NON-TOXIC HEALTH CARE: SECOND EDITION (2019) Alternatives to Hazardous Chemicals in Medical Devices: Phthalates and Bisphenol A - Health Care ...
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
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
We have known for decades that certain hazardous and health practitioners are starting to come toge- from medical devices, particularly for vulnerable
vulnerable groups. Consistent technical imple-
chemicals leach out of medical devices, such as ther to lead this change; many European healthca- population groups.
mentation of Annex I.II.10.4 of the MDR must
phthalates in plastic tubing. One of Health Care Wit- re providers have already moved to eliminate PVC, In 2017, the European Council adopted the Medical therefore be ensured. The benefit-risk assess-
hout Harm (HCWH) Europe’s first campaigns focu- DEHP, and BPA from healthcare practice. HCWH Devices Regulation (MDR), fully applicable to medi- ment of the presence of hazardous chemicals
sed on the elimination of DEHP, the most common- Europe has highlighted a number of examples in cal devices placed on the EU market as of 26 May in certain medical devices should therefore be
ly used phthalate, in intravenous drips. Our work in recent years, some of which are listed in this report. 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
treatment using multiple devices. political and regulatory action, such as in France for harmful chemicals with safer alternatives. l Devices should be subject to stringent com-
example, where tubes and pipes containing DEHP pliance assessment of required labelling by a
The endocrine-disrupting properties of these che- Phthalates and Bisphenol A (BPA) are substances of
are banned in paediatric, neonatal, and maternity Competent Authority. Information labelled in
micals are now well established; we have seen an particular concern that are often found in medical
departments in hospitals. The new Medical Devices accordance with the MDR must be accessible
increase in endocrine-related diseases such as bre- devices. Phthalates are commonly used as plastic
Regulation introduces provisions that would help to the public via the revamped European Data-
ast and testicular cancers, thyroid disorders, infer- softeners in PVC-based medical devices, whilst BPA
phase out endocrine disrupting chemicals, carcino- base on Medical Devices (EUDAMED)
tility, and diabetes throughout Europe over the last 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 the medical device industry. A major concern sur- devices needs increased transparency
This second edition of Non-toxic Healthcare forms
alternatives are available and technically feasible. rounding these substances is that they are known
an important part of HCWH Europe’s work to rai- l Sustainable procurement guidelines should
This is a positive step and one that HCWH Europe endocrine disrupting chemicals (EDCs), which may
se awareness about the presence of hazardous provide incentives for the substitution of ha-
will continue to follow and support through its im- interfere with the normal functioning of the human
substances in medical devices and the consequent zardous chemicals in medical devices
plementation. endocrine system and therefore present a hazard
risks to patients. This report also contains a new
Prevention is always better than cure, and this the- to different physiological and developmental pro- l Funding for research and development of alter-
chapter specifically examining the health impact of
me is central to the recommendations laid out in cesses. EDCs can impact upon the human body native substances and products and for clinical
plastics in healthcare.
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
INTRODUCTION ment procedures lack integration of endocrinolo-
gy concepts, the effects of EDCs in human health
exposure can be harmful for patients as they will
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.
present in medical devices to improve plastic per- Substances that are commonly found in medical
reviewed the latest science and declared that the
evidence for adverse reproductive effects is strong
BOX 2
formance e.g. plasticisers, flame-retardants, fillers, devices and are of particular concern are phthala- and mounting for effects in areas such as neuroen- What are phthalates?
colourings, impact modifiers, and stabilisers. These 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- Phthalates are a group of chemical substan-
thyroid systems, and insulin resistance. Further, the
of the final product (in some case up to 80%) and cent years due to their widespread use in consu- ces, primarily used as plasticisers (softeners) in
effects may also be transmitted to future generati-
can leach out of products and have adverse effects mer products and the risks they pose to human plastics to make them more flexible. Depen-
ons.11
on human health and the environment. health and the environment. The endocrine-dis- ding on the number of carbon atoms in their
A European Parliament study reviewed the scienti-
Concerns regarding hazardous chemical exposure rupting properties of these chemicals are also well alkyl side-chains they are divided into:
fic evidence of endocrine disruption, the extent of
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
BOX 1 devices decades of multidisciplinary research in endocrino-
logy, ecotoxicology, toxicology, epidemiology, clini-
carbons (e.g. DEHP, DBP, DIBP and BBP)
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, and other disciplines, endocrine disruption is now bons. (e.g. DEP and DMP)
(Regulation 2017/745 on medical devices1) including consumption of contaminated food and an important and validated scientific concept.12 The Phthalates are abundant in polyvinyl chloride
water, air and dust inhalation/ingestion, and dermal evidence therefore justifies classifying EDCs as a
Any instrument, apparatus, appliance, software, (PVC) medical devices such as blood bags, in-
absorption. Human biomonitoring studies have de- specific class of hazard, equivalent to that of car-
implant, reagent, material, or other article inten- travenous bags, tubing, catheters, respiratory
tected hazardous chemicals like phthalates and cinogenic, mutagenic, reprotoxic chemicals (CMRs).
ded by the manufacturer to be used, alone or in 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 Di-2-ethylhexyl phthalate (DEHP) has for many
l Diagnosis, prevention, monitoring, predic- blood, sperm, and saliva.2 3 4 5 6 7 8 9 The majority of
exposure from other sources: EDCs are ubiquitous years been the most commonly used phthala-
tion, prognosis, treatment, or alleviation of studies show widespread exposure to phthalates
and the entire population is already exposed. Furt- te ester plasticiser in medical devices. A 2014
disease in unborn children and infants across Europe. The
hermore, vulnerable population groups such as survey in the Danish Medical Device Industry
l Diagnosis, monitoring, treatment, allevia- new European Human Biomonitoring (HBM4EU)
neonates, infants, pregnant and breast-feeding wo- found that 95% of products contained DEHP.14
tion of, or compensation for, an injury or Initiativei (2017-2021) aims to coordinate and ad-
men, and the elderly are not adequately protected DEHP can contribute up to 40% of weight of
disability vance human biomonitoring in Europe. The project
from the risk of exposure to these chemicals. The intravenous bags and up to 80% of weight in
represents a joint effort of Members States, the
l Investigation, replacement or modifica- most at risk groups comprises dialysis patients and medical tubing.15 Leaching of DEHP from PVC
European Environment Agency, and the European
tion of the anatomy or of a physiological neonates in intensive care units, as they experien- medical devices has been documented since
Commission. One of the objectives of HBM4EU is to
or pathological process or state ce frequent and intimate contact with a number of the late 1960s.16 17 18 Use of PVC medical de-
generate scientific evidence on the causal relation-
medical devices containing EDCs. Premature babies vices may lead to a higher exposure to DEHP
l Providing information by means of in vitro ships between exposure to prioritised chemicals
and infants are particularly sensitive to phthalate than everyday sources affecting the general
examination of specimens derived from (including phthalates and bisphenols) and the ad-
effects, as their reproductive system is still develo- population.19
the human body, including organ, blood, verse health effects and public health implications.
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).
device may be assisted in its function by such formation and growth, sexual maturation, stress re-
Despite claims that exposure to hazardous chemi-
means. sponse, and behaviour.10 As traditional risk assess-
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-
What is Bisphenol A? ta and breast milk.26 Exposure to DEHP and DBP repeated medical treatment using medical devices, mon early and chronic complications of prematu-
has been linked with reproductive alteration inclu- and patients undergoing haemodialysis are at risk rity.52
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,
tion equipment, neonatal care medical devices, centration of the general population in the US).54
nufactured and/or imported in the European including reproductive toxicity in women and men,
Economic Area (EEA) annuallyiii, from which and urinary catheters have demonstrated releases Recent clinical studies provide information about
cancer, insulin resistance and type II diabetes, over-
over 95% of BPA is used in the production of of BPA.23 Length of contact time (duration of expo- the overall significant exposure to BPA during hae-
weight and obesity, allergy and asthma.6 Growing
polycarbonates and epoxy resins.20 21 sure), temperature and pH, among other parame- modialysis treatment in patients suffering from
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 The materials used in medical devices are also an
tors, syringes and blood oxygenators. BPA has (erectile dysfunction, miscarriage), cardiovascular care units, infants undergoing prolonged medical important factor. In one study, BPA concentrations
been shown to leach from medical devices diseases, thyroid, immune and metabolic diseases procedures, and for dialysis patients.23 The risk of among infants in one healthcare unit were approxi-
into liquids.22 23 European PVC manufacturers (diabetes), childhood obesity as well as general/ab- adverse effects due to BPA may exist in patients un- mately 17 times higher than another unit.54 Patients
informed the Scientific Committee on Emer- dominal obesity and hypertension, neurodevelop- dergoing dialysis treatment since BPA accumulates undergoing regular continuous ambulatory peri-
ging and Newly Identified Health Risks (SCE- ment impairments, respiratory conditions and in systemic circulation due to reduced renal clea- toneal dialysis using plasticiser-free devices had
NIHR) that they no longer use BPA as stabiliser behaviour alterations (anxiousness, hyperactivity, rance. Although the benefit of medical devices has reduced levels of phthalates in urine and blood.57
or antioxidant in PVC production.23 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- that, where practical, medical devices that do not
ii https://echa.europa.eu/ reduced from 50% to 13% in neonates fed through
tility.44 leach BPA should be used.23 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-
There is growing evidence that many phthalates exposed patients. There is emerging evidence that
complex diseases (cancers and diabetes).45 presentative of acute to sub-chronic exposure in a
and BPA can present a hazard to human health and the use of medical devices containing DEHP is po-
toxicological context).
are recognised in the EU as endocrine-disrupting tentially harmful for the brain development and
Exposure through medical devices A number of observations from the scientific lite- function of critically ill children. Belgian clinicians
compounds. Evidence comes from in vitro and ani-
rature are available, confirming the link between identified a clear link between previously hospita-
mal studies as well as clinical and epidemiological
Exposure to hazardous chemicals through medi- use of plastics in medical devices and exposure of lised children’s long-term neurocognitive test re-
studies encompassing both prenatal and postnatal
cal devices can be enteral (via the digestive tract), patients to phthalates and/or BPA. A strong asso- sults and their individual exposure to the phthalate
exposures.
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 late metabolites, explained by leaching from medi-
Newly Identified Health Risks (SCENIHR)19 which majority of human exposure. Several studies have two neonatal intensive care units.47 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 from medical devices and recorded levels in uri- high-risk neonates.48 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
der mature animals; ii) even low-level exposures to Another recent study highlighted the impact of acu-
plastic devices into body fluids and subsequent mi- tubes had increased levels of DEHP in their urine.49
DEHP during pregnancy can affect male genital de- te mono-2-ethylhexyl phthalate (MEHP, the primary
gration into human tissues was first reported in the Certain vulnerable patients groups such neonates
velopment.24 metabolite of DEHP) exposure on cardiac electrop-
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
cardiac death (SCD).61 As emphasised by the aut- for high exposure to DEHP19 and BPA23 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 her risk due to their lower birth weight com-
These data strongly support SCENIHR’s recommen-
dation to use medical devices with low DEHP and l Enteral nutrition in neonates and adults bined with the fact they require many medi-
The European legal framework on hazar-
BPA release potential, whenever possible. cal interventions. In addition, the unborn and
l Heart transplantation or coronary artery dous chemicals in medical devices
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 mical regulations – the EU Regulation 1907/2006
l Peritoneal dialysis
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- the age of 3 months.3 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
from polycarbonate l Chemical substances, either on their own or
Phthalates and BPA have been detected in aquatic
as mixtures. Examples of mixtures include lu-
4. Haemodialysis and marine environments, terrestrial ecosystems
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 Articles (that is, objects with a function deter-
These substances have also been shown to bioac- l
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
DEHP (authorisation list)65 and BPA (candidate list)66 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). ticsEuropeiiii (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-
DEHP, BBP, DBP, and DIBP.69 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 determining the transitional period. Consequently,
in collaboration with the Member States and the
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
DCHP (Dicyclohexyl phthalate) 84-61-7 Toxic for reproduction; Endocrine disrup- been added (Annex IV), specific to medical devices
more robust EU legislative framework to ensure
ting properties for human health and monitoring and control instruments for which
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 establishment of a comprehensive EU database on
DPP (Dipentyl phthalate) 131-18-0 Toxic for reproduction
– 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-
tion, “Devices shall be designed and manufactured in BOX 6 pean Commission, it will also be accessed by the Many alternative substances and materials have
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-
tified Bodies, Economic Operators (manufacturers, hazardous chemicals used in medical devices, in-
sed by substances or particles, including wear debris, Regulation (EU) 2017/745, Annex
authorised representatives, importers, sponsors), cluding for phthalates and BPA. There is a choice
degradation products and processing residues, that I.II.10.4 (Substances: 10.4.1. Design
experts, and the public, including medical instituti- now to be made between safer alternatives or ig-
may be released from the device.” and manufacture of devices):
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
that would help phase out endocrine disrupting Creating greater transparency will allow for a better
terials used therein that: with the MDR there is a real opportunity to accele-
chemicals (EDCs), carcinogenic, mutagenic and re- understanding of what medical devices are placed
rate the process of phasing-out phthalates and BPA
protoxic substances (CMRs), and phthalates in me- l Are invasive and come into direct contact on the EU market and who is ultimately responsi-
and minimise patients, and in particular vulnerable
dical devices if safer alternatives are available and with the human body ble for them. The level of access, however, will differ
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 or other substances, including gases, to/ Theoretically, procurers (such as hospitals and Com-
multiple sources, but healthcare should not be one
(benefit-risk assessment) to the Notified Body for from the body, or petent Authorities) will be able to access, search,
of these. As Kambia and co-authors stated already
the presence of those substances if they are pre- transport or store such medicines, body and filter the content of EUDAMED to identify safer
more than fifteen years ago, when exposures to
sent above a certain concentration (see Box 6). The fluids or substances, including gases, to medical devices for their procurement process.
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
in a concentration that is above 0,1 % w/w rable.71
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-
dition, the risk in terms of hazards associated with
dical devices’ labelling (in accordance with provisi-
ons laid down in Annex I.II.10.4.5). It also specifies
BOX 7
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
should provide information on residual risks for I.II.10.4 (Substances: 10.4.5. Labelling):
phthalates covered under MDR Annex I Chapter II
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 PVC-free Blood Bag project ment’s safety can be guaranteed.
of the Treaty on the Functioning of the European Eastman Chemical Company has teamed up
The French National Agency for the Safety of Medi-
Union (EU) and aims to ensure a high level of en- The PVC-free Blood Bag Project (www.pvcfree- with BloodCenter of Wisconsin (BCW) on a cli-
cines and Health Products (ANSM) tested medical
vironmental, consumer and human health protecti- bloodbag.eu) was a Life+ collaborative initiati- nical trial evaluating a new plasticiser for blood
devices on the French market, targeting 3 thera-
on through preventive decision-making in the case ve between industry and the healthcare sector bags. The aim of the trial is to evaluate the
peutic areas in which PVC devices were presented
of risk. Nevertheless, the decision whether or not that aimed to demonstrate that it is possible stability of red blood cells in di-2-ethylhexyl te-
as DEHP-free: haemodialysis, enteral feeding and
to apply the precautionary principle appears to be to produce a blood bag without using PVC. rephthalate (DEHT) plasticised containers com-
infusion.77 During market surveillance ANSM obser-
poorly defined, with ambiguities inherent in deter- The project, which was completed in 2017, has pared with standard di-2-ethylhexyl phthalate
ved that a large number (around 70%) of these de-
mining what level of uncertainty and significance of shown that it is possible to produce a comple- (DEHP) plasticised containers. The trial expan-
vices in which DEHP was not added as plasticiser,
hazard justifies invoking it.72 Decision makers prefer tely PVC-free set of four bags, which can store ded upon the use of DEHT as an alternative to
actually contained residual quantities of DEHP, with
to wait until overwhelming scientific evidence is gat- red blood cells and fulfil the requirement spe- DEHP for bags to store red blood cells in AS-1
however, concentrations lower than 1,000 ppm
hered, often taking a long time to achieve, and po- cifications including a gap analysis for CE-mar- and PAGGSM preservative solutions. The trial
(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-
effects cannot be undone. ral-purpose plasticizer, is a viable alternative
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 The Safer Medical Devices Database by
been replaced by alternative materials or substan- Initiative, and Karolinska University Hospital
and benign toxicology profile.74 HCWH Europe
ces. In the case of the phthalates, phthalate-free or is now working towards a PVC-free blood pro-
PVC-free medical devices are available for nearly all cessing and storage system. Their objective is “PVC blood bags without phthalates of concern
are just around the corner” 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
ing a phase-out programme for phthalates or BPA
Many hospitals have already made considerable PVC-free blood bags on the European market.
is knowing what alternatives are available and the
progress, having adopted phase-out policies and Demonstrating widespread demand is critical
impact and effectiveness of the alternative. Enga-
committing to using products that are less harmful to achieving that goal and other European he-
gement and communication with manufacturers is
althcare providers are invited to show support
for patients. However, most of these initiatives are
for this initiative by signing a Letter of Intent,
Governmental Initiatives therefore essential. To enable healthcare procurers
only happening due to the commitment of indivi- to identify medical devices that do not contain PVC
duals and in spite of a lack of political or regulatory available here: 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 altogether.15 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- when appropriate evidence becomes available.
No clinical studies have systematically compared
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-
In 2014, the Danish Environmental Protection of raw materials for all plastics used in the compo-
se interested in substituting hazardous chemicals
Agency published a report looking at alternative sition of the various parts of a medical device and
in products. The Case Story database in the portal
plasticisers in medical devices to DEHP, BBP, DBP not just PVC.
includes the assessment of alternative substances
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) 19You can also read
