FDA recommends transition to safer duodenoscopes

The FDA released a statement, Thursday, Aug. 29, recommending duodenoscope manufacturers and health care facilities begin transitioning to new, innovate scopes that are less risky to patients.

The new recommendation suggests phasing out duodenoscopes with fixed endcaps and adopting devices with disposable endcaps or switching to fully disposable scopes when the technology becomes widely available.

Current duodenoscopes are difficult to clean for reuse and contain continual levels of contamination, according to the FDA. Disposable caps can make it easier to clean these devices or can completely eliminate the need to clean them for reuse.

“We recognize that a full transition away from conventional duodenoscopes to innovative models will take time and immediate transition is not possible for all health care facilities due to cost and market availability,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the statement. “This is why we’re communicating with health care facilities now—so they can begin developing a transition plan to replace conventional duodenoscopes—and those facilities that are purchasing duodenoscopes with fixed endcaps can invest in the newer, innovative models.”

Shuren also announced new steps to “advance continued efforts to help assure the safety of patients undergoing procedures with duodenoscopes.” That includes an FDA order for new postmarket surveillance studies on devices with disposable endcaps and the “real-world” contamination rates in duodenoscope labeling.

The FDA also revealed findings from its postmarket human factors studies from U.S. duodenoscope manufacturers Fujifilm, Olympus and Pentax, which found users “frequently” had difficulty understanding and following manufacturer’s reprocessing instructions and couldn’t adequately complete reprocessing in a real-world setting.

“These actions announced today are part of our robust, ongoing effort to gather information on the effectiveness of duodenoscope reprocessing to prevent between-patient contamination.”