Brussels 22/10/2013— In today’s plenary session, the European Parliament (EP) voted favorably for the European Commission’s proposal on Medical Devices that among other issues stipulates a ban on hazardous chemicals in medical devices.
The ban applies to chemicals that are carcinogenic, mutagenic and reprotoxic (CMR), such as certain phthalates and metals, or that have endocrine disrupting properties (EDCs), and which are contained in medical devices that are invasive or come into contact with the body of patients or are used to administer, transport or store medicines, body fluids or other substances, including gases in concentrations above 0.1% by weight. Health Care Without Harm (HCWH) Europe, a Brussels-based organization representing the voice of the European healthcare sector welcomes today’s EP vote. Executive Director Anja Leetz states “this is a huge victory coming from the European Parliament, particularly considering that currently, aside from minimal labeling requirements, there are no restrictions on using hazardous substances in medical devices“. The amendment adopted today, submitted to the Plenary by MEP Michèle Rivasi on behalf of the Greens, still allows the use of CMRs and EDCs in medical devices for a maximum of four years through a derogation process. Manufacturers may ask for exemption in the case that the elimination or substitution of these substances is technically impracticable, the reliability of the substitute substance is not ensured or if the negative impact caused by the substitution outweighs the benefits on the patient’s health and safety. Finally, the amendment also introduces that EDCs are to be identified not only through the procedure specified in REACH, but also by scientific evidence of their effects on human health or the new criteria being developed by the European Commission. Looking ahead towards the trilogue, Ms Leetz continues “we now hope that the European Council follows suit and that countries like France, who have already banned the phthalate DEHP in tubing for neonates, and Denmark whose Health Minister supported the phase out of phthalates in medical devices will make their voice heard”.
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