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FDA Increases Oversight of Endoscopes Linked to 'Superbug' Infections

Mar 16, 2015

The Food and Drug Administration (FDA) is increasing oversight of endoscopes associated with a number of "superbug" infection outbreaks.

The FDA has released stricter guidelines for manufacturers of reusable medical instruments, including specialized endoscopes – duodenoscopes – used to diagnose and treat conditions in the pancreas and bile ducts. Such scopes are used in about 500,000 procedures in the U.S. each year, The Associated Press reports. The agency is asking manufacturers to show that the devices can be completely disinfected.

The FDA issued a draft version of the new guidelines in 2011 and now wants to accelerate the implementation process because of recent episodes of infection, according to Dr. Stephen Ostroff, the FDA’s chief scientist. In the last month, two Los Angeles hospitals have reported superbug infections following an endoscope procedure. Seven patients at Ronald Reagan UCLA Medical Center contracted an antibiotic-resistant strain of bacteria – carbapenem-resistant Enterobacteriaceae (CRE) – after undergoing endoscopic procedures with a device made by Olympus Corp. Two patients died. At Cedars-Sinai Medical Center, four patients were infected with the same superbug after being treated with the same Olympus scope. Pentax Medical and Fujifilm also manufacture the devices.

The complex design of the duodenoscope makes the instruments difficult to clean. Bodily fluids and other particles can remain in the device's crevices even after cleaning and disinfection according to manufacturer’s instructions, the AP reports.

The FDA has announced a two-day meeting in mid-May to gather opinions on how to improve the design and regulation of duodenoscopes. Contamination problems have been reported with devices made by all three manufacturers of the devices, according to the AP. FDA officials stressed that the FDA cannot force manufacturers to redesign products, and, even if the duodenoscope is redesigned, it could take years before the new device reaches the market.

Some hospitals have already adopted new disinfection procedures, including sterilizing scopes with toxic ethylene oxide gas, or quarantining the scope after use and testing for dangerous bacteria. But quarantine could prove expensive because each duodenoscope can cost about $40,000, according to the AP.

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