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FDA Looks to Update Labels for Devices Connected With “Superbug”

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Jasmine Roziers3 years ago

According to MassDevice, the U.S. Food and Drug Administration (FDA) is currently working to change labels on medical devices that have been linked to the “superbug” outbreak in California.

About the Duodenoscope Label changes

The FDA released a warning last week that current duodenoscopes sanitation procedures may be insufficient. Duodenoscopes are medical devices used for gastrointestinal procedures.

The device is threaded through the patients' mouth, throat, and stomach. According to the FDA, the design is complex, which makes it hard to properly clean. 

Proposed label changes could include new sanitary products like cleaning stringent and instructions on how to disinfect these medical devices. The FDA would also like to include new warnings for the medical devices. 

Duodenoscopes Linked to UCLA “Superbug” Outbreak

The FDA’s decision to accelerate the label changes comes after a mass exposure event at the UCLA Ronald Reagan Medical Center.

The center estimates that as many as 180 people were exposed to Carbapenem-Resistant Enterobacteriaceae (CRE), an antibiotic resistant “superbug”, while undergoing endoscopic procedures.

There have been seven confirmed infections and two of the infected patients have died.

The manufacturer of the duodenscopes that were during the procedure, Olympus, is currently facing two lawsuits regarding outdated product labels.


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