injections in treatment of sudden diseases

sensorineural hearing loss for patients who have failed to improve Sense organ 6. with initial systemic steroid treatments. Largely unproven (58) Manual micro-perforator Instrument Stapedotomy: to create a hole in stapes footplate Er:YAG laser Appliance Stapedotomy: to create a hole in stapes footplate Piston prostheses, e.g. platinum wire Prosthesis Stapedotomy: prostheses to allow movement in ossicular chain prosthesis; heat-activated nitinol stapes piston prosthesis Modified Lippy prosthesis Prosthesis Reconstruction of incus. For use in middle ear reconstruction Middle ear prosthesis (titanium) Prosthesis Ossicular reconstruction Cochlear implant (HiRes 120 with Implant and Treats severe to profound sensorineural hearing loss, usually in young Harmony processor, HiRes90K, software people. Specific programming software includes Fitting to Outcomes Clarion II, Nucleus Freedom, eXpert (FOX) Advanced Bionics Corporation or Cochlear Corporation devices) Continues… 89 90 2015 Systematic review of needs for medical devices for ageing populations part ofthisproject.part Independent searches were Five senseorgandiseaseswere investigated as 6.4 CONCLUSION 2013). Australia, personalcommunication, 7February (M Schultz, MemorialHospital, Adelaide, South hearing aidsmay beoffered asanalternative maysurgery beavoided inelderly peopleand Due to the complications of surgery, stapedectomy is removed andreplaced withamicro-prosthesis. various manners. Instapedectomy, thestapes bone Ossicular reconstruction can beundertaken in mechanical problems associatedwithhearingloss. There are many procedures for thetreatment of is dependentonthenature ofthehearingloss. brainstemimplants.auditory The choiceofimplant anchored hearingaids, middle earimplantsand hearing loss, including cochlearimplants, bone- A rangeofimplantabledevices isavailable for myringoplasty). conventional (type1tympanoplastyor surgery of thetympanic membrane without theneed for sponge andfibringluetoassistinthe regeneration use ofbasicfibroblast growth factor, agelatin method describedanovel therapy involving the a CT: computedtomography; Er:YAG: aluminiumgarnet. erbium-dopedyttrium Device Cochlear implantelectrode teleconference facilities Remote programming systemwith Auditory brainstemimplant Auditory Cordelle Bone-anchored hearingaid: BAHA® Vibrant™ Soundbridge) devices (Carina™, Esteem™, Fully implantablemiddle-ear hearing system Med-El electricacousticstimulation Electric acousticstimulation aid insameear Hybrid cochlearimplantplushearing Closed-loop cochlearimplant Proprietary marks have wasreadily identified marks been includedwherethisinformation throughsourcematerial. Proprietary a Description Implant software Appliance and Implant Implant Implant aid Implant and Implant Function electrode atdifferent stimulation andcanbeinserted depths power consumption(noevidence). Electrodes canbedual-orsingle- Improves simulation ofspecificneuralpopulationsand reduces Facilitates remote programming ofcochlearimplant Treats sensorineuralhearingloss by directly stimulating brainstem Treats bilateralpermanentconductive hearingloss conventional hearingaids. Stimulates round window membrane who are medically unabletowear, orhave failedtreatment with, Treats mixed orconductive hearingloss, inpatients particularly Improves electrical(midandhighfrequencies) andacousticstimulation Alternative tocurrent open-loopsystem (both mechanical andsensorineural)that have led developed toaidorrepair thephysical problems strategies. large number ofdevices haveA been diseases, however, there wasafocus onpreventive devices were identified; aswithophthalmic For oticdiseases, nospecificpreventive medical those countries. the number ofpeoplewitheye diseaseishigherin disease indeveloping countries, andconsequently nutrition profoundly affect thepatternofeye in climate, insectvectors, socialsurroundings and Limited ophthalmicresources andstaff, variations Preventive strategiesmay belocation-specific. were preventive alsoimportant strategies. condition. Healthy dietandavoidance ofsmoking stop ultraviolet radiationfrom aggravating the of symptomssomeeye diseasesandto spectacles may beusedtoprevent theprogression devices. Preventive eyewear suchaslensesand of eye andtheuseofhandhelddiagnostic charts were focused onearly detectionthrough theuse For ophthalmicdiseases, preventive strategies diseases. prevention, diagnosisortreatment ofsenseorgan were identified asbeingusedcommonly inthe conducted oneachdiseaseandarangeofdevices to deafness. These devices vary widely in cost and 7. Quigley HA. Number of people with glaucoma complexity and in many cases require specialist worldwide. Br J Ophthalmol. 1996;80:389–93. surgical skills. For the ageing population, bilateral 8. Johnson GJ, Foster PJ. Can we prevent angle-closure glaucoma? Eye (Lond). 2005;19:1119–24. sensorineural hearing loss is commonly assisted 9. BMJ Evidence Centre. Glaucoma. London: BMJ by conventional external hearing aids; many Publishing Group; 2011 (http://bestpractice.bmj. associated paper- and computer-based tools are com.proxy.library.adelaide.edu.au/best-practice/ available to assist in the proper use of these aids. monograph/372/highlights/overview.html, accessed 19 February 2014). Generally, the devices used in the prevention, 10. Bollinger K, Kim J, Lowder CY, Kaiser PK, Smith diagnosis and treatment of sense organ conditions SD. Intraocular pressure outcome of patients with fluocinolone acetonide intravitreal implant will be dependent on the patient’s presentation, for noninfectious uveitis. Ophthalmology. the clinician’s preference and experience, and 2011;118:1927–31. the accessibility of devices. In particular, the 11. D’Eliseo D, Pastena B, Longanesi L, Grisanti F, Negrini accessibility and availability of devices varies V. Comparison of deep sclerectomy with implant and combined glaucoma surgery. Ophthalmologica. substantially between developed and developing 2003;217:208–11. countries, and between facilities in similar areas. 12. Ivandic BT, Hoque NN, Ivandic T. Early diagnosis The relative availability of medical devices will of ocular hypertension using a low-intensity laser have downstream effects on the overall approach irradiation test. Photomed Laser Surg. 2009;27:571–5. to sense organ disease. In settings with low access 13. Pablo LE, Larrosa JM, Polo V, Ferreras A, Alias EG, to diagnostic tools, for example, patients may Honrubia FM. Performance of GDx and HRT in the Finnish evidence-based guideline for open-angle enter treatment at later stages in the disease and glaucoma. Eye (Lond). 2010;24:297–303. thus have poor prognosis. Additionally, many of 14. Staffieri SE, Ruddle JB, Kearns LS, Barbour JM, Edwards the devices identified require trained experts to TL, Paul P, et al. 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Graefes Arch Screening adults aged 50 years or older for hearing Clin Exp Ophthalmol. 2009;247:1297–306. loss: a review of the evidence for the U.S. preventive 48. Neelam K, Muldrew A, Hogg R, Stack J, Chakravarthy U, services task force. Ann Intern Med. 2011;154:347–55. Beatty S. Grading of age-related maculopathy: slit-lamp 54. Bogardus ST, Yueh B, Shekelle P. Screening and biomicroscopy versus an accredited grading center. management of adult hearing loss in primary care. Retina. 2009;29:192–8. JAMA. 2003;289:1986–90. 49. Parodi MB, Toto L, Mastropasqua L, Depollo M, 55. Gates GA, Cooper JC. Incidence of hearing decline in Ravalico G. Prismatic correction in patients affected the elderly. Acta Otolaryngol. 1991;111:240–48. by age-related macular degeneration. Clin Rehabil. 56. Valete-Rosalino CM, Rozenfeld S. Auditory screening 2004;18:828–32. in the elderly: comparison between self-report and 50. Schmitz-Valckenberg S, Fleckenstein M, Gobel AP, audiometry. Braz J Otorhinolaryngol. 2005;71:193–200. Sehmi K, Fitzke FW, Holz FG, et al. Evaluation of 57. Yueh B, Collins MP, Souza PE, Boyko EJ, Loovis autofluorescence imaging with the scanning laser CF, Heagerty PJ, et al. Long-term effectiveness of ophthalmoscope and the fundus camera in age- screening for hearing loss: the screening for auditory related geographic atrophy. Am J Ophthalmol. impairment – which hearing assessment test 2008;146:183–92. (SAI-WHAT) randomized trial. J Am Geriatr Soc. 51. Yueh B, Shekelle P. Quality indicators for the care of 2010;58:427–34. hearing loss in vulnerable elders. J Am Geriatr Soc. 58. Balkany TJ, Whitley M, Shapira Y, Angeli SI, Brown K, Eter 2007;55(Suppl. 2):S335–9. E, et al. The temporalis pocket technique for cochlear implantation: an anatomic and clinical study. Otol Neurotol. 2009;30:903–7. diseases 6. Sense organ 6.

93 94 2015 Systematic review of needs for medical devices for ageing populations in preventing thedevelopment of Alzheimer’s vascular risk factors, especially hypertension, found good thecontrol evidence supporting of vascular andlifestyle factors. recent reviewA risk factors that have been investigated include the development of Alzheimer’s disease (5). Other increase the probability of, but donotguarantee, have beenimplicated as risk factors. These genes For late-onset Alzheimer’s disease, several genes The causeof Alzheimer’s diseaseisunknown. the principalfeature (4). slowly progressive, impairmentas withmemory 65 years, usually inthelate70s. This dementiais is the most common and occurs after the age of can beearly orlateinonset. The late-onsetform behavioural disturbances) (3).disease Alzheimer’s (mainly apathy andsocialwithdrawal, butalso basic activitiesofdaily living, andbehaviour changes progressive deteriorationintheabilitytoperform Alzheimer’s problems, diseaseincludememory followed by vasculardementia(2). Symptomsof of dementia, contributing to60–70%ofcases, Alzheimer’s diseaseisthemostcommontype Introduction VASCULAR DEMENTIA DISEASE AND 7.2 ALZHEIMER’S older peopleworldwide (2). major causesofdisabilityanddependencyamong and 115.4millionin2050. Dementiaisoneofthe double every 20years, to65.7millionin2030 people withdementiaisprojected toalmost new cases every year people have dementiaandthere are 7.7million language andjudgement. Worldwide, 35.6million comprehension, calculation, learningcapacity, Dementia affects memory, thinking, orientation, to interfere withaperson’s daily functioning(1). multiple cognitive domainsthatare severe enough characterized by progressive deteriorations in Dementia isdefinedasaclinicalsyndrome 7.1 INTRODUCTION 7. Neuropsychiatric conditions (2). The total number of applied tothesearch results: English languageand and vasculardementia. The following filters were diagnosis ortreatment of Alzheimer’s disease devices thatcouldbeusedintheprevention, incorporating textandMeSHtermstoidentify An apriorisearch wasdeveloped strategy Methodology vascular dementiaisusually lateinlife (4). mobility andbalanceproblems (3). Onsetof incontinence,problems suchasurinary decreased vascular dementiamore commonly have physical In comparisonto Alzheimer’ disease, peoplewith including hypertensive cerebrovascular disease(4). controlled trialsandsystematicreviews. published withinthepastfive years andrandomized the brainasaconsequenceofvasculardisease, Vascular dementiaistheresult ofinfarction of manipulation oflifestyle factors(5). disease, butonly weak orinsufficient evidence for #9 #8 #7 #6 #5 #4 #3 #2 #1 #8 AND #1 #8 AND #2 OR#3#4#5 #6OR#7 senile dementia alzheimers andlateonset vascular dementia senile dementia[MeSHterms] alzheimers disease, lateonset[MeSHterms] vascular dementia[MeSHterms] OR (rehabilitat*) OR(alleviat*)) (prevention) OR(monitoring)(screening) (diagnos*) OR(therap*) OR(treatment*) OR terms]) OR(therapeutics [MeSHterms])OR [MeSH terms])OR(aftertreatment [MeSH prevention[MeSH terms])OR(secondary prevention[MeSH terms])OR(primary ((diagnosis [MeSHterms])OR(rehabilitation OR (material*)(machine*)) AND (apparatus) OR(good*) OR(implement*) OR (appliance*) OR(instrument*) (aid*) OR(equipment)(armamentarium) instruments [MeSHterms])OR(device*) OR (assistive devices [MeSHterms])OR(surgical ((equipment andsupplies[MeSHterms])OR (senior) OR(elderly) OR(geriatric)) AND for theaged[MeSHterms])OR(aged) ((aged [MeSHterms])OR(healthservices Results clinical guidelines state that the Mini-Mental State The strategy yielded 100 results. On the title and Examination appears to be one of the more widely abstract screen, 53 studies were identified that used cognitive scales (3,7). reported the use of a device for the prevention, In addition to scales for assessing cognitive diagnosis or treatment of Alzheimer’s disease or function, functional decline and behavioural and vascular dementia. In addition, following clinical psychological symptoms, a range of other tests expert opinion on the results of the initial are used to diagnose dementia. These include a search, clinical practice guidelines were used to clinical diagnosis (involving medical history and supplement the literature results. During these physical examinations), blood tests, neuroimaging searches it was noted that the American Academy tests, electroencephalography, cerebrospinal of Neurology is in the process of updating its fluid examinations and genetic tests. No specific guidelines on diagnosis of dementia. The key medical devices were identified in relation to studies retrieved (including clinical guidelines) clinical diagnosis, blood tests or genetic tests. for full text review are summarized in Table 42. All references were used to inform the list of Cerebrospinal fluid biomarkers reportedly devices presented in Table 43. In most instances differentiate patients with Alzheimer’s disease from the studies identified could not be designated a patients with other dementias and from people level of evidence due to the fact that they were without dementia (3). Electroencephalography may clinical practice guidelines. help to differentiate between Alzheimer’s disease, subjective complaints and psychiatric diagnoses Of the 53 articles from the initial search, two were (7). One guideline reported that cerebrospinal identified that reported on the use of treatments fluid analysis and electroencephalography are not (5,6). recommended as routine investigations (3). The majority of studies identified in the initial A limited number of devices were identified search were on the use of cognitive, functional, from the retrieved studies in relation to global and neuropsychiatric scales used to (1) treatment for Alzheimer’s disease and are listed diagnose or screen for Alzheimer’s disease or mild in Table 43. Other therapies were also identified, cognitive impairment, or (2) stage patients with including music, exercise, relaxation and cognitive dementia, or (3) assess outcomes in Alzheimer’s stimulation; however, no specific medical devices clinical trials (Table 43). A very large number of were mentioned in relation to these therapies, tests are available, and there does not appear and the effectiveness of these therapies was not to be an endorsed gold standard, although two ascertained.

Table 42 Alzheimer’s disease – key studies

Study Level of Primary focus Secondary focus evidence

Black et al 2009 (8) NA Scales used to measure outcomes of None conditions clinical trials for Alzheimer’s disease 7. Neuropsychiatric 7. Chertkow et al NA Guidance on diagnosis and treatment Physical exercise, cognitive activity 2008 (6) of MCI and cognitive impairment with no dementia Lonie et al 2009 (9) NA MCI screening tests None Patterson et al NA Guidance on risk assessment and Protective clothing and head protection 2008 (5) primary prevention of Alzheimer’s disease 95 96 2015 Systematic review of needs for medical devices for ageing populations could notbedetermined. Otherdiagnostic identified scalesare available in different languages disease andvasculardementia. Whether the identified that discriminate between Alzheimer’s one ofthemore commonscales. Two scaleswere Examination wasreportedby two guidelinesto be for diagnosis, althoughtheMini-MentalState does notappear tobeasinglegold standard scale scales appear toassesssimilarfactors, andthere or specifically Alzheimer’s disease. Many ofthe people withmildcognitive impairment, dementia global andneuropsychiatric scales usedtoassess identified a large number of cognitive, functional, the diagnosisofdementia. Specifically the results Most oftheretrieved studieswere related to 7.3 CONCLUSION CT: computedtomography; MRI: magneticresonanceimaging; PET: positron-emissiontomography; SPECT: singlephoton-emissioncomputedtomography. treatment and diagnosis for identified –devices disease Table Alzheimer’s 43 MCI: mildcognitive impairment, NA: notapplicable. machine Bright-light therapy (phototherapy) Physical restraint machine Continuous positive airway pressure magnetic stimulation machine Repetitive high-frequency transcranial Treatment Electroencephalography machine Needle F-deoxyglucose PET; CT Tomography systems: SPECT; PET; Functional Spectroscope Functional MRIsystem Diagnosis Device SIGN 2006(3) etal2010(7) Hort (10) Rikkert etal2011 NA NA NA management of Alzheimer’s disease Guidelines ondiagnosisand management ofdementia Guidelines ondiagnosisand Scales usedtostagedementia Appliance Other Appliance Appliance Appliance Consumable Appliance Appliance Appliance Description with Alzheimer’s disease with Alzheimer’s Treats rest–activity (circadian) disruptionininstitutionalized people Restrains peoplewithdementiaandbehavioural problems obstructive sleepapnoea Improves cognitive functioninpeoplewith Alzheimer’s diseasewith Alzheimer’s disease Improves cognitive functioninpeoplewithmildtomoderate disease Differential diagnosisofatypicalclinicalpresentations of Alzheimer’s Collects cerebrospinal fluid for biomarker testing distinguishing dementiafrom depression etc. dementia, increasing diagnosticconfidencein evaluation ofdementia, Medical andnuclear imagingsystemsdistinguishingbetween typesof andfunction Assesses brainmorphology flow Measures activityindifferent regions ofbrainby examiningblood Function association with thesetherapies. medicaldevices wereno particular mentionedin were reported insomestudiesand guidelines; exercise, relaxation therapy andcognitive therapy respect totherapy for Alzheimer’s disease. Physical A smallnumber ofdevices were identified with disease. specifically diagnose dementia or Alzheimer’s rule out other medical conditions rather than equipment. Many ofthedevices are used to patient basisandaccording toaccessspecific the choiceoftestsmay onapatient-by- vary diagnosis ofdementiaisunclear. Itislikely that analysis. The necessityofallthesedevices inthe electroencephalography andcerebrospinal fluid tools identified includedneuroimaging devices, None None None REFERENCES 6. Chertkow H, Massoud F, Nasreddine Z, Belleville S, Joanette Y, Bocti C, et al. Diagnosis and treatment 1. Qiu C, De Ronchi D, Fratiglioni L. The epidemiology of dementia: 3. Mild cognitive impairment and of the dementias: an update. Curr Opin Psychiatry. cognitive impairment without dementia. CMAJ. 2007;20:380–85. 2008;178:1273–85. 2. Dementia. Geneva: World Health Organization; 2012 7. Hort J, O’Brien JT, Gainotti G, Pirttila T, Popescu BO, (http://www.who.int/mediacentre/factsheets/fs362/ Rektorova I, et al. EFNS guidelines for the diagnosis en/#, accessed 19 February 2014). and management of Alzheimer’s disease. Eur J Neurol. 3. International statistical classification of diseases and 2010;17:1236–48. related health problems, 10th revision. Geneva: 8. Black R, Greenberg B, Ryan JM, Posner H, Seeburger World Health Organization; 2010 (http://apps.who. J, Amatniek J, et al. Scales as outcome measures int/classifications/icd10/browse/2010/en#/F00-F09, for Alzheimer’s disease. Alzheimers Dement. accessed 19 February 2014). 2009;5:324–39. 4. Management of patients with dementia: a national 9. Lonie JA, Tierney KM, Ebmeier KP. Screening for mild clinical guideline 2006. Edinburgh: Scottish cognitive impairment: a systematic review. Int J Geriatr Intercollegiate Guidline network; 2006 (http://www. Psychiatry. 2009;24:902–15. sign.ac.uk/pdf/sign86.pdf, accessed 19 February 2014). 10. Rikkert MG, Tona KD, Janssen L, Burns A, Lobo A, 5. Patterson C, Feightner JW, Garcia A, Hsiung GY, Robert P, et al. Validity, reliability, and feasibility of clinical MacKnight C, Sadovnick AD. Diagnosis and treatment staging scales in dementia: a systematic review. Am J of dementia: 1. Risk assessment and primary prevention Alzheimers Dis Other Demen. 2011;26:357–65. of Alzheimer disease. CMAJ. 2008;178:548–56. conditions 7. Neuropsychiatric 7.

97 98 2015 Systematic review of needs for medical devices for ageing populations in large, well-equipped teachinghospitals, usually controlled trialsare mostfrequently undertaken practice toanother. For example, randomized be neededintranslating efficacydatafrom one a huge range of jurisdictions, although care would identified inthisway would alsobe relevant across widely betweenvary eachdevice. The literature although thevolume andqualityofthisinformation have clinicalsafety andeffectiveness evidence data, published research. These devices will, therefore, on devices commonly included inpeer-reviewed review toidentify devices focuses theinformation Using theresults from asystematicliterature and techniques. interventions, aswell asthenewer medicaldevices on someofthemore establisheddevices and and systematicreviews, provided information range ofliterature, includingclinicalliterature this project, however, theidentificationofabroad peer-reviewed publications. Duringthe course of focus ofclinicaltrialsandmay notbereflected in andtechnologiesmayinterventions notbethe readership results thatare ofinterest tojournaleditorsand likely tobebiasedtowards and interventions limitations.certain Peer-reviewed literature is a priori and unbiased methodology, there are Although theliterature searches provided an regularly thansomeothersources. reference databasesandupdatesitsindexingmore (1). PubMedwaschosenasitusesanumber of review by identifyingstudiesoflower quality a range of sources may add bias to the overall work. Additionally, highly detailedsearches across provide littleadded valuefor significantadditional that theuseofmultiple sources would probably this research project, however, itwasconsidered the CochraneLibrary. Given thebroad focus of databases, such as Embase, Current Contents and would be beneficial to search other relevant For atruly comprehensive literature review it 8.1 METHODS 8. Discussion (2). Well-established andconventional conditions. The research focus anddescriptionof regarding medical devices for arangeofhealth the results are areflection oftrends in research on thepeer-reviewed literature; consequently, usedinthisreviewThe methodology focused management anddevices. degrees ofbiasintermstheirpreferred clinical countries. Individual cliniciansalsohave varying may bemore commonthaninmany developing use of complex and expensive medical devices by developed countries, where theaccesstoand These guidelinesare alsocommonly produced infrastructure applicable tothatjurisdiction. within thecontextofskills, resources and but they andwritten are oftencountry-specific are evidence-based andinternationally recognized, appropriate clinicalmanagementandinmany cases practice guidelinesare invaluable indetermining medical devices may also be subject to bias. Clinical Other sources ofinformation regarding needed beyond thescopeofthisreport. efficacy ofeachidentified medical device was settings. detailedreport on the safety and A especially whenapplied toothercountriesor be directly applicable tonormalclinicalpractice, inclusion criteriafor patientselectionandmay not the systematic literature review may nothave the initialresults from aclinicalperspective that In someinstances, itwasclearwheninvestigating relevant procedures, anddevices. interventions a clinicalmanagementperspective, reflected most broad rangeofdevices that, whenconsidered from The majority of literature searches identified a RESOURCES 8.2 USEOFSUPPLEMENTARY clinical practice. necessarily bereflective ofcurrent or accepted device applications found intheliterature may not staff techniques and devices and with specialist skilled in developed countrieswithaccesstomodern (3,4). These trialscommonly have strict very identified all the key devices associated with the and conditions. In this report the information management of a specific condition. In these regarding each device was provided in line with circumstances, clinical practice guidelines were how it was reported in the original study, to avoid used to establish the broader clinical management any misinterpretation of the results and misleading pathways and identify any missing interventions the reader. or devices. The primary example of this is the Within each topic, some medical devices or groups literature search for dementia and Alzheimer’s of devices were commonly identified. Where disease, where the result was focused mainly relevant, this has been mentioned narratively in the on a wide range of cognitive, functional, global results. For example, MRI and CT were common and neuropsychiatric scales used for testing and imaging devices across cancers and cerebrovascular screening purposes. Reference to clinical practice conditions. Various forms of endoscope were used guidelines identified further interventions related frequently for diagnostic and therapeutic purposes mainly to clinical diagnosis. These included blood for a range of gastrointestinal cancers. Ultrasound tests, neuroimaging tests (nuclear and contrast), was commonly used for diagnosis and in providing electroencephalography, cerebrospinal fluid guidance for biopsy and surgical procedures. examinations and genetic tests. It is likely that this experience with dementia and Alzheimer’s disease In some circumstances, the nature or role of is a result of a literature bias in the field, possibly each device was not clear from the title and associated with the fact that dementias are often abstract searches, for example when the device diagnosed through the exclusion of other diseases was novel or the authors used trade names. In and conditions rather than via a specific test these cases, broader descriptors have been used leading to a definitive diagnosis. to provide clarity to the report, with registered trade names listed as specific examples of devices 8.3 OVERALL RESULTS OF INCLUDED that are marketed internationally (for example, MEDICAL DEVICES various cochlear implants for hearing loss). In Some topics were highly represented in the addition, similar devices, such as endoscopes, have literature, for example topics related to the been grouped together rather than reported condition of cardiovascular diseases. In these cases, independently. This work was undertaken to criteria (limiting to high-quality levels of evidence provide a level of clinical reasoning to what would and more recent publications) were applied to otherwise be a crude list of medical devices. increase the overall quality and relevance of the Where specifically identified, however, proprietary pool of literature. Other topics were clearly less and marketing names were kept to avoid any highly represented in the identified literature, for potential misinterpretation of information from example cancers of the mouth and oropharynx, studies where the particular medical device may and lymphoma. Due to the smaller total in the have been distinct from others. overall literature search results, these topics Where there were many medical device options were not limited by study type. The variability for a given intervention, it was difficult to assess between each of the 19 independent searches what the more common techniques may be and is representative of the research and publication the clinical benefits of each device. For example, focus of certain specialties. a wide range of imaging devices may be used The level of detail provided in terms of the during diagnosis and staging for cancers. In these composition and clinical utility of each identified circumstances, the device used may be informed medical device also varied across devices, studies by its availability and may also be guided by clinical Discussion 8. 99 100 2015 Systematic review of needs for medical devices for ageing populations this issuemay benefitfrom further research. absolute cost–effectiveness ofthesedevices, and more detailedexaminationofthecomparative or maintain. The scopeofthis report didnotallow a devices expensive beingvery topurchase, useand cheap,items beingvery andlarger, more complex of theidentified medicaldevices, withsomebasic Clearly there issignificantvariabilityin thecosts delivery.service the availability ofappropriate infrastructure for and othertelemedicinefacilitieswould dependon resynchronization therapy implant function. These in cochlearimplantsandfor monitoringcardiac the useofremote programming technologies Other benefits for peoplein remote areas include was notclearfrom research. thispreliminary safety ofthesenewer typesofradiotherapy device absolute orcomparative clinicaleffectiveness or in majormetropolitan centres isdifficult. The areas where regular accesstolargerhospitals convenience topatientslivinginruralorremote to olderpatientsandmay alsobeofgreat adverse events. This may bemore acceptable radiation with fewer sessions and fewer potential of offering anequivalenttherapeutic doseof of radiation, whichhasthepotentialbenefit accurate, ofhigherdoses image-guideddelivery Similarly, radiotherapy devices offer more on theseissues. effectiveness would inform beneededtofurther and detailedstudiesofcomparative safety and need oftheseadditional testswasoftenunclear, procedure. The absoluteandcomparative clinical as alower doseofirradiation duringthescanning specificity and with less risk to the patient, such new versions offering improved imagequalityand devices, are undercontinual improvement, with These imagingdevices, aswithallothermedical neoplasms.the presence orlocationofsecondary undertaken toconfirminitial results ortoestablish a number ofadditional imagingtestsmay be commonly, CTorMRI); where available, however, with oneortwo imagingtechniques(most staging ofspecific cancers is initially accomplished preference. For example, initialdiagnosisand TNM investigation. exceptionwasfound insomeof An may notbespecifictoany ofthetopicsunder equipment ofany surgicaloperatingtheatre and devices would be considered to be standard diffused across alljurisdictions. These basicmedical basic devices are readily available andhighly It isalsoreflective oftheassumptionthatthese in locationsofmedium-orhigh-resource settings. literature are generally tested, trialledandpiloted medical devices reportedinthe peer-reviewed but notdescribed. This reflects thefactthat technologies astheuseofthesewasoftenimplicit not well understood, asageis normally oneof of theageing process toeachofthesetopics is other diseasestates. The specific relationship conditionsassociatedwith others are secondary various aetiologies. Someare idiopathicand project cover abroad range of conditions, with The topicsidentified for research withinthis 8.4 PREVENTIVEDEVICES poorly represented intheidentified literature. all, ofthesetests. Ingeneral, diagnostictestswere device would have beeninvolved for most, ifnot It islikely, however, thatsomeform ofmedical absence ofany specificinstrumentorequipment. diagnostic tests, the testwasmentioned in the low-resource settings. For many oftheinvitro in high-resource settingsandtheirapplication in limitations intransferability ofresults obtained similar across jurisdictionsandpointstothe equipmentortestingprotocolspathology are described. This may reflect anassumptionthat was infrequently andimprecisely reported equipmenttotestbiopsy samples of pathology It wasalsoapparent from theresults thattheuse and maskswere identified. topics,the ophthalmology where specificbandages large number of these simple or conventional literature. Overall thesearch didnotidentifya this level ofdetailwasnotseenintheidentified search results. Inthe majority of cases, however, and soonwere notexplicitly excludedfrom the equipment, medicalgases, anaesthesia services surgical tables, othersurgicalinstrumentsand Basic surgicalequipmentsuchassutures, scalpels, a number of factors involved in the progression support heart function, the choice of which would of these diseases. Relatively few preventive be initially informed by the type and severity of the devices were identified, and all were associated heart failure, but may also be informed through with specific known risk factors. One preventive patient choice. A cardiac resynchronization procedure that was identified was prophylactic therapy device provides continual pacing to mastectomy. In general, this would be considered improve ventricular function and has the aim only for women at very high risk of breast cancer, of improving quality of life. These devices are and the decision to progress with this radical available with or without a defibrillator function, therapy would include consideration of familial which would have the added benefit of providing risk together with genetic tests. Oophorectomy protection against sudden cardiac arrest and may also be an option in a similar population. death. It may be that some older patients would Screening of known risk factors (hepatitis for liver choose not to be implanted with a defibrillator, cancer, H. pylori screening for stomach cancer) or due to the fact that the defibrillator may cause control and education of lifestyle choices (smoking painful shocks with no associated clinical benefit. for lung cancer, exercise and dietary education for Certain cancers can be treated with a variety cardiovascular conditions, hearing protection) are of ablation techniques delivered percutaneously among the few other preventive interventions or through laparoscopy or laparotomy, in some that were identified from the literature search. instances aided by the use of a robot. It appears For cancers, screening for early stages of the as if the gold standard, where possible, is surgical disease is possible for certain conditions. The resection of the tumour, although ablative removal of colorectal polyps may reduce the technologies may be an option to patients who risk of colorectal cancer, and early detection and have contraindications for conventional surgery, treatment of Barrett’s oesophagus may reduce the or may be used as a palliative measure. Therefore, risk of developing oesophageal cancer. although minimally invasive options are becoming more common and may, in certain instances, 8.5 DEVICES ASSOCIATED WITH OLDER offer benefits compared with open surgery, their PEOPLE choice may depend on a range of factors, including A few examples were identified of devices with comparative effectiveness with conventional specific relevance to older people. Mammography surgical treatment, clinical presentation, risk and may be advised for older patients, whereas patient preference. younger women may benefit from ultrasound In the main, these examples were identified from due to the increased density of the breast tissue. a clinical consideration of the search results, and It may be that elderly people and patients with there were few examples of devices that were comorbidities may benefit from minimally invasive directly aimed at the elderly population in the technologies that are becoming more common literature. Exemptions to this were devices for across a range of specialties. In hypertensive heart hearing loss. Many trials and studies were focused disease, valve insufficiencies may be treated with on elderly populations, including for screening open or less invasive percutaneous surgery. The and diagnosis (questionnaires, audiometers), aids mid- and long-term effectiveness of percutaneous and treatments (external hearing aids, cochlear valve replacement procedures is unclear at the implants), and various programmes and methods moment, but they may offer an option to older to improve the effectiveness of or compliance with patients unable to undergo conventional valve external or implantable hearing aids (including replacement surgery. software, algorithms, educational programmes and Patients with chronic heart failure may be offered online material). a range of implantable devices to protect or 8. Discussion 8.

101 102 2015 Systematic review of needs for medical devices for ageing populations focused specifically onthe Western Pacific Region the 19topics ofinterest. This information wasnot broad information ofclinicalrelevance oneachof usedinthisprojectThe methodology hasprovided 8.6 FUTURERESEARCH AREAS considerations. beliefs togetherwithothersocietalandcultural be informed by a range of personal choices and the final decision regarding the treatment may but even where thesealternatives are available may offer new oralternative treatment options, for surgicalinterventions. Newer medicaldevices often present withcomorbiditiesorare unsuitable inelderly populations,importance asolderpeople care orchronic diseasesmay beofparticular Medical devices withapplications inpalliative as adecision-aidtoguidechemotherapy. of acancertobeunderstoodandwasusually used personalized medicineenablesthegeneticprofile was theuseofgenetictesting. This typeof with cancersoftheprostate, breast andstomach Another relatively novel associated intervention devices. clinical utilityandcost–effectiveness ofthese reviewpreliminary wasnotabletoestablishthe the current conventional options; however, this improvements may offer clinicalbenefits beyond of mammography andMRI. These technological increasingly common, suchasthecombination Hybrid imagingtechnologiesare becoming used for ophthalmicandhearingproblems. cancers, andawidevarietyoftestsdevices a varietyofstaplers usedinsurgicalresection of and function(suchasthe Third Eye Retroscope®), modifications toendoscopesimprove vision evolution ofmedicaldevices. This included Many exampleswere identified ofthecontinued radiation therapy inthetreatment ofbreast cancer. degeneration andtheuseofintraoperative for macular filtering blood in the treatment of dry examples includetheuseofplasmarheopheresis scanning” for thepurposesofthisproject. Some identified thatcouldbeconsidered “horizon Some experimentalornovel were interventions technology assessmentundertaken inone technology in eachcountry. systematicreview A orhealth dependent ontheskillsavailable andinfrastructure andbe couldvary different oftheservice parts would remain similar, theavailability andcostof delivery thebasicelementsofservice Although and would likely tocountry. from country vary device would beprocedure-based where relevant these searches. Cost–effectiveness issuesfor each results from thisproject couldbeusedtoinform peer-reviewed literature. The complete literature through acomprehensive systematicreview of and couldbeadvisedinanevidence-based manner effectiveness are likely tobecross-jurisdictional over awidearea. Clinicalissuesofsafety and region accountsfor alargenumber ofcountries in which they are treated, is highly variedas the within the Western PacificRegion, andtheway The specifichealthproblems inageingpopulations and isbroadly applicableworldwide. toany country 19 subconditions thatare thecauseofmost to provide arobust listof devices relevant to This project hasusedsystematicmethodology 8.7 CONCLUSIONS negatively impacted. access toarangeofneededtherapeutic devices is and TNM staging. Without appropriate diagnosis, diagnosis infrastructure, includingimaging, biopsy environmental riskfactors, andappropriate (such asfor hepatitis), preventive measures for also needstoestablishscreening programmes cancers,cancer andany secondary a jurisdiction effective clinical treatments for treating the liver management ofliver cancer, as well asestablishing framework. For instance, tobetruly effective inthe canbeestablishedonlyor intervention withinthis true clinicaleffectiveness ofany individualdevice with each, are clearly linked toeachother, andthe therapeutic strategies, andthedevices associated management pathway. Preventive, diagnosticand requires aconsiderationof all aspectsof the management ofany given healthcondition This project hashighlightedthateffective clinical (5). country maycountry beadapted for application inanother morbidity and mortality in elderly people in the 2. Young SN. Bias in the research literature and conflict of Western Pacific Region. A final list of needed interest: an issue for publishers, editors, reviewers and authors, and it is not just about the money. J Psychiatry devices will likely benefit from a consideration Neurosci. 2009;34:412–17. of other methods, including those of economic 3. Merlin T, Weston A, Tooher R. Extending an evidence evaluation and social impact, input regarding hierarchy to include topics other than treatment. BMC clinical, policy, organizational and infrastructure Med Res Methodol. 2009;9:34–42. issues, and research contextualizing the results to 4. NHMRC levels of evidence and grades for recommendation for developers of guidelines. each country in the Western Pacific Region. Canberra, ACT: National Health and Medical Research Council; 2009 (http://www.nhmrc.gov.au/_files_nhmrc/ It is intended that the output of this report will file/guidelines/stage_2_consultation_levels_and_ inform future research, with the ultimate aim grades.pdf, accessed 19 February 2014). to improve access of elderly people to needed 5. Adapting existing HTAs from one country into other devices. settings. Copenhagen: European Network for Health Technology Assessment; 2011 (http://www.eunethta. eu/outputs/eunethta-hta-adaptation-toolkit, accessed REFERENCES 19 February 2014). 1. Egger M, Juni P, Bartlett C, Holenstein F. How important are comprehensive literature searches and the assessment of trial quality in systematic reviews? Empirical study. Health Technol Assess. 2003;7:1–76. 8. Discussion 8.

103 104 2015 Systematic review of needs for medical devices for ageing populations e d c b a Designations of levels of evidence according to type of research question research of type to according evidence of Table levels of A1.1 Designations RESEARCH QUESTION DESIGNATIONS OFLEVELSEVIDENCE ACCORDING TO TYPE OF Annex 1 Level of the reference standard can be determined through quality appraisal ofthestudy(4). throughqualityappraisal of thereference standardcanbe determined reference standardshouldbeprespecified. Thesecaninclude thechoiceofreference standard(s)anditstiminginrelationtotheindextest. Thevalidity inthecontextofdiseaseunderreview.The validityofthereference standardshouldbedetermined thevalidityof for determining Criteria to eachdifferent outcome. different studydesigns, theoverall level ofevidenceshouldrelatetoeachindividual outcome/result, asdifferent studies(andstudydesigns)may contribute Systematic reviewqualityshouldbe assessed separately. A systematicreview shouldconsistofatleasttwo studies. Insystematicreviewsthatinclude onthelikelihood thattheresultshavevalidity andthusarerated beenaffected by bias, thanwhetherthesystematicreviewitselfisofgood quality. rather results, reducingthelikelihood thattheresultsareaffected by chance. Systematicreviews of lower-level evidencepresentresultsoflikely poorinternal Systematic reviewsoflevel IIevidenceprovide moredatathantheindividual studies, andany meta-analyses willincreasetheprecisionofoverall A systematicreviewwillbeassignedalevel ofevidenceonly ashighthestudiesitcontains, exceptwherethosestudiesareoflevel IIevidence. such asnuclear radiation), thenthe “aetiology” ofevidenceshouldbeused. hierarchy evidence(i.e. exposure, cannotallocategroupstoapotentialharmful acausalrelationshiponlyit ispossible usingobservational andethicaltodetermine evidence, acausalrelationshipusingexperimental If itispossible andethicaltodetermine thenthe “intervention” ofevidenceshouldbe used. hierarchy If oftheimpacttestonpatientmanagementandhealthoutcomes consideration The dimensions of evidence apply only to studies of diagnostic accuracy. To assess the effectiveness of a diagnostic test there also needs to be a Definitions ofthesestudydesignsareprovided onpages7–8ofref. (1). III-3 III-1 III-2 IV I II d studies; or more single-arm control study; two controls: historical without concurrent Comparative study with control group interrupted time series control study; study;cohort case– parallel control group time serieswithout some othermethod) (alternate allocationor controlled trial Pseudo-randomized experimental trial; randomized controls: non- with concurrent Comparative study level IIstudies Systematic review of Intervention post-test outcomes post-test orpre-test/ Case serieswitheither trial Randomized controlled j interrupted a i

III-1 evidence required for level IIand does notmeetcriteria reference standard that Comparison with study Diagnostic case–control valid reference standard blinded comparisonwith with independent, Study oftestaccuracy Diagnostic accuracy clinical presentation (6) patients withdefined among non-consecutive clinical presentation patients withdefined among consecutive level IIstudies Systematic review of (no reference standard) Study ofdiagnosticyield valid reference standard blinded comparisonwith with independent, Study oftestaccuracy f f b k e e

controlled trial of randomized in singlearm among patients prognostic factors Analysis of disease different stagesof of patientsat study cohort Case seriesor study cohort Retrospective cohort study cohort Prospective Prognosis All ornone of level IIstudies Systematic review (2,3). h g cohort study cohort Retrospective All ornone study cohort Prospective series study orcase Cross-sectional study Case–control Aetiology studies review oflevel II Systematic c h control study study;cohort case– experimental trial; randomized controls: non- with concurrent Comparative study controlled trial Randomized method) or someother (alternate allocation controlled trial Pseudo-randomized Intervention Screening Case series studies or more single-arm control study; two controls: historical without concurrent Comparative study level IIstudies Systematic review of f Well-designed population based case–control studies (e.g. population-based screening studies where test accuracy is assessed on all cases, with a random sample of controls) do capture a population with a representative spectrum of disease and thus fulfil the requirements for a valid assembly of patients. In some cases, however, the population assembled is not representative of the use of the test in practice. In diagnostic case–control studies, a selected sample of patients already known to have the disease is compared with a separate group of normal healthy people known to be free of the disease. In this situation, patients with borderline or mild expressions of the disease and conditions mimicking the disease are excluded, which can lead to exaggeration of both sensitivity and specificity. This is called spectrum bias or spectrum effect, because the spectrum of study participants will not be representative of patients seen in practice (5). g At study inception, the cohort is either non-diseased or all at the same stage of the disease. A randomized controlled trial with people who are either non-diseased or at the same stage of the disease in both arms of the trial would also meet the criterion for this level of evidence. h All or none of the people with the risk factor(s) experience the outcome, and the data arise from an unselected or representative case series, which provides an unbiased representation of the prognostic effect. For example, no smallpox develops in the absence of the specific virus, and clear proof of the causal link has come from the disappearance of smallpox after large-scale vaccination. i This also includes controlled before-and-after (pre-test/post-test) studies and adjusted indirect comparisons (i.e. use A vs B and B vs C to determine A vs C with statistical adjustment for B). j Comparing single-arm studies, i.e. case series from two studies. This would also include unadjusted indirect comparisons (i.e. use A vs B and B vs C to determine A vs C with no statistical adjustment for B). k Studies of diagnostic yield provide the yield of diagnosed patients, as determined by an index test, without confirmation of the accuracy of this diagnosis by a reference standard. These may be the only alternative when there is no reliable reference standard. Source: Merlin T et al. Extending an evidence hierarchy to include topics other than treatment: revising the Australian “levels of evidence”. BMC Med Res Methodol. 2009;9:34. Hierarchies adapted and modified from refs (6–9).

REFERENCES 5. Mulherin SA, Miller WC. Spectrum bias or spectrum effect? Subgroup variation in diagnostic test evaluation. 1. How to use the evidence: assessment and application Ann Intern Med. 2002;137:598–602. of scientific evidence. Canberra, ACT: National Health and Medical Research Council; 2000 (http://www. 6. How to present the evidence for consumers: nhmrc.gov.au/guidelines/publications/cp69, accessed preparation of consumer publications. Canberra, ACT: 19 February 2014). National Health and Medical Research Council; 1999 (http://www.nhmrc.gov.au/guidelines/publications/cp66, 2. Guidelines for the assessment of diagnostic technologies. accessed 19 February 14). Canberra, ACT: Medical Services Advisory Committee; 2005. 7. Diagnostic testing emerging from the gloom? Bandolier. 1999;70 (http://www.medicine.ox.ac.uk/bandolier/ 3. Sackett DL, Haynes RB. The architecture of diagnostic band70/b70-5.html, accessed 19 February 14). research. BMJ. 2002;324:539–41. 8. Lijmer JG, Mol BW, Heisterkamp S, Bonsel GJ, Prins 4. Whiting PRA, Reitsma JB, Bossuyt PM, Kleijnen J. The MH, Meulen JH, Bossuyt PM. Empirical evidence of development of QUADAS: a tool for the quality design-related bias in studies of diagnostic tests. JAMA. assessment of studies of diagnostic accuracy included 1999;282:1061–6. in systematic reviews. BMC Med Res Methodol. 2003;3:25. 9. Phillips B, Ball C, Sackett D, Badenoch D, Straus S, Haynes B, Dawes M. Levels of evidence. Oxford: Centre for Evidence-Based Medicine; 2001.

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Systematic review of needs for medical devices for ageing populations

Commissioned to the Australian Safety and Efﬁ cacy Register of New Interventional Procedures – Surgical (ASERNIP-S) by the World Health Organization (WHO)