The US Food and Drug Administration (FDA) is recommending that gastroenterologists transition to using disposable duodenoscopes because of ongoing problems with cleaning to remove pathogens from conventional re-usable duodenoscopes.
In an announcement made on 29 August to healthcare facilities and manufacturers the FDA said a switch to use of disposal duodenoscopes was needed because data from postmarketing studies showed a small but significant risk of infection from inadequate reprocessing of conventional duodenoscopes.
The FDA is recommending a transition away from fixed endcap models including Olympus Corporation’s TJF-Q160, TJF-Q180V, PJF-160 and JF-140F; Fujifilm Medical Systems USA’s ED-530XT; and Pentax Medical’s ED-3490TK.
Two duodenoscopes with disposable end caps: Fujifilm Corporation, model ED-580XT and Pentax Medical, model ED34-i10T were not affected by the announcement.
“Because of challenges with cleaning these devices for reuse (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,” said Dr Jeff Shuren MD, director of the FDA’s Center for Devices and Radiological Health.
“Disposable designs simplify or eliminate the need for reprocessing, which may reduce between-patient duodenoscope contamination as compared to reusable, or fixed endcaps,” he added.
In its statement, the FDA said postmarketing studies had also shown that duodenoscope users frequently had difficulty understanding and following manufacturers’ reprocessing instructions and were not able to successfully complete reprocessing, which may leave the duodenoscopes contaminated.
“The FDA continues to work with manufacturers to conduct additional testing and revise reprocessing instruction manuals, as appropriate. However, the best path to reducing the risk of disease transmission by duodenoscopes is through innovative device designs, such as those with disposable components, that make reprocessing easier, more effective or unnecessary.”
Dr Shuren said the FDA recognised that a complete transition away from conventional duodenoscopes to innovative disposable models could not happen immediately.
“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. 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. “
The FDA said it would also be ordering new postmarket surveillance studies on duodenoscopes with disposable endcaps, requesting the inclusion of real-world contamination rates in duodenoscope product information.
The regulator is also issuing warning letters to manufacturers of certain test strips used to assess duodenoscope cleanliness that have not been through proper FDA premarket review.