Over half a million duodenoscope procedures are performed in the U.S. each year to diagnose and treat diseases in the pancreas, bile duct and gallbladder. Yet recent tests, performed by manufacturers at the demand of the FDA, found one in 20 devices still contain microbes like Escherichia coli after proper cleaning, a ratio far worse than anticipated. Hundreds have been infected in dozens of outbreaks linked to duodenoscopes since 2012, including outbreaks of antibiotic-resistant bacteria.
Most duodenoscopes are manufactured by Olympus Medical Systems Corp., Pentax of America and Fujifilm Medical Systems USA. They claim that following their cleaning and disinfection instructions make the devices safe for patients.
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