FDA recommends transition to duodenoscopes with innovative designs

To date, the FDA has cleared three duodenoscopes with newer design features that can facilitate cleaning, reduce contamination, and reduce disease transmission following reprocessing.


The FDA is recommending that hospitals and endoscopy facilities transition away from duodenoscopes with fixed endcaps to those with newer design features that allow for more effective reprocessing.

Innovative duodenoscope designs incorporate disposable components that can facilitate cleaning, reduce contamination, and reduce disease transmission following reprocessing, the FDA said in a Jan. 15 safety communication. To date, the FDA has cleared a fully disposable duodenoscope and two duodenoscopes with disposable endcaps.

“Please note, we recognize that a full transition away from conventional duodenoscopes to the newer, innovative models will take time,” the FDA said. The agency continues to work with manufacturers to increase the supply of duodenoscopes with disposable components and to develop other new and innovative designs that will further minimize or eliminate the risk of patient infection.