FDA knew infection risks of duodenoscopes years prior to recent outbreaks

The U.S. Food and Drug Administration knew roughly six years ago that duodenoscopes posed a risk for harboring organisms and spreading infections, according to a USA Today investigation and report.

In 2009, epidemiologists at the Florida Department of Health and the Centers for Disease Control and Prevention sent emails and spoke on the phone with the FDA about infections in Florida hospitals that likely occurred because organizations were having difficulty cleaning scopes properly, according to the report. They urged the FDA to issue a safety alert to hospitals about the issue.

The FDA didn't issue such a warning until this winter, after several more superbug outbreaks occurred due to the hard-to-clean nature of the scopes.

"The FDA missed numerous red flags," Rep. Ted Lieu, D-Calif., told USA Today. "They knew for years that these scopes were difficult to clean, and when they realized that they should have begun issuing safety alerts and had the manufacturers look at new designs."

Duodenoscopes have been linked to several carbapenem-resistant Enterobacteriaceae infection outbreaks in recent years and months, including outbreaks at Ronald Reagan UCLA Medical Center in Los Angeles, Cedars-Sinai Medical Center in Los Angeles and Seattle-based Virginia Mason Medical Center.

An FDA panel recently advocated for sterilizing the medical scope, instead of using the high-level disinfection method of cleaning, to protect patients and limit the infections caused by the scopes.

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