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FDA ISSUES SAFETY ALERT ABOUT INFECTION RISKS WITH DUODENOSCOPES

FDA ISSUES SAFETY ALERT ABOUT INFECTION RISKS WITH DUODENOSCOPES

The FDA recently issued a safety communication about potentially serious health risks associated with the use of ERCP endoscopes (also called duodenoscopes). These medical devices are "flexible, lighted tubes that are threaded through the mouth, throat, stomach, [in order to reach] the small intestine [or duodenum]." Their use "allows the injection of contrast dye [for imaging] or the insertion of other instruments to obtain tissue samples for biopsy or treat certain abnormalities." Duodenoscopes are utilized during a procedure called endoscopic retrograde cholangiopancreatography (or ERCP) which "is the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions."

According to the FDA, the complex design of duodenoscopes may hinder their proper cleaning and disinfection. In particular, they feature an elevator mechanism whose "moving parts... contain microscopic crevices that may not be reached with a [cleaning] brush." Body fluids can remain in the crevices, and if they "contain microbial contamination, subsequent patients may be exposed to serious infections... including multidrug-resistant bacterial infections."

Between January 2013 and December 2014, the FDA has received reports "relating to possible microbial transmission from reprocessed duodenoscopes" that affected about 135 patients. Furthermore, both "medical publications and adverse event reports associate multidrug-resistant bacterial infections [with the use of] duodenoscopes, even when manufacturer reprocessing instructions are followed correctly."

The FDA recommendations include meticulous manual cleaning of duodenoscopes even when using automated cleaning tools and "taking a duodenoscope out of service until it has been verified to be free of pathogens if a patient develops an infection with a multidrug-resistant organism following ERCP..."

Sources:

FDA,

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm

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