Use duodenoscopes with disposable component: USFDANovember 15, 2019
The US FDA is recommending that duodenoscope manufacturers and health care facilities transition to different types of duodenoscopes that may pose less risk to patient safety.
Specifically, because of challenges with cleaning these devices for reuse and persistently high levels of contamination, the agency is recommending moving away from using duodenoscopes with fixed endcaps to those with disposable components that include disposable endcaps—or to fully disposable duodenoscopes when they become available.
Disposable designs simplify or eliminate the need for reprocessing, which may reduce between-patient duodenoscope contamination as compared to reusable, or fixed endcaps.
“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, J.D, director of the FDA’s Center for Devices and Radiological Health.
“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.”
While the risk of infection from inadequate reprocessing is relatively low, the FDA is taking action because of continuing elevated levels of contamination in duodenoscopes.
Reprocessing of duodenoscopes involves cleaning outside surfaces, interior channels and the elevator recess to remove tissue and fluids, followed by treatment to kill microorganisms. After thorough cleaning, high-level disinfection is intended to reduce harmful microbes so that the device is reasonably assured to be free of the risk of disease transmission.
Information from postmarket surveillance human factors studies indicate that many steps in the reprocessing instructions cannot be reliably followed by health care facilities.