SCENIHR adopts opinion on reprocessing Single Use Devices (SUD)

bio_subbu

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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
 

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bio_subbu

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The report's poor rigor in regard to its definition of device types that fall within the "critical" category causes its focus on degree of use criticality as a key factor in determination of allowability of reprocessing of single use devices, to be wholly ineffective.

Many "non-critical" single-use equipment cover/drape devices perform essential roles in establishment of the sterile field, particularly in procedures during which inherently non-sterilizable imaging equipment must be used in close overhead proximity to the invasive site. The essential nature of establishment of a sterile field for invasive procedures in order to avoid infection is universally recognized.

We envision this scenario in reprocessing situations, based on our subject matter expertise for such devices:

A single-use-labeled device no longer provides an integral fluid barrier at the time of its delivery to the reprocessor because of subtle damage sustained during removal from equipment at the conclusion of the prior procedure.

And/or, a single-use-labeled device is not able to be adequately cleaned of prior-patient contamination sufficiently for re-sterilization to be practically effective.

The reprocessor, in spite of best cost-effective efforts, is not physically able to detect the fluid barrier breakdown and/or remnant contamination with regulatorily adequate assurance; perhaps fails to recognize that these conditions exist, due to their difficult detectability; and "validates" their re-sterilization cycle for what they declare to be "typical worst case" conditions (per ISO 11135).

If the device has no direct patient contact but has secondary invasive contact i.e. must be handled by sterile-garbed clinical personnel in the course of the invasive procedure--which commonly is the case for imaging-equipment sterile barrier covers--what does it mean to categorize them as "non-critical" based on no direct patient contact?

I'm very unimpressed by the report. Device makers are all expected to attain high levels of analytical skill and procedural understanding in regard to clinical performance and risk. We should be able to expect the same from rule-makers.
 
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