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FDA Says Duodenoscope Design can Impede Cleaning, Potentially Spread Bacterial Infections

Feb 20, 2015

The U.S. Food and Drug Administration (FDA) has issued a new safety alert concerning endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes; these devices are flexible, lighted tubes that are placed into the top of the small intestine (duodenum) by being threaded though the mouth, throat and stomach. The FDA states that the complex design of duodenoscopes, or ERCP endoscopes, can inhibit effective cleaning.

"Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly." the Feb. 19 alert states. The FDA said that the risk of infection should be lowered when the duodenoscopes are cleaned meticulously, but cautioned that it does not completely prevent it.

According to HCPlive, the UCLA Health System found that endoscopic procedures between October 2014 and January 2015 may have exposed over 100 patients to a superbug, which has been linked to at least two deaths.

The FDA said it was closely monitoring the link between reprocessed duodenoscopes and the transmission of infectious agents. This includes multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli. The FDA received a total of 75 medical device reports related to potential microbial transmission from reprocessed duodenoscopes. These reports include roughly 135 patients in the United States, although it is possible that these figures are underestimations.

The agency is collaborating with the Centers for Disease Control and Prevention to further investigate the issue. Doctors should warn patients about the risks associated with ERCP procedures. Symptoms to be aware of include fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools.

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