FDA Seeks Move to New Duodenoscopes
FDA has issued a safety alert that recommends healthcare providers transition to duodenoscopes with innovative designs that are safer and eliminate the need for reprocessing. The agency is also mandating new postmarket surveillance study orders to manufacturers of duodenoscopes with disposable endcaps to gather more information and verify that 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,” the alert says.
The alert also updates results from postmarket surveillance studies that are trying to determine contamination rates for current duodenoscopes. The agency previously communicated interim study results showing higher than expected contamination levels, and this concern remains, it says. “The most recent studies from Fujifilm, Olympus, and Pentax continue to show elevated rates of contamination, including the presence of high concern organisms, defined as organisms that are more often associated with disease transmission, such as E. coli and Pseudomonas aeruginosa,” it adds.
FDA strongly recommends that duodenoscopes using disposable components can help with cleaning, reduce contamination and reduce disease transmission following reprocessing. “Disposable designs may reduce between-patient duodenoscope contamination by half as compared to reusable, or fixed endcaps,” it says. To date, two duodenoscopes with disposable endcaps have been cleared: