The Food and Drug Administration is recommending that duodenoscope manufacturers and healthcare facilities transition to different types of duodenoscopes that may pose less risk to patient safety.
Specifically, 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. Disposable designs simplify or eliminate the need for reprocessing, which may reduce between-patient duodenoscope contamination as compared to reusable, or fixed endcaps.
“We recognize that a full transition away from conventional duodenoscopes to innovative models will take time and immediate transition is not possible for all healthcare facilities due to cost and market availability,” said Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health, in a statement. “This is why we’re communicating with healthcare 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 healthcare facilities with their transition plans.
FDA also announced additional actions the agency is taking to advance continued efforts to help assure the safety of patients undergoing procedures with duodenoscopes, including FDA ordering new postmarket surveillance studies on duodenoscopes with disposable endcaps, requesting the inclusion of real-world contamination rates in duodenoscope labeling and issuing letters to manufacturers of certain test strips used to assess duodenoscope cleanliness that have not been through proper FDA premarket review.
Reprocessing difficulties
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. Failure to correctly reprocess a duodenoscope could result in tissue or fluid from one patient remaining in a duodenoscope and potential for disease transmission. Information from postmarket surveillance human factors studies indicate that many steps in the reprocessing instructions cannot be reliably followed by healthcare facilities.
The safety communication also outlines results of postmarket human factors studies the FDA required of each U.S. duodenoscope manufacturer (Fujifilm, Olympus and Pentax) to evaluate whether healthcare facility staff could understand and follow the manufacturer’s reprocessing instructions in real-world healthcare settings. The results of these studies suggest that 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 said it 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.
Fixed endcap duodenoscopes have a plastic or rubber cap permanently glued to the metal edges around the distal end to prevent tissue injury from the metal edges on the scopes, but when permanently affixed, the endcaps also limit the accessibility to clean the crevices at the distal end.
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. Additionally, other firms have publicly announced plans to develop fully disposable duodenoscopes.
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. Removing these devices from the market too quickly could create a shortage of duodenoscopes and prevent patients from accessing this beneficial and often life-saving procedure. The FDA believes, at this time, the continued availability of these devices is in the best interest of the public health.
The FDA is reminding patients that the risk of infection from inadequate reprocessing is relatively low and patients should not cancel or delay any planned procedure without first discussing the benefits and risks with a health care professional.
In addition to transitioning to safer devices, the FDA is communicating with device manufacturers to encourage them to develop innovative approaches for the entire duodenoscope reprocessing procedure to provide a high margin of safety and reduce the risk of infection associated with reprocessed duodenoscopes.
ATP strips
In addition, the FDA also announced that it is aware that some healthcare facilities are using adenosine triphosphate, or ATP, test strips, to assess duodenoscope cleaning. These test strips claim to indicate the presence of live microbes inside of duodenoscopes. However, to date, the FDA is not aware of any legally marketed ATP test strips cleared by the agency for this use, which means the FDA has not reviewed them for effectiveness in assessing reprocessing. Prior to being legally marketed in the U.S., an FDA premarket review is necessary to help assure that ATP test strips are adequately validated and properly labeled.
The FDA has contacted manufacturers of ATP test strips advising them of the FDA’s requirements for manufacturing, testing and labeling for medical devices marketed for assessing duodenoscope reprocessing and has requested they submit data to support the clearance of the strips for this use. As for any unauthorized use of a medical device, if the companies do not come into compliance, the agency will consider whether to take enforcement action if necessary. In the meantime, the FDA is asking healthcare facilities not to rely on these test strips to assess duodenoscope cleaning.
