FDA Urges Transition to Disposable Duodenoscopes

Megan Brooks

August 29, 2019

The US Food and Drug Administration (FDA) recommended today that duodenoscope manufacturers and health care facilities transition to duodenoscopes that have disposable components that may pose less risk to patient safety.

In April, the FDA said interim results of postmarket surveillance studies of duodenoscopes continue to show unacceptably high contamination rates after reprocessing, with deaths and infections still occurring, as reported by Medscape Medical News.

Due to challenges with cleaning these devices for reuse and persistent high levels of contamination, the agency is now 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.

Disposable designs simplify or eliminate the need for reprocessing, which may reduce between-patient duodenoscope contamination as compared to reusable, or fixed endcaps, the agency said in a safety communication.

Immediate Transition Not Feasible

The FDA is recommending a gradual transition to duodenoscopes with disposable components because full-market withdrawal of conventional, fixed endcap duodenoscopes is not feasible at this time and could lead to a shortage. "The FDA believes, at this time, the continued availability of these devices is in the best interest of the public health," the agency 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," Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in the release.

"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," said Shuren.

The FDA is working with manufacturers to increase the supply of disposable cap duodenoscopes and develop new device designs that will further reduce or eliminate the risk of patient infection, Shuren said.

Specifically, the FDA is recommending healthcare facilities 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.

The FDA has cleared two duodenoscopes with disposable end caps: Fujifilm Corporation, model ED-580XT and Pentax Medical, model ED34-i10T. Other firms have announced plans to develop fully disposable duodenoscopes.

Illegal Test Strips

The FDA also said today that results of postmarket "human factors" studies suggest that users "frequently" have trouble understanding and following manufacturers' reprocessing instructions and are 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," the FDA said.

The FDA also said today it will require new postmarket studies for manufacturers and request real-world contamination rates in duodenoscope labeling. 

Today's FDA safety communication also includes a warning about certain test strips illegally marketed to assess duodenoscope cleanliness.

According to the FDA, some healthcare facilities are using adenosine triphosphate (ATP) test strips that claim to indicate the presence of live microbes inside of duodenoscopes. However, there are no legally marketed ATP test strips cleared by FDA for this use, the agency said.

The FDA has contacted manufacturers of ATP test strips, advising them of the agency's requirements for manufacturing, testing, and labeling for medical devices marketed for assessing duodenoscope reprocessing. The FDA has requested that manufacturers submit data to support the clearance of the strips for this use.

In the meantime, the FDA is asking healthcare facilities not to rely on these test strips to assess duodenoscope cleaning.

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