(Reuters) — The FDA said an advisory panel is slated to discuss the transmission of “superbug” infections through endoscopy procedures in U.S. hospitals.
A 2nd top Los Angeles hospital reported an outbreak of drug-resistant “superbug” infections last week, and dozens more potential exposures, from procedures performed with a fiber-optic instrument called duodenoscope.
The gastroenterology & urology devices panel is scheduled to meet May 14-15, the federal safety watchdog said today.
A top FDA official said earlier this month that manufacturers’ tests of procedures to clean medical scopes linked with “superbug” outbreaks contained flaws that render their cleaning instructions unreliable.
Duodenoscopes have been associated with episodic infections for more than a decade. But an increasing number of germs have developed a resistance to antibiotics, making them potentially more dangerous and difficult to treat.
A top Los Angeles hospital, Cedars-Sinai Medical Center, said last week that 4 patients had been infected with bacteria from a contaminated scope and 67 more were at risk, weeks after UCLA Ronald Reagan hospital reported 7 patients were similarly infected and scores more potentially exposed. Across the country in Connecticut, Hartford Hospital has also reported a similar outbreak involving at least five infections and more than 280 potential exposures.
Between 2013 and 2014, the FDA said it received reports of 135 possible microbial transmission from reprocessed duodenoscopes. The federal safety watchdog has been under pressure to review current protocol of sterilizing the instruments after a string of superbug outbreaks at hospitals across the country.
Although the FDA said Olympus put its TJF-Q180V duodenoscope on the market without the agency’s clearance, Olympus claimed that, based on the FDA’s policy, a modified version of its previously approved scope did not require a new marketing approval.
Top makers of the devices include Olympus, Fujifilm Holdings (TSE:4901) and Hoya Corp.‘s (TYO:7741) Pentax subsidiary.
