Olympus Corp. warned hospitals in Europe about the risk of patient infections associated with a certain type of gastrointestinal scope two years before the devices were linked to a deadly superbug outbreak in California, the Los Angeles Times reports.
The outbreak of carbapenem-resistant Enterobacteriaceae (CRE), which caused two patient deaths at UCLA Medical Center and sickened others at Cedars-Sinai Medical Center in Los Angeles, also has cropped up at hospitals in North Carolina, Pittsburgh, Seattle and Chicago, FierceHealthcare reported. The patients contracted CRE, an antibiotic-resistant "nightmare bacteria" that can kill as many as half of patients in whom it reaches the bloodstream, after they were treated with a specialized device known as a duodenoscope.
The Food and Drug Administration (FDA) warned hospitals in February that the complex design of these devices makes them difficult to sterilize. And just days after an agency official indicated the manufacturers' tests of recommended cleaning procedures may be flawed, the FDA issued stricter guidelines for manufacturers that require they prove future versions of the devices can be cleaned properly before entering the market. Though it has been criticized for not acting more quickly, the FDA has refused to take the existing devices off the market because it says they are used in 500,000 potentially life-saving procedures each year that diagnose and treat cancers and other digestive diseases.
Now Olympus finds itself under fire amid news that it first alerted European hospitals about the infection risk posed by duodenoscopes in January 2013--and didn't issue a similar warning in the U.S. until the day after the L.A. Times reported about the UCLA outbreak. The FDA told the newspaper that it learned last summer about letters Olympus sent to European hospitals, but did not alert U.S. hospitals because the agency was working with Olympus and two other manufacturers to evaluate their cleaning protocols.
The families of patients affected by the CRE outbreak have sued Olympus, alleging negligence and fraud on the part of the Japanese company. Olympus declined to comment on either its alert to European and U.S. hospitals or the pending litigation against it, according to the L.A. Times.
But for Rep. Ted Lieu (D-Los Angeles), who continues to call for congressional hearings into the matter, limited civil suits aren't enough. "That is not how device makers should run their business," he told the newspaper. "It's clear Olympus knew something was not correct about its existing cleaning instructions."
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