FDA issues alert about scopes tied to CRE infections

After duodenoscopes were tied to two recent outbreaks of carbapenem-resistant Enterobacteriaceae infections, the U.S. Food and Drug Administration issued a "safety communication" about all side-viewing duodenoscopes to "raise awareness…that the complex design of ERCP endoscopes may impede effective reprocessing."


Two recent CRE infection outbreaks, one at Virginia Mason Medical Center in Seattle and another at Ronald Reagan UCLA Medical Center in Los Angeles are believed to be caused by the scopes, even though staff at both hospitals correctly followed the manufacturer's recommendations for sterilizing the tool.

In the alert, the FDA urges people to closely follow all manufacturer instructions for cleaning and processing the duodenoscopes, as "strict adherence to the manufacturer's reprocessing instructions will minimize the risk of infection," and to report problems with reprocessing the device to the FDA and the manufacturer.

Despite what the FDA recommends, Virginia Mason officials started going above and beyond manufacturer recommendations for sterilizing the scopes, quarantining them for two days and testing them to make sure they are completely free of CRE. Additionally, UCLA officials also stated that the hospital now cleans the scopes in a way that goes beyond what the manufacturer recommends in order to prevent infections.

However, the FDA, in its alert, states, "Deviations from the manufacturer's instructions for reprocessing may contribute to contamination. The benefit of using cleaning accessories not specified in the manufacturer's instructions, such as channel flushing aids, brushes, and cleaning agents, is not known."

According to the FDA, more than 500,000 procedures using the duodenoscopes are performed in the U.S. each year, and the agency received just 75 medical device reports relating to possible microbial transmission from reprocessed scopes in a two-year span.

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