FDA: Use duodenoscopes with disposable parts to prevent infections
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September 5, 2019
To protect patients from infection, the FDA now recommends healthcare facilities transition to duodenoscopes with disposable parts. Cleaning these devices has proven to be a challenge in the past, as their designs often prevented them from being fully decontaminated. Disposable designs simplify or eliminate the need for reprocessing, which may reduce between-patient duodenoscope contamination as compared to reusable, or fixed endcap, scopes.
“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 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. We are also encouraging the manufacturers of these duodenoscope models to assist health care facilities with their transition plans.”
Fixed endcap duodenoscopes have a plastic or rubber cap permanently glued to the metal edges around the distal end to prevent tissue injury from the metal edges on the scopes, but when permanently affixed, the endcaps also limit the accessibility to clean the crevices at the distal end. The new scopes will include disposable endcaps, though fully disposable duodenoscopes may become an option someday.
“We continue to work with manufacturers to increase the supply of disposable cap duodenoscopes and the development of other new and innovative device designs that will further minimize or eliminate the risk of patient infection,” said Shuren. “Duodenoscopes remain critical to life-saving care for many patients in the U.S. While the risk of infection from inadequate reprocessing is relatively low, we are taking action because of continuing elevated levels of contamination in duodenoscopes.”
Attention to duodenoscopes infections reached a zenith in 2015, after several companies were proven to have hidden their product’s reprocessing design flaws, leading to dozens of outbreaks and a handful of deaths.
“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 postmarket 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. “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.”
Read the full FDA briefing here.