FDA recommends using disposable endcaps or fully disposable duodenoscopes, replacing duodenoscopes with fixed endcaps
Biovica has a clear path to a 510(k) submission and clearance for DiviTum (Credit: The U.S FDA / Wikipedia)
The US Food and Drug Administration (FDA), in its announcement, has recommended duodenoscope manufacturers and health care facilities to use duodenoscopes to reduce risks topatient safety.
Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat and stomach into the top of the small intestine (duodenum), and are used in endoscopic retrograde cholangiopancreatography (ERCP) procedures, to diagnose and treat problems in the pancreas and bile ducts.
FDA recommends using disposable endcaps or fully disposable duodenoscopes, replacing duodenoscopes with fixed endcaps, which pose challenges in cleaning for reuse and persistent high levels of contamination. The regulatory body said that disposable devices eliminate the need for reprocessing, and help reducing duodenoscope contamination compared to reusable, or fixed endcaps.
FDA Centre for Devices and Radiological Health director Jeff Shuren said: “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.
“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.”
Duodenoscopes are complex devices that comprise of reusable components
Duodenoscopes are complex devices that comprise of reusable components that must be cleaned and sanitised after each procedure through reprocessing, a lengthy procedure with many steps to remove tissue and fluids, followed by treatment to kill microorganisms.
A high-level disinfection is used to reduce harmful microbes, avoiding the disease transmission through device. The failure of duodenoscope reprocessing may result in disease transmission through tissue or fluid remained in the device.
A fixed endcap duodenoscope is designed with a plastic or rubber cap permanently attached to the metal edges around the distal end to prevent tissue injury from the metal edges on the scopes, which also limits the accessibility to clean the crevices at the distal end.
To address the issue, FDA has suggested the use of disposable components to simplify cleaning, reduce contamination and reduce disease transmission following reprocessing.
Shuren added: “We are also encouraging the manufacturers of these duodenoscope models to assist health care facilities with their transition plans. 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.”
“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.”