The FDA is now recommending healthcare facilities to use duodenoscopes with disposable parts in order to protect patients from infection. It was proven to be a challenge to clean these devices in the past, as their designs prevented them from being fully decontaminated. Disposable designs improve or eliminate for the requirement for reprocessing, which may reduce between-patient duodenoscope contamination as compared to reusable or fixed end cap.
Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a press release, “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,” He further adds, “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 end caps can invest in the newer, innovative models.”
Because of the post-market human factors, the agency issued the safety communication — which the FDA previously required of each manufacturer of duodenoscopes — that as the users were having difficulty in following the reprocessing instructions, it could lead to contamination.
The agency believes that even though the FDA is still working to revise these instructions, moving forward towards scopes and disposable components will be the best way to reduce the risk of transmission of infections.
To discuss the issues of duodenoscope reprocessing, the FDA has plans to hold a General Hospital and Personal Use Devices Panel of the Medical Device Advisory Committee later this year, as well as the transition to newer designs for devices with disposable components.
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