FDA is Sharing Recommendations and Updates to Help Improve Duodenoscope Reprocessing

https://www.fda.gov/medical-devices/safety-communications/fda-recommending-transition-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication?utm_campaign=2019-08-29%20CDRH%20Safety%20Comm%20-%20%20Recommendations%20and%20Updates%20to%20Help%20Improve%20Duodenoscope%20Reprocessing&utm_medium=email&utm_source=Eloqua

Today, the U.S. Food and Drug Administration (FDA) issued a Safety Communication titled “The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety.” Within this communication, the FDA is providing an update on the mandated postmarket surveillance study results for duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) since issuing the April 2019 Safety Communication.   This Safety Communication also provides additional recommendations and updates including the FDA: Recommending that hospitals and endoscopy facilities begin transitioning to duodenoscopes with innovative designs that facilitate or eliminate the need for reprocessing. Issuing new mandated postmarket surveillance study orders to manufacturers of duodenoscopes with disposable endcaps to gather more information and verify that the new designs reduce the contamination rate. Upon completion of the postmarket surveillance studies, the FDA expects the labeling on duodenoscopes with disposable endcaps to be updated with contamination rate data. Warning health care facilities that adenosine triphosphate (ATP) test strips should not be used to assess duodenoscope cleaning.  To date, the FDA has not evaluated them for effectiveness for assessing duodenoscope reprocessing.  Manufacturers of ATP test strips are advised to submit data to support the legal marketing of these strips for this use. Planning to convene the General Hospital and Personal Use Device Panel of the Medical Device Advisory Committee in late 2019 to further discuss duodenoscope reprocessing. The FDA is also reminding patients that the risk of infection from inadequate reprocessing is relatively low and patients should not cancel or delay any planned procedure without first discussing with their health care provider.

Read the Safety Communication