The Food and Drug Administration (FDA) has stepped up its oversight of the medical scopes linked to potentially fatal “superbug” outbreaks.
In the last month, two Los Angeles hospitals have reported multi-drug resistant infections in patients following a duodenoscope procedure, despite following manufacturer’s cleaning guidelines. The duodenoscope’s complex design, which is intended to help the physicians drain fluids, makes the instrument extremely difficult to clean, the Associated Press (AP) reports. Bodily fluids can remain in the crevices even after cleaning and disinfection.
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, according to the AP. Two patients died from the infection. Last week another Los Angeles Hospital, Cedars-Sinai Medical Center, reported that four patients were infected with the same superbug after being treated with the same Olympus scope.
The FDA released stricter guidelines for manufacturers of reusable medical instruments, including specialized endoscopes used in about half a million medical procedures annually. The agency will ask manufacturers to submit scientific data showing that their devices can be safely disinfected, the AP reports.
The FDA issued a draft version of new guidelines in 2011 but now hopes to pick up the pace of implementation because of the recent infections, according to Dr. Stephen Ostroff, the FDA’s chief scientist. The FDA will hold a two-day meeting in May to gather expert opinion on improving the design and regulation of the duodenoscopes. Ten members of Congress asked the FDA to answer questions about the devices, including how the agency reviews their cleaning instructions, according to the AP. Some hospitals have already adopted extra cleaning procedures, including sterilizing scopes with toxic ethylene oxide gas. Other steps include quarantining the scope after each use and performing laboratory testing to identify any dangerous bacteria.
Federal regulators stress that these devices are essential for treating tumors, gallstones and other blockages around the pancreas and bile ducts. The agency is working to see how the design could be improved, but stressed that the agency cannot force manufacturers to redesign products. And, outside experts say it could take years before a redesigned device actually reaches the market.