FDA calls for transition to disposable duodenoscopes

The US Food and Drug Administration (FDA) has recommended devicemakers and healthcare facilities use duodenoscopes with disposable endcaps or fully disposable versions when they become available, in order to avoid patient infection.

Duodenoscopes are flexible, lighted tubes that are placed via the mouth, throat and stomach into the top of the small intestine, called the duodenum, to detect and treat problems in the pancreas and bile ducts.

Commonly, the devices come with reusable components that are difficult to clean. Reprocessing of duodenoscopes involves numerous steps and incorrect reprocess could lead to disease transmission.

Postmarket surveillance studies revealed that healthcare facilities fail to follow many steps in reprocessing instructions.

Duodenoscopes with a fixed endcap come with a permanently attached plastic or rubber cap, which impacts the cleaning of the crevices at the distal end.

The FDA has said that disposable versions could enable simple or no reprocessing, mitigating contamination risk compared to reusable or fixed endcaps.

FDA Center for Devices and Radiological Health director Jeff Shuren said: “We recognise 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.

“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.”

Shuren added that the risk of infection due to poor reprocessing of duodenoscopes is relatively low but the latest move is based on continuing increased contamination levels in devices.

The FDA recommended healthcare facilities to transition away from the fixed endcap models of Olympus Corporation, Fujifilm Medical Systems USA and Pentax Medical.

FDA also called for new postmarket surveillance studies on duodenoscopes with disposable endcaps. Additionally, it has asked for duodenoscope labels to include real-world contamination rates.