The European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has concluded that certain design features make single use devices (SUDs) unsuitable for reprocessing. The commission will finalize their report and submit it to the European Parliament.
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. A copy of SCENIHR's opinion can be found here.
S. Subramaniam
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. A copy of SCENIHR's opinion can be found here.
S. Subramaniam
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