Drug/Device Pipeline

FDA Urges Move to Duodenoscopes With Disposable Components

Because of the challenges associated with the reprocessing and cleaning of duodenoscopes with fixed endcaps, the FDA is recommending that manufacturers of the device and health care facilities transition to duodenoscopes with disposable components.

“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,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “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.”

The agency issued the safety communication because post-market human factors studies — which the FDA previously required of each manufacturer of duodenoscopes — revealed that users were having difficultly following reprocessing instructions, which could lead to contamination.

Although the FDA is still working with manufacturers to revise these instructions, the agency believes that moving toward scopes with disposable components will be the best way to reduce risk for transmission of infections.

The FDA has plans to hold a General Hospital and Personal Use Devices Panel of the Medical Device Advisory Committee later this year to discuss the issues surrounding duodenoscope reprocessing, as well as the transition to newer designs for devices with disposable components.

“Today we’re also announcing additional actions we’ve taken to advance continued efforts to help assure the safety of patients undergoing procedures with duodenoscopes, including FDA ordering new post-market surveillance studies on duodenoscopes with disposable endcaps, requesting the inclusion of real-world contamination rates in duodenoscope labeling and issuing letters to manufacturers of certain test strips used to assess duodenoscope cleanliness that have not been through proper FDA premarket review,” Shuren said in the release. “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.”

Because of the challenges associated with the reprocessing and cleaning of duodenoscopes with fixed endcaps, the FDA is recommending that manufacturers of the device and health care facilities transition to duodenoscopes with disposable components.

“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,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “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.”

The agency issued the safety communication because post-market human factors studies — which the FDA previously required of each manufacturer of duodenoscopes — revealed that users were having difficultly following reprocessing instructions, which could lead to contamination.

Although the FDA is still working with manufacturers to revise these instructions, the agency believes that moving toward scopes with disposable components will be the best way to reduce risk for transmission of infections.

The FDA has plans to hold a General Hospital and Personal Use Devices Panel of the Medical Device Advisory Committee later this year to discuss the issues surrounding duodenoscope reprocessing, as well as the transition to newer designs for devices with disposable components.

“Today we’re also announcing additional actions we’ve taken to advance continued efforts to help assure the safety of patients undergoing procedures with duodenoscopes, including FDA ordering new post-market surveillance studies on duodenoscopes with disposable endcaps, requesting the inclusion of real-world contamination rates in duodenoscope labeling and issuing letters to manufacturers of certain test strips used to assess duodenoscope cleanliness that have not been through proper FDA premarket review,” Shuren said in the release. “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.”