Brussels — On 21 March 2013, HCWH Europe organised, and MEP Corine Lepage (ALDE) hosted, a parliamentary lunch workshop to discuss why we should move towards a non-toxic European healthcare system and demand for alternatives to harmful chemicals in medical devices. The event also aimed at contributing to the current debate in the European Parliament on the new European Commission’s proposal on the Medical Device Regulation.

MEP Corinne Lepage pointed out that patients who need these devices are dependent and should not be considered as guinea pigs. This issue is crucial but does unfortunately not seem on the radar screen of the European decision makers. We need to reinforce the rules before and after the placing on the market and we need an ambitious legislation on this issue.

The workshop conveyed the opinion of medical device producers, doctors and hospital facility managers about their experience in producing, purchasing and using medical devices without EDCs and in particular phthalates. Phthlates are used as PVC plasticizers and are abundant in PVC-based medical devices such as blood bags, intravenous bags, tubes, catheters and disposable gloves, primarily in the form of the phthalate di-(2-ethylhexyl)phthalate (DEHP). Phthalates may leak directly into human body, and different scientific studies have found phthalates and their metabolites in urine, blood, naval cord blood, semen, breast milk, placental tissue and amniotic fluid.

Anja Leetz called for a more ambitious legislative proposal on medical devices that aims to achieve an EDCs-free European healthcare sector. Anja stated that we require strong regulatory leadership that will both raise awareness on this issue amongst healthcare professionals and push producers to develop more alternatives to phthalates and PVC in medical devices.

The trailer of the movie "Hazardous Chemicals in our Blood" produced by the Danish Ecological Council and to be released next week provided a starting point for the discussion.

Sami-Frank Rifai explained how C2DS has been raising awareness on the problem of phthalates in medical devices and noted a growth in demand for these products, which ultimately lead to the adoption in France of law to ban the use of DEHP in tubes in paediatric, neonatology and maternity wards in hospitals by 2015. This is an important step towards the phase out of phthalates at the European level.

Charlotta Brask presented the chemicals strategy of the Stockholm County Council that has lead to a 90% reduction of hazardous chemicals between 2007 and 2011. The chemicals strategy is based on the Stockholm County Council phase-out list that is aligned with the REACH candidate criteria and applied throughout the procurement process. Charlotta further noted that there is the need for the healthcare sector to work together, share criteria and increase the demand for alternatives that minimize exposure to endocrine disruptive chemicals.

Dr. Armin Reidel presented the range of DEHP-free alternatives commercialised by Fresenius Medical Care, including systems for blood collections, preparation and storage. He also mentioned the lack of awareness on the risks of softeners, such as DEHP, by hospital managers and the resulting low demand for phthalates-free medical devices.

Mrs. Stigh presented the challenges to bring safe blood bags into healthcare and the first results of the Life+ Environment project PVCfreeBloodBag, a collaboration between industry and the healthcare sector, aimed at demonstrating that it is possible to produce a PVC-free blood bag.

Prof. Andreas Lischka mentioned the growing scientific evidence that exists on the toxic effects of plasticizers in PVC-containing medical devices, in particular DEHP, pointing at the risks for foetus, new-borns and infants. In addition, Prof Lischka presented the successful example of the Children Hospital ”Klinderklik Glanzing” that, in collaboration with the Vienna Hospitals Association, has phased out PVC containing medical devices in the neonatal unit.

Health Care Without Harm Europe calls on the legislators, hospital systems and general public to increase the pressure on industry to encourage the production and commercialization of medical devices that do not contain phthalates and consequently cause no harm to the health of European citizens.

Note for Editors:

At the EU level, DEHP was identified as a Substance of Very High Concern (SVHC) according to Article 57c of the Regulation 1907/2006/EC (REACH). DEHP is classified as a reproductive toxicant that may impair fertility and cause harm to unborn children. Despite of being made up from as much as 20-40% DEHP medical devices are exempted from the authorization process (Article 60(2) and 62(6)).

Who is Who:

Mrs. Corinne Lepage is a French politician, member of the European Parliament and a former minister of the Environment that has always been a fierce defender of environmental interests in and outside her political career.
Mrs. Anja Leetz is the Executive Director of Health Care Without Harm Europe, an international coalition of hospitals and healthcare systems, medical professionals, health-affected constituencies and environmental and health organizations. HCWH mission is to transform the healthcare sector worldwide so that it becomes environmentally and ethically sustainable and no longer a source of harm.
Mr. Sami-Frank Rifai is the Director of the Hôpital Privé d’Evry in Paris, and Treasurer of the Comité pour le Développement Durable en Santé (C2DS). C2DS is a French NGO with 330 hospital members that promotes better practices to manage the environmental, human and economic impact of healthcare activities.
Mrs. Charlotta Brask is Head of the Environmental Department of the Stockholm County Council (Sweden), which has committed to continuously decrease their environmental impact in the healthcare and transport sector and has implemented an ambitious environmental plan.
Dr. Armin Reidel is Business Unit Manual Blood Processing Director at Fresenius Kabi, (Germany), part of the Fresenius Medical Care. Fresenius Medical Care was the first medical company certified by the Nordic Ecoloabel (SWAN) for its PVC-free medical products.
Mrs. Lena Stigh is Project Manager for the EU LIFE+ project PVCfreeBloodbag.eu in the Jegrelius Institute for Applied Green Chemistry, Regional council of Jämtland, Sweden.
Prof. Dr. Andreas Lischka is the former Head of the “Kinderklinik Glanzing” Children Hospital, which is part of the Vienna Hospital Association, and has been for many years involved in a campaign to phase out PVC.

Towards Non-Toxic Healthcare Workshop Report

Charlotta Brask's presentation

Sami-Frank Rifaï presentation

Prof Andreas Lischka's presentation

Lena Stigh's presentation

Stockholm County Council phase out list of chemicals

Health Care Without Harm is an international coalition of more than 500 organizations in 53 countries, working to transform the health care sector worldwide, without compromising patient safety or care, so that it is ecologically sustainable and no longer a source of harm to public health and the environment. Visit the HCWH website for more information.