FDA Calls For Duodenoscope Manufacturers To Create New Easier-To-Sterilize Designs

Federal regulators appear to be throwing in the towel on finding a way to adequately sterilize duodenoscopes as they are currently designed, indicating that medical device manufacturers need to redesign the products, which have been linked to reports of “superbug” infection outbreaks among patients exposed to the same tools, which may be impossible to properly clean between patients.

FDA officials issued a press release on August 29, announcing recommendations that manufacturers of the endoscopic tools transition to different types of designs that are easier to clean and less likely to put patients at risk of potentially lethal infections. The announcement comes following years of investigations into how to “reprocess” or sterilize the devices adequately following a number of infection outbreaks.

Duodenoscopes are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures, but difficulties cleaning device manufactured by several different companies have resulted in reports of serious hospital infection outbreaks, typically involving aggressive, antibiotic-resistant “superbugs”, which have caused a number of severe injuries and deaths.

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The safety of the devices first emerged after a  duodenoscope infection outbreak at UCLA’s Ronald Reagan Medical Center in February 2015, involving carbapenem-resistant enterobacteriaceae (CRE) infections that resulted in at least seven infections and two deaths. At least 200 other patients had to undergo testing after being placed at risk by duodenoscopes manufactured by Olympus Corp.

The infections were linked to problems with the “reprocessing” instructions provided by the manufacturer, which are used to clean the devices for use by another patient. FDA reviewers determined that the instructions sent out at the time were inadequate and that even if the recommended steps were followed to clean ERCP endoscopes, flaws in the design may allow them to become easily contaminated.

However, tests say that 1-in-20 duodenoscopes still retain bacteria between patients, even after several attempts to revise the cleaning processes, and the FDA warns that it is done trying.

Instead, the agency is going to push the industry away from using duodenoscopes with fixed endcaps, and toward those with disposable components or fully disposable duodenoscopes.

“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,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the press 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.”

Shuren said the FDA is also encouraging manufacturers to help hospitals and other healthcare facilities to transition away from the old models to the new ones.

This announcement came after a New York Times report revealed that a growing number of experts were pushing the FDA in this direction due to failed efforts to sterilize the current designs. Because of the inner tubing, they cannot be exposed to high heat like many medical devices, and the movable elevator tip and inner tubing are difficult to clean by hand.

Manufacturers have issued reprocessing instructions that sometimes involve 100 steps, and often force cleaning personnel to rely on visual inspection of micro-crevices to look for blood or tissue debris.

Similar problems with bronchoscopes have led to the development of single use devices there, but duodenoscopes are far more complex, and no one has reportedly developed a one-use duodenoscope to date.


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