Healthcare facilities should switch from using duodenoscopes with fixed endcaps to those with disposable components that include disposable endcaps—or to fully disposable duodenoscopes when they become available, the FDA said in a new Drug Safety Communication.
The move will improve patient safety due to “challenges with cleaning these devices for reuse (reprocessing) and persistent high levels of contamination,” the agency said in a statement. “Disposable designs simplify or eliminate the need for reprocessing, which may reduce between-patient duodenoscope contamination as compared to reusable, or fixed endcaps,” FDA 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,” says Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “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.”
The FDA has cleared two duodenoscopes with disposable end caps: Fujifilm Corporation, model ED-580XT and Pentax Medical, model ED34-i10T. Other firms have publicly announced plans to develop fully disposable duodenoscopes.
FDA is also encouraging the manufacturers of fixed end duodenoscope models to assist healthcare 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,” Shuren says.
“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,” he adds.
FDA is also ordering new postmarket surveillance studies on duodenoscopes with disposable endcaps, is requesting the inclusion of real-world contamination rates in duodenoscope labeling, and is issuing letters to manufacturers of certain test strips used to assess duodenoscope cleanliness that have not been through proper FDA premarket review.
“These actions…are part of our robust, ongoing effort to gather information on the effectiveness of duodenoscope reprocessing to prevent between-patient contamination,” Shuren says.
Duodenoscopes include reusable and hard-to-clean components and must be cleaned and sanitized to be re-used, known as reprocessing, after each patient through a lengthy procedure – one that currently consists of hundreds of steps, FDA said. “Reprocessing of duodenoscopes involves cleaning outside surfaces, interior channels and the elevator recess to remove tissue and fluids, followed by treatment to kill microorganisms. After thorough cleaning, high-level disinfection is intended to reduce harmful microbes so that the device is reasonably assured to be free of the risk of disease transmission,” the agency says.
Failure to correctly reprocess a duodenoscope could result in tissue or fluid from one patient remaining in a duodenoscope and potential for disease transmission.
Postmarket surveillance human factors studies indicate that many steps in the reprocessing instructions cannot be reliably followed by healthcare facilities, FDA says.
FDA also ordered manufacturers of duodenoscopes with disposable endcaps to conduct postmarket surveillance studies to gather more information and verify that the new designs reduce the contamination rate.
After the postmarket surveillance studies have been completed, the FDA expects the labeling on duodenoscopes with disposable endcaps to be updated with contamination rate data. “Including the contamination rate would allow patients and health care professionals to make informed decisions about the potential risks associated with the duodenoscope,” the agency says.