Health associations call for EU legislation on single use medical devices

Five health associations have adopted a joint Manifesto to call attention to the need for EU-wide legislation on the reprocessing of medical devices intended for single use.

Background

Eucomed, the Medical Technology Industry Association, the Patients' Association (PA), the International Alliance of Patients' Organisations (IAPO), the European Medical Association (EMA), the Standing Committee of European Doctors (CPME) and the Standing Committee of Nurses of the EU (PCN) have adopted a joint Manifesto, in which they call for EU regulation of all reprocessing of single-use medical devices by hospitals, reprocessors and original manufacturers. The Medical Devices Directive 93/42/EEC currently does not cover the reprocessing of such medical devices.

The five health associations argue the practice of reusing single-use medical devices by hospitals endangers the health and safety of patients as well as healthcare workers due to the risk of hepatitis and CJD (Creutzfeld-Jakob disease) infection.

In addition, referring to research in this area, the lobby group cautions about the significant impairment of performance and safety of a reprocessed single-use device. Therefore, the group says, patients should be asked to give their informed consent to the reuse of medical devices originally designed for single use, taking into account the dangers of infection as well as the possibility of device malfunction.

 

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