The U.S. Food and Drug Administration is working to speed label changes for medical devices linked to a "superbug" outbreak in California, possibly to include new warnings and more stringent cleaning and disinfecting instructions, say Reuters reporting.
Last week the FDA warned that the complex design of the reusable duodenoscopes, which are threaded through the mouth, throat and stomach and used in a variety of gastrointestinal procedures, makes them difficult to disinfect properly, even when instructions provided by the manufacturers are followed.
The urgency in updating risk information comes as the FDA faces some criticism for taking more than three years to issue definitive guidelines on the instructions manufacturers must give for disinfecting the scopes, a delay that critics say may have contributed to the failure to keep the devices from causing infections.
The outbreak may have exposed 179 patients to a potentially deadly, drug-resistant strain of bacteria at UCLA's Ronald Reagan Medical Center in Los Angeles and contributed to two deaths. The FDA said last week that from 2013 to 2014 it received 75 reports, involving 135 patients, of possible contamination from reused duodenoscopes.
Experts say that if a new cleaning method is established, the agency would expect companies to reflect that in their labels. One possible protocol is being developed by the U.S. Centers for Disease Control and Prevention and is close to being finalized.
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