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.

According to the current risk-based classification, automated endoscope reprocessors are Class II medical devices. Hence, they should be placed on the market under the 510(k) premarket notification framework.
The scope of the notice published by the FDA covers the following aspects:
  • AERs evaluation to be conducted by the Agency,
  • Validation of reprocessing effectiveness,
  • Validation testing.
Additionally, the scope of the notice covers other important aspects related to automated endoscope reprocessors, including the actions to be taken by the authority with regard to such devices.

AERs Evaluation

To determine the best approach to evaluating the effectiveness of automated endoscope repressors, the Agency considers factors related to infections patients could be subject to due to the reuse of endoscopes, which are multiple-use medical devices. In particular, the Agency analyzes how such devices are used in healthcare institutions (clinical environment). 
The information notice provides an overview of the actions considered by the FDA as necessary in order to ensure the safety of patients and the effectiveness of automated endoscope reprocessors. These actions include the following: 
  • 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. 

Validation Testing

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

According to the document, the FDA already has experience contacting medical device manufacturers with regard to AERs they produce and asking them to clarify the scope of medical devices for which they could be used. The actions taken by the authority also include the issuance of Safety Communications intended to warn healthcare professionals about the potential issues associated with some automated endoscope reprocessors. The FDA further continues the evaluation of endoscope reprocessing methods available in order to determine the most efficient ones.
In summary, the present information notice published by the FDA describes the most important aspects associated with automated endoscope reprocessors intended to disinfect and sterilize duodenoscopes as the most complex devices of this type. The document addresses key safety-related issues and provides certain recommendations to be considered by the medical device manufacturers, as well as the other parties involved. 

How Can RegDesk Help?

RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.