NON- TOXIC HEALTH CARE:
Alternatives to Hazardous Chemicals in Medical Devices: Phthalates and Bisphenol A
SECOND EDITION (2019) TABLE OF CONTENTS
Foreword 4
Executive Summary 5
Introduction 6
Hazard of chemicals contained in medical devices 6
Hazards for human health 8
Exposure through medical devices 8
Hazards for the environment 11
The European legal framework on hazardous chemicals in medical devices 11
Why update this report now? 15
Chapter 1: Substituting hazardous chemicals in Medical Devices 16
Governmental Initiatives 17
Non-Governmental Initiatives 17
Chapter 2: Alternatives to phthalates 19
Chapter 3: Alternatives to BPA 20
Chapter 4: Best practices in European healthcare 21
Chapter 5: The health impact of plastics in healthcare 22
General background 22
Plastics in healthcare - Medical plastics 28
Impacts of medical plastics 29
Case studies of plastic waste management in European hospitals 32
Initiatives from the medical devices industry 32
The way forward / The urgency to act on plastics 34
Chapter 6: Conclusions and recommendations 36
Conclusions 36
HCWH Europe’s Recommendations 37
References 39
2 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 3 FOREWORD EXECUTIVE SUMMARY
Modern healthcare makes use of a wide range of HCWH Europe promotes the substitution of harm- Medical devices play a critical role in healthcare but Within this report, HCWH Europe examines the plastic-based medical products to provide high ful substances by demonstrating that many alter- may contain hazardous substances in their com- health impact of plastics in healthcare, and pre- quality and effective treatment to patients. As a natives with safer toxicological profiles are available position that can leach into patients during their sents a number of recommendations for policy consequence high volumes of plastic single-use on the market. We aim to accelerate the shift to- use and compromise patient safety. Concerns have makers, competent authorities, notified bodies and products and complex plastic composites are rou- wards substitution within the European healthcare been raised by different societal groups including healthcare providers, to move towards non-toxic tinely used by the European health sector and it is sector, supported by research, evidence, collabo- governmental bodies, healthcare professionals, healthcare and minimise the risk to patients wit- becoming increasingly important to understand the ration, and greater awareness. Progressive manu- scientists and civil society organisations, regarding hout compromising medical care: impact these materials have on human health. facturers, governments, health systems, hospitals, the potential health impacts of chemical exposure l European legislation must protect the most and health practitioners are starting to come toge- from medical devices, particularly for vulnerable We have known for decades that certain hazardous vulnerable groups. Consistent technical imple- ther to lead this change; many European healthca- population groups. chemicals leach out of medical devices, such as mentation of Annex I.II.10.4 of the MDR must re providers have already moved to eliminate PVC, phthalates in plastic tubing. One of Health Care Wit- In 2017, the European Council adopted the Medical therefore be ensured. The benefit-risk assess- DEHP, and BPA from healthcare practice. HCWH hout Harm (HCWH) Europe’s first campaigns focu- Devices Regulation (MDR), fully applicable to medi- ment of the presence of hazardous chemicals Europe has highlighted a number of examples in sed on the elimination of DEHP, the most common- cal devices placed on the EU market as of 26 May in certain medical devices should therefore be recent years, some of which are listed in this report. ly used phthalate, in intravenous drips. Our work in 2020. Importantly, some of the provisions within subject to the most stringent conformity as- this area has also highlighted the high exposure to Importantly, the move towards substitution needs this regulation have the potential to act as an en- sessment procedures by a Notified Body bisphenol A (BPA) of new-borns receiving medical to be further encouraged and supported by strong gine for substituting medical devices that contain l treatment using multiple devices. political and regulatory action, such as in France for harmful chemicals with safer alternatives. Devices should be subject to stringent com- pliance assessment of required labelling by a The endocrine-disrupting properties of these che- example, where tubes and pipes containing DEHP Phthalates and Bisphenol A (BPA) are substances of Competent Authority. Information labelled in micals are now well established; we have seen an are banned in paediatric, neonatal, and maternity particular concern that are often found in medical accordance with the MDR must be accessible increase in endocrine-related diseases such as bre- departments in hospitals. The new Medical Devices devices. Phthalates are commonly used as plastic to the public via the revamped European Data- ast and testicular cancers, thyroid disorders, infer- Regulation introduces provisions that would help softeners in PVC-based medical devices, whilst BPA base on Medical Devices (EUDAMED) tility, and diabetes throughout Europe over the last phase out endocrine disrupting chemicals, carcino- is used to produce certain plastics such as polycar- decades. genic, mutagenic and reprotoxic substances, and bonates and epoxy resins that have applications in l The market authorisation process for medical particularly phthalates in medical devices, if safer This second edition of Non-toxic Healthcare forms the medical device industry. A major concern sur- devices needs increased transparency alternatives are available and technically feasible. an important part of HCWH Europe’s work to rai- rounding these substances is that they are known l Sustainable procurement guidelines should This is a positive step and one that HCWH Europe se awareness about the presence of hazardous endocrine disrupting chemicals (EDCs), which may provide incentives for the substitution of ha- will continue to follow and support through its im- substances in medical devices and the consequent interfere with the normal functioning of the human zardous chemicals in medical devices plementation. risks to patients. This report also contains a new endocrine system and therefore present a hazard l Funding for research and development of alter- chapter specifically examining the health impact of Prevention is always better than cure, and this the- to different physiological and developmental pro- native substances and products and for clinical plastics in healthcare. me is central to the recommendations laid out in cesses. EDCs can impact upon the human body this report. Opting for safer alternatives in health- at very low concentrations and can combine with and epidemiological projects that compare the care to prevent patients (particularly children and other endocrine disruptors to produce additive ef- performance of these alternatives should be other vulnerable groups), from being exposed to to- fects. Despite difficulties to demonstrate a causal prioritised. xic chemicals will help prevent devastating lifelong link, some associations between EDC exposure and long-term health consequences in these groups. In diseases are apparent: evidence shows that foetu- doing the healthcare sector will be fulfilling its duty ses, children, and pregnant women are the most to first do no harm. vulnerable groups. Awareness of actions to eliminate harmful plastics Will Clark, Executive Director - must be increased within the healthcare sector, Health Care Without Harm (HCWH) Europe highlighting that a high level of patient care and safety can be maintained. Furthermore, as some of the most highly trusted community figures, he- althcare professionals have the capacity and moral obligation to educate the communities they serve and help trigger widespread beneficial behaviour changes in plastic use.
4 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 5 ment procedures lack integration of endocrinolo- exposure can be harmful for patients as they will INTRODUCTION gy concepts, the effects of EDCs in human health be primarily from the vulnerable populations and/ and the environment are mostly dismissed in the or maybe rendered more susceptible to toxic insult existing risk assessment framework. In particular, through (critical) illness. A precautionary approach effects from early life, chronic low-dose, and/or and eliminating exposure to hazardous chemicals multiple simultaneous exposures are not taken into wherever possible is therefore appropriate in the consideration. Increased incidence of diseases and case of medical devices and recognised under the Medical devices are an essential feature of modern groups of vulnerable patients that undergo multip- illnesses in humans from neonatal/infancy through healthcare, playing an important role in prevention, le medical interventions or are exposed chronically to adulthood has been associated with exposure to diagnosis, monitoring, and treatment of diseases over extended periods, including infants in neona- these substances.4 10 In 2015, the Endocrine Society and disabilities. Hazardous chemicals are often tal care or dialysis patients. reviewed the latest science and declared that the present in medical devices to improve plastic per- BOX 2 Substances that are commonly found in medical evidence for adverse reproductive effects is strong formance e.g. plasticisers, flame-retardants, fillers, devices and are of particular concern are phthala- and mounting for effects in areas such as neuroen- colourings, impact modifiers, and stabilisers. These What are phthalates? tes and Bisphenol A (BPA). These substances have docrine, sexual development, obesity, metabolism, harmful chemicals can represent a high percentage been the subject of intense political debate in re- thyroid systems, and insulin resistance. Further, the Phthalates are a group of chemical substan- of the final product (in some case up to 80%) and cent years due to their widespread use in consu- effects may also be transmitted to future generati- ces, primarily used as plasticisers (softeners) in can leach out of products and have adverse effects mer products and the risks they pose to human ons.11 plastics to make them more flexible. Depen- on human health and the environment. health and the environment. The endocrine-dis- A European Parliament study reviewed the scienti- ding on the number of carbon atoms in their Concerns regarding hazardous chemical exposure rupting properties of these chemicals are also well fic evidence of endocrine disruption, the extent of alkyl side-chains they are divided into: through medical devices are particularly relevant to established. EDC exposure, and the associated health effects l High-chain length - with more than six car- and consequent costs of treatment. Published in bons (e.g. DINP, DIDP, DPHP, and DIUP) Hazard of chemicals contained in medical May 2019, the study concluded that after several l Transitional-chain length - with three to six devices decades of multidisciplinary research in endocrino- carbons (e.g. DEHP, DBP, DIBP and BBP) BOX 1 logy, ecotoxicology, toxicology, epidemiology, clini- Humans are exposed to environmental contami- cal research, epigenetics, environmental sciences l Low-chain length - fewer than three car- EU definition of a medical device nants from several sources and exposure pathways, 1 and other disciplines, endocrine disruption is now bons. (e.g. DEP and DMP) (Regulation 2017/745 on medical devices ) including consumption of contaminated food and 12 an important and validated scientific concept. The Phthalates are abundant in polyvinyl chloride water, air and dust inhalation/ingestion, and dermal Any instrument, apparatus, appliance, software, evidence therefore justifies classifying EDCs as a (PVC) medical devices such as blood bags, in- absorption. Human biomonitoring studies have de- implant, reagent, material, or other article inten- specific class of hazard, equivalent to that ofcar- travenous bags, tubing, catheters, respiratory tected hazardous chemicals like phthalates and ded by the manufacturer to be used, alone or in cinogenic, mutagenic, reprotoxic chemicals (CMRs). masks, or disposable gloves - approximately BPA in almost every individual analysed and in a va- combination, for human beings for one or more Researchers and healthcare practitioners are par- 40% of all plastic-based medical devices are riety of human tissues and fluids such as placental of the following specific medical purposes: ticularly concerned that exposure to EDCs from made from PVC.13 tissue, breast milk, amniotic fluid, urine, blood, cord medical devices compounds adds to the existing l Diagnosis, prevention, monitoring, predic- blood, sperm, and saliva.2 3 4 5 6 7 8 9 The majority of Di-2-ethylhexyl phthalate (DEHP) has for many exposure from other sources: EDCs are ubiquitous tion, prognosis, treatment, or alleviation of studies show widespread exposure to phthalates years been the most commonly used phthala- and the entire population is already exposed. Furt- disease in unborn children and infants across Europe. The te ester plasticiser in medical devices. A 2014 hermore, vulnerable population groups such as new European Human Biomonitoring (HBM4EU) survey in the Danish Medical Device Industry l Diagnosis, monitoring, treatment, allevia- neonates, infants, pregnant and breast-feeding wo- 14 Initiativei (2017-2021) aims to coordinate and ad- found that 95% of products contained DEHP. tion of, or compensation for, an injury or men, and the elderly are not adequately protected vance human biomonitoring in Europe. The project DEHP can contribute up to 40% of weight of disability from the risk of exposure to these chemicals. The represents a joint effort of Members States, the intravenous bags and up to 80% of weight in most at risk groups comprises dialysis patients and 15 l Investigation, replacement or modifica- European Environment Agency, and the European medical tubing. Leaching of DEHP from PVC neonates in intensive care units, as they experien- tion of the anatomy or of a physiological Commission. One of the objectives of HBM4EU is to medical devices has been documented since ce frequent and intimate contact with a number of 16 17 18 or pathological process or state generate scientific evidence on the causal relation- the late 1960s. Use of PVC medical de- medical devices containing EDCs. Premature babies ships between exposure to prioritised chemicals vices may lead to a higher exposure to DEHP l Providing information by means of in vitro and infants are particularly sensitive to phthalate (including phthalates and bisphenols) and the ad- than everyday sources affecting the general examination of specimens derived from effects, as their reproductive system is still develo- 19 verse health effects and public health implications. population. the human body, including organ, blood, ping and they have much higher relative phthalates and tissue donations One of the major reasons for concern surrounding intakes. In addition, the unborn and young children This does not include devices/treatments that phthalates and BPA is that they are known endo- are not able to metabolise chemical substances in achieve the principal intended action by phar- crine disrupting chemicals (EDCs) that can mimic the same way as adults, due to the on-going de- macological, immunological or metabolic me- or otherwise interfere with hormone production or velopment of their organs and maturation of the ans, in or on the human body, but a medical function. EDCs can therefore interfere with organ different systems (see Box 5). formation and growth, sexual maturation, stress re- device may be assisted in its function by such Despite claims that exposure to hazardous chemi- sponse, and behaviour.10 As traditional risk assess- means. cals through medical devices represents a small proportion of an individual’s overall exposure, this i www.hbm4eu.eu
6 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 7 higher risk of male reproductive disorders after the potential human health risks posed by DEHP in multiple medical devices simultaneously, sequenti- prenatal and postnatal exposure to phthalates.25 It medical devices. ally, or intermittently.50 51 Neonates in intensive care BOX 3 has been proven that phthalates can transfer from According to the SCENIHR premature neonates in are exposed to DEHP at much higher levels than mothers to foetuses and neonates through placen- neonatal intensive care units, infants subjected to existing safe limits, which might contribute to com- 26 What is Bisphenol A? ta and breast milk. Exposure to DEHP and DBP repeated medical treatment using medical devices, mon early and chronic complications of prematu- 52 has been linked with reproductive alteration inclu- and patients undergoing haemodialysis are at risk rity. Bisphenol A (4,4-dihydroxy-2,2-diphenylpropa- ding low sperm concentration, shortened anogeni- of DEHP-induced effects.19 Patients in a neonatal Premature infants in neonatal intensive care units ne or BPA) is a chemical substance used as a tal distances (a measure of feminisation of exter- intensive care unit (NICU) are exposed to phthalate undergoing treatment were also found to have BPA monomer in the production of polymers such nal genitalia), endometriosis, hypospadias, shorter mixtures through the complex materials used con- levels 10 times higher than the general population, as polycarbonate, epoxy resins, polysulfone, pregnancy duration, changes in neurobehaviour in currently in NICU care: respiratory circuits, intrave- presumably from BPA leaching from medical devi- and polyacrylate. BPA is also used as an an- neonates, infants and children, cholestasis, derma- nous equipment, enteral feeding supplies, and in- ces.53 Infants in neonatal intensive care units using tioxidant and inhibitor in the polymerisation titis, heart disease and perturbations in inflamma- cubators are likely vehicles of phthalate exposure.46 a large number of PVC-containing medical devices of PVC and as a precursor for the synthesis of tory responses.27 28 29 30 31 32 A recent comprehensive Whilst evidence of BPA leaching into patients is had also higher concentrations of urinary BPA (one the flame retardant tetrabromobisphenol A and critical review addressed the health hazards more limited, dialysers, dental materials, circula- order of magnitude higher than the median con- (TBBPA). Up to 1 million tonnes of BPA is ma- posed by phthalates on children and adolescents, 54 tion equipment, neonatal care medical devices, centration of the general population in the US). nufactured and/or imported in the European including reproductive toxicity in women and men, iii and urinary catheters have demonstrated releases Recent clinical studies provide information about Economic Area (EEA) annually , from which cancer, insulin resistance and type II diabetes, over- of BPA.23 Length of contact time (duration of expo- the overall significant exposure to BPA during hae- over 95% of BPA is used in the production of weight and obesity, allergy and asthma.6 Growing 20 21 sure), temperature and pH, among other parame- modialysis treatment in patients suffering from polycarbonates and epoxy resins. evidence suggests that prenatal phthalate exposu- ters, has been shown to increase the release of BPA end-stage renal disease (ESRD).55 A recent study de- BPA has applications in medical devices that res may have neurodevelopmental consequences33 from polycarbonate.23 The SCENIHR opinion on the monstrated overexposure to BPA and its chlorina- have both direct and indirect contact with pa- 34 35 36 and can affect IQ, attention, hyperactivity, and safety of the use of Bisphenol A in medical devices ted derivatives of patients with ESRD during online tients including those made of polycarbonate, social communication of children.37 38 concluded that there is a risk when BPA is directly haemodiafiltration (OL-HDF) due to BPA leaching polysulfone, and PVC such as medical tubing, Exposures to BPA are associated with many health available for systemic exposure after non-oral ex- from different medical devices.56 catheters, haemodialysers, newborn incuba- effects in humans, including reproductive effects posure routes, especially for neonates in intensive tors, syringes and blood oxygenators. BPA has The materials used in medical devices are also an (erectile dysfunction, miscarriage), cardiovascular care units, infants undergoing prolonged medical been shown to leach from medical devices important factor. In one study, BPA concentrations diseases, thyroid, immune and metabolic diseases procedures, and for dialysis patients.23 The risk of into liquids.22 23 European PVC manufacturers among infants in one healthcare unit were approxi- (diabetes), childhood obesity as well as general/ab- adverse effects due to BPA may exist in patients un- 54 informed the Scientific Committee on -Emer mately 17 times higher than another unit. Patients dominal obesity and hypertension, neurodevelop- dergoing dialysis treatment since BPA accumulates ging and Newly Identified Health Risks (SCE- undergoing regular continuous ambulatory peri- ment impairments, respiratory conditions and in systemic circulation due to reduced renal clea- NIHR) that they no longer use BPA as stabiliser toneal dialysis using plasticiser-free devices had behaviour alterations (anxiousness, hyperactivity, 57 23 rance. Although the benefit of medical devices has reduced levels of phthalates in urine and blood. or antioxidant in PVC production. depression).39 40 41 42 43 BPA has recently also been also to be considered, the SCENIHR recommends Moreover, the level of cholestasis in neonates was suggested to be an emerging threat to male infer- ii https://echa.europa.eu/ that, where practical, medical devices that do not reduced from 50% to 13% in neonates fed through tility.44 23 leach BPA should be used. With the exception of a DEHP-free catheter.58 Particularly worrying is the fact that exposure to dialysis patients (for which treatment is repeated A growing number of studies suggest the link bet- phthalates and Bisphenol A can lead to cumulative over long time periods and can be considered si- ween exposure of patients to phthalates and/or Hazard for human health adverse effects on future generations such as neu- milar to chronic exposure), the exposure to BPA via BPA from medical devices and adverse effects in ral and immune disorders, infertility, and late-onset medical devices is generally of limited duration (re- exposed patients. There is emerging evidence that There is growing evidence that many phthalates complex diseases (cancers and diabetes).45 presentative of acute to sub-chronic exposure in a the use of medical devices containing DEHP is po- and BPA can present a hazard to human health and toxicological context). are recognised in the EU as endocrine-disrupting tentially harmful for the brain development and A number of observations from the scientific lite- compounds. Evidence comes from in vitro and ani- Exposure through medical devices function of critically ill children. Belgian clinicians rature are available, confirming the link between mal studies as well as clinical and epidemiological identified a clear link between previously hospita- Exposure to hazardous chemicals through medi- use of plastics in medical devices and exposure of studies encompassing both prenatal and postnatal lised children’s long-term neurocognitive test re- cal devices can be enteral (via the digestive tract), patients to phthalates and/or BPA. A strong asso- exposures. sults and their individual exposure to the phthalate parenteral (intravenously), transcutaneous (via the ciation was found between the use of DEHP-contai- DEHP during their stay in intensive care.59 Critically The effects of DEHP in animals has been thoroughly skin), or through inhalation. Dietary exposure to ning medical devices and urinary concentrations of ill children had very high circulating levels of phtha- reviewed by Scientific Committee on Emerging and phthalates and BPA is expected to account for the three DEHP metabolites in infants receiving care in 19 late metabolites, explained by leaching from medi- Newly Identified Health Risks (SCENIHR) which 47 majority of human exposure. Several studies have two neonatal intensive care units. DEHP leached cal devices, and these levels were associated with concluded that i) the testis toxicity of DEHP is age described phthalates, (particularly DEHP), leaching from endotracheal tubes immediately after use in the significant attention-deficit observed four years dependent, with immature animals being more 48 from medical devices and recorded levels in uri- high-risk neonates. Premature neonates receiving later. susceptible to testicular toxicity by DEHP than ol- ne and blood. The leaching of DEHP from medical treatment through feeding tubes and endotracheal Another recent study highlighted the impact of acu- der mature animals; ii) even low-level exposures to plastic devices into body fluids and subsequent mi- tubes had increased levels of DEHP in their urine.49 te mono-2-ethylhexyl phthalate (MEHP, the primary DEHP during pregnancy can affect male genital de- gration into human tissues was first reported in the 24 Certain vulnerable patients groups such neonates metabolite of DEHP) exposure on cardiac electrop- velopment. late 1960s.16 Nearly 60 years after this discovery, / children are exposed during intense care to mul- hysiology in the heart. It concluded that heightened A review of human epidemiology studies found a regulators are still struggling to define and manage tiple invasive medical procedures and therefore to
8 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 9 clinical exposure to plasticised medical products periments and in vitro studies show that exposure might have cardiac safety implications.60 Several to environmentally relevant concentrations of BPA clinical observations point to the possible involve- BOX 4 BOX 5 have shown detrimental effects in invertebrates ment of BPA/DEHP exposure in dialysis patients in- and all vertebrate classes.63 Similarly, exposure to creased cardiovascular (CV) mortality and sudden Medical procedures with potential Why neonates and children are more different phthalates and/or their metabolites has 61 19 23 cardiac death (SCD). As emphasised by the aut- for high exposure to DEHP and BPA vulnerable caused adverse effects at various endpoints in hors, importantly, BPA/DEHP exposure may be a aquatic organisms at environmentally relevant ex- modifiable risk factor for SCD in dialysis as alternati- l Exchange transfusion of blood in neon- The levels of exposure to hazardous chemi- posures.67 There are studies that indicate that BPA ves to BPA and DEHP do exist and could potentially ates cals are of particular concern for unborn chil- can especially affect development, reproduction, be used as replacements for dialysis procedures. dren, neonates, and children. These groups immune function and metabolism in aquatic speci- l Extracorporeal membrane oxygenation Replacement of BPA- and DEHP-leaching plastics are being exposed to hazardous chemicals at es.68 Besides the chemical contamination of a wide (ECMO) treatment of neonates and of may reduce morbidity and mortality of patients with a highly vulnerable moment when important range of natural habitats, these compounds also adults ESRD undergoing dialysis and of other patients un- aspects of their development can be altered, create a waste management problem. The disposal dergoing invasive interventions with prolonged ex- l Total Parenteral Nutrition (TPN) in neon- perhaps with lifelong consequences. Further- of PVC medical waste can release dioxins and ot- posure to plastics (e.g. cardiac surgery). Prospective ates more, their low body weight means the expo- her persistent environmental pollutants, which can clinical studies and randomised controlled trials are l Multiple procedures in sick neonates sure can be relatively higher than for adults. have a detrimental impact on human health and needed to test this hypothesis. Premature babies are subject to an even hig- the environment. l Haemodialysis These data strongly support SCENIHR’s recommen- her risk due to their lower birth weight com- bined with the fact they require many medi- dation to use medical devices with low DEHP and l Enteral nutrition in neonates and adults The European legal framework on hazar- cal interventions. In addition, the unborn and BPA release potential, whenever possible. l dous chemicals in medical devices Heart transplantation or coronary artery young are not able to metabolise chemical bypass graft surgery substances in the same way as adults, due to European medical devices manufacturers have to l Massive blood transfusion of red blood the on-going development of their organs and comply not only with the EU Medical Devices Re- cells and plasma maturation of the different systems. For exam- gulation 2017/745 but also with a number of che- ple, the glucuronidation mechanisms that are l Peritoneal dialysis mical regulations – the EU Regulation 1907/2006 responsible for the excretion of some phthala- on the Registration, Evaluation, Authorisation and Six scenarios considered as representative te metabolites are not fully developed before Restriction of Chemicals (REACH) and the EU Direc- situations of release of BPA from medical de- 3 the age of 3 months. Finally, expected longer tive 2011/65/EU on the Restriction of Hazardous vices: life spans could mean that this group will be Substances in Electrical and Electronical Equipment 1. External contact with a medical device exposed for a longer time to these substan- (RoHS II). containing BPA ces. All these factors may put this group at an increased risk of suffering deleterious effects. 2. Contact with oral/dental material and/or The REACH Regulation orthodontic equipment The REACH regulation makes a distinction between 3. Contact with implants such as valves, medical devices that are: pacemakers and insulin dispensers made Hazards for the environment l Chemical substances, either on their own or from polycarbonate Phthalates and BPA have been detected in aquatic as mixtures. Examples of mixtures include lu- and marine environments, terrestrial ecosystems 4. Haemodialysis bricants, dental filling materials and bone ce- and in the atmosphere in concentrations that are 5. Prolonged surgical procedures such as ments. likely to adversely affect a number of species.62 63 bypass operations and transplantations These substances have also been shown to bioac- l Articles (that is, objects with a function deter- 6. Prolonged exposure to different sources cumulate in some species of molluscs and crusta- mined by their shape, surface or design rather of BPA in intensive care units. ceans.64 Phthalates have been measured in a range than their chemical composition (Article 3.3). of environmental matrices, including sludge, dust, Examples include catheters, contact lenses soil, air, and water, and are ubiquitous contami- and medical implants. nants in the environment. Phthalates and BPA can In practice, most medical devices are likely to quali- reach the environment from industrial discharges, fy as articles under REACH. sewage, landfill leachates and natural breakdown of A medical device that qualifies as a substance/ plastics in the environment. mixture is subject to most of the requirements of 65 66 DEHP (authorisation list) and BPA (candidate list) REACH, including registration. Pursuant to Articles are both classified by the European Commission as 60(2) and 62(6) of REACH, an application for aut- “toxic to aquatic life with long lasting effects” and horisation is not required for a substance used in endocrine disrupting chemical for environment. a medical device. Article 60(2) states that the Com- Data collected from wildlife studies, laboratory ex- mission shall not consider the risks to human health
10 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 11 arising from the use of a substance in a medical de- European Parliament. Phthalates in the Authorisation List65 vice regulated by the MDR. Nonetheless, suppliers, In the case of BPA, this has been classified as toxic distributors or retailers of medical devices have the for reproduction, an EDC for human health and an duty to communicate information about the pre- EDC for environment, and listed on the Candidate Phthalate CAS number Reason for inclusion sence of Substances of Very High Concern – SVHCs List of SVHCs under REACH in 2017. However, Plas- if requested by a consumer in 45 days (Article 33). iiii ticsEurope (the leading pan-European industrial DIPP: Diisopentyl phthalate CAS 605-50-5 Toxic for reproduction Several phthalates are classified as toxic for repro- association) brought a case to the EU court against duction under the EU Regulation (EC) No 1272/2008 BPA's classification as a SVHC and against the iden- DIBP: Diisobutyl phthalate CAS 84-69-5 Toxic for reproduction; Endocrine disrup- on the classification, labelling and packaging of sub- tification of BPA as an endocrine disruptor with im- ting properties for human health stances and mixtures (the CLP Regulation) and are pact on health. This year, the General Court of the listed on the Candidate List of SVHCs under REACH EU dismissed both claims. PlasticsEurope also chal- (see Table 1). Seven of those phthalates had subse- lenged the identification of BPA as an endocrine BBP: Benzylbutyl phthalate CAS 85-68-7 Toxic for reproduction; Endocrine disrup- quently been added to the Authorisation List (An- disruptor with impact on the environment in a third ting properties for human health nex XIV of REACH) due to their classification as toxic case (the judgment is expected in November 2019). for reproduction (see Table 1). DEHP: Bis(2-ethylhexyl) phtha- CAS 117-81-7 Toxic for reproduction; Endocrine disrup- The European Chemicals Agency (ECHA) has recent- iii https://www.plasticseurope.org/en late ting properties for human health; Endocri- ly submitted a recommendation to the European ne disrupting properties for environment Commission to amend Authorisation List entries by adding the endocrine disrupting properties of DBP: Dibutyl phthalate CAS 84-74-2 Toxic for reproduction; Endocrine disrup- 69 DEHP, BBP, DBP, and DIBP. They were identified ting properties for human health as substances of very high concern (SVHCs) due to endocrine disrupting properties with effects on hu- man health. DEHP was also identified for its effects PIPP: n-pentyl-isopentyl phtha- CAS 776297-69-9 Toxic for reproduction on the environment. One important impact of this late is that the REACH authorisation process will be able to address – and work to phase out in the longer DMEP: Bis(2-methoxyethyl) CAS 117-82-8 Toxic for reproduction term – the use of DEHP in medical devices. The aut- phthalate horisation process places significant emphasis on the substitution of affected substances. The actual amendment of the entries including the final deci- sion on the dates, by which companies will need to apply for authorisation to ECHA and on exemptions RoHS II Directive tion cycles for medical devices and monitoring and of uses, will be made by the European Commission control instruments were taken into account while The RoHS II Directive (2011/65/EU) was adopted to in collaboration with the Member States and the determining the transitional period. Consequently, limit the concentration of six hazardous substances the restriction of the use of DEHP, BBP, DBP and (including lead, mercury and toxic flame retardants) DIBP applies to medical devices, including in vitro TABLE 1 in electrical and electronic equipment with a view medical devices, and monitoring and control instru- to contributing to the protection of human health ments, including industrial monitoring and control Phthalates in the Candidate List of Substances of Very High Concern (REACH)66 and the environment. From July 2014, the RoHS II instruments, from 22 July 2021. Directive also applies to electrical and electronic medical devices. In vitro medical devices are cove- Phthalate CAS number Reason for inclusion red from July 2016 and active implantable medical The Medical Devices Regulation (MDR) devices are exempted. Additional exemptions have The new MDR aims to create a modernised and been added (Annex IV), specific to medical devices DCHP (Dicyclohexyl phthalate) 84-61-7 Toxic for reproduction; Endocrine disrup- more robust EU legislative framework to ensure and monitoring and control instruments for which ting properties for human health better protection of public health and patient safety a reliable alternative was not available. and include, among others, stronger rules on clini- DHP (Dihexyl phthalate) 84-75-3 Toxic for reproduction Directive (EU) 2015/863 (often referred to as "RoHS cal and performance evaluation, reinforced desig- 3") amends Directive 2011/65/EU adding four sub- nation and oversight processes of Notified Bodies, stances to the original six restricted substances DPP (Dipentyl phthalate) 131-18-0 Toxic for reproduction establishment of a comprehensive EU database on – Bis(2-ethylhexyl) phthalate (DEHP), Butyl benzyl medical devices (EUDAMED) to be made publicly phthalate (BBP), Dibutyl phthalate (DBP) and Dii- available, and stricter requirements related to the 1,2-benzenedicarboxylic acid, CAS 84777-06-0 Toxic for reproduction sobutyl phthalate (DIBP) – in view of their negati- use of hazardous substances. When the MDR takes dipentylester, branched and ve impact on recycling and on human health and effect in May 2020, manufacturers will have to com- linear the environment during electrical and electronic ply with new rules for almost every kind of product waste management operations. The longer innova-
12 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 13 in the medical device spectrum. cess will be extended. The database will not only be Why update this report now? According to the new EU Medical Devices Regula- used by the Competent Authorities and the Euro- Many alternative substances and materials have tion, “Devices shall be designed and manufactured in pean Commission, it will also be accessed by the BOX 6 appeared in recent years for many of the most such a way as to reduce as far as possible the risks po- Medical Devices Coordination Group (MDCG), No- hazardous chemicals used in medical devices, in- sed by substances or particles, including wear debris, Regulation (EU) 2017/745, Annex tified Bodies, Economic Operators (manufacturers, cluding for phthalates and BPA. There is a choice degradation products and processing residues, that I.II.10.4 (Substances: 10.4.1. Design authorised representatives, importers, sponsors), now to be made between safer alternatives or ig- may be released from the device.” and manufacture of devices): experts, and the public, including medical instituti- ons. noring the potential dangers to patients. The new Annex I.II.10.4 of the MDR introduces provisions Devices, or those parts thereof, or those ma- European legislation was long in the making, but Creating greater transparency will allow for a better that would help phase out endocrine disrupting terials used therein that: with the MDR there is a real opportunity to accele- understanding of what medical devices are placed chemicals (EDCs), carcinogenic, mutagenic and re- rate the process of phasing-out phthalates and BPA l Are invasive and come into direct contact on the EU market and who is ultimately responsi- protoxic substances (CMRs), and phthalates in me- and minimise patients, and in particular vulnerable with the human body ble for them. The level of access, however, will differ dical devices if safer alternatives are available and groups, exposure to these harmful chemicals. technically feasible. Manufacturers of medical de- between the types of user. l (Re)administer medicines, body liquids We are all exposed to endocrine disrupters from vices are required to provide adequate justification Theoretically, procurers (such as hospitals and Com- or other substances, including gases, to/ multiple sources, but healthcare should not be one (benefit-risk assessment) to the Notified Body for petent Authorities) will be able to access, search, from the body, or of these. As Kambia and co-authors stated already the presence of those substances if they are pre- and filter the content of EUDAMED to identify safer transport or store such medicines, body more than fifteen years ago, when exposures to sent above a certain concentration (see Box 6). The medical devices for their procurement process. fluids or substances, including gases, to hazardous chemicals in medical devices can be term “notified body” refers to the typically private be (re)administered to the body Originally, the new database’s launch was suppo- avoided through careful selection of materials, companies charged with evaluating the quality and sed to coincide with the date of application for the Shall only contain the following substances not doing it is both unprofessional and undesi- safety of medical devices in the EU. MDR in May 2020. However, in October 2019, the 71 in a concentration that is above 0,1 % w/w rable. The Scientific Committee on Health, Environmen- Commission announced that the launch would be where justified: tal and Emerging Risks (SCHEER) of the European delayed by two years. The Commission plans to Commission prepared the Guidelines on the benefit- l Category 1 Carcinogen, Mutagen, Repro- have the new database ready when another piece risk assessment of the presence of phthalates in certain ductive Toxins (CMRs) of legislation — the in vitro diagnostics regulation — medical devices covering phthalates, which are carci- l Endocrine disrupting chemicals comes into full effect in May 2022. nogenic, mutagenic, and toxic to reproduction (CMR) or have endocrine disrupting (ED) properties.70 Before a justification can be accepted as valid, seve- ral steps need to be taken, including giving conside- The presence of hazardous substances (subject to ration to the possible use of alternative substances, justification) will have to be indicated on the me- materials, designs, and medical treatments. In ad- dical devices’ labelling (in accordance with provisi- BOX 7 dition, the risk in terms of hazards associated with ons laid down in Annex I.II.10.4.5). It also specifies such alternatives should be weighed against the that, if such devices are intended to treat children or pregnant or nursing women, the manufacturer Regulation (EU) 2017/745, Annex risk of the use of CMR 1A/1B and/or ED identified I.II.10.4 (Substances: 10.4.5. Labelling): phthalates covered under MDR Annex I Chapter II should provide information on residual risks for point 10.4.1. However, the risk by itself is not the these patient groups and if applicable on appro- Where devices, parts thereof or materials used only parameter to consider; an evaluation must priate precautionary measures (see Box 7). therein as referred to in Section 10.4.1. con- also be made of the impact of the possible alter- Information labelled in accordance with this annex tain substances referred to in points (a) or (b) natives on the functionality, the performance and is one of the mandatory Unique Device Identifiers of Section 10.4.1. in a concentration above 0,1 the overall benefit-risk ratio of the medical device. (UDI) data elements to be provided by the manu- % weight by weight (w/w), the presence of tho- These Guidelines are intended to be used by the facturer to the UDI database. This information on se substances shall be labelled on the device relevant stakeholders, e.g. manufacturers, notified the devices will be accessible to the public via the itself and/or on the packaging for each unit bodies and regulatory bodies. The approach taken European Database on Medical Devices (EUDA- or, where appropriate, on the sales packaging, in these Guidelines may also be used for a benefit- MED). with the list of such substances. risk assessment of other CMR/ED substances pre- EUDAMED’s purpose is to strengthen market sur- If the intended use of such devices includes sent in medical devices. As foreseen by the MDR, veillance and transparency in the field of medical treatment of children or treatment of preg- adherence to these Guidelines will become man- devices, by providing national Competent Authori- nant or breastfeeding women or treatment of datory. ties with fast access to information. EUDAMED in other patient groups considered particularly current form contains data on medical devices that vulnerable to such substances and/or materi- have been collected and entered by Competent als, information on residual risks for those pa- Authorities and the European Commission and is tient groups and, if applicable, on appropriate currently only accessible by these parties. The MDR, precautionary measures shall be given in the however, calls for EUDAMED to be revamped: the instructions for use. information will be more comprehensive and ac-
14 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 15 CHAPTER 1
Substituting hazardous chemicals in medical devices
Exposure to phthalates or BPA can be minimised and maternity departments in hospitals in France. by adopting a precautionary approach and repla- This law also paves the way for a future ban on cing medical devices with phthalate-free and BPA- BOX 8 DEHP and other phthalates in all medical devices free devices, which can fulfil the same function. The Progress made by the industry if alternative materials are available and the equip- precautionary principle is enshrined in Article 191 ment’s safety can be guaranteed. PVC-free Blood Bag project Eastman Chemical Company has teamed up of the Treaty on the Functioning of the European The French National Agency for the Safety of Medi- with BloodCenter of Wisconsin (BCW) on a cli- Union (EU) and aims to ensure a high level of en- The PVC-free Blood Bag Project (www.pvcfree- cines and Health Products (ANSM) tested medical nical trial evaluating a new plasticiser for blood vironmental, consumer and human health protecti- bloodbag.eu) was a Life+ collaborative initiati- devices on the French market, targeting 3 thera- bags. The aim of the trial is to evaluate the on through preventive decision-making in the case ve between industry and the healthcare sector peutic areas in which PVC devices were presented stability of red blood cells in di-2-ethylhexyl te- of risk. Nevertheless, the decision whether or not that aimed to demonstrate that it is possible as DEHP-free: haemodialysis, enteral feeding and rephthalate (DEHT) plasticised containers com- to apply the precautionary principle appears to be to produce a blood bag without using PVC. infusion.77 During market surveillance ANSM obser- pared with standard di-2-ethylhexyl phthalate poorly defined, with ambiguities inherent in deter- The project, which was completed in 2017, has ved that a large number (around 70%) of these de- (DEHP) plasticised containers. The trial expan- mining what level of uncertainty and significance of shown that it is possible to produce a comple- vices in which DEHP was not added as plasticiser, 72 ded upon the use of DEHT as an alternative to hazard justifies invoking it. Decision makers prefer tely PVC-free set of four bags, which can store actually contained residual quantities of DEHP, with DEHP for bags to store red blood cells in AS-1 to wait until overwhelming scientific evidence is gat- red blood cells and fulfil the requirement spe- however, concentrations lower than 1,000 ppm and PAGGSM preservative solutions. The trial hered, often taking a long time to achieve, and po- cifications including a gap analysis for CE-mar- (0.1%) being observed for most of them. tentially delaying action to a point where risks and king.73 concluded that DEHT, a non-phthalate gene- ral-purpose plasticizer, is a viable alternative effects cannot be undone. The majority of Swedish healthcare providers to DEHP. Although structurally and functional- On the European market, several manufacturers and other organisations, including Health Non-Governmental Initiatives ly similar to DEHP, DEHT (or Eastman 168 SG) offer products where phthalates/PVC or BPA have Care Without Harm Europe, supported this is metabolically distinct with a comprehensive been replaced by alternative materials or substan- Initiative, and Karolinska University Hospital The Safer Medical Devices Database by and benign toxicology profile.74 ces. In the case of the phthalates, phthalate-free or is now working towards a PVC-free blood pro- HCWH Europe PVC-free medical devices are available for nearly all cessing and storage system. Their objective is “PVC blood bags without phthalates of concern 75 One of the issues that hospitals face when start- product categories except blood bags (see Box 8). to identify a partner with the ability to launch are just around the corner” ing a phase-out programme for phthalates or BPA PVC-free blood bags on the European market. Many hospitals have already made considerable is knowing what alternatives are available and the Demonstrating widespread demand is critical progress, having adopted phase-out policies and impact and effectiveness of the alternative. - Enga to achieving that goal and other European he- committing to using products that are less harmful gement and communication with manufacturers is althcare providers are invited to show support for patients. However, most of these initiatives are therefore essential. To enable healthcare procurers for this initiative by signing a Letter of Intent, Governmental Initiatives only happening due to the commitment of indivi- to identify medical devices that do not contain PVC available here: duals and in spite of a lack of political or regulatory Three European countries – Denmark, France and and/or DEHP or BPA, and that are already available impetus. (https://www.karolinska.se/en/karolinska-univer- Germany – have taken legislative steps to reduce on the European market, HCWH Europe launched In a project for the European Commission’s Direc- sity-hospital/about-karolinska/environment-and- the use of phthalates and/or BPA. All three count- in 2014 an online listing of DEHP-free, PVC-free or torate General Environment, the Swedish Environ- sustainability/pvc-free-blood-bag/). ries have addressed, to varying degrees, the issue BPA-free medical products available in the Euro- mental Management Council developed a set of EU of DEHP-containing medical devices and provide pean market – the Safer Medical Devices Database Green Public Procurement (GPP) criteria with re- political support to efforts to improve healthcare (safermedicaldevices.org). Manufacturers, procurers gards to electrical and electronic medical devices. in this regard. The Nordic Council of Ministers, the and anyone else working in the healthcare sector In 2014, the creation of Green Public Procurement official inter-governmental body for cooperation in that would like to provide information about PVC-, Criteria about electrical and electronic medical de- the Nordic Region also promotes the Swan Ecola- DEHP- or BPA-free medical devices, are invited to vices missed the opportunity to incorporate a crite- bel, which among other product categories also in- do so. rion on phasing out BPA due to insufficient scienti- cludes certain healthcare products. fic evidence and supply chain transparency. Given As all cases were described in the previous edition The Swedish Substitution List by the the growing amount of data and new tools available of Non-toxic Healthcare report76, and only new in- Substitution group on chemicals to track the presence of substances, updating this formation has been included in 2019 edition. policy tool would better support sustainable procu- Since 1 July 2015 tubing/pipes containing DEHP The Swedish regions and counties and the Swedish rement strategies aimed at phasing out hazardous have been banned for use in paediatric, neonatal, Environmental Management Council, through the chemicals.
16 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 17 CHAPTER 2
national Substitution Group on chemicals, maintain The ChemSec Marketplace Alternatives to phthalates and regularly update a Substitution List for hazar- dous substances in the healthcare sector, available The Marketplace (https://marketplace.chemsec.org/) Alternative substances for replacing phthalates European Pharmacopoeia since 2018. Today, ot- online.78 The Substitution List compiles information is a business to business website where buyers and exist for a number of products, including the ma- her plasticisers such as Di-isononyl cyclohexanoate on products available in the Swedish market to help sellers of alternatives to hazardous chemicals can jority of applications in medical devices. Several (DINCH), Tri-2-ethylhexyl trimellitate (TEHTM), and healthcare procurers make healthier and more in- interact. Not only does it provide a unique market companies already manufacture DEHP-free medi- Dioctyl Terephthalate (DOTP) are being proposed formed choices. Products are organised by product opportunity for producers of safer alternatives, but cal devices, either by using PVC plasticisers other in medical applications, such as medical tubing and category (use), and possible alternatives of the ha- also a one-stop shop for downstream user compa- than DEHP or by avoiding the use of PVC material blood bags. zardous substances are listed for each product, in- nies looking to substitute hazardous chemicals in 15 altogether. Tables summarising the applications, advantages, cluding at least one supplier. their products. A survey of the Denmark medical industry showed disadvantages, toxicity and main knowledge gaps that in 2014, 95% of the manufacturers still used relating to known alternative plasticisers to phtha- The Substitution Portal by Kooperations- Chemicals substitution by INERIS DEHP.81 However, 60% of the companies had also lates or known alternative polymers to PVC were in- stelle Hamburg IFE GmbH and partners products that do not contain phthalates, and 80% cluded in the previous edition of Non-toxic Health- This website (https://substitution.ineris.fr/en), set up of those using phthalates believed that substitution care report.76 These have been moved to the Safer The Substitution Support Portal – SUBSPORT (http:// by the French National Institute for Industrial En- should not be problematic over a period of 3-5 ye- Medical Devices Database (safermedicaldevices.org) www.subsport.eu) - is a multi-lingual collaborative vironment and Risks (INERIS) provides support to ars.81 with the intention of keeping them updated as and project coordinated by Kooperationsstelle Ham- economic operators engaged in a substitution ap- No clinical studies have systematically compared when appropriate evidence becomes available. burg IFE GmbH (a consultancy based in Germany), proach in order to promote the dissemination and the health outcomes of different substances used A concern that has been raised by a study from the International Chemical Secretariat – ChemSec sharing of information. The website currently offers in medical devices, particularly comparing DEHP Genay et al. (2011).84 and by the French National (a non-profit organisation based in Sweden), Gront- information provided by companies on the alterna- and other phthalates with alternatives. Nonethe- Agency for the Safety of Medicines and Health Pro- mij (a consultancy based in Denmark) and the Insti- tives available for three families of substances: bis- less, a number of studies from manufacturers, ducts77 is that not all DEHP-free devices are in prac- tuto Sindical de Trabajo, Ambiente y Salud - ISTAS phenols, phthalates and alkylphenol ethoxylates. regulatory agencies, researchers and NGOs have tice DEHP-free, as DEHP was present in small quan- (a technical body of one of the Spanish workers They are illustrated by concrete applications and looked into alternatives for phthalates or PVC in tities (below 0.1% by weight). These results point to unions). The project aims to provide useful informa- include medical devices. medical devices.19 82 83 the necessity for manufacturers to verify the purity tion on substitution and provide resources to tho- of raw materials for all plastics used in the compo- se interested in substituting hazardous chemicals In 2014, the Danish Environmental Protection sition of the various parts of a medical device and in products. The Case Story database in the portal Agency published a report looking at alternative not just PVC. includes the assessment of alternative substances plasticisers in medical devices to DEHP, BBP, DBP for ten substances or groups of substances of high and DIBP. The overall purpose of the report was to concern – including BPA – plus several case studies come up with a list of alternatives to help guide ma- from hospitals. nufacturers of medical devices to substitute these plasticisers.14 The report screened available infor- mation existing in the REACH registration dossiers The GreenScreen® Chemicals Alternative for a list of substances and found that the values of Assessment and the Plastics Scorecard by the “no effect level” (DNEL) for the general popula- the Clean Production Action tion were all higher in comparison with DEHP, mea- ning these substances would in principle be safer The GreenScreen® for Safer Chemicals79, developed than DEHP.14 In the Plastics Scorecard: Evaluating by the non-profit organisation Clean Production Ac- the Chemical Footprint of Plastics report, the plastic tion80, employs an open, transparent methodology footprint of polyolefin and PVC in IV bags was com- to perform chemical hazard assessment. A wide pared.83 The results of the comparison showed that range of professionals, governmental and non-go- the substitution of PVC bags by polyolefin-based vernmental bodies and manufacturers use it to polymers greatly reduced the chemical footprint of assess the hazard of chemicals and their potential the products. effect on human health and the environment. The goal is to push for the substitution of hazardous The plasticisers industry has been investing and chemicals by safer alternatives. developing alternatives to DEHP in medical devi- ces. These alternatives have been included in the
18 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 19 CHAPTER 3 CHAPTER 4
Alternatives to BPA Best practices in European healthcare
The hazardous properties of BPA and those of taining BPA that are used in medical devices inclu- Healthcare facilities and professionals play an im- some of its alternatives have been reviewed in se- de many of the alternatives for phthalates such as portant role in the substitution of hazardous che- veral studies.21 23 The substitution of BPA can be polyethylene, polypropylene, polyurethane, silicone micals. They have both an ethical responsibility to Non-toxic Healthcare: done by replacing BPA with chemical alternatives and acetylo-nitrile-butadiene-styrene. Other com- use products that are less hazardous for patients or by substituting the plastic polymer with another mon replacements include ceramic, stainless steel, and the purchasing power to push manufacturers Alternatives to Phthalates and plastic polymer or material. glass and acrylic. towards safer and lower impact products. In Euro- Bisphenol A in Medical Devices Other bisphenols have been indicated as potential The information available for the alternatives to BPA pe, public procurement of goods accounts for 16% 91 substitutes for BPA. This is the case for bisphenol in medical devices is considerably less than that of the total European market. S, bisphenol F and bisphenol AP. However, existing existing for phthalate alternatives. More specific Hospitals throughout Europe are working to mini- data shows that due to their similar structure they BPA alternatives have only appeared more recently mise the exposure of their patients to hazardous can have similar or even worse health effects than and information about them is much more sparse chemicals. The first step of many hospitals has BPA.21 85 86 87 Therefore, when evaluating the safety and the data gaps much larger. Manufacturers al- been to identify which products contain substan- of compounds for consumer use, it may be prudent ready replacing BPA in their medical devices inclu- ces of concern and develop an internal substitution PVC-free initiative of Helsinki University to consider entire classes instead of individual com- de Didactic89, Technoflex90, Mamivac, Nipro Europe. strategy or policy. Many have launched substitution Hospital (Finland) pounds.88 projects, particularly targeting DEHP and PVC in Tables summarising the applications, advantages, One of the environmental objectives at Helsinki Uni- medical devices. These strategies and policies help The SCENIHR report on BPA in medical devices disadvantages, toxicity and main knowledge gaps versity Hospital (HUS) is responsible procurement, hospitals in their purchasing decisions. made only a brief overall note of existing studies of possible alternatives to BPA in medical devices taking into consideration important ecological and 23 on both bisphenol S and bisphenol F toxicity. One were printed in the previous edition of Non-toxic HCWH Europe’s factsheet PVC/DEHP phase-out is social aspects and giving priority to products that 76 common conclusion from all the reviews is that Healthcare report . These have been moved to the possible anywhere in Europe: Model hospitals show are considered more sustainable. Medical gloves because BPA is used ubiquitously, there is no sin- Safer Medical Devices Database (safermedicaldevi- how to succeed, shows that already in 2007, hos- are a product’s group completely PVC-free now. gle replacement for all industrial solutions. Known ces.org) with the intention to keep them updated as pitals across Europe (Austria, Denmark, Sweden, HUS aims to radically reduce the use of PVC in all alternatives to BPA or to the plastic polymer con- and when appropriate evidence becomes available. Czech Republic, Slovakia, France, Italy, the Nether- product groups by the end of 2020, where replace- lands) were phasing out PVC medical devices in or- ment is possible, particularly medical tubing, which der to protect patients from DEHP and other alter- conventionally contains PVC.95 PVC-free tubing has 92 native plasticisers. already been requested in procurement specifica- In 2008, HCWH published a report with information, tions.96 examples, and guidance for healthcare facilities to improve their purchasing decisions regarding che- micals – Guide to Choosing Safer Products and Chemi- How hospital districts in Finland are ta- cals: Implementing Chemicals Policy in Health Care.93 king steps to reduce the use of PVC In 2018, HCWH Europe published Guidelines for the KEINO Competence Centre for sustainable and 94 procurement of safer medical devices. innovative public procurement (https://www.han- In the 2014 edition of this report, HCWH Europe kintakeino.fi/en) and HUS invited hospital districts collated information on best practices in Euro- to a meeting in March 2019, to create a vision of a pean hospitals and approaches towards non-toxic responsible procurement.97 98 During this meeting, healthcare (HCWH 2014). Initiatives taken by the hospitals presented a range of different sustainable Hospital of Southern Jutland (Denmark), Stockholm procurement objectives. Among these, the reduc- County Council (Sweden), the Westfriesgasthuis tion of PVC use received a lot of support.98 Hospital (The Netherlands), the Vienna Hospitals Association (Austria) were described. Only new information has been included in 2019 update.
20 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 21 CHAPTER 5
The health impacts of plastics in healthcare risation or recycling). Additives can also be used for Table 2. specific properties defining their application (e.g. 110 115 The increased global focus on plastics can be ex- General background hardness, softness, resistance to ultraviolet light, Two main categories of polymers. plained by the growing awareness of the environ- flame formation resistance). A joint project by ECHA mental consequences of plastics production and and the plastics industry listed over 400 functional What are plastics? Thermoplastics Thermosets un- consumption, particularly in relation to plastic was- additives or pigments currently used in plastics, in- can be melted and dergo a chemical te generation. The human dependence on plastics In the EU, plastic is defined as “a material consisting cluding information on the polymers they are most hardened reversibly change during hea- in everyday life is reflected in its ubiquitous presen- of a polymer as defined in point 5 of Article 3 of Re- commonly found in and the typical concentration ting – they cannot ce as litter in the environment. gulation (EC) No 1907/2006, to which additives or ot- ranges.111 be re-melted and her substances may have been added, and which can Plastic pollution has drawn significant attention reformed) function as a main structural component of final pro- from the media, the public, and scientists span- ducts, with the exception of natural polymers that have ning diverse fields, including polymer science, eco- BOX 9 not been chemically modified”.106 Common exam- Common exam- logy, and toxicology. To date the impacts of plastic ples ples have been primarily studied within marine environ- It is important to understand that plastics are not a Main types of plastics ments99, and whilst plastic contamination was first single, specific material, although they are often re- Polyethylene te- Polyurethane (PUR) Oxo-degradable plastics include additives reported on nearly 50 years ago, the United Nati- ferred to as such. Plastics are a large family of che- rephthalate (PET) Epoxy resins which, through oxidation, lead to fragmenta- ons Environment Programme only identified plastic micals, composed of a great variety of materials de- Polypropylene (PP) tion into micro-fragments or to chemical de- Unsaturated poly- 100 signed to meet thousands of very different needs debris in the ocean as an emerging issue in 2011. 106 Polystyrene (PS) ester and applications. Over 5,300 polymer formulations composition. More recently, microplastics in freshwater101 and Polyethylene (PE) Acrylic resins are commercially available107 and more than 4,000 Biodegradable plastics are capable of decom- terrestrial102 environments has been become an known chemicals are associated with plastic packa- posing physically and biologically, ultimately Polyvinyl chloride Silicone emerging concern. There is also a new research ging alone.108 In principle, plastics can be develo- into carbon dioxide (CO ), biomass, and water. (PVC) Vinyl ester exploring the impact of plastics on antimicrobial re- 2 ped with virtually any combination of properties to In accordance with European standards for pa- Fluoropolymers sistance.103 104 accommodate almost any application. Plastics are ckaging, these plastics are recoverable through Single-use plastics and plastic packaging present therefore increasingly being used in diverse appli- composting and anaerobic digestion.106 a substantial part of this problem. Short-term use cations such as packaging, building and construc- Bioplastics: (also known as biopolymers) are with long-term environmental consequences, with tion, mobility and transport, electronics, agriculture, made from renewable plant feedstocks (e.g. Plastic production and pollution most plastic waste currently disposed of in landfills healthcare, sport and leisure, and energy.109 corn, sugar beet, or sugar cane). Bioplastics or incinerated. Plastics and the chemicals used in Plastics are used almost everywhere. It has been Plastics are chains of molecules (monomers) lin- can consist of mixtures including other plas- their manufacture now contaminate our soils, ri- estimated that a total of 8,300 million metric tonnes ked together in chains called polymers. The vast tic(s) and are not necessarily biodegradable; vers, oceans, air, and increasingly our food supply. of virgin plastic has been produced globally so far, majority of plastics are composed of polymers of however, they do generally present a lower 116 This significant societal challenge has stimulated of which only 30% of it is still in use. In 2017, glo- carbon and hydrogen, either alone or with oxy- risk to the environment in comparison to con- research on plastic uses and its impacts on human bal plastic production reached 348 million tonnes, gen, nitrogen, chlorine, fluorine or sulphur.110 Tho- ventional plastic.105 Polylactic acid (PLA), plant- health.105 of which 64.4 million tonnes was in Europe (EU28, se polymers follow a different production process derived polyethylene terephthalate (PET), and Norway, and Switzerland). Packaging and building/ This chapter discusses the state of understanding (e.g. condensation and cross-linking), have different polyhydroxyalkanoate (PHA) are all bioplastics. construction accounted for 39.7% and 19.8% of the of medical plastics used in healthcare and their im- chemical structure (e.g. acrylics, polyesters, polyole- Microplastics are not a specific kind of plas- total plastics respectively, whilst 16.7% of the total pact on health. We aim to present a picture about fins, silicones, polyurethanes and halogenated plas- tic but rather any type of plastic solid partic- plastics produced in 2017 were used to produce how plastics are being used in healthcare and the tics), and all have different properties, which make le smaller than 5mm112. Particles smaller than medical equipment together with other non-medi- effects of plastics on human health, from produc- it impractical for different polymers to be recycled 0.1mm are defined as nanoplastics113. Primary cal uses, such as furniture and technical parts used tion through to end-of-life. We also ask whether it together. Generally speaking, plastics can be divi- microplastics are materials deliberately desig- for mechanical engineering.115 is possible to reduce plastic use and plastic waste ded into four key groups: oxo-degradable plastics, ned and manufactured to be of small size (e.g. in the healthcare sector and what healthcare insti- High production volumes of plastic and high de- biodegradable plastics, bioplastics, and microplas- cosmetic microbeads), while secondary micro- tutions are doing to address this emerging global mand have led to the global problem of plastic pol- tics (see Box 9). In addition, two main categories of plastics are unintentionally formed through challenge. lution in the environment. In 2015, there was 6,300 polymers can be clearly distinguished: thermoplas- the wear and tear of larger pieces of plastic, million metric tonnes of plastic waste produced, of tics and thermosets (see Table 2). including synthetic textiles, that have undergo- which only 9% was recycled.116 With regards to plas- Plastics can contain various additives to improve ne fragmentation and weathering, during their tic packaging, 95% of material value is estimated to 114 their behaviour during manufacturing (lubricants, use or disposition in the environment. be lost (not recycled).117 Globally, plastic production catalysts, stabilisers, solvents, and aids for polyme- and plastic incineration is estimated to produce 400
22 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 23 118 125 126 133 million tonnes of CO2 a year. In Europe, 41.6% of partners , and Adelphi. and 70% by 2030. textiles for example can contain flame-retardants, collected plastic (27.1 million tonnes) is used for The United Nations Environment Programme’s Glo- EU Directive (2019/904) on the reduction of the impact plasticisers, coatings, modifiers, catalysts, and other 115 energy recovery whilst 27.3% ends up in landfill. bal Plastic Platform, launched in September 2018, of certain plastic products on the environment performance enhancing additives and residuals. The remaining 31.1% of plastic waste is recycled When recycled into new products, the output tends seeks to reduce plastic pollution through new com- In June 2019, the European Commission adopted with 63% of recycling occurring in the EU.115 to be non-homogeneous and highly contaminated, mitments. The network also promotes the transi- a Directive on the reduction of the impact of cer- and therefore not suitable for use in toys, food con- It is important to recognise that the global trade in tion to a circular economy in which design, pro- tain plastic products on the environment.134 The tact materials, and other applications.138 waste plastics has seen the movement of significant duction, consumption and disposal of plastics are Directive lays down market restrictions of single- 127 volumes of plastic waste from developed countries taken into account. use plastic products, as well oxo-degradable plastic Voluntary actions from the European plastics in- to developing countries, where environmentally un- In October 2018, the New Plastics Economy Glo- products, including cotton bud sticks, straws, and dustry also focus only on recycling and reusing of 139 sound recycling and disposal practices can exacer- bal Commitment was launched, led by the Ellen food and beverage containers made of expanded plastics. Whilst important components of working bate exposure to toxic compounds. China’s decisi- MacArthur Foundation128. As of 2019 this has over polystyrene. towards a circular economy, other aspects, such as on to ban the import of contaminated plastic waste reduction of plastics use (and single-use plastic in 400 signatories including businesses and govern- Restriction under consideration: Microplastics is predicted to result in the displacement of 111 ments.129 particular), and ‘detoxification’ of plastics need to million metric tonnes of plastic waste by 2030.119 ECHA has prepared an Annex XV restriction re- be addressed as well. The World Economic Forum (WEF) also launched a port135 on the use of intentionally added microplas- In 2019, human exposure to persistent organic The Alliance to End Plastic Waste (AEPW), compri- platform in 2018 for public-private actions towards tic particles in consumer or professional use pro- pollutants due to poor management of imported 130 sing over 35 global companies from different parts a circular economy , which includes plastics. The ducts.136 The public consultation on microplastics plastics was noted in Ghana with sampling at a ‘re- of the plastics value chain, has a mission is to “elimi- partnership’s ambition is to prevent plastic pollu- ran until 20 September 2019.137 cycling site’ revealing some of the highest levels of 140 tion reaching the sea by 2025.130 nate plastic waste in the environment”. Crucially, 120 dioxins ever recorded. however, the reduction of single-use plastic is not As China reduced imports of nearly a million tons Plastics can enter marine, freshwater, and terres- Industry initiatives to be found in the AEPW plans. of mixed plastic waste in 2018, waste-exporting na- trial environments, reaching air, soils, rivers and tions turned to South East Asian countries, which The Circular Plastics Alliance was launched in De- lakes.105 It has been estimated that there are 5.25 Globally, industry efforts are only focussing on end- soon became overwhelmed. In May 2019, world go- cember 2018, bringing together public and private trillion particles of plastics in the oceans globally, of-life plastics, increasing the use of recycled con- vernments supported developing countries to refu- stakeholders from the plastics value chain. The all- weighing 268,940 tonnes.121 Of the plastic debris tent with the intention of keeping materials in the se toxic mixed plastic waste shipments through the iance’s target is to annually re-use 10 million tonnes detected in the western North Pacific Ocean 89% value chain longer. In practice, this means that ma- UN Basel Convention.131 The majority of the world’s of recycled plastics in products and packaging by 122 terials are being recycled that were never optimised came from single-use plastic items. In the EU, 80- 2025.141 The declaration of the alliance was adop- governments created new regulations requiring for human and environmental health.138 Polymeric 85% of marine litter plastic, half of which is single- ted on 20 September 2019, with more than 100 waste exporters to declare the content of mixed materials such as foam, plastic food packaging and use plastic. Within the EU, 75,000 – 300,000 tonnes 141 waste shipments and enable receiving countries to signatories. of microplastics end up in the environment annual- refuse plastic waste imports. ly118, and a 2019 study suggested that atmospheric transportation and deposition of microplastics is contributing to the contamination.123 The European legal framework Single-use plastics are a growing problem, yet whilst The European Strategy for Plastics in a Circular Eco- biodegradable and compostable plastics were de- nomy signed as a potential solution, these plastics also In December 2015, the European Commission ad- pose problems to ecosystems.124 opted an EU action plan for the Circular Economy Despite the fact that huge amounts of polymers are and identified plastics as a priority area. The action produced, imported, and used in Europe and there plan stated that plastic recycling is necessary in a is wide expose, companies currently have no ob- circular economy.132 ligation to register these chemicals and therefore In January 2018, the European Commission relea- provide information on their health and environ- sed the European Strategy for Plastics in a Circular mental hazards. At the time of the REACH regula- Economy118, which lays out the vision for Europe’s tion’s adoption in 2007, polymers were considered new plastics economy. Under the strategy key play- to be less hazardous than monomers and were ers should improve the design of plastic products therefore exempted. so that at least 50% of plastic waste is recycled by 2030. Global initiatives related to mitigation of Modernising and developing markets for recycled plastics impact on the environment products should also be addressed.124 As the global use of plastics rises, so too do initia- EU Directive (2018/852) on packaging and packaging tives to mitigate the environmental and health im- waste pacts of plastics. Global conventions to tackle plas- In July 2018, the revised legislative framework on tic pollution have been suggested by the Center for waste entered into force setting recycling rate tar- International Environmental Law (CIEL) and their gets for plastic in packaging waste: 65% by 2025
24 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 25 Impact of plastics on human health intermediates, solvents, surfactants, plasticizers, Findings showed that143: pendent on size, associated chemicals, and dose. stabilizers, biocides, flame-retardants, accelerators, As with the previous study, recommendations for l 74% of the plastic extracts contained chemicals The presence of toxic or potentially toxic substan- and colorants, among other functions.142 future research are provided.146 In general, micro- triggering at least one endpoint relevant for as- ces in plastic products has a negative impact on the plastics to which human are exposed via different Most plastic-associated chemicals are not covalent- sessing health impacts – including baseline to- environment and human health, and affects all pha- routes can potentially cause inflammation, genoto- ly bound to the polymer, so they can be released xicity (62%), oxidative stress (41%), cytotoxicity ses of the life cycle of plastic products. Persistent xicity, oxidative stress and cell necrosis, and over at all stages of the plastics’ lifecycle via migration to (32%), estrogenicity (12%), or antiandrogenicity organic pollutants (POPs) are used as additives in time, these effects could also lead to tissue dama- 138 liquids or solids or via volatilisation. This can result (27%). a large volume of plastic polymers. Short Chain 105 in a transfer of chemicals from products/packaging ge, fibrosis, and cancer. Chlorinated Paraffins (SCCPs) used in PVC and ethy- l to consumer e.g. via food. A recent comprehensive Plastics contain large mixtures of chemicals A 2019 report by Science Advice for Policy by Euro- lene-vinyl acetate (EVA), for example, have already scientific study on the toxicity of chemicals present – many of those are unknown and difficult to pean Academies: Scientific Perspective on Microplas- been listed under the Stockholm Convention. Seve- in plastic products confirmed toxicity of complex identify. tics in Nature and Society113 and the report from the ral other chemicals (e.g., cadmium, lead, polycyclic chemical content.143 Researchers analysed 34 wide- l Out of 260 chemicals tentatively identified (in- World Health Organization Microplastics in drinking aromatic hydrocarbons) are also used as additives ly used consumer products made from plastics, in- cluding monomers, additives, and non-inten- water114 concluded that, based on the information or found as contaminants in plastics. cluding products coming in contact with food such tionally added substances,) 27 of were priori- currently available, there are no emerging health Evidence concerning the health risks posed by plas- as refillable water bottles and food wraps. This ana- tised based on high in vitro toxicity, including concerns relating to microplastics. However, both tics is mounting. It is important to recognise that lysis covers eight major polymer types: polyvinyl well-known additives such as benzophenones, reports outline that further research is needed. plastics can cause risks to human health during chloride (PVC), polyurethane (PUR), polyethylene butylated hydroxytoluene or triethyl phospha- Particularly worrying is fact that that plastic par- their whole lifecycle, through the different expo- terephthalate (PET), polystyrene (PS), Polypropyle- te, as well as less known isomers such as deca- ticles and plastic associated chemicals are found sure routes: inhalation, ingestion, and contact with ne (PP), high-density polyethylene (HDPE), low-den- noic acid. almost in every human studied. Recent reports skin. Challenges of the life cycle management of sity polyethylene (LDPE) and polylactic acid (PLA). suggest that microplastics are entering the human plastics and their impact on health have been re- l Extracts of polyvinyl chloride (PVC) and poly- Researchers found toxic compounds in a majority body through drinking water, food, and air. A 2018 cently addressed in detail by Center for Internatio- urethane (PUR) were observed to induce the of the plastic extracts and proposed a prioritisation study from the Medical University of Vienna and the 105 highest toxicity at most endpoints from the nal Environmental Law. of chemicals entering into their composition accor- eight polymer types investigated. Environment Agency of Austria analysed stool sam- Human exposure during the extraction and trans- ding to their toxicity. ples from participants across eight countries and portation of fossil feedstock required for producing l All “bioplastics” made of polylactic acid (PLA) found microplastics and up to nine different types plastic can be linked to cancer, neurotoxicity, and were also observed to be of toxicity levels simi- of plastic resins in every sample tested.147 reproductive and developmental toxicity. During The review of known plastic-associated lar to that of PVC and PUR. 142 Another study showed alarming levels of plastic in the refinement and production of plastic resins and chemicals and their hazard concluded that: l The toxicities of low-density polyethylene children's bodies. According to a study by the Ger- additives, impairment of the nervous system, leuk- (LDPE), polystyrene (PS), and polypropylene man Environment Ministry and the Robert Koch aemia, and low birth weight have been reported. In- (PP) varied depending on the endpoint measu- Institute, plastic by-products were found in 97% of cineration, co-incineration, gasification, and pyroly- red. blood and urine samples from 2,500 children tes- sis cause toxic chemicals to be released into the air, 63 rank highest for human health hazards ted between 2014 and 2017.148 Younger children water, and soils. These releases can cause cancers, Compared with chemicals used in plastics, even were reported to be the most affected by plastic in- as well as neurological and immune damage. Du- less is known about the toxic effects of plastic par- gestion. The study has not yet been published, and ring use, consumers can ingest and inhale micro- 68 rank highest for environmental hazards according 144 ticles in the human body. A scientific literature the results were made available by the government plastics together with other toxic substances (such to the harmonised hazard classifications assigned by review on health impacts and human exposure to upon request by a Green Party inquiry into the ef- as additives), which can potentially cause cancers, the European Chemicals Agency within the Classification, plastic through diet and inhalation revealed that fects of chemicals on public health.148 diabetes, and developmental toxicity.105 Labelling and Packaging (CLP) microplastics might accumulate and exert localised It should be broadly understood that toxic additives The review of known plastic-associated chemicals particle toxicity by inducing or enhancing an immu- need to be substituted with non-chemical alterna- and their hazards concluded that of the 906 chemi- ne response.145 If inhaled or ingested, chemical to- tives or non-toxic substances to reduce human ex- cals likely associated with plastic packaging, 63 rank 7 of the 906 substances are classified in the xicity could occur due to the localised leaching of posure, as well as to make recycling easier.138 highest for human health hazards and 68 for en- European Union as persistent, bioaccumulative, component monomers, endogenous additives, and vironmental hazards according to the harmonised and toxic (PBT), or very persistent, very bioaccu- adsorbed environmental pollutants. Currently ZonMw, the Netherlands Organisation mulative (vPvB) for Health Research and Development, coordinates hazard classifications assigned by the European Chronic exposure is anticipated to be of greater 15 short-term projects investigating the effects of Chemicals Agency within the Classification, Label- concern due to the accumulative effect that could 142 micro- and nanoplastics on human health, and fo- ling and Packaging (CLP). Further, 7 of the 906 occur. This is expected to be dose-dependent but a 15 substances are classified as endocrine dis- cusing in particular on uptake via ingestion and in- substances are classified in the European Union as robust evidence-base of exposure levels is current- rupting chemicals (EDC). halation and effects of, potential translocation to persistent, bioaccumulative, and toxic (PBT), or very ly lacking.145 A literature review by Smith et al. (2018) brain and placenta, and potential effects on immu- persistent, very bioaccumulative (vPvB), and 15 as focused on exposure to microplastics through ne system.149 endocrine disrupting chemicals (EDC). Of the 906 seafood and the potential implications for human chemicals, 34 are also recognised as EDC or poten- 34 substances are recognized as EDC or potential EDC in health. The authors concluded that the toxicity as- tial EDC in the recent EDC report by the United Nati- the recent EDC report by the United Nations Environment sociated with consuming microplastics is likely de- ons Environment Programme. The identified hazar- Programme dous chemicals are used in plastics as monomers,
906 chemicals likely associated with plastic packaging 200 300
26 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 27 Plastics in healthcare - Modern healthcare uses many plastic-based me- plastics recyclers and processors about the com- plasticisers, flame retardants, stabilisers, antioxi- dical products to provide high quality treatments mon streams of plastic waste (see Box 10) generated dants – for examples see Box 11). Unfortunately, Medical plastics and solutions. However, this exerts pressure on en- in clinical settings.155 due to a lack of full transparency in the supply chain The market in plastic medical devices and pharma- vironment throughout the supply chain, which in- and incompleteness of publicly available informa- ceutical packaging continues to grow. A key bene- cludes plastic packaging, single-use products made tion on both the use and amount of numerous sub- fit in medicine and public health is the versatility of different (often mixed) plastics and materials fre- stances in medical plastics, our knowledge is cur- of these materials which, when combined with an quently containing hazardous chemicals. Plastics BOX 10 rently limited. extremely low cost, has enabled the mass produc- used in healthcare therefore pose a direct risk to While hazard, exposure and epidemiological data patients and staff, and produces a significant volu- tion of disposable single-use health care products The most common recyclable health- on a small number of prominent plastic-associated me of waste, which contributes to wider environ- that are both functional and hygienic. The industry care plastic waste streams155: chemicals such as DEHP and BPA is abundant and points out that modern healthcare would be im- mental harm. growing, it remains challenging to form a true as- possible without many plastic-based medical pro- There has been a gradual transformation from re- l Polypropylene (PP) (product: sterilisation sessment of the chemical safety of medical plastics, ducts.150 151 useable non-plastic to disposable plastic products wraps which are used for surgical instru- despite this being an important source of patient Fibres and resins used in medical applications in- in healthcare over the last 30 years, with most com- ments to prevent contamination) exposure. At the same time, the breadth of re- mon arguments for this transition being an increa- search identifying negative human health impacts clude polyvinyl chloride (PVC), polypropylene (PP), l Homo-polymer PP (product: containers polyethylene (PE), polystyrene (PS) as well as nylon, sed focus on infection prevention and control and of many of the plastic additives present in widely 152 such as pitchers, basins, and cups) polyethylene terephthalate (PET), polyamide (PA), cost effectiveness. It remains unclear whether used consumer products is conclusive that there polycarbonate (PC), acrylonitrile butadiene (ABS), what is required is more effective sterilisation pro- l Polypropylene (PP) or high-density poly- polyetheretherketone (PEEK) and polyurethane cedures, rather than disposable equipment. Use of ethylene (HDPE) (product: irrigation bott- (PU). The most widely used plastic material in me- re-useable devices can often reduce costs in the les) long run, as well as reducing packaging and clinical BOX 11 dical applications is PVC followed by PE, PP, PS and l Polyethylene terephthalate glycol (PETG) waste.152 Further evidence in the form of whole-li- PET. PVC is most widely used in pre-sterilised sing- or high impact polystyrene (HIPS) (pro- 151 fe costing calculations undertaken during procure- Some examples of devices / additives le-use medical applications. duct: trays) ment exercises is required. used in healthcare Traditionally, metals, glass and ceramics were used In the study of Minoglou et al. (2017)153 healthcare l Low-density polyethylene (LDPE) or high- for medical implants, devices and supports. Ho- 51 density polyethylene (HDPE) (product: fle- l PVC medical devices/ Plasticisers: DEHP wever, polymers are often better suited to certain waste generation rates (kg/bed/day) of some Euro- xibles such as Non-Woven and Film Plas- applications as they offer lighter weight and bet- pean countries are presented: Latvia: 1.18, Nether- l PVC medical devices/ Alternative plasti- tics) ter biocompatibility. Plastics are for example key lands: 1.7, Bulgaria: 2, France and UK: 3.3, Germany cisers (APs): TOTM, DEHT, DINCH, DEHA, 51 components of modern prosthetic devices offering and Greece: 3.6, Norway: 3.9, Italy: 4, and Spain: 4.4. ATBC, DiDP, DiNP, and DPHP Overall, plastic waste generation in the EU in 2016 greater flexibility, comfort and trouble-free mobility. l Continuous venovenous hemofiltration reached 17,590,000 tonnes, and healthcare and Plastic packaging, with its excellent barrier proper- (CVVH) and extracorporeal membrane biological waste generation was 2,020,000 tonnes.iiv ties, lightweight, low cost, durability, and transparen- oxygenation (ECMO) medical devices/ cy, is particularly suitable for medical applications. Plastic use and waste disposal varies across he- Impacts of medical plastics Phosphate flame retardants (PFRs)159 althcare providers in Europe and there is a lack of Today, medical plastics are everywhere, from exa- In the previous chapters of this report, the focus l Linear polyethylene surgical sutures/ Co- mination gloves to sterile syringes and IV tubes or precise data showing the extent of medical and non- medical plastics use and volumes of waste. Where has been on plastic medical devices containing lour additive: Chromium-cobalt-alumini- heart valves. There is also an array of plastic dispo- 160 evidence has been gathered, the need for transfor- phthalates and BPA and the possible risks they um oxide sable medical products in use, including bed pans, pose to patients during medical treatments. This mative action is clear. The UK’s National Health Ser- l Polypropylene sutures, Polybutester sutu- insulin pens, IV tubes, tube fittings, plastic cups and chapter outlines how toxic chemicals are genera- vice, for example, recovers only about 5% of plastic res, Polybutylene terephthalate sutures/ pitchers, eye patches, surgical and examination glo- ted throughout the lifecycle of plastic medical pro- waste and pays to dispose of 133,000 tonnes of plas- Colour additive: [Phthalocyaninato(2-)] ves, inflatable splints, inhalation masks, tubing for ducts, for example, dioxins generated during PVC dialysis, disposable gowns, wipes and droppers, uri- tic each year, significantly contributing to its £700m copper160 annual waste disposal bill.154 Whilst general public production and disposal, which can also pose a risk ne continence and ostomy products. l Medical devices of different types: Fil- awareness of plastics’ harmful impacts is increasing to human health. Importantly, innovations in plastics are making lers, Reinforcement, Composites; Release in Europe, the healthcare sector is largely unaware Although beyond the scope of this report, it is im- more and more new procedures possible. Plastics Agents; Slip Additives/Internal Lubricants; of the impacts from its own plastic consumption and portant to emphasise that the use of plastics in he- are now being used as orthopaedic devices, whe- Catalysts; Impact Modifiers and Toughe- how to go about reducing this. Recent studies have althcare is not limited to medical devices and other re they align, support or correct deformities. Thin ners; Radiation Stabilizers; Optical Bright- challenged received wisdom concerning the use of medical products. Electronics, upholstered furnitu- tubes called catheters are used to unblock blood eners; Pigments, Extenders, Dyes, Mica; single-use plastics in infection prevention and cont- re, cups and cutlery used in the staff canteen, and vessels. Synthetic material also plays a vital role for Coupling Agents; Thermal Stabilizers; and rol, and demonstrate the potential to reduce, reuse, PVC coverings in hospitals are entirely or partially 161 diseased arteries that cannot be helped via vessel 156 157 158 Antistats and recycle at a much higher rate.152 made from plastic materials. support, whereby the affected section of the aorta Medical plastics comprise a diverse and heteroge- l Medical devices and medical textiles whe- is removed and the gap bridged by a flexible plas- The Healthcare Plastics Recycling Council has pre- neous group of polymers and each product has an re PTFE is used: PFOA as impurity from tic prosthesis. Artificial corneas made from special pared a guidance document to inform and educate individual and complex chemical composition (i.e. manufacturing162 silicone, flexible and made of biomechanics similar iv Eurostat. (2019) https://ec.europa.eu/eurostat/home? 151 one or more polymers, multiple additives such as to a natural cornea can restore clear vision again.
28 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 29 are significant risks to human health and a precau- ly set the provisional tolerable weekly intakes for tionary approach is warranted.105 ê PFOA at 6 nanograms (ng) per kilogram of body This section describes emerging groups of chemi- Convention, a treaty to control and phase out BOX 13 weight, lowering it from 1,500 ng daily – a clear cals used in plastic production due to their known major persistent organic pollutants (POPs). acknowledgement that these chemicals are much impacts on human health. It deals with groups of Examples of healthcare applications more damaging to human health than previously chemicals rather than individual substances, in or- Flame-retardants of PFAS162 165 167 168 thought. A large portion of the EU population alrea- 172 der to focus on the reduction in the use of entire dy exceeds these new safety levels. Polybrominated diphenyl ethers (PBDEs) are classes rather than the phasing out of individual l Dental restorative material organobromine compounds that are used as problematic chemicals one at a time. Such an ap- Flame-retardants flame-retardants. They are structurally similar l Medical devices (e.g. sensors, cardiovascu- proach helps develop coordinated strategies for to the PCBs and other polyhalogenated com- lar devices, vascular catheters, protection reducing the production and use of chemicals of There are many different types of flame retar- pounds, consisting of two halogenated aro- tubing, implants and orthopaedic devices) concern and prevents regrettable substitutions. dants, which are used to protect products from matic rings. PBDEs are classified according to l Invasive medical devices (e.g. guide wires, burning. In the healthcare sector, polybrominated the average number of bromine atoms in the balloon catheters and introducer sheets) diphenylethers (PBDEs) are used most frequently; molecule. Since the 1990s, environmental con- their chlorine analogs are polychlorinated diphe- l Radiopaque catheters (e.g. catheters for cerns were raised because of the high hydro- nyl ethers (PCDEs). Halogenated phosphate flame angiography and indwelling needle cathe- BOX 12 phobicity of PBDEs and their high resistance retardants were reported in some applications as ters) to degradation processes. Swedish scientists well. The PBDEs family contains 209 substances, Perflourinated chemicals first reported substances related to pentaBDE l Medical textiles (e.g. surgical gowns and which are termed congeners. Each is a mixture of were accumulating in human breast milk.163 drapes, masks and caps, medical implants, brominated substances.176 Because of their toxicity Per- and polyfluoroalkyl substances (PFAS) are Halogenated phosphate flame retardant, Tris surgical patches) and persistence, the industrial production of some a group of man-made chemicals that includes (1,3-dichloro-2-propyl) Phosphate (TDCPP) and PBDEs (decaBDE, hexaBDE, heptaBDE, tetraBDE, PFOA, PFOS, GenX, and many other chemicals. its blends are used as flame-retardants in the pentaBDE,) is restricted under the Stockholm Con- PFAS have been manufactured and used in a manufacture of polyurethane foam. vention).177 178 179 variety of industries around the globe, inclu- ding in the United States since the 1940s. The Exposure to PFASs has been associated with hepa- To date, PBDEs impacts on human health is limi- widespread use of PFAS and their ability to tic, cardiovascular, endocrine, immune, reproducti- ted, as most studies have been conducted on an- 176 remain intact in the environment means that ve, and developmental effects.169 One recent study imals. The impact of PBDEs on developing ner- over time PFAS levels from past and current showed that exposure to eight PFAS compounds vous and reproductive system, developing and Perfluoroalkyl and polyfluoroalkyl mature endocrine system, and the liver and the uses can result in increasing levels of environ- substances (PFAS) was associated with altered kidney and thyroid mental contamination. functioning.170 The most known PFASs are perfluo- male reproductive system, have raised concerns 176 PFASs contain a wide group of substances164 of in animal studies. PBDEs have been shown to PFOA and PFOS have been the most extensi- rooctanoic acid (PFOA) and perfluorooctanesulfo- which a significant amount have no CAS number nic acid (PFOS), extremely persistent (also called have hormone-disrupting effects, in particular, on vely produced and studied of these chemicals. 180 (the unique reference number that allows chemical oestrogen and thyroid hormones. The studies Both chemicals are persistent, bioaccumulati- ‘forever chemicals’) and toxic chemicals that beca- substances to be identified).165 It has been estima- 171 have shown that even a single dose administered ve, and toxic substances (PBT). Due to these me also global contaminants. PFOS, PFOA and ted that there are nearly 5,000 types of PFAS in the to rat during development of the brain can cause properties it may cause severe and irreversi- related substances are included in the Stockholm global market with plenty different applications.166 Convention. permanent changes in behaviour of offspring and ble adverse effects on the environment and 181 Unfortunately, applications within the healthcare permanently impaired spermatogenesis. human health. PFOA and a number of PFOA- A considerable number of adverse health effects sector are much less well known (see Box 13).165 The health hazards of PBDEs have attracted in- related substances are found throughout the have been linked with PFOA exposure in humans: in- creasing scrutiny, and have been shown to reduce environment, including remote areas, since creased cholesterol levels, ulcerative colitis, thyroid fertility in humans at levels found in typical house- they can be transported over long distances disease, cancers, pregnancy-induced hypertension, holds.182 The studies in humans found effects of via water and air. Based on their PBT and CMR and reduced birth weight.172 Strong evidence has (PBDEs) on thyroid regulation during pregnancy183, properties, PFOA and its salt (APFO) have been been found in toxicology and epidemiology studies neurodevelopment effects184, and behavioural de- identified as substances of very high concern that humans exposed to PFOA and PFOS are at risk velopment in children.185 Moreover, it has been re- (SVHC) under REACH. Certain PFAS chemicals for immunosuppression.173 A literature review sum- ported that memory domains in early adolescence are no longer manufactured in the United marised the epidemiological evidence for the influ- can be affected following prenatal and postnatal States as a result of phase-outs including the ence that pre- and postnatal exposures to PFASs exposure to PBDEs.186 Some epidemiological re- PFOA Stewardship Program in which eight ma- may have on health outcomes in offspring, with a sults indicate that PBDEs could act as developmen- jor chemical manufacturers agreed to elimina- particular focus on birth outcomes and postnatal tal neurotoxicants.187 In general, more research, te the use of PFOA and PFOA-related chemi- growth, immunomodulatory effects and neurode- in particular epidemiology studies, is needed to cals in their products and as emissions from velopment.174 Studies on health impacts in children obtain greater support for associations between their facilities. Currently, the use of both PFOS found associations with PFAS exposure and dysli- PBDEs and certain health impacts in humans. and PFOA is restricted under the Stockholm pidemia, vaccine response asthma, renal function, and the onset of menstruation.175 Recently, the phosphate flame retardant (PFR) me- ê The European Food Safety Agency (EFSA) recent- tabolites were found in urine samples from patients
30 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 31 in intensive care unit (ICU): 4-hydroxyphenyl phenyl At the outset, the difficulties in sorting plastics were facilities recycle the HALYARD* Sterilization Wrap PVCMed Alliance (The European Council of Vinyl phosphate (4-HO-DPHP), 4-hydroxyphenyl diphenyl related to insufficient or unclear labelling on packa- used in operating rooms. The wrap consists of poly- Manufacturers) describes challenges and oppor- phosphate (4-HO-TPHP), bis(2-butoxyethyl) phos- ging.190 The plastics are currently sorted into three propylene fabric, which is recyclable. In North Ame- tunities of PVC plastic recycling in hospitals.198 PVC phate (BBOEP), and bis(2-butoxyethyl) 30-hydroxy- containers depending on the following plastic ty- rica there are now nearly 300 healthcare facilities, Recycling in Hospitals estimates that PVC-based 2-butoxyethyl phosphate (3-HO-TBOEP).159 Overall, pes: PET-plastic 01, PE-LD-plastic 04, PE-HD-plastic which together prevent 4 million pounds of wrap medical products are estimated to represent about the levels of the metabolites were higher in urine 02 and PP-plastic 05. ending up in landfills.196 one-quarter of all plastic waste.199 PVCMed states samples from intensive care unit (ICU) patients In Australia and New Zealand, Kimberley-Clark has that medical-grade PVC is a high-quality compound in comparison to urine samples from the control University Hospital of Leuven (UZ Leuven, initiated a KIMGUARD* Sterile Wrap recycling pro- that can be recycled into many new soft PVC appli- group.159 The results of this study are preliminary Belgium) gram together with SITA-MediCollect. Used, clean, cations, however, the presence of DEHP plasticiser (there are no previous studies), but as the highest may compromise recycling. This will become less of Every year Belgian hospitals throw away millions and uncontaminated KIMGUARD* Sterile Wrap PFRs levels were found in patients that were in con- an issue as the use of DEHP is phased out. Current- of baby feeding bottles after a single use, creating products are collected by SITA MediCollect, which tact with continuous venovenous hemofiltration ly, in the UK, more than 10 hospitals are part of the more than 300 tonnes of high-quality plastic ma- recycles the products into polypropylene pellets. (CVVH) and extracorporeal membrane oxygenation RecoMed scheme200, funded by the European PVC terial which are then incinerated. Sirris, a Belgian These pellets are then used to make buckets, rain (ECMO), this study could suggest that PFRs are ori- 197 industry’s sustainable development programme Vi- non-profit organisation, together with a working drains and corrugated packaging. ginating from indwelling medical devices used in nylPlus®.201 group of interested parties, started the 'Baby Bottle the ICU.159 Further research into the possible toxic Reborn' pilot project in 2013 at the University Hos- effects of these chemicals released from medical pital of Leuven (UZ Leuven).191 The project aimed devices is urgently needed. to recycle this material stream by identifying and solving the legal, technical and logistical obstacles Case studies of plastic waste in the way. The result is that the disposable bottles are now sorted at the hospital before being recyc- management in European led into new raw materials. From the experiences hospitals gathered in this project, it is hoped that the project can be rolled out to other hospitals.192 The following examples describe initiatives already being undertaken to address many plastic material Onze Lieve Vrouwe Gasthuis Hospital in Ams- streams in European healthcare providers. terdam (OLVG, The Netherlands)
Aarhus University Hospital (Denmark) An analysis of the plastic waste stream from OVLG hospital in Amsterdam was conducted by the social Aarhus University Hospital (AUH) is investigating enterprise, Circle Economy193 as part of the Dutch new approaches to manage plastic packaging was- Ministry of Infrastructure and Environment’s Ne- te through increased recycling and circular econo- derland Circulair initiative.194 The analysis of nine 188 my of plastic packaging. Through collaboration bags from OVLG’s operating room was performed, with industry, focus is put on the development and and concluded that disposables packaging makes testing of a value chain model for the creation of up over 50% of plastic waste, and is composed of environmental and commercial values out of hospi- nearly 15 different types of plastic materials.195 The 188 189 tal plastic packaging waste. Preliminary recom- largest estimated plastic type used in disposables 188 mendations are as follows : reduce the number packaging based on weight were Polypropylene of polymers; prioritise use of recyclable polymers, (PP), followed by Polyethylene Terephthalate (PET), and consider recycling of resources in the design Mixed High Density Polyethylene (HDPE) with Coa- of packaging. ted Medical Grade Paper, and Polyvinyl chloride (PVC).195 In addition, 45% of plastic products were Helsinki University Hospital (HUS, Finland) not labelled and nearly 20% of the plastic waste In 2018, waste prevention was addressed in a new was composed of mixed materials either (different group of HUS called Ekologinen ATeK. This group is kinds of plastic or plastic combined with other ma- working towards an operating room model, which terials such as paper and aluminium).195 is as environmentally sustainable as possible, in dif- 96 ferent areas of activity. Initiatives from the medical In a press release in June 2019190, HUS highlighted that most of its plastic waste originates from ope- devices industry rating rooms dealing with musculoskeletal surgery. Halyard Health has developed a BLUE RENEW* This is because all of the equipment used is packa- Sterilization Wrap Recycling Program. The program ged separately (including individual screws). started in 2010 with the aim of helping healthcare
32 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 33 The way forward / The urgency is also important in order to encourage a circular veraging its combined purchasing power. Through l Focus on quick-win substitutions. For example, economy; to reduce the risk to primary consumers’ strategic partnerships and collective action, Euro- phase-out non-medical single-use plastics and to act on plastics health in the first instance, but also and to avoid pean healthcare can stimulate adoption and de- substitute harmful medical plastics with exis- “Use of plastic goods in the healthcare sector has beco- the presence of banned toxic chemicals in products velopment of new products and packaging and lead ting safer alternatives. made from of recycled materials, thereby reducing us out of the current plastics crisis. me ‘epidemic’ and most of it is being used in the name l Facilitate dialogue between manufacturers, secondary risk to human health and the environ- of low cost and patient safety”.152 Awareness about actions to eliminate harmful plas- suppliers, procurement specialists, clinicians ment. Plastics, plasticisers, and other additives to poly- tics must be raised within the healthcare sector, and recyclers to assess the full scope of oppor- mers are ubiquitous in modern society, however, The success of the plastics circular economy in Eu- highlighting that a high level of patient care and sa- tunity across the value chain in healthcare. rope does not rely on recycling and reuse only and fety can be maintained. Furthermore, as some of their increasing use causes environmental harm l Establish an overarching strategy for plastics and poses a clear and defined risk to human health. there is a need to reduce the unnecessary use of the most highly trusted figures in society, healthca- plastics, particularly in healthcare. A growing num- re professionals have the capacity and moral obli- substitution and reduction using the 5 Rs con- In the healthcare sector, plastics are used in medi- ber of hospitals and healthcare providers are ma- gation to educate the communities they serve and cept (reduce, replace, reuse, recycle, rethink). cal devices and other medical applications because king efforts to reduce single-use and non-essential trigger widespread beneficial behaviour changes in l Identify how plastics reduction in healthcare they fulfil number of specific performance and sa- plastics, and increasing recycling wherever possib- plastic use. We recommend the following immedia- can align with work in other sectors and the fety requirements. Unfortunately, certain specialist le. For those medical devices where it is currently te actions for European healthcare providers: broader movement. healthcare devices contain plastics made using essential to use plastics, safer plastics can often be toxic materials, despite the availability of safer al- l Educate staff and patients about environmen- substituted. Elimination of problematic or unneces- ternatives. Further, high volumes of plastic waste, tal and health hazards of plastic usage. sary plastics should happen through design/rede- including single-use products, packaging, and com- sign, innovation, and new delivery models. Proper l Undertake baseline assessments to improve plex plastic composites (often made from toxic ma- diversion and recycling are also crucial for plastics understanding of the scale of plastic use and terials), are generated in healthcare facilities. Due use reduction. In the future, all essential plastics waste. to fear of contamination, recycling of medical de- should be 100% reusable, recyclable, or compost- vices has often been considered a “no-go” option in l Discourage use of plastic-related material un- able. the waste industry.202 less absolutely necessary; encourage the use The European healthcare sector, with 12,990 hos- of reusable instruments and materials hospi- Further work towards phasing out of hazardous pitals and over 2.8 million hospital beds, is a major tals (whilst safeguarding patient care), infor- chemicals and substitution with non-toxic alterna- purchaser of goods and services. The sector, the- med by whole-life costing evaluations. tives should be encouraged and supported, highl- refore, has the potential to drive transformation in ighting that a high level of patient care and safety the production and consumption of plastics by le- must be maintained. Elimination of toxic chemicals
34 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 35 CHAPTER 6
Conclusions and recommendations HCWH Europe’s by a Competent Authority. Information labelled in accordance with the MDR should be publicly availa- Recommendations A number of governments, regulatory authorities, Conclusions ble via the revamped European Database on Medi- cal Devices (EUDAMED), so that procurers, resear- healthcare systems, hospitals, healthcare profes- l Apply the precautionary principle in EU legis- Citizens’ exposure to DEHP and BPA during medical chers and other stakeholders have easy access to sionals and medical devices manufacturers have lation so that hazardous chemicals, such as procedures contributes to a continuous, long-term, data on the devices. Clinical data used to approve endorsed a move towards medical devices that are phthalates and BPA contained in medical de- and low-level exposure to a mixture of different devices should also be made publicly available so free from hazardous chemicals, so that patients vices, are phased-out if safer alternatives are hazardous chemicals, which causes or enhances that healthcare professionals can better evaluate do not have to be exposed to unnecessary risks available and technically feasible. European adverse effects on human health and the environ- the risks and benefits of the medical products and when safer alternatives are available. This is even legislation must protect the safety of patients ment. European manufacturers of medical devices, make informed decisions. more important when patients’ exposure can be and healthcare workers and, in particular, the under some regulatory pressure, have increased minimised without compromising medical care, most vulnerable groups. Improved disclosure of product ingredients would for example by opting for a safer alternative that the development of alternatives to both phthalates allow healthcare professionals to better unders- Consistent technical implementation of Annex performs the same function. The phase-out of and BPA in medical devices. Most medical devices tand where hazardous substances are present and I.II.10.4 of the MDR must be ensured, in particular hazardous chemicals in medical devices is suppor- containing phthalates can be substituted relatively to prioritise their replacement. to protect the most vulnerable groups. The benefit- ted by international and European organisations easily with less hazardous alternatives at an affor- risk assessment of the presence of hazardous che- l Avoid regrettable substitutions. representing more than 500 hospitals, medical dable cost.204 Several companies already manufac- micals in certain medical devices should therefore institutions and healthcare systems and 16 million ture DEHP-free medical devices either by using PVC l Implement data requirements for medical de- be subject to the most stringent conformity assess- healthcare professionals.203 plasticisers other than DEHP or not using PVC ma- vices approval and registration in the EUDA- terial at all. ment procedures by a Notified Body. MED. Since widely available and safer alternative medical Legislation has a crucial double role in both pro- The safety evaluation of medical devices needs to devices exist, we can protect foetuses, neonates, tecting patients and consumers from exposure to be improved. The substitution of a hazardous che- pre-pubescent children, and other vulnerable pa- hazardous chemicals and in sparking innovation. mical with a structurally similar substance to mini- tients from exposure to DEHP by insisting on DEHP- The adoption of progressive legislation can be a mise impact on the manufacturing of the product free, PVC-free and BPA-free products. The use of considerable driver of innovation leading to the de- or with a substance for which toxicity data is not 205 206 DEHP should not be granted to any medical device velopment of safer alternatives. The inclusion available must be avoided.206 of certain phthalates in the Authorisation List un- when safer alternatives are available. The existing data requirements on chemicals used der REACH, for example, has led to an increase in Further development of safer medical devices by in medical devices (for instance the lack of a requi- the number of patented alternatives.207. The MDR’s manufacturers, along with greater demand by ca- rement to provide information about alternatives requirement for manufacturers to provide justifi- regivers and hospitals, could result in a complete used in a device) hamper the development of ade- cation for the use of hazardous chemicals above transition away from DEHP and BPA. quate data on the use, performance and safety of certain thresholds in invasive medical devices, in those alternatives. Furthermore, if a compound has addition to the need for application for authorisa- a history of use, then its on-going use is assured. tion expected in the near future for DEHP, should For example, continued use of DEHP is justified on also ultimately lead to an increase in innovation and the grounds that it has been used for many years substitution in the health technology sector. and that it helps in the treatment of patients, re- l Increase transparency of the market authorisa- gardless of its proven negative health impacts. Bet- tion process for medical devices and improve ter evidence concerning the technical performance the access to the authorisation data on medi- of alternatives is needed to guarantee that safer cal devices. alternatives are adopted. The market authorisation for medical devices needs l Standards, certifications and tools similar to to be improved to ensure that approved medical the EC GPP, the EU Ecolabel and the Nordic devices are both efficient and safe for patients. The Swan label, among others, should be applied expanded labelling of hazardous substances intro- to establish harmonised environmental crite- duced in the new MDR should be a driver for subs- ria for medical devices and different groups of titution by raising awareness in the healthcare com- hazardous chemicals to avoid any gaps and in- munity about the chemical composition of medical consistencies. devices. Those devices should be subject to strin- gent compliance assessment of required labelling
36 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 37 REFERENCES
1. European Union. (2017) Regulation (EU) 8. Deutsche Welle. (2019). Alarming level of 2017/745 of the European Parliament and of plastic in children's bodies, German study the Council of 5 April 2017 on medical devi- shows. https://www.dw.com/en/alarming-le- ces, amending Directive 2001/83/EC, Regula- vel-of-plastic-in-childrens-bodies-german-study- tion (EC) No 178/2002 and Regulation (EC) No shows/a-50432823 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA 9. Santé Publique France. (2019). Les résultats relevance.). https://eur-lex.europa.eu/legal-con- de l'étude Esteban. https://www.santepubli- tent/EN/TXT/?uri=CELEX%3A32017R0745 quefrance.fr/etudes-et-enquetes/esteban/les-re- sultats-de-l-etude-esteban 2. Vandentorren, S. et al. (2011) Dosages du bisphénol A et des phthalates chez les 10. Bergman, Å. et al. (2012) State of the Sci- femmes enceintes: résultats de l’étude pilote ence of Endocrine Disrupting Chemicals ELFE, 2007. Bulletin épidémiologique hebdo- 2012: Summary for Decision-Makers. madaire, Volume 25. http://foxoo.com/_inter- https://wedocs.unep.org/bitstream/hand- nautes/0000006120/photos/beh%202011%20 le/20.500.11822/17015/State_Science_Endocri- 25%20300611.pdf ne_Disrupting_Chemicals.pdf?sequence=1
3. Fischer, CJ. et al. (2013) Phthalates in the 11. Endocrine Society. (2019) Endocrine-Dis- NICU: is it safe? Journal of Paediatrics and rupting Chemicals. https://www.endocrine.org/ Child Health, Volume 49, Issue 9. https://www. topics/edc/where-we-stand ncbi.nlm.nih.gov/pubmed/23714420 12. The European Parliament. (2019) Endocrine 4. Weinberger, B. et al. (2014) Effects of mater- Disruptors: from Scientific Evidence to Hu- nal exposure to phthalates and bisphenol man Health Protection. http://www.europarl. l Adopt regional and national strategies and l Make available research funds for clinical and A during pregnancy on gestational age. The europa.eu/RegData/etudes/STUD/2019/608866/ tools to phase out hazardous chemicals in me- epidemiological studies on chemical exposure, Journal of Maternal-Fetal and Neonatal Medi- IPOL_STU(2019)608866_EN.pdf dical devices, such as the substitution group particularly for comparing exposure and out- cine, Volume 27, Issue 4. https://www.ncbi.nlm. of chemicals created by the Swedish Environ- comes in patients being treated with similar 13. PVCMed Alliance. (Last accessed 31/10/2019) nih.gov/pubmed/23795657 mental Management Council and the Swedish devices but containing different chemicals. The added value of PVC medical devices. County Councils. https://pvcmed.org/medical-devices/ l Prioritise research and innovation funding for 5. Haug, LS. et al. (2018) In-utero and childhood Sustainable procurement guidelines should pro- the development of safer products that redu- chemical exposome in six European mother- 14. Nielsen, BS. et al. (2014). Alternatives vide incentives for the substitution of hazardous ce chemical exposure of all types in the health child cohorts. Environment international, to classified phthalates in medical de- chemicals in medical devices. Procurement practi- technology sector. Volume 121. https://www.sciencedirect.com/sci- vices. Environmental Project No. 1557, ces can contribute to a quicker phase-out of certain ence/article/pii/S016041201831225X?via%3Di- l Provide greater incentives for healthcare facili- 2014. https://www2.mst.dk/Udgiv/publicati- hazardous chemicals in medical devices by driving hub ons/2014/03/978-87-93178-27-4.pdf manufacturers to develop alternatives to those ties to consider substitution. chemicals/products and by assessing if the availa- Funding for research and development of alterna- 6. Benjamin, EJ. et al. (2017). Heart disease and 15. Tickner, J. et al. (1999) The Use of Di-2-Ethyl- ble alternatives are feasible. The healthcare sector tive substances and products and for clinical and stroke statistics-2017 update: a report from hexyl Phthalate in PVC Medical Devices: is a growing industry with a high demand for equip- epidemiological projects that compare the perfor- the American Heart Association. Circulation, Exposure, Toxicity, and Alternatives. Lowell ment that can, through responsible purchasing po- mance of these alternatives should be prioritised. Volume, 135, Issue 10, https://europepmc.org/ Center for Sustainable Production. http:// licies, drive the market. Hospitals are increasingly Governmental authorities should support the de- articles/pmc5408160 www.sustainableproduction.org/downloads/ velopment of safer alternatives to medical devices demanding products that are free of certain groups 7. Karačonji, IB. et al. (2017). Facts about phtha- DEHP%20Title%20and%20Contents.pdf containing hazardous chemicals and prioritise fun- of chemicals, thereby driving research, innovation late toxicity in humans and their occurrence ding for the development of those substitutes. The 16. Jaeger, RJ. et al. (1970) CONTAMINATION and lowering the market price of the products. The in alcoholic beverages. Archives of Industrial diversion of funding for these alternatives can be OF BLOOD STORED IN PLASTIC PACKS. The introduction of green procurement criteria at the Hygiene and Toxicology, Volume 68, Issue complementary to the adoption of stricter regula- Lancet, Volume 296, Issue 7664. https://www. regional, national and European levels can lead to 2. https://content.sciendo.com/view/journals/ tions. thelancet.com/journals/lancet/article/PIIS0140- the phase-out of hazardous chemicals in medical aiht/68/2/article-p81.xml devices. 6736(70)92734-0/fulltext
38 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 39 17. Latini, G. et al. (2010) Materials degrada- 23. SCENIHR (Scientific Committee on Emerging of Health and Disease, Volume 8, Issue 2. 39. Lind, PM. et al. (2011) Circulating levels of tion in PVC medical devices, DEHP leaching and Newly Identified Health Risks). (2015) https://www.ncbi.nlm.nih.gov/pmc/articles/ bisphenol A and phthalates are related to and neonatal outcomes. Current Medicinal Opinion on Safety of the use of bisphenol PMC5332297/ carotid atherosclerosis in the elderly. At- Chemistry, Volume 17, Issue 26. https:// A in medical devices. https://ec.europa.eu/ herosclerosis, Volume 218, Issue 1. https:// www.ingentaconnect.com/content/ben/ health/scientific_committees/emerging/docs/sce- 32. Radke, EG. et al. (2018) Phthalate exposure www.sciencedirect.com/science/article/abs/pii/ cmc/2010/00000017/00000026/art00011 nihr_o_040.pdf and male reproductive outcomes: A system- S0021915011003911 atic review of the human epidemiological 18. Tickner, JA. et al. (2001) Health risks posed 24. Swan, SH. et al. (2015) First trimester phtha- evidence. Environment International, Volume 40. Rochester, JR. (2013) Bisphenol A and hu- by use of Di-2-ethylhexyl phthalate (DEHP) late exposure and anogenital distance in 121, Issue 1. https://www.sciencedirect.com/sci- man health: A review of the literature. Re- in PVC medical devices: a critical review. The newborns. Human Reproduction, Volume ence/article/pii/S0160412018303404 productive Toxicology, Volume 42. https:// American Journal of Industrial Medicine, Vo- 30, Issue 4. https://www.ncbi.nlm.nih.gov/pub- www.sciencedirect.com/science/article/pii/ lume 39, Issue 1. https://www.ncbi.nlm.nih.gov/ med/25697839 33. Polanska, K. et al. (2014) Phthalate exposu- S0890623813003456 pubmed/11148020 re and child development: The Polish Mo- 25. Bonde, JP. et al. (2016) The epidemiologic ther and Child Cohort Study. Early Human 41. Roen, EL. et al. (2015) Bisphenol A expo- 19. SCENIHR (Scientific Committee on Emerging evidence linking prenatal and postnatal expo- Development, Volume 90, Issue 9. https:// sure and behavioral problems among and Newly-Identified Health Risks). (2015) sure to endocrine disrupting chemicals with www.sciencedirect.com/science/article/abs/pii/ inner city children at 7-9 years of age. En- Scientific Opinion on the safety of medical male reproductive disorders: a systematic re- S0378378214001510?via%3Dihub vironmental Research, Volume 142. https:// devices containing DEHP-plasticized PVC or view and meta-analysis. Human Reproduction www.sciencedirect.com/science/article/pii/ other plasticizers on neonates and other Update, Volume 23, Issue 1. https://academic. 34. Kraft, AD. et al. (2016) Unmasking silent S0013935115000158 groups possibly at risk. https://ec.europa.eu/ oup.com/humupd/article/23/1/104/2605945 neurotoxicity following developmental health/scientific_committees/emerging/docs/sce- exposure to environmental toxicants. Neu- 42. Casas, M. et al. (2015) Exposure to bisphenol nihr_o_047.pdf 26. Main, KM. et al. (2006) Human Breast Milk rotoxicology Teratology, Volume 55. https:// A during pregnancy and child neuropsycho- Contamination with Phthalates and Alterati- www.sciencedirect.com/science/article/pii/ logical development in the INMA-Sabadell 20. FAO (Food and Agriculture Organization of ons of Endogenous Reproductive Hormones S0892036216300162 cohort. Environmental Research, Volume 142. the United States) & WHO (World Health in Infants Three Months of Age. Environmen- https://www.sciencedirect.com/science/article/pii/ Organization) (2011). Toxicological and tal Health Perspectives, Volume 114, Issue 35. Mundy, WR. et al. (2015) Expanding the S001393511530044X Health Aspects of Bisphenol A: Report of Joint 2. https://ehp.niehs.nih.gov/doi/full/10.1289/ test set: Chemicals with potential to disrupt FAO/WHO Expert Meeting 2–5 November ehp.8075 mammalian brain development. Neurotoxi- 43. Tudurí, E. et al. (2018) Timing of Exposure 2010 and Report of Stakeholder Meeting cology Teratology. Volume 52, Part A. https:// and Bisphenol-A: Implications for Diabetes on Bisphenol A 1 November 2010 Ottawa, 27. Swan, SH. et al. (2005) Decrease in Anogenital www.sciencedirect.com/science/article/abs/pii/ Development. Frontiers in Endocrinology, Vo- Canada. https://apps.who.int/iris/bitstream/ Distance among Male Infants with Prenatal S0892036215300362?via%3Dihub lume 9, Issue 648. https://www.frontiersin.org/ Phthalate Exposure. Environmental Health articles/10.3389/fendo.2018.00648/full handle/10665/44624/97892141564274_eng. 36. Jankowska, A. et al. (2019) Prenatal and early pdf?sequence=1&isAllowed=y Perspective, Volume 113, Issue 8. https://ehp. niehs.nih.gov/doi/full/10.1289/ehp.8100 postnatal phthalate exposure and child 44. Cariati, F. et al. (2019) Bisphenol a: an emer- 21. ANSES (French agency for food, environmen- neurodevelopment at age of 7 years–Polish ging threat to male fertility. Reproductive tal and occupational health & safety). (2013) 28. Matsumoto, M. et al. (2008) Potential ad- Mother and Child Cohort. Environmental Re- Biology and Endocrinology, Volume 17, Issue Opinion of the French Agency for Food, Envi- verse effects of phthalic acid esters on search, Volume 177. https://www.sciencedirect. 6. https://link.springer.com/article/10.1186/ ronmental and Occupational Health & Safety human health: A review of recent studies com/science/article/pii/S0013935119304232 s12958-018-0447-6 on the assessment of the risks associated on reproduction. Regulatory Toxicology and Pharmacology, Volume 50, Issue 1. https:// 37. Ejaredar, M. et al. (2015) Phthalate exposure 45. Singh, S. (2012) Epigenetic Effects of Environ- with bisphenol A for human health, and on and childrens neurodevelopment: A system- mental Chemicals Bisphenol A and Phthala- toxicological data and data on the use of bis- www.sciencedirect.com/science/article/abs/pii/ S0273230007001316 atic review. Environmental Research, Volume tes. International Journal of Molecular Scien- phenols S, F, M, B, AP, AF and BADGE. https:// 142. https://www.sciencedirect.com/science/ ces, Volume 13, Issue 8. https://www.mdpi. www.anses.fr/en/system/files/CHIM2009sa- 29. Hauser, R. et al. (2005) PHTHALATES AND article/pii/S0013935115001899 com/1422-0067/13/8/10143 0331Ra-0EN.PDF HUMAN HEALTH. Occupational and environ- 38. Huang, HB. et al. (2015) Fetal and Childhood 46. Van Vliet, EDS. et al. (2011) A review of alter- 22. Aschberger, K. et al. (2010) Bisphenol A and mental medicine, Volume 62, Issue 11. https:// oem.bmj.com/content/62/11/806 Exposure to Phthalate Diesters and Cogni- natives to di (2-ethylhexyl) phthalate-contai- baby bottles: challenges and perspectives. tive Function in Children Up to 12 Years of ning medical devices in the neonatal intensive https://www.researchgate.net/profile/Dimosthe- 30. Bornehag, C-G. et al. (2015) Prenatal Phtha- Age: Taiwanese Maternal and Infant Cohort care unit. Journal of Perinatology, Volume 31. nis_Sarigiannis/publication/228903741_Bisphe- late Exposures and Anogenital Distance in Study. PLoS ONE, Volume 10, Issue 6. https:// https://www.nature.com/articles/jp2010208 nol_A_and_Baby_Bottles_Challenges_and_Per- Swedish boys. Environment Health Perspecti- journals.plos.org/plosone/article?id=10.1371/ spectives/links/02bfe50d1898773eda000000/ ves, Volume 123, Issue 1. https://ehp.niehs.nih. journal.pone.0131910 47. Weuve, J. et al. (2006) Exposure to Phthala- Bisphenol-A-and-Baby-Bottles-Challenges-and- gov/doi/pdf/10.1289/ehp.1408163 tes in Neonatal Intensive Care Unit Infants: Perspectives.pdf Urinary Concentrations of Monoesters and 31. Tran, Vy. et al. (2017) Prenatal Phthalate Oxidative Metabolites. Environmental Health Exposure and 8-Isoprostane among Mexi- Perspectives, Volume 114, Issue 9. https://ehp. can-American Children with High Prevalence niehs.nih.gov/doi/full/10.1289/ehp.8926 of Obesity. Journal of Developmental Origins
40 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 41 48. Chiellini, F. et al. (2011) Physical-chemical 56. Bacle, A. et al. (2019) Overexposure to Bis- 64. Oehlmann, J. et al. (2009) A critical analysis 72. Garnett, K. et al. (2016) Multi-Case Review of assessment of di-(2-ethylhexyl)-phthalate phenol A and Its Chlorinated Derivatives of of the biological impacts of plasticizers on the Application of the Precautionary Principle leakage from poly(vinyl chloride) endotracheal Patients with End-Stage Renal Disease during wildlife. Philosophical Transactions of the in European Union Law and Case Law. Risk tubes after application in high risk newborns. Online Hemodiafiltration. Biomolecules, Vo- Royal Society B: Biological Sciences. https:// Analysis, Volume 37, Issue 3. https://onlinelib- International Journal of Pharmaceutics, Volu- lume 9, Issue 9. https://www.mdpi.com/2218- royalsocietypublishing.org/doi/pdf/10.1098/ rary.wiley.com/doi/full/10.1111/risa.12633 me 409, Issues 1-2. https://www.sciencedirect. 273X/9/9/403/htm rstb.2008.0242 com/science/article/pii/S0378517311001591 73. Layman Report (2017) One step closer to a 57. Mettang, T. et al. (2000) Influence of plastici- 65. ECHA (European Chemicals Agency). (Last ac- safe blood bag: Public healthcare and plastic 49. Su, PH. et al. (2012) Exposure to di(2-ethyl- ser-free CAPD bags and tubings on serum, cessed 01/11/2019) Authorisation List. https:// makers demonstrate how to remove barriers hexyl) phthalate in premature neonates in urine, and dialysate levels of phthalic acid echa.europa.eu/authorisation-list to PVC-free blood bags in the spirit of REACH. a neonatal intensive care unit in Taiwan. esters in CAPD patients. Peritoneal Dialysis http://www.pvcfreebloodbag.eu/wp-content/ Pediatric Critical Care Medicine, Volume 13, International, Volume 20, Issue 1. http://www. 66. ECHA (European Chemicals Agency). (Last uploads/2015/02/Layman-report-PVCfreeBlood- Issue 6. https://journals.lww.com/pccmjournal/ pdiconnect.com/content/20/1/80.short accessed 01/11/2019) Candidate List of sub- Bag.pdf Abstract/2012/11000/Exposure_to_di_2_ethyl- stances of very high concern for Authorisa- hexyl__phthalate_in.9.aspx 58. von Rettberg, et al. (2009) Use of Di(2-Ethyl- tion. https://echa.europa.eu/candidate-list-table 74. Graminske, S. et al. (2018) In vitro evalua- hexyl)Phthalate–Containing Infusion Systems tion of di(2-ethylhexyl)terephthalate-plas- 50. Demirel, A. et al (2016) Hidden Toxicity in Increases the Risk for Cholestasis. Pediatrics, 67. Oehlmann, J. et al. (2008) A critical evaluation ticized polyvinyl chloride blood bags for red Neonatal Intensive Care Units: Phthalate Volume 124, Issue 2. https://pediatrics.aappu- of the environmental risk assessment for blood cell storage in AS-1 and PAGGSM Exposure in Very Low Birth Weight Infants. blications.org/content/124/2/710 plasticizers in the freshwater environment in additive solutions. Transfusion, Volume 58, Journal of Clinical Research in Pediatric Endo- Europe, with special emphasis on bisphenol Issue 5. https://www.ncbi.nlm.nih.gov/pub- crinology, Volume 8, Issue 3. https://www.ncbi. 59. Verstraete, S. et al. (2016) Circulating phtha- A and endocrine disruption. Environmen- med/29574766 nlm.nih.gov/pubmed/27097850 lates during critical illness in children are tal Research, Volume 108, Issue 2. https:// associated with long-term attention deficit: a www.sciencedirect.com/science/article/pii/ 75. Medical Plastics News. (2017) It’s in the bag: 51. Malarvannan, G. et al. (2019) Phthalate and study of a development and a validation co- S0013935108001606 Eastman evaluates new plasticiser for blood alternative plasticizers in indwelling medi- hort. Intensive Care Medicine, Volume 42, Is- bag. https://www.medicalplasticsnews.com/ cal devices in pediatric intensive care units. sue 3. https://link.springer.com/article/10.1007/ 68. Canesi, L. et al. (2015) Environmental news/it%E2%80%99s-in-the-bag/ Journal of Hazardous Materials, Volume 363. s00134-015-4159-5 Effects of BPA: Focus on Aquatic Spe- https://www.sciencedirect.com/science/article/pii/ cies. Dose-Response, Volume 13, Is- 76. Health Care Without Harm Europe. (2014) S0304389418308811 60. Jaimes III, R. et al. (2019) Plasticizer Interaction sue 3. https://journals.sagepub.com/doi/ Non-toxic Healthcare: Alternatives to Phtha- With the Heart: Chemicals Used in Plastic full/10.1177/1559325815598304 lates and Bisphenol A in Medical Devices. 52. Mallow, EB. et al. (2014) Phthalates and Medical Devices Can Interfere With Cardiac https://noharm-europe.org/EDCs-report critically ill neonates: device-related exposu- Electrophysiology. Circulation: Arrhythmia 69. ECHA (European Chemicals Agency). (2019) res and non-endocrine toxic risks. Journal of and Electrophysiology, Volume 12. https:// Endocrine disrupting properties to be added 77. ANSM (Agence Nationale de Sécurité du Perinatology, Volume 34. https://www.nature. www.ahajournals.org/doi/full/10.1161/CIR- for four phthalates in the Authorisation List. Médicament et des Produits de Santé). (2016) com/articles/jp2014157 CEP.119.007294 https://echa.europa.eu/-/endocrine-disrupting- Market surveillance of PVC medical devices properties-to-be-added-for-four-phthalates-in- presented DEHP-free. https://www.ansm.sante. 53. Völkel, W. et al. (2011) Determination of free 61. Tereshchenko, LG. et al. (2019) Does plastic the-authorisation-list fr/content/download/97323/1236357/version/1/ and total bisphenol A in urine of infants. En- chemical exposure contribute to sudden file/Report_PVC-medical-devices-DEHP-free- vironmental Research, Volume 111, Issue 1. death of patients on dialysis? Heart Rhythm, 70. SCHEER (Scientific Committee on Health, may2016.pdf https://www.sciencedirect.com/science/article/pii/ Volume 16, Issue 2. https://www.heartrhy- Environmental and Emerging Risks). (2019) S0013935110001581 thmjournal.com/article/S1547-5271(18)30821- Guidelines on the benefit-risk assessment of 78. Swedish Environmental Management Council. X/abstract the presence of phthalates in certain medi- (Last accessed 01/11/2019) THE SUBSTI- 54. Calafat, AM. et al. (2009) Exposure to Bisphe- cal devices covering phthalates, which are TUTION LIST for substitution of hazardous nol A and Other Phenols in Neonatal Intensi- 62. Crain, DA. et al. (2007) An ecological assess- carcinogenic, mutagenic, toxic to reproduc- substances in the health care sector. The ve Care Unit Premature Infants. Environmen- ment of bisphenol-A: Evidence from com- tion (CMR) or have endocrine-disrupting (ED) national substitution group on chemicals in tal Health Perspectives, Volume 117, Issue parative biology. Reproductive Toxicology, properties, final version adopted at SCHEER articles. http://www.pvcfreebloodbag.eu/wp-con- 4. https://ehp.niehs.nih.gov/doi/full/10.1289/ Volume 24, Issue 2. https://www.sciencedirect. plenary on 18 June 2019. https://ec.europa.eu/ tent/uploads/2015/02/substlista_EN_120921.pdf ehp.0800265 com/science/article/pii/S0890623807001840 health/sites/health/files/scientific_committees/ ® scheer/docs/scheer_o_015.pdf 79. GreenScreen. (2019) GreenScreen For Safer 55. Bacle, A. et al. (2016) Determination of bis- 63. Flint, S. et al. (2012) Bisphenol A exposure, Chemicals. https://www.greenscreenchemicals. phenol A in water and the medical devices effects, and policy: A wildlife perspective. Jour- 71. Kambia, K. et al. (2003) Evaluation of child- org/ used in hemodialysis treatment. International nal of Environmental Management, Volume hood expo- sure to di(2-ethylhexyl) phtha- Journal of Pharmaceutics, Volume 505, Issues 104. https://www.sciencedirect.com/science/ late from perfusion kits during long-term 80. Clean Production Action. (2019) Clean Pro- 1-2. https://www.sciencedirect.com/science/artic- article/pii/S0301479712001405 parenteral nutrition. International Journal duction Action. https://www.cleanproduction. le/pii/S0378517316301934 of Pharmaceutics, Volume 262, Issues 1-2. org/ https://www.sciencedirect.com/science/article/pii/ S0378517303003351
42 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 43 81. Huntley, P. (2014) Alternatives to Classified 89. Packaging Insights. (2013) Didactic Introduces 98. Motiva Ltd. (2019) Sairaanhoitopiirien kehit- 106. European Commission. (2019) Directive (EU) Phthalates in PVC Medical Devices Confe- BPA-free Medical Infusion Devices Made With täjäryhmä – yhteenveto käynnistämistilai- 2019/904 of the European Parliament and of rence. The classified phthalates should be Eastman Tritan™ Copolyester. https://www. suudesta. https://www.hankintakeino.fi/sites/ the Council of 5 June 2019 on the reduction phased out of medical devices. https://pvc.dk/ packaginginsights.com/news/didactic-introdu- default/files/media/file/Sairaanhoitopiirien%20 of the impact of certain plastic products on wp-content/uploads/2016/02/pvc-alternativer- ces-bpafree-medical-infusion-devices-made-with- kehitt%C3%A4j%C3%A4ryhm%C3%A4%20 the environment (Text with EEA relevance). til-klassificerede-ftalater-program.pdf eastman-tritan-copolyester.html %E2%80%93%20yhteenveto%20k%C3%A4yn- https://eur-lex.europa.eu/legal-content/EN/ nist%C3%A4mistilaisuudesta%2014.3.2019.pdf TXT/?uri=uriserv:OJ.L_.2019.155.01.0001.01. 82. Lowell Center for Sustainable Production. 90. Emballages Magazine. (2013) Phthalates et ENG&toc=OJ:L:2019:155:FULL (2011) TECHNICAL BRIEFING: PHTHALATES BPA sous perfusion. https://issuu.com/infopro/ 99. Law, KL. (2017) Plastics in the Marine Envi- AND THEIR ALTERNATIVES: HEALTH AND docs/feuilletable_emb_950 ronment. Annual Review of Marine Science, 107. CAMPUS. (2019) CAMPUS® - a material ENVIRONMENTAL CONCERNS. https://www. Volume 9. https://www.annualreviews.org/doi/ information system for the plastics industry. sustainableproduction.org/downloads/Phthala- 91. European Commission. (2017) Public procu- full/10.1146/annurev-marine-010816-060409 https://www.campusplastics.com/campus/list teAlternatives-January2011.pdf rement. https://ec.europa.eu/trade/policy/acces- sing-markets/public-procurement/ 100. UNEP (United Nations Environment Program- 108. Groh, KJ. et al. (2019) Overview of known 83. Rossi, MS. et al. (2014) THE PLASTICS SCORE- me). (2011) UNEP YEAR BOOK: EMERGING plastic packaging-associated chemicals and CARD: Evaluating the Chemical Footprint of 92. Health Care Without Harm Europe. (2007) ISSUES IN OUR GLOBAL ENVIRONMENT their hazards. The Science of the total en- Plastics. Version 1.0. https://www.bizngo.org/ PVC/DEHP Phase-out is possible anywhere in 2011. http://wedocs.unep.org/bitstream/hand- vironment, Volume 651, Part 2. https://www. sustainable-materials/plastics-scorecard-full-re- Europe: Model hospitals show how to suc- le/20.500.11822/8276/-UNEP%20Year%20 ncbi.nlm.nih.gov/pubmed/30463173 port-download ceed. https://noharm-europe.org/sites/default/ Book%202012_%20emerging%20issues%20 files/documents-files/2675/PVC_DEHP_Phase- in%20our%20global%20environment- 109. PlasticsEurope. (2019) WHAT ARE PLASTICS? 84. Genay, S. et al. (2011) Experimental study Out_Europe.pdf 2011UNEP_YEARBOOK_Fullreport.pdf?sequen- https://www.plasticseurope.org/en/about-plas- on infusion devices containing polyvinyl ce=5&isAllowed=y tics/what-are-plastics chloride: To what extent are they di(2-ethyl- 93. Health Care Without Harm. (2008) Guide to hexyl)phthalate-free? International Journal Choosing Safer Products and Chemicals: Im- 101. Wagner, M. et al. (2018) Freshwater Micro- 110. EEA (European Environment Agency). (2019) of Pharmaceutics, Volume 412, Issues 1-2. plementing Chemicals Policy in Health Care. plastics: Emerging Environmental Conta- Preventing plastic waste in Europe. https:// https://www.sciencedirect.com/science/article/pii/ https://noharm-uscanada.org/sites/default/files/ minants? The Handbook of Environmental www.eea.europa.eu/publications/preventing- S0378517311002961 documents-files/57/Guide_to_Safer_Chems.pdf Chemistry, Volume 58. https://link.springer. plastic-waste-in-europe com/book/10.1007/978-3-319-61615-5 85. Molina-Molina, JM. et al. (2013) In vitro study 94. Health Care Without Harm Europe. (2018) 111. ECHA (European Chemicals Agency). (Last on the agonistic and antagonistic activities of GUIDELINES for the procurement of safer 102. Rillig, MC. (2012) Microplastic in Terres- accessed 01/11/2019) Mapping exercise – bisphenol-S and other bisphenol-A congeners medical devices. https://noharm-europe.org/ trial Ecosystems and the Soil? Environ- Plastic additives initiative. https://echa.europa. and derivatives via nuclear receptors. Toxico- sites/default/files/documents-files/5720/Guide- mental Science & Technology, Volume eu/mapping-exercise-plastic-additives-initiative logy and Applied Pharmacology, Volume 272, lines_for_Procurement_of_Safer_and_Sustaina- 46. https://pubs.acs.org/doi/pdf/10.1021/ ble_Medical_Devices_Final_WEB.pdf 112. Crippa, M. et al. (2019) A CIRCULAR ECONO- Issue 1. https://www.sciencedirect.com/science/ es302011r?rand=iv97i94e MY FOR PLASTICS - Insights from research article/pii/S0041008X1300224X 95. HUS Ympäristöohjelma. (2016-2020) Ympä- 103. Laganà, P. et al. (2019) Do plastics serve as a and innovation to inform policy and funding 86. Meng, Z. et al. (2018) Effects of perinatal ristövastuu – osa kaikkea HUS:n toimintaa. possible vector for the spread of antibiotic re- decisions, 2019 (M. De Smet & M. Linder, exposure to BPA and its alternatives (BPS, https://www.hus.fi/hus-tietoa/Documents/HUS_ sistance? First insights from bacteria associa- Eds.). https://www.hbm4eu.eu/wp-content/up- BPF and BPAF) on hepatic lipid and gluco- ymparistoohjelma_2016-2020_lowres.pdf ted to a polystyrene piece from King George loads/2019/03/2019_RI_Report_A-circular-eco- nomy-for-plastics.pdf se homeostasis in female mice adolescent 96. HUS (Helsinki University Hospital). (2018) Island (Antarctica). International Journal of offspring. Chemosphere, Volume 212. https:// YMPÄRISTÖ-kertomus 2018. https://www. Hygiene and Environmental Health, Volume 113. SAPEA (Science Advice for Policy by European www.sciencedirect.com/science/article/pii/ hus.fi/hus-tietoa/ymparistovastuu/Documents/ 222, Issue 1. https://www.sciencedirect.com/sci- Academies). (2019) A SCIENTIFIC PERSPEC- S0045653518315480?via%3Dihub HUS%20Ymp%C3%A4rist%C3%B6kertomus%20 ence/article/pii/S1438463918304255 TIVE ON MICROPLASTICS IN NATURE AND 87. Carvaillo, J-C. et al. (2019) Linking Bisphenol 2018.pdf 104. Yang, Y. et al. (2019) Plastics in the marine SOCIETY. https://www.sapea.info/wp-content/ uploads/report.pdf S to Adverse Outcome Pathways Using a 97. KEINO Competence Centre. (Last accessed environment are reservoirs for antibio- Combined Text Mining and Systems Biology 01/11/2019) Sairaanhoitopiirien yhteistyöver- tic and metal resistance genes. Environ- 114. WHO (World Health Organization). (2019) Approach. Environmental Health Perspecti- kosto vastuullisiin hankintoihin -tapaaminen mental International, Volume 123. https:// Microplastics in drinking-water. https://www. ves, Volume 127, Issue 4. https://ehp.niehs.nih. 14.3.2019. https://www.hankintakeino.fi/fi/ www.sciencedirect.com/science/article/pii/ who.int/water_sanitation_health/publications/ gov/doi/10.1289/EHP4200 tapahtumat/2019/sairaanhoitopiirien-yhteistyo- S0160412018319822 microplastics-in-drinking-water/en/ verkosto-vastuullisiin-hankintoihin-tapaaminen 88. Rochester, JR. et al. (2015) Bisphenol S and F: 105. CIEL (Center for International Environmental 115. PlasticsEurope. (2018) Plastics – the Facts A Systematic Review and Comparison of the Law). (2019) Plastic & Health: THE HIDDEN 2018: An analysis of European plastics Hormonal Activity of Bisphenol A Substitutes. COSTS OF A PLASTIC PLANET. https://www.ciel. production, demand and waste data. Environmental Health Perspectives, Volume org/wp-content/uploads/2019/02/Plastic-and- https://www.plasticseurope.org/application/ 123, Issue 7. https://www.ncbi.nlm.nih.gov/pmc/ Health-The-Hidden-Costs-of-a-Plastic-Planet-Fe- files/6315/4510/9658/Plastics_the_facts_2018_ articles/PMC4492270/ bruary-2019.pdf AF_web.pdf
44 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 45 116. Geyer, R. et al. (2017) Production, use, and 124. European Commission. (2018) REPORT FROM REGIONS Closing the loop - An EU action 141. European Commission. (Last accessed fate of all plastics ever made. Science Ad- THE COMMISSION TO THE EUROPEAN PAR- plan for the Circular Economy. https://eur- 01/11/2019) Circular Plastics Alliance. https:// vances, Volume 3, Issue 7. https://advances. LIAMENT AND THE COUNCIL on the impact of lex.europa.eu/legal-content/EN/TXT/?uri=CE- ec.europa.eu/growth/industry/policy/circular- sciencemag.org/content/3/7/e1700782 the use of oxo-degradable plastic, including LEX:52015DC0614 plastics-alliance_en oxo-degradable plastic carrier bags, on the 117. World Economic Forum, Ellen MacArthur environment. https://ec.europa.eu/environ- 133. European Union. (2018) Directive (EU) 142. Groh, KJ. et al. (2019) Overview of known plas- Foundation and McKinsey & Company. (2016) ment/circular-economy/pdf/oxo-plastics.pdf 2018/852 of the European Parliament and tic packaging-associated chemicals and their The New Plastics Economy — Rethinking the of the Council of 30 May 2018 amending hazards. Science of the Total Environment, future of plastics. https://www.ellenmacarthur- 125. CIEL (Center for International Environmental Directive 94/62/EC on packaging and pa- Volume 651, Part 2. https://www.sciencedirect. foundation.org/publications/the-new-plastics- Law). (2018) Toward a New Global Convention ckaging waste (Text with EEA relevance). com/science/article/pii/S0048969718338828 economy-rethinking-the-future-of-plastics with a Multi-Layered Governance Approach to https://eur-lex.europa.eu/legal-content/EN/ Address Plastic Pollution. https://www.ciel.org/ TXT/?uri=uriserv:OJ.L_.2018.150.01.0141.01. 143. Zimmermann, L. et al. (2019) Benchmarking 118. European Commission. (2018) COMMUNI- reports/toward-a-new-global-convention-with-a- ENG&toc=OJ:L:2018:150:TOC the in Vitro Toxicity and Chemical Composi- CATION FROM THE COMMISSION TO THE multi-layered-governance-approach-to-address- tion of Plastic Consumer Products. Environ- EUROPEAN PARLIAMENT, THE COUNCIL, plastic-pollution/ 134. European Union. (2019) Directive (EU) mental Science & Technology, Volume 53, THE EUROPEAN ECONOMIC AND SOCIAL 2019/904 of the European Parliament and of Issue 19. https://pubs.acs.org/doi/abs/10.1021/ COMMITTEE AND THE COMMITTEE OF THE 126. Simon, N. et al. (2017) Strengthening Plastic the Council of 5 June 2019 on the reduction acs.est.9b02293 REGIONS: A European Strategy for Plastics in Governance: Towards a New Global Con- of the impact of certain plastic products on a Circular Economy. https://eur-lex.europa.eu/ vention. https://www.adelphi.de/en/publication/ the environment (Text with EEA relevance). 144. Environmental Health News. (2019) The resource.html?uri=cellar:2df5d1d2-fac7-11e7- stopping-global-plastic-pollution-case-interna- https://eur-lex.europa.eu/legal-content/EN/ attention on microplastic pollution is wel- b8f5-01aa75ed71a1.0001.02/DOC_1&for- tional-convention TXT/?uri=uriserv:OJ.L_.2019.155.01.0001.01. comed. But scientists can do better. https:// mat=PDF ENG&toc=OJ:L:2019:155:FULL www.ehn.org/better-microplastic-pollution-sci- 127. UNEP (United Nations Environment Program- ence-2640872954.html?rebelltitem=1#rebellti- 119. Carrig, D. (2018) The US used to ship 4,000 me). (2018) Nations commit to fight plastic 135. ECHA (European Chemicals Agency). (2019) tem1 recyclable containers a day to China. Where pollution together during the UN General As- ANNEX XV RESTRICTION REPORT PROPOSAL will the banned trash go now? https://eu.usa- sembly. https://www.unenvironment.org/news- FOR A RESTRICTION. https://echa.europa.eu/ 145. Wright, S. et al. (2017) Plastic and Human today.com/story/news/nation-now/2018/06/21/ and-stories/press-release/nations-commit-fight- documents/10162/12414bc7-6bb2-17e7-c9ec- Health: A Micro Issue? Environmental Science china-ban-plastic-waste-recycling/721879002/ plastic-pollution-together-during-un-general 652a20fa43fc & Technology, Volume 51, Issue 12. https:// pubs.acs.org/doi/10.1021/acs.est.7b00423 120. Bruce-Vanderpuije, P. et al. (2019) The state 128. Ellen MacArthur Foundation. (2017) NEW 136. ECHA (European Chemicals Agency). of POPs in Ghana- A review on persistent PLASTICS ECONOMY: We launched a Global (2019) Registry of restriction intentions 146. Smith, M. et al. (2018) Microplastics in Sea- organic pollutants: Environmental and human Commitment to address plastic waste and until outcome. https://echa.europa.eu/ food and the Implications for Human Health. exposure. Environmental Pollution, Volume pollution at its source. https://www.newplastic- registry-of-restriction-intentions/-/dislist/de- Current Environmental Health Reports, 245. https://www.sciencedirect.com/science/ar- seconomy.org/ tails/0b0236e18244cd73 Volume 5, Issue 3. https://link.springer.com/ ticle/pii/S0269749118329580 article/10.1007/s40572-018-0206-z 129. Ellen MacArthur Foundation. (2019) NEW 137. ECHA (European Chemicals Agency). (2019) 121. Eriksen, M. (2014) Plastic Pollution in the PLASTICS ECONOMY GLOBAL COMMITMENT Submitted restrictions under consideration. 147. Schwabl, P. et al. (2018). ASSESSMENT OF World's Oceans: More than 5 Trillion Plastic JUNE 2019 REPORT. https://www.ellenmacart- https://echa.europa.eu/restrictions-under-consi- MICROPLASTIC CONCENTRATIONS IN HU- Pieces Weighing over 250,000 Tons Afloat at hurfoundation.org/assets/downloads/GC-Re- deration/-/substance-rev/22921/term MAN STOOL - PRELIMINARY RESULTS OF A Sea. PLoS ONE, Volume 9, Issue 12. https:// port-June19.pdf PROSPECTIVE STUDY. United European Gas- journals.plos.org/plosone/article?id=10.1371/ 138. Stockholm Convention (2019) Plastic and troenterology Journal, Volume 6. www.ueg.eu/ journal.pone.0111913 130. PACE. (Last accessed 01/11/2019) Platform toxic additives, and the circular economy: the education/document/assessmentof-microplastic- for Accelerating the Circular Economy: A role of the Basel and Stockholm Conventions. concentrations-in-human-stoolpreliminary-re- 122. Chiba, S. et al. (2018) Human footprint in the PUBLIC-PRIVATE COLLABORATION PLAT- 9th COPs Meeting Switzerland, 29 April -10 sults-of-a-prospectivestudy/180360 abyss: 30 year records of deep-sea plastic de- FORM AND PROJECT ACCELERATOR FOR THE May 2019. Information documents: UNEP/ bris. Volume 96. https://www.sciencedirect.com/ CIRCULAR ECONOMY. https://www.accelerate- POPS/COP.9/INF/28/Add.1 http://chm.pops. 148. Spiegel Online. (2019) Fast alle Kinder sind science/article/pii/S0308597X17305195 circulareconomy.org/ int/TheConvention/ConferenceoftheParties/Mee- mit Weichmachern belastet. https://www.spie- tings/COP9/tabid/7521/Default.aspx gel.de/gesundheit/schwangerschaft/weichma- 123. Bergmann, M. et al. (2019) White and won- 131. Basel Convention. (2011) BASEL CONVEN- cher-und-pfoa-fast-alle-kinder-mit-gesundheits- derful? Microplastics prevail in snow from the TION: Controlling transboundary movements 139. EuPC (2018) Working for a Sustainable Plas- kritischen-chemikalien-belastet-a-1286708.html Alps to the Arctic. Science Advances, Volume of hazardous wastes and their disposal. http:// tics Industry in Europe: The European Plastics 5, Issue 8. https://advances.sciencemag.org/ www.basel.int/ Industry Voluntary Commitments. http://www. 149. ZonMw. (2019) Microplastics & Health. https:// content/5/8/eaax1157/tab-pdf circularplastics.org/ www.zonmw.nl/fileadmin/zonmw/documenten/ 132. European Commission. (2015) COMMUNI- LSH/Microplastics___Health/Projectdescriptions_ CATION FROM THE COMMISSION TO THE 140. Alliance to End Plastic Waste. (2019) ADDRES- Microplastics___Health_2019-2020.pdf EUROPEAN PARLIAMENT, THE COUNCIL, SING AN ISSUE OF GLOBAL PROPORTIONS. THE EUROPEAN ECONOMIC AND SOCIAL https://endplasticwaste.org/ COMMITTEE AND THE COMMITTEE OF THE
46 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 47 150. PlasticsEurope. (2019) PLASTICS IN HEALTH- 159. Bastiaensen, M. et al. (2019) Metabolites of 166. FDA (U.S. Food & Drug Administration). (2019) 174. Liew, Z. et al. (2018) Developmental Expo- CARE APPLICATIONS. https://www.plasticseuro- phosphate flame retardants and alternati- Per and Polyfluoroalkyl Substances (PFAS). sures to Perfluoroalkyl Substances (PFASs): pe.org/en/about-plastics/healthcare ve plasticizers in urine from intensive care https://www.fda.gov/food/chemicals/and-poly- An Update of Associated Health Outcomes. patients. Chemosphere, Volume 233. https:// fluoroalkyl-substances-pfas Current Environmental Health Reports, Vo- 151. CRAFTECH® INDUSTRIES INC. (2019) THE www.sciencedirect.com/science/article/pii/ lume 5, Issue 1. https://link.springer.com/artic- MANY USES OF PLASTIC MATERIALS IN MEDI- S0045653519311865 167. Stockholm Convention. (2008) Perfluorooc- le/10.1007%2Fs40572-018-0173-4 CINE. https://www.craftechind.com/the-many- tane sulfonic acid, its salts and perfluorooc- uses-of-plastic-materials-in-medicine/ 160. FDA (U.S. Food & Drug Administration). (2015) tane sulfonyl fluoride. http://www.pops.int/ 175. Rappazzo, KM. et al. (2017) Exposure to Summary of Color Additives for Use in the Implementation/Alternatives/AlternativestoPOPs/ Perfluorinated Alkyl Substances and Health 152. Chauhan, MN. et al. (2019) Use of Plastic United States in Foods, Drugs, Cosmetics, and ChemicalslistedinAnnexB/Perfluorooctanesulfo- Outcomes in Children: A Systematic Review Products in Operation Theatres in NHS and Medical Devices. https://www.fda.gov/industry/ nicacidandperfluorooctane/tabid/5869/Default. of the Epidemiologic Literature. International Environmental Drive to Curb Use of Plas- color-additive-inventories/summary-color-addi- aspx Journal of Environmental Research and Public tics. World Journal of Surgery and Surgical tives-use-united-states-foods-drugs-cosmetics- Health, Volume 14, Issue 7. https://www.mdpi. Research, Volume 2, Issue 1088. http://www. and-medical-devices#table4A 168. OECD (Organisation for Economic Co-ope- com/1660-4601/14/7/691/htm surgeryresearchjournal.com/pdfs_folder/wjssr- ration and Development). (2013) SYNTHESIS v2-id1088.pdf 161. McKeen, LW. (2014) 3-Plastics Used in Me- PAPER ON PER- AND POLYFLUORINATED 176. ATSDR (Agency for Toxic Substances and dical Devices. Handbook of Polymer Appli- CHEMICALS (PFCS). https://www.oecd.org/env/ Disease Registry). (2017) TOXICOLOGICAL 153. Minoglou, M. et al. (2017) Healthcare Waste cations in Medicine and Medical Devices. ehs/risk-management/PFC_FINAL-Web.pdf PROFILE FOR POLYBROMINATED DIPHENYL Generation Worldwide and Its Dependence https://www.sciencedirect.com/science/article/pii/ ETHERS (PBDEs). https://www.atsdr.cdc.gov/ on Socio-Economic and Environmental Fac- B9780323228053000037?via%3Dihub 169. ATSDR (Agency for Toxic Substances and toxprofiles/tp207.pdf tors. Sustainability, Volume 9, Issue 2. https:// Disease Registry). (2018) Toxicological Profile www.mdpi.com/2071-1050/9/2/220 162. POPRC (Persistent Organic Pollutants Review for Perfluoroalkyls. Draft for Public Comment. 177. Stockholm Convention. (2008) Decabromo- Committee) (2018) Report of the Persistent https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf diphenyl ether (commercial mixture, c-de- 154. SDU (Sustainable Development Unit). (Last Organic Pollutants Review Committee on caBDE). http://chm.pops.int/Implementation/ accessed 01/11/2019) Waste hotspot: Plas- the work of its fourteenth meeting - Adden- 170. Blake, BE. et al. (2018) Associations between Alternatives/AlternativestoPOPs/Chemicalslistedi- https://www.sduhealth.org.uk/documents/ tics. dum to the risk management evaluation on longitudinal serum perfluoroalkyl substance nAnnexA/cdecaBDE/tabid/5985/Default.aspx AboutUs/LTP%20comms/plastics%20(2%20sli- perfluorooctanoic acid (PFOA), its salts and (PFAS) levels and measures of thyroid hor- des)%20v1.1.pptx PFOA-related compounds. UNEP/POPS/ mone, kidney function, and body mass index 178. Stockholm Convention. (2008) HexaBDE and POPRC.14/6/Add.2. http://www.pops.int/The- in the Fernald Community Cohort. Environ- heptaBDE. http://chm.pops.int/Implementation/ 155. HPRC (Healthcare Plastics Recycling Coun- mental Pollution, Volume 242, Part A. https:// Alternatives/AlternativestoPOPs/Chemicalsliste- cil). (2019) Healthcare Plastics: Guidance Convention/POPsReviewCommittee/Reportsand- Decisions/tabid/3309/Default.aspx www.sciencedirect.com/science/article/pii/ dinAnnexA/HexaBDEandheptaBDE/tabid/5862/ for Recyclers. https://docs.wixstatic.com/ S0269749118328185 Default.aspx ugd/49d7a0_46a9a9caee44404e82fd70ff- 163. Lind, Y. et al. (2003) Polybrominated diphenyl 964eee32.pdf ethers in breast milk from Uppsala County, 171. Food & Water Watch. (2019) These Chemi- 179. Stockholm Convention. (2008) TetraBDE and Sweden. Environmental Research, Volume 93, cals Are Forever: Water Contamination from pentaBDE. http://chm.pops.int/Implementation/ 156. Marklund, A. et al. (2003) Screening of orga- PFOA, PFOS, and other PFAS. https://www. Alternatives/AlternativestoPOPs/Chemicalsliste- nophosphorus compounds and their dis- Issue 2. https://www.sciencedirect.com/science/ article/pii/S0013935103000495 foodandwaterwatch.org/insight/these-chemicals- dinAnnexA/TetraBDEandpentaBDE/tabid/5868/ tribution in various indoor environments. are-forever-water-contamination-pfoa-pfos-and- Default.aspx Chemosphere, Volume 53, Issue 9. https:// 164. Buck, RC. et al. (2011) Perfluoroalkyl and other-pfas www.sciencedirect.com/science/article/pii/ polyfluoroalkyl substances in the environ- 180. Costa, LG. et al. (2011) Is decabromodi- S0045653503006660?via%3Dihub ment: Terminology, classification, and origins. 172. EFSA CONTAM Panel (EFSA Panel on Con- phenyl ether (BDE-209) a developmental taminants in the Food Chain). (2018) Risk neurotoxicant? Neurotoxicology, Volume 157. van der Veen, I. et al. (2012) Phosphorus Integrated Environmental Assessment and Management, Volume 7, Issue 4. https://setac. to human health related to the presence of 32, Issue 1. https://www.ncbi.nlm.nih.gov/pub- flame retardants: Properties, production, en- perfluorooctane sulfonic acid and perfluo- med/21182867 vironmental occurrence, toxicity and analysis. onlinelibrary.wiley.com/doi/abs/10.1002/ieam.2 58%4010.1002/%28ISSN%291551-3793.PFAS rooctanoic acid in food. EFSA Journal, Volume Chemosphere, Volume 88, Issue 10. https:// 16, Issue 12. https://efsa.onlinelibrary.wiley. 181. Kuriyama, SN. et al. (2005) Developmental ex- www.sciencedirect.com/science/article/pii/ 165. KEMI (Swedish Chemicals Agency). (2015) com/doi/epdf/10.2903/j.efsa.2018.5194 posure to low dose PBDE 99: effects on male S0045653512004353 Occurrence and use of highly fluorinated fertility and neurobehavior in rat offspring. 173. DeWitt, JC. et al. (2019) Exposure to per- Environmental Health Perspectives, Volume 158. NHS (National Health Service). (2019) NHS substances and alternatives. Report from a government assignment. https://www.kemi.se/ fluoroalkyl and polyfluoroalkyl substances 113, Issue 2. https://www.ncbi.nlm.nih.gov/pub- bids to cut up to 100 million plastic straws, leads to immunotoxicity: epidemiological med/15687051 https://www. en/global/rapporter/2015/report-7-15-occurren- cups and cutlery from hospitals. and toxicological evidence. Journal of Expo- england.nhs.uk/2019/10/nhs-bids-to-cut-up- ce-and-use-of-highly-fluorinated-substances- sure Science & Environmental Epidemiology, 182. Harley, KG. et al. (2010) PBDE Concentrations to-100-million-plastic-straws-cups-and-cutlery- and-alternatives.pdf Volume 29. https://www.nature.com/articles/ in Women’s Serum and Fecundability. Envi- from-hospitals/ s41370-018-0097-y ronmental Health Perspectives, Volume 118, Issue 5. https://ehp.niehs.nih.gov/doi/10.1289/ ehp.0901450
48 NON-TOXIC HEALTHCARE - SECOND EDITION (2019) NON-TOXIC HEALTHCARE - SECOND EDITION (2019) 49 183. Stapleton, HM. et al. (2011) Associations 192. Sirris. (2016) Successful recycling of feeding 202. WHO (World Health Organization). (2018) between Polybrominated Diphenyl Ether bottles to be expanded. https://www.sirris.be/ CIRCULAR ECONOMY AND HEALTH: OPPOR- (PBDE) Flame Retardants, Phenolic Metaboli- blog/successful-recycling-feeding-bottles-be-ex- TUNITIES AND RISKS. http://www.euro.who. tes, and Thyroid Hormones during Pregnancy. panded int/__data/assets/pdf_file/0004/374917/Circular- Environmental Health Perspectives, Volume Economy_EN_WHO_web_august-2018.pdf?ua=1 119, Issue 10. https://ehp.niehs.nih.gov/doi/ 193. Circle Economy. (Last accessed 01/11/2019) full/10.1289/ehp.1003235 CIRCLE ECONOMY: practical, scalable imple- 203. Health Care Without Harm Europe. (2013) mentation of the circular economy. https:// Declaration on Safe Medical Equipment. 184. Herbstman, JB. et al. (2010) Prenatal Expo- www.circle-economy.com/ https://noharm-europe.org/sites/default/files/ sure to PBDEs and Neurodevelopment. documents-files/1133/Declaration.pdf Environmental Health Perspectives, Volume 194. Nederland Circulair. (Last accessed 01/11/ 118, Issue 5. https://ehp.niehs.nih.gov/doi/ 2019) Circulair ondernemen. https://www. 204. KEMI (Swedish Chemicals Agency). (2015) full/10.1289/ehp.0901340 circulairondernemen.nl/ Phthalates which are toxic for reproduction and endocrine-disrupting – proposals for a 185. Vuong, AM. et al. (2018) Exposure to polybro- 195. Circle Economy and Nederland Circulair. (Last phase-out in Sweden. https://www.kemi.se/glo- minated diphenyl ethers (PBDEs) and child accessed 01/11/2019) HEALTHCARE PLAS- bal/rapporter/2015/report-4-15-phatalates.pdf behavior: Current findings and future directi- TIC WASTE: ANALYSIS OF OLVG HOSPITAL ons. Hormones and Behaviour, Volume 101. PLASTIC WASTE STREAMS. https://www.circu- 205. Lischka A. et al. (2011) Substituting phthala- https://www.sciencedirect.com/science/article/ lairondernemen.nl/uploads/669c6eb7189f26e- tes in plastic medical devices: the Austrian abs/pii/S0018506X17303240 44986a9ef69c15569.pdf experience-PVC-free neonatal intensive care unit of children’s Hospital Glanzing in Vien- 186. Cowell, WJ. et al. (2018) Associations between 196. Halyard Health. (2018). BLUE RENEW*: Are na. https://www.semanticscholar.org/paper/ prenatal and childhood PBDE exposure and you ready to BLUE RENEW*? https://www. Substituting-Phthalates-in-Plastic-Medical-Devi- early adolescent visual, verbal and working halyardhealth.com/solutions/surgical-solutions/ ces%EF%BC%9A-Lischka-Nentwich/07a6871ff- memory. Environment International, Volume sterilization-solutions/blue-renew.aspx 35b9aab8db4cf3c78d307accf8922c7 118. https://www.sciencedirect.com/science/ar- 197. Kimberley-Clark Australia & New Zealand. ticle/pii/S016041201830045X 206. French Law No. 2011-1442, article 3, provides (2012) Kimberly-Clark Health Care. http://www. for the prohibition, as of 1st July 2015, of the 187. Linares, V. et al. (2015) Human exposure to sustainability.kimberly-clark.com.au/2012/pro- use of DEHP-containing tubing in paediatric, PBDE and critical evaluation of health ha- ducts/kimberly-clark-health-care/ neonatology and maternity wards. zards. Archives of Toxicology, Volume 89, Is- 198. PVCMed Alliance. (2019) Challenges and 207. Tuncak, B. (2013) DRIVING INNOVATION: sue 3. https://link.springer.com/article/10.1007/ opportunities of plastics recycling in hospi- s00204-015-1457-1 How stronger laws help bring safer chemi- tals – PVCMed interviewed by PlasticsToday. cals to market. https://www.ciel.org/reports/ 188. Aarhus University Hospital. (2017) Aarhus https://pvcmed.org/challenges-and-opportuni- driving-innovation-how-stronger-laws-help- University Hospital fights plastic waste. https:// ties-of-plastics-recycling-in-hospitals-pvcmed-in- bring-safer-chemicals-to-market-full-version-see- www.en.auh.dk/press-room/news-archive/2017/ terviewed-by-plasticstoday/ also-executive-summary-resume-en-francais- aarhus-university-hospital-fights-plastic-waste/ 199. Informa Markets. (2019) A path to recycling tuncak-february-2013-2/ 189. Backer, S. (2018) Circular solutions for health- medical plastic waste from down under. care: Enabling circular solutions in healthca- https://www.plasticstoday.com/medical/path- re plastics. http://2018.cleanmedeurope.org/ recycling-medical-plastic-waste-down-un- CME18%20presentations/CME18_D7_Backer.pdf der/143541910360208
190. HUS (Helsinki University Hospital). (2019) 200. Axion Ltd. (2019) RecoMed: PVC take-back HUS haluaa kierrättää sairaalamuovit. https:// scheme for single-use medical devices. www.sttinfo.fi/tiedote/hus-haluaa-kierrattaa- https://axiongroup.co.uk/services/specialist-col- sairaalamuovit?publisherId=23980819&relea- lection-schemes/recomed/ seId=69860351 201. VinylPlus. (2019) VinylPlus, Committed to Sus- 191. Sirris. (2015) Sirris helps recycle hospitals’ tainable Development. https://vinylplus.eu/ baby feeding bottles. https://www.sirris.be/ blog/sirris-helps-recycle-hospitals-baby-feeding- bottles
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Author: Dorota Napierska, Chemicals Policy & Projects Officer Background research: Meri Syväntö, Research Assistant Design: prinzdesign Berlin, Marc Prinz, Maren Maiwald Published: December 2019 Photos: Titel: AlekZotoff@istockphoto, Evgeniia Medvedeva @istockphoto (P.2), pekkak@istockphoto (P.10), kzenon@istockphoto (P.12), Birute@ istockphoto (P.15), Sasiistock@istockphoto (P.18), FatCamera@istockphoto (P.20), digicomphoto@istockphoto (P.25), FangXiaNuo@istockphoto (P.33), baranozdemir@istockphoto (P.34,35), KatarzynaBialasiewicz@istockphoto (P.38)
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