The FDA is recommending that healthcare facilities start using duodenoscopes with disposable components to reduce the risk of patient infection.
Duodenoscopes — used to diagnose and treat diseases in the pancreas, bile duct and gallbladder — are particularly difficult to clean, which has resulted in persistently high levels of contamination. Hundreds of patients have been sickened by infections transmitted through the devices.
Due to the infection risk, the FDA is recommending that healthcare organizations begin transitioning from duodenoscopes with fixed endcaps to those with disposable endcaps — or to fully disposable duodenoscopes when they come to the market.
The FDA said it is aware that the transition will take some time given the cost and market availability of duodenoscopes with disposable parts.
"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, 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."