FDA Warning: Design of Medical Scope Linked to Superbug” Deaths May Prevent Effective Cleaning

A bacterial "superbug" linked to two deaths and several infections at Ronald Reagan-UCLA Medical Center was transmitted from patient to patient by a medical device, health officials said Thursday.

There may also be more infections, authorities said.

Almost 180 patients at Ronald Reagan-UCLA Medical Center have been notified that they may have been exposed to the bacteria, Enterobacteriaceae (CRE), between October 2014 and January 2015.

The devices, called duodenoscopes, are used for diagnosing and treating certain problems of the biliary or pancreatic systems, and were known for needing rigorous disinfection. They are used in an estimated 500,000 procedures each year.

The Food and Drug Administration also issued a new warning, saying that the design of the minimally invasive device can harbor the dangerous bacteria, even if the manufacturer's detailed cleaning instructions are followed correctly.

"Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it," said the warning, released Thursday morning.

About 135 patients across the U.S. may have been exposed to bacteria transmitted with the devices in 2013 and 2014, according to 75 reports delivered to the FDA.

The FDA recommended that doctors inform patients of the risks of using ERCP endoscopes before a procedure, and afterwards telling them what symptoms to look for that could indicate a CRE infection.

UCLA has called each of the 179 patients who may have been exposed to to CRE, hospital officials said. The  hospital's two duodenoscopes that may have been infected are no longer being used.

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