The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published an information notice dedicated to Automated Endoscope Reprocessors (AERs) – medical devices used to reprocess endoscopes of various types, as well as accessories thereto. Such devices are intended to remove microorganisms by virtue of disinfectants or sterilant liquids.
- AERs evaluation to be conducted by the Agency,
- Validation of reprocessing effectiveness,
- Validation testing.
- Active cooperation with the medical device manufacturers in the context of reprocessing instructions and recommendations intended to ensure the effectiveness of the reprocessing methods used. It is stated that the authority pays special attention to cooperation with the manufacturers of automated endoscope reprocessors, which, according to the labeling, are intended to operate with duodenoscopes.
- Assessment of the validation study protocols and test data provided by the medical device manufacturers with regard to AERs.
- Review of adverse event reports and safety-related information deriving from other sources in order to identify potential connections between automated endoscope reprocessors and cases of infectious agents` transmission.
- Assessment of the data collected in the course of validation studies.
- Cooperation with healthcare facilities subject to outbreaks of infections in order to identify whether automated endoscope reprocessors could be related to such outbreaks.
- Providing recommendations to healthcare professionals regarding measures to be taken to reduce the risks arising in the case of duodenoscopes reprocessed by means of automated endoscope reprocessors.
Automated Endoscope Reprocessors: Validation of Reprocessing Effectiveness
Further, the FDA describes the way the effectiveness of automated endoscope reprocessors should be validated. As mentioned, the FDA has identified a potential connection between the use of duodenoscopes that have been reprocessed and transmission of infection among patients. Thus, the Agency requires the medical device manufacturers to provide validation testing data with regard to all AERs they manufacture.
According to the information notice, the manufacturers are obliged to carry out validation testing intended to evaluate the effectiveness of medical devices. The acceptable threshold indicated by the authority is a 99.9% reduction of the most resistant microbes at several locations on the duodenoscope to prevent infection transmission.
Initially, the requirement to provide validation data regarding disinfection and sterilization as a part of a 510(k) premarket notification submission was introduced earlier in 2017. The Agency also states that the substantial equivalence approach could be applied – the medical device manufacturer shall demonstrate the medical device in question is equal in its functions and characteristics to a similar medical device already placed on the market in order to confirm compliance with the applicable regulatory requirements in terms of safety and effectiveness. Such information on validation and the appropriate test data should be included in the instructions for use submitted by the manufacturer.
It is also important to mention that due to the complexity of duodenoscopes, the Agency recommends applying automated endoscope reprocessors as an ancillary measure, while manual cleaning should be performed by default. The aforementioned manual cleaning performed strictly in accordance with the recommendations provided by the medical device manufacturer is deemed to be the most efficient cleaning method.
According to the present information notice published by the FDA, only 5 medical device manufacturers based in the US produced automated endoscope reprocessors intended to reprocess duodenoscopes. Further, the Agency provides the list of these manufacturers stating they have achieved compliance with the applicable regulatory requirements in terms of safety and effectiveness.
The validation performed relates to the most complex case – duodenoscopes with a fixed endcap. As stated by the FDA, fixed endcap duodenoscopes have a plastic or rubber cap permanently glued to the metal edges around the distal end to prevent tissue injury from the metal edges on the scopes, but when permanently affixed, the endocarps also limit the accessibility to clean the crevices at the distal end. It is important to mention that due to this factor, the authority encourages the slight transition to new models of duodenoscopes, the design of which simplifies their reprocessing or even eliminates the need for it entirely. However, each new duodenoscope design should be subject to performance evaluation and validation testing.
As mentioned, the information notice contains a list of medical device manufacturers, together with the names of their products, as well as indications that validation test results are adequate and confirm compliance with the applicable requirements. For the purpose of the document, the term Adequate means that the Agency completed its review of the manufacturer-provided validation data and test reports, determined that the data achieves acceptable high-level disinfection or liquid chemical sterilization of duodenoscopes used in AERs. The FDA also highlights certain limitations associated with the use of some of the automated endoscope reprocessors listed in the notice. These limitations are related to the types of duodenoscopes that could be reprocessed by such devices.
FDA Actions and Additional Aspects
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