Few other medical device problems received as much attention in the press in 2015 as a duodenoscope's potential to spread pathogens. The devices were associated with outbreaks in hospitals in Seattle, Los Angeles, and outside Chicago, ultimately prompting FDA to release warnings related to the device and convene an FDA advisory panel to discuss the subject.
In May, the FDA advisory panel recommended overhauling the cleaning protocols for the instruments and called for the use of ethylene oxide gas to clean them--a potential costly procedure that the FDA recommends as a supplemental measure to ensure sterility. The agency also recommended three other methods to clean the devices, but has acknowledged that they also have shortcomings.
One challenge with duodenoscopes is that cleaning biologic debris is a time consuming process for hospital staff but if that procedure is not done properly, subsequent disinfection or sterilization can be less effective. Adding to the challenges of cleaning duodenoscopes is their design, which includes hard-to-reach narrow channels. It was this very problem that was linked to several outbreaks of carbapenem-resistant Enterobacteriaceae in 2014 and 2015.
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