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Non-toxic Healthcare:

Alternatives to Phthalates and

Bisphenol A in Medical Devices

ACKNOWLEDGMENTS

Author: Maria José Amaral, PhDResearch: Maria José Amaral, PhD, Cristina Grigore - HCWH Europe, Paul Whaley With special thanks to: Grazia Cioci - HCWH Europe, Ted Schettler, PhD - Science and Environmental Health Network, Ruth Stringer - HCWH

Editor: Mary Taylor

Copyright of images: Shutterstock.com

Design: Emily J Fischer | www.emilyjscher.com

Published 31 December 2014

Table of contents

FOREWORD4

EXECUTIVE SUM

MARY 6 I

NTRODUCTION

8

Hazards of chemicals contained in medical devices

9

Hazards for human health

10

Exposure through medical devices

11

Hazards for the environment

13 The European legal framework on hazardous chemicals in medical devices 14

Why publish this report now?

15 CHAPTER 1: SUBSTITUTING HAZARDOUS CHEMICALS IN MEDICAL DEVICES 16

Governmental initiatives

18

Non-governmental initiatives

20

CHAPTER 2: AL

TERNATIVES TO PHTHALATES

22

CHAPTER 3: AL

TERNATIVES TO BISPHENOL A

26

CHAPTER 4: BEST PRA

CTICES IN EUROPEAN HEALTHCARE

30

Hospital of Southern Jutland substitution pr

oject (Denmark) 32
Stockholm County Council"s phase-out list (Sweden) 32
Kar olinska University Hospital substitution programme (Sweden) 33
PV C-free Paediatrics and Neonatology Department in the Westfriesgasthuis (Netherlands) 33
PV C-free Neonatal Intensive Care Units of the Vienna Hospitals Association (Austria) 33
CHAPTER 5: RECOMMENDATIONS AND CONCLUSIONS OF HEALTH CARE WITHOUT HARM EUROPE 34

HCWH Europe"s Recommendations 35

Conclusions

37

REFERENCES

38
4

Non-toxic Healthcare:

Alternatives to Phthalates and Bisphenol A in Medical Devices

Foreword

Prevention of disease is an essential part of

healthcare. We vaccinate our children to stim ulate immunity. We operate with sterile instru ments to prevent infection. We educate preg- nant mothers in order to promote foetal health.

As physicians we took an oath to treat our

patients in the best manner possible, and we swore to "?rst do no harm". Preventing disease is still better than treating it. And that is what this report is about: choosing better alternatives in daily healthcare, in order to prevent disease further down the line.

PVC (polyvinyl chloride) is a widely used plas-

tic. It is often made more ?exible by the use of the phthalate DEHP, long considered to have toxic characteristics. The European Union has banned the use of DEHP in toys for children under the age of 3 years (1999/815/EC). Young children tend to put toys in their mouths and

DEHP leaches out of the plastics, exposing the

developing child to the chemical. One of the ?rst campaigns of HCWH Europe was to elimi nate DEHP, the most commonly used phthalate, in intravenous drips. We've known for decades that phthalates leach out of medical devices such as tubing. Yet better alternatives were not available thirty years ago. That is no longer the case. It is then a matter of choice: do we choose better alternatives or do we choose to ignore the potential danger to the patients we are try- ing to treat? There is mounting evidence of en docrine disruption: unintentionally in?uencing hormone systems is unwise. We have seen an increase in breast and testicular cancers, in thy- roid disorders, and infertility throughout Europe over the last decades. It is then alarming to note that these endocrine systems are in?uenced by phthalates.

Similarly, bisphenol A (BPA) has been linked to

endocrine disruption. This report presents the

evidence in a clear and concise manner. BPA was initially developed as a synthetic oestrogen in 1891. Due to the availability of more potent

synthetic oestrogens, such as thalidomide, BPA was not widely used until the second half of the twentieth century. Now it is a major part of daily life: from the ink of cash register paper to the linings of beverage cans - and in medical de- vices. Until recently BPA was also found in baby bottles.

A number of years ago the American Medical

Association issued a statement encouraging

healthcare providers to reduce the use of prod ucts containing PVC and DEHP, and to choose better alternatives (Res. 502, A-06). Many Eu ropean healthcare providers have also made a conscious choice to eliminate PVC, DEHP and

BPA from daily healthcare. A number of exam

ples are discussed in this report. But still not enough is being done. This is partly due to limit- ed political will. Although a number of European countries, such as Denmark and France, have taken bold steps towards elimination, European legislation is still lacking. Currently, the EU Di rectives on medical devices are under revision and a new proposal for a regulation on medical devices is under discussion in the European in stitutions. It would be disappointing should eco- nomic issues prevail above doing what is right: protecting our patients and preventing disease.

This report presents evidence that policy makers

should not ignore. The report is a plea to poli ticians and governing bodies to adopt stringent legislation to eliminate the use of PVC, DEHP and

BPA in healthcare. Legislation would stimulate

healthcare providers to choose better products.

What could be more important than the health

of Europe's citizens?

Gavin W. ten Tusscher, MD, PhD, paediatrician

Westfriesgasthuis, Hoorn, Netherlands

6

Non-toxic Healthcare:

Alternatives to Phthalates and Bisphenol A in Medical Devices 7 Medical devices play a critical role in healthcare but may contain hazardous substances in their composition that can leach out into patients during their use, compromising patient safety.

Concerns have been raised by dierent societal

groups, including governmental bodies, health care professionals, scientic researchers and civil society organisations, regarding the poten tial health eects of chemical exposure through medical devices to vulnerable groups of the population.

At the end of 2012, the European Commission

adopted a proposal for a Reg- ulation to recast the existing

Directives on medical devic-

es. In its report, the Europe- an Parliament voted in favour of an amendment that would strengthen the current rules on hazardous substances in medical devices, enforcing the phase-out of these substances when safer alter- natives are available.

Substances that are commonly present in med

ical devices and which are of particular concern are phthalates and bisphenol A (BPA). Phthalates are commonly used as softeners in PVC-based medical devices while BPA is used in a variety of plastics with applications in the medical device industry. One of the major reasons of concern with these substances is that they are endocrine disrupting chemicals that may interfere with the normal functioning of the endocrine system and present a hazard to dierent physiological and developmental processes.

Health Care Without Harm Europe"s mission is

to transform the healthcare sector so that it is ecologically sustainable and no longer a source of harm to public health and the environment.

At the same time, this must happen without

Executive Summary

compromising patient safety or care. This report is part of HCWH Europe"s work to raise aware- ness on the presence of hazardous substances in medical devices and the risks to patients, and most importantly to promote the substitution of these substances by showing that many alterna tives with better toxicological proles are avail able on the market. Change is not only possible but it is already on the way. This change is be- ing led by certain manufacturers, governments, health systems, hospitals and health practi tioners and needs to be further encouraged and supported by political and regulatory action.

HCWH Europe proposes a number of specic

recommendations to promote a move towards non-toxic healthcare, minimising the hazards to patients without compromising medical care:quotesdbs_dbs30.pdfusesText_36

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