The future of public health took a positive step forward last week when the European Parliament’s Internal Market (IMCO) and Employment (EMPL) Committees tabled amendments that support the phase out of hazardous chemicals in medical devices.
As neither the IMCO nor EMPL Committee is the leading Committee for the Regulation Proposal on Medical Devices, health and environmental NGOs were happy to hear the result and are optimistic about the Environment Committee (ENVI) following suit when they vote in July 2013. HCWH Europe’s Policy Director Grazia Cioci commented “although it is a small victory, we are one step closer to achieving a more sustainable healthcare system that phases out hazardous chemicals in medical devices”.
The Regulation Proposal on Medical Devices requires the phase out of substances that are carcinogenic, mutagenic and reprotoxic (CMRs) and substances that have an adverse effect on the hormone system (EDCs) in all medical devices if safer alternatives exist. The highly hazardous CMR and EDC substances can be released from medical devices during use and they are commonly used in such medical devices as medical tubing, hemodialysers, new-born incubators and dental composite resins, to name but a few. They are known to contribute to causing serious health effects, including hormone related cancers, birth defects, reproductive impairments, diabetes and neurological disorders.
However, it wasn’t all positive news. The vote on tackling the unintended release of nanomaterials into the body from medical devices did not go so well. Despite the 2007 recommendation by the European Commission’s Medical Devices Experts Group on New and Emerging Technologies, whereby patients and users shall be protected from unintended release of nanomaterials into the body, the IMCO Committee vote wanted only medical devices that are intended to intentionally release nanomaterials to go down a strict authorisation route. Cioci points out that “the Committee does not take into consideration the recommendations of the EC’s Expert Group and the potential risks to human health from accidental and unexpected release."
If the vote on the EC proposal for a Regulation on Medical Devices, which is scheduled for 10th July in the Environment Committee, confirms the positive outcome of the IMCO and EMPL Committees’ decision, the EC proposal for a Regulation on Medical Devices will be considerably improved and the protection of patients, healthcare practitioners and users of medical devices will be guaranteed.
HCWH Europe is a non-profit coalition of European hospitals, healthcare systems, medical associations, healthcare professionals, local authorities and environmental and health organisations. They aim 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.