Conceding that conventional duodenoscopes cannot be reliably reprocessed between patients, the Food and Drug Administration (FDA) is recommending that manufacturers and providers move to disposable components for the intricate devices.
“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,” the agency stated.1 “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 action comes after a meeting earlier this year at the Centers for Disease Control and Prevention (CDC), where FDA officials told CDC infection advisors that some 3-5% of reprocessed duodenoscopes remain contaminated with potentially infectious organisms. (See Hospital Infection Control & Prevention, July 2019.)
Expressing alarm at this clear threat to patient safety, the CDC’s Hospital Infection Control Practices Advisory Committee (HICPAC) urged the FDA to take action. In a remark that now seems prescient, Lisa Maragakis, MD, MPH, co-chair of HICPAC, said, “It really does call for a disposable product or a complete paradigm shift and redesign.”
That appears to be what the FDA is attempting, but duodenoscopes will remain a concern during a transition period that could take years.
“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,” the FDA 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.
Duodenoscopes became a national concern in 2014, when the CDC reported2 a 2013 outbreak of carbapenem-resistant Enterobacteriaceae linked to the devices. The intricate scopes are used to assess the pancreas and other organs in endoscopic retrograde cholangiopancreatography (ERCP).
Some 500,000 ERCP procedures using duodenoscopes are performed annually in the United States. Research has revealed that the standard protocol at many hospitals of reprocessing these scopes with high-level disinfection - even if it is performed twice consecutively3 - still leaves patients at some risk.
“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 healthcare professional,” the agency stated.
In addition to transitioning to safer devices, the FDA is calling on device manufacturers to develop new duodenoscope reprocessing procedures that will reduce the risk and infection. Discussions at the CDC meeting indicated that some reprocessing instructions have as many as 40 steps, increasing the likelihood of a breach in aseptic technique at some point in the process. The FDA hopes the transition to more scopes with disposable endcaps will reduce and simplify duodenoscope reprocessing, lowering the risk of infection as the devices are reused on patients.
“We are also encouraging the manufacturers of these duodenoscope models to assist healthcare facilities with their transition plans,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said 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.”
Additional FDA actions include ordering new post-market surveillance studies on duodenoscopes with disposable endcaps, and requesting the inclusion of “real-world contamination rates” in scope labeling.
- FDA. FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection. Aug. 29, 2019. Available at: https://bit.ly/2K1yVud. Accessed Nov. 8, 2019.
- Centers for Disease Control and Prevention. Notes from the field: New Delhi metallo-beta-lactamase Producing Escherichia coli associated with endoscopic retrograde cholangiopancreatography — Illinois, 2013. MMWR Morb Mortal Wkly Rep 2014;62:1051.
- Rex DK, Sieber M, Lehman GA, et al. A double-reprocessing high-level disinfection protocol does not eliminate positive cultures from the elevators of duodenoscopes. Endoscopy 2018;50:588-596.