FDA panel pushes for sterilization of hard-to-clean scopes

Several members of a U.S. Food and Drug Administration advisory panel are calling for mandatory sterilization of duodenoscopes to prevent the spread of potentially deadly pathogens, according to a Wall Street Journal report.

Currently, the devices are subject to high-level disinfection prior to being used on patients. Sterilization is a step above this process.

"The ideal would be to mandate that these devices be sterilized," Irving Nachamkin, a member of the panel, said, according to the WSJ.

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Another panel member testified: "There is an urgent need to shift from high-level disinfection to sterilization."

Duodenoscopes have been tied to several outbreaks of antibiotic-resistant infections recently, at places like Virginia Mason Medical Center and Ronald Reagan UCLA Medical Center in Los Angeles. Several suggestions have been made on how to make the scopes safer for patients, such as culturing them for bacteria after reprocessing and closely following manufacturer instructions on cleaning with the correct tools.

UCLA Medical Center has already started sterilizing the scopes, a process that kills superbugs like carbapenem-resistant enterobacteriaceae, according to the WSJ. So has Pittsburgh-based UPMC. However, the gas used in the sterilization process can be toxic to staff, and the process increases the wait time necessary before the scope can be used again.

According to the WSJ, the FDA cannot mandate changes in healthcare practices. But, it could work with manufacturers of the scopes to change the recommended protocols to include sterilization.

More articles on reprocessing:
How long can endoscopes be stored after reprocessing?
When cleaning guidelines aren’t enough: How to protect your facility from dirty devices
8 ways to prevent duodenoscope infections

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