European Union Attempt to Reduce Presence of Toxic Chemicals in Medical Devices Falls Short
June 2016 marked a significant milestone in the path towards safer medical devices in Europe, as the European Council's Permanent Representatives Committee and the ENVI Committee of the European Parliament endorsed an agreement on new medical device regulations reached with the European Parliament in May. The new regulation sets low concentration limits for hazardous chemicals such as Carcinogenic, Mutagenic, and Reprotoxic substances (CMRs) and Endocrine Disrupting Chemicals (EDCs) contained in medical devices. This was important progress, noted Health Care Without Harm (HCWH) Europe, which has sought to remove these chemicals from medical products wherever possible. Scientific committees are now poised to define the specific guidelines based on the most up to date scientific information and research to ensure that medical devices containing CMRs and EDCs are used as safely as possible and only when necessary.
To inform safe usage, manufacturers will be required to both label medical devices that contain EDCs and also provide information for proper usage with vulnerable populations. However, HCWH Europe notes that the compromised ability of the European Commission to define what EDCs are through REACH limits the effectiveness of the new guidelines, “as they require such a high amount of evidence that it will be virtually impossible to identify more than fraction of substances posing a threat to human health and the environment from hormone disruption.” Currently, the REACH process that is used to identify and define EDCs throughout the European Union has not proven to be particularly effective, having identified only a handful of EDC substances. Additional work to improve definitions will be necessary to fully protect patient health and the environment.
Health Care Without Ham has been working to shift markets away from PVC and DEHP-containing medical devices. For instance, one of the Healthier Hospitals Safer Chemicals Challenge goals urges hospitals to eliminate the use of thesin priority medical device categories.
[Source: HCWH Europe]
