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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

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