FDA recommends transition to duodenoscopes with disposable endcaps

While a full transition away from conventional duodenoscopes to innovative models will take time, health care facilities should develop plans to transition away from older models that have fixed endcaps, the FDA said.

The FDA recommended on Aug. 29 that duodenoscope manufacturers and health care facilities transition away from duodenoscopes with fixed endcaps to those with disposable endcaps and other components.

While fully disposable duodenoscopes are not yet available, partially disposable designs simplify or eliminate the need for reprocessing, which may reduce between-patient duodenoscope contamination as compared to reusable/fixed endcaps, the FDA said. A full transition may not be immediately possible for all health care facilities due to cost and market availability; however, facilities should plan to transition away from purchasing duodenoscopes with fixed endcaps and begin investing in newer, innovative models, according to the agency.

The FDA safety communication also outlined the results of postmarket human factors studies it required of each U.S. duodenoscope manufacturer (Fujifilm, Olympus, and Pentax). The results suggested that users frequently had difficulty understanding and following manufacturers' reprocessing instructions and were not able to successfully complete reprocessing, potentially leaving the duodenoscopes contaminated.

While the FDA continues to work with manufacturers to revise instruction manuals, the agency said that “the best path to reducing the risk of disease transmission by duodenoscopes is through innovative device designs, such as those with disposable components, that make reprocessing easier, more effective or unnecessary.”