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Duodenoscopes - Review Your Cleaning Checklist

In July 2019, the FDA published an update ( https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes) regarding it's continued focus on duodenoscope reprocessing. On Aug 6, 2019, The New York Times published an article regarding duodenoscopes and how hard they are to clean (https://www.nytimes.com/2019/08/06/health/duodenoscopes-infections-hospitals-antibiotics.html ). The article suggests that instead of high level disinfection, this medical device should be sterilized or taken off the market. The Society of Gastroenterology Nurses Association (SGNA) in collaboration with American Gastroenterological Association (AGA) and the American Society for Gastrointestinal Endoscopy (ASGE) responded to the NY Times article, stating they are working to develop solutions to improve the duodenoscope process.


In the meantime, it is worth the effort to review your processes for how you are cleaning this flexible endoscope. Make sure to review your instructions for use (IFU). IFUs are the foundation for your process. Then, build your competency based on the IFU and process. When reviewing your practice consider the following:


  1. Do you know how long it is from your precleaning until the duodenoscope is actually cleaned? A lengthy time period form preclean to processing will trigger different processes. You will need to review your IFUs.

  2. Are staff certified as competent by someone that is knowledgeable in the process and were they observed performing the skill? A vendor representative may instruct your staff and assist with teaching/creating superusers, but someone from your organization should sign off on the competency.

  3. What quality items are you utilizing to validate your cleaning? Refer to IFUs for recommendations such as ATP or surveillance testing (https://www.fda.gov/media/111081/download).




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