The U.S. FDA is recommending that duodenoscope manufacturers and healthcare facilities transition to different types of duodenoscopes that may pose less risk to patient safety. Specifically, because of challenges with cleaning these devices for reprocessing and persistent 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.
According to FDA officials, 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 healthcare facilities due to cost and market availability,” says Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “This is why we’re communicating with healthcare 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.”
Duodenoscopes—flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum)—are used in more than 500,000 endoscopic retrograde cholangiopancreatography procedures a year, a potentially life-saving procedure to diagnose and treat problems in the pancreas and bile ducts. These complex devices include reusable and hard-to-clean components and must be cleaned and sanitized to be reprocessed after each patient through a lengthy procedure—one that currently consists of hundreds of steps.
“Duodenoscopes remain critical to life-saving care for many patients in the U.S.,” Shuren asdds. “While the risk of infection from inadequate reprocessing is relatively low, we are taking action because of continuing elevated levels of contamination in duodenoscopes.”
Specifically, the FDA is recommending healthcare facilities transition away from fixed endcap models including Olympus Corp.’s TJF-Q160, TJF-Q180V, PJF-160 and JF-140F; Fujifilm Medical Systems USA’s ED-530XT; and Pentax Medical’s ED-3490TK. The FDA has cleared two duodenoscopes with disposable end caps: Fujifilm Corporation, model ED-580XT and Pentax Medical, model ED34-i10T. Additionally, other firms have publicly announced plans to develop fully disposable duodenoscopes.