FDA advisory panel: Superbug-linked scopes put patients in danger

An advisory panel convened by the Food and Drug Administration (FDA) urged the agency to better protect patients from specialized medical scopes linked to recent superbug outbreaks, the L.A. Times reports.

Patients in hospitals around the country have been sickened and even killed after contracting carbapenem-resistant Enterobacteriaceae (CRE), "nightmare bacteria" that the FDA has warned can live on devices known as duodenoscopes even after they have been cleaned according to their manufacturers' instructions, FierceHealthcare has reported. Duodenoscopes are used in endoscopic retrograde cholangiopancreatograph (ERCP) procedures, in which they are threaded down patients' throats to treat gallstones, cancers and other disorders of the digestive system.

The FDA has said previously that it will not move to take duodenoscopes off the market because they are the only devices that can be used in "life-saving" ECRP procedures. Panel members including doctors, consumer advocates and health experts supported that decision in the panel's two-day meeting late last week, according to the L.A. Times. However, they said the FDA must do more to ensure that duodenoscopes can be safely used.

"We have heard enough data to say these devices are not safe using current conditions," said Irving Nachamkin, M.D., a pathology professor at the University of Pennsylvania School of Medicine.

The panel members also criticized major dudenoscope manufacturer Olympus, which is facing lawsuits regarding the outbreaks and declined to participate in the FDA forum. Though the company issued new cleaning instructions and a new brush to aid cleaning in March, according to the newspaper, panel members said it is impossible to determine whether these new measures are effective without data from the company.

That dearth of data is part of why the panel did not settle on any one best practice for sterilization, said Bryce Mays, M.D., a gastroenterologist at Fort Belvoir Community Hospital in Virginia.

A spokesman for the company, however, told the L.A. Times that it has provided data to the FDA showing the scopes can be cleaned effectively with its new instructions and brush, which the FDA confirmed after the meeting. Both the FDA and Olympus have been criticized for not alerting hospitals and the public sooner about duodenoscopes' infection risk.

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