Specialized endoscopes that are used to perform a common medical procedure have contributed to at least 13 deaths and 121 injuries in recent years by spreading bacteria among patients. A panel of medical experts at the Food and Drug Administration meets this week to consider the safety of the devices. The instruments, known as duodenoscopes, have intricate channels that can harbor pathogens from one patient and spread them to others, even after cleaning. The panel will weigh whether the existing cleaning guidelines are adequate and, if not, how to improve them.
U.S. regulators might take a cue from a Dutch hospital that faced the same problem three years ago: a spike in drug- resistant infections detected in January 2012 among patients who underwent the procedures using the same model of Olympus scope suspected of spreading bacteria in several outbreaks in the United States. Researchers report in a recent article in the journal Endoscopy that the hospital, Erasmus MC University Medical Center, in Rotterdam, halted its outbreak by reverting to an older model of scope that researchers believe is easier to clean.
The problem isn’t isolated to a single model of the device. Nine U.S. hospitals have reported outbreaks linked to scopes from all of the three major manufacturers: Olympus, Pentax, and Fujifilm. But the Olympus scope, model number TJF-Q180V, is getting extra scrutiny for two reasons. Olympus is the dominant maker of the scopes, with about 85 percent of the U.S. market, according to the FDA. And that particular model has not been cleared by the FDA’s process for overseeing medical devices, though earlier versions have.
Olympus didn’t respond to a request for comment. The Japanese device maker is facing 14 lawsuits in California, Pennsylvania, and Washington state “alleging injuries sustained by the use of the same product—the TJF-Q180V duodenoscope,” according to a May 1 filing in U.S. District Court in California.
The model features a sealed channel that may be difficult to rid of trapped organic material. The version it replaced, the Dutch researchers wrote, features a removable cap that can be taken off so the inside pieces of the scope can be flushed clean. In the Rotterdam outbreak, 22 of the 30 patients infected over five months had the procedure done with an Olympus TJF- Q180V. Reverting to using the earlier Olympus scope stopped the outbreak.
Duodenoscopes are used to diagnose and treat problems in tiny ducts connecting the small intestine to the pancreas or gallbladder. The procedure is done more than 600,000 times a year in the U.S., the FDA says.
Under the FDA’s rules for medical devices, manufacturers are allowed to determine on their own whether to notify the regulator about changes to an existing product. Olympus sold the new model to hospitals for years before the FDA determined it needed a separate review and asked the company to submit a new application in March 2014. The lack of clearance wasn’t made public until this year. The agency is still evaluating that submission. The FDA says there’s no evidence the lack of clearance is associated with the infections.
The FDA is aware of the report from Erasmus, agency spokeswoman Jennifer Dooren said in an e-mail. The U.S. regulator hasn’t pulled the scope from the market, citing concerns about causing a shortage of instruments needed for sometimes life-saving treatments. In March, Olympus issued new instructions for cleaning the scopes, which the FDA urged hospitals to adopt “as soon as possible.”
Olympus warned hospitals in Europe about the difficulty in cleaning the new model scopes as early as January 2013, the Los Angeles Times reported in April. That was two years before problems came to light in the U.S. The FDA didn’t publicly warn that effective cleaning of the devices “may not be possible” until a Feb. 19 safety alert, the day after news of an outbreak at UCLA Medical Center made headlines.
The agency and the manufacturer have faced criticism and inquiries from members of Congress. U.S. Sen. Patty Murray, a Democrat from Washington, has asked the FDA for a full review of problems with the devices, including whether the agency’s system for monitoring changes to devices is adequate.
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