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CRE outbreaks lead to FDA warning on duodenoscopes

Accreditation Insider, February 24, 2015

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On the heels of outbreaks of antibiotic-resistant Carbapenem-resistant Enterobacteriaceae (CRE) that killed patients in Los Angeles and North Carolina, the Food and Drug Administration (FDA) last week issued a warning about the use of duodenoscopes.

The scopes are used in more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures annually, according to the FDA. ERCP is the least invasive method of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions. The warning says that the complex design of duodenoscopes may impede effective reprocessing, the process healthcare facilities use to clean and disinfect or sterilize reusable devices.

The FDA recommends that healthcare providers follow manufacturers’ instructions for reprocessing the scopes. In addition, providers should inform patients about ERCP benefits and risks, discuss what patients should expect following the procedure, and have a comprehensive quality program for reprocessing devices. The warning comes in the wake of recent outbreaks at UCLA’s Ronald Reagan Medical Center in Los Angeles, in which two patients died, and in North Carolina, where 18 patients were infected with CRE and two died, according to the Charlotte Observer.

Read the FDA warning.



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