Report on the reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 93/42/EEC
Reprocessing of medical devices.
The EC published on 30 August 2010 their report on the issue of reprocessing of medical devices in the European Union. The report, which does not contain any policy measures, is an assessment of the issue regarding public health, ethical, legal, economic and environmental aspects.
This document aims to give a clear overview of the situation in Europe of reusable and single-use medical devices .First of all it describes the evolution of those instruments (from majority of reusable instruments to the diffusion of single-use devices during the 80s and the 90s) and then it analyzes the situation in the EU and in other Countries such as the US, Canada and Japan.
In order to understand the possible risks of a reprocessed device, the Scientific Committee on emerging and Newly Identified Health Risks (SCENIHR) has been charged with a study and the elaboration of a report. The major hazards identified by the SCENIHR are remaining contamination, the persistence of chemical substances used during the reprocessing process and the alterations in the performance of the single use medical devices due to the reprocessing.
The report includes not only safety considerations but also economic and environmental issues.
In the report, the EC recognizes that the "reuse of single use medical devices may not be without risk from a public health point of view" and highlights the fact that "to date, no comprehensive study clearly demonstrates that reprocessing single use medical devices is globally a cost effectiveness and environmental friendly practice when done under high quality standards". The EC also points out that in order to identify the potential risks associated with this practice the entire reprocessing cycle needs to be "evaluated and validated".