A federal lawmaker is seeking details from the manufacturer of medical scopes that have been linked to several "superbug" bacteria outbreaks at U.S. hospitals, increasing pressure on the company.
U.S. Rep. Ted Lieu, D-Calif., wants to know when Olympus Corp. first learned of the problems and about its plans to redesign and replace the specialized medical scopes, according a letter sent Monday. Lieu has previously called for congressional hearings to investigate problems with the devices.
Olympus scopes were linked to infections of antibiotic-resistant bacteria in 11 patients — two of whom died — at two separate Los Angeles hospitals last month. Hospital staff said the infections occurred despite following Olympus' instructions for cleaning the devices, known as duodendoscopes.
Similar outbreaks involving tainted medical scopes previously sickened dozens of patients at hospitals in suburban Chicago and Seattle.
The problems have touched off a national discussion about the safety of reusable medical instruments and how they are regulated. The Food and Drug Administration says it is not recalling any duodenoscopes because they are critical for day-to-day hospital care, used in a half-million U.S. procedures each year. Instead the agency is requiring more data on cleaning efficiency before allowing new duodenoscopes on the market and asking manufacturers to redesign older devices.
In the meantime, FDA regulators have recommended hospitals regularly test duodenoscopes for the presence of dangerous bacteria, a laboratory process which can take two days or longer. As a result, some hospitals are purchasing more duodenoscopes to make up for those out of commission for testing. The devices can cost up to $40,000 each.
"It seems fundamentally unfair for Olympus to be selling more duodenoscopes to these same hospitals as a result of the design problems created by Olympus in the first place," states Lieu, whose congressional district includes both LA hospitals affected by the problem.
Lieu asks whether Olympus will consider donating scopes to hospitals "until the design or cleaning problems have been resolved."
Duodenoscopes consist of a flexible fiber-optic tube that is threaded down the throat, through the stomach and small intestine to diagnose and treat conditions in the pancreas and bile ducts. The tip of the scope includes moveable parts for instruments to help remove tumors, gallstones and other blockages. But this complex design also makes the instruments difficult to clean. Bodily fluids and other particles can stay in the device's joints and crevices even after cleaning and disinfection.
A spokesman for Olympus Corporations of the Americas said in a statement the company is reviewing Lieu's letter.
"As a medical device manufacturer, Olympus continuously strives to improve our products for safe and effective use," said Mark Miller, a vice president with the company, which is based in Japan.
The FDA previously disclosed that Olympus did not seek federal clearance for the latest version of its duodenoscope, which it began selling in 2010. FDA clearance is required for all substantive updates to medical devices sold in the U.S. The company's Olympus TJF-Q180V duodenoscope is currently under FDA review.
Despite the lack of clearance, the FDA said doctors should not stop using the device because it's not clear that a federal review would have prevented the contamination problems. The agency said infections have been reported with devices from both of Olympus' competitors, Pentax Medical and Fujifilm.