Brussels — After multiple postponements, the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) voted yesterday on the medical device regulation proposal and took a positive step towards a safer healthcare sector.
The ENVI Committee supported a set of amendments tabled by the Member of European Parliament (MEP) Sirpa Pietikäinen from the Internal Market and Consumer Protection (IMCO)Committee that call for the phase out of substances classified as carcinogenic, mutagenic and reprotoxic (CMRs) and those that disrupt the hormone system (EDCs).
As a result of yesterday’s ENVI vote, phthalates - a very hazardous group of chemical substances used as plasticisers for PVC and therefore present in many medical devices - shall be banned from 1st of January 2020 in medical devices that are invasive or used to transport and administer liquids into and from the body and employed for treatment on children, pregnant and nursing women.
Additionally, all CMRs and EDCs that are present in medical devices used on other, less vulnerable groups will be phased out, whenever safer alternatives are available, within 8 years of entry into force of the Regulation. In the case that no safer alternatives exist, the manufacturer has to provide a justification for the use of these substances.
Unfortunately, the amendment supporting the identification of EDCs according to the new criteria currently being developed by the European Commission has not gone through the MEPs vote. In the case of nanomaterials, the ENVI committee decided to weaken the European Commission’s proposal and open an easier route of pre-market authorisation for medical devices containing nanomaterials without taking into consideration the potential risks for human health from the accidental release of these compounds from the devices. This highlights the lack of clear provisions at the European level for products that exhibit at the same time pharmacological and mechanical functions. This means that patients and workers may be exposed to nanomaterials with unknown consequences.
HCWH Europe Executive Director Anja Leetz states, “yesterday’s ENVI vote regarding EDCs and CMRs is a necessary and positive first step towards implementing a toxic-free European healthcare system. HCWH Europe believes that strong EU legislation can push the healthcare sector to move away from unsustainable practices that pollute the environment and contribute to disease.” It is now down to Member States to act for the protection of human health and the environment by supporting the phase out of CMRs and EDCs in medical devices.
The phase out of hazardous chemicals in medical devices has also been widely supported by over 900 hospitals, medical institutions and healthcare systems and over 16 million healthcare professionals worldwide - all of whom work with and use medical devices on a daily basis and have co-signed a declaration on safer medical devices initiated by HCWH Europe.
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.