In continued efforts to protect patient safety, FDA orders new postmarket studies for manufacturers, requests real-world contamination rates in duodenoscope labeling and warns about certain test strips illegally marketed to assess duodenoscope cleanliness
FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection
For Immediate Release:
August 29, 2019
Today, the U.S. Food and Drug Administration is recommending that duodenoscope manufacturers and health care 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 health care facilities due to cost and market availability,” said Jeff Shuren, M.D., J.D., 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. 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. Today we’re also announcing additional actions we’ve taken 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. These actions announced today are part of our robust, ongoing effort to gather information on the effectiveness of duodenoscope reprocessing to prevent between-patient contamination.”
Duodenoscopes—flexible, lighted tubes that are threaded through the mouth, throat and stomach into the top of the small intestine (duodenum)—are used in more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures a year, a potentially life-saving procedure to diagnose and treat problems in the pancreas and bile ducts. These complex devices 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. 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 health care facilities.
The safety communication issued today also outlines results of postmarket human factors studies the FDA required of each U.S. duodenoscope manufacturer (Fujifilm, Olympus and Pentax) to evaluate whether health care facility staff could understand and follow the manufacturer’s reprocessing instructions in real-world health care 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 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 health care 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 previously required postmarket surveillance studies from each U.S. duodenoscope manufacturer (Olympus, Fujifilm and Pentax) to determine the real-world contamination rates for duodenoscopes and serve as measures for the effectiveness of reprocessing. Because these studies continue to show elevated rates of contamination in fixed endcap duodenoscopes, including the presence of organisms more often associated with disease transmission, such as E. coli, the FDA believes that incorporating disposable components can simplify cleaning, reduce contamination and reduce disease transmission following reprocessing. While not every exposure to a contaminated scope leads to infection, any rate of contamination is concerning, which is why the FDA is taking multiple steps to address the issue.
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.
Also, the FDA announced that it has 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. The FDA believes that designs, such as ones with disposable endcaps, that need fewer reprocessing steps and allow for instructions that are easier to follow, can lower contamination rates and thus, help protect patients from the risk of infection. Upon completion of the postmarket surveillance studies, 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. In addition, after the May 2019 Centers for Disease Control Healthcare Infection Control Practices Advisory Committee, the FDA requested the inclusion of real-world contamination rates on the label of fixed endcap duodenoscopes.
In addition, the FDA also announced today that it is aware that some health care 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 health care facilities not to rely on these test strips to assess duodenoscope cleaning.
Lastly, the FDA plans to convene a General Hospital and Personal Use Devices Panel of the Medical Device Advisory Committee in late 2019 to discuss these issues, including duodenoscope contamination rates, expanding validated reprocessing methods, options to improve reprocessing, potential for sterilization of duodenoscopes, approaches for new device designs or technology to reduce infection transmission by duodenoscopes and challenges that may delay the transition to these designs and technologies. The meeting date will be available in the FDA Advisory Committee Calendar when available.
The FDA will keep the public informed if significant new information becomes available.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.