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Public Health (20-04-2010)

Safety of reprocessed medical devices marketed for single-use - Adoption of scientific opinion

Today, the Commission's independent Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) publishes its opinion on the safety of reprocessed medical devices marketed for single-use.

A single-use medical device (SUD) is a device intended to be used once only for a single patient. Examples of SUDs are single-use syringes and needles, catheters and breathing tubes.

The Directive (93/42/EEC) regulating the placing of medical devices on the EU-market distinguishes between devices that are intended for reuse and those intended for single-use only. However, the practice of reprocessing SUDs is not regulated at EU-level and legislation in Member States differs. A few countries allow the reprocessing of SUDs, others prohibit the practice and some have no specific legislation.

The Commission asked the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) to assess whether the reprocessing of SUDs may constitute a hazard for human health.

Although clinical data is limited, the SCENIHR opinion identifies several potential hazards of re-using SUDs that may lead to a risk for patients. The opinion concludes that certain design features make a SUD unsuitable for reprocessing. Major hazards can arise from inadequate cleaning, disinfection and/or sterilization, resulting in contamination and possibly causing toxic reactions or infections. Chemicals used for disinfection may also affect the performance of the device. Areas of particular concern are the potential contamination with agents that cause transmissible spongiform encephalopathies (TSEs) and the risk of using reprocessed SUDs in invasive medical procedures. Other hazards mentioned in the opinion include poor traceability of a reprocessed SUD and loss of documentation such as the instructions for use.

The Commission will now finalize the report on the issue of the reprocessing of medical devices in light of the SCENIHR opinion and will submit it to the European Parliament and the Council in accordance with Directive 93/42/EEC.

The Opinion can be found here.

More information on the Scientific Committees can be found here.