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| Olympus TJF-Q180V duodenoscope--Courtesy of Olympus Australia |
Rep. Ted Lieu (D-CA) is calling for a federal investigation into the duodenoscope safety scare that has claimed lives and spread the dangerous pathogen CRE to patients across the nation. And he just sent a letter to Olympus asking the company why it did not seek FDA clearance for a 2010 redesign of its duodenoscope, if it plans to redesign the device in the future, and when the company first learned of the risk posed by the device.
Lieu's Los Angeles area district was one of the hardest hit by the outbreak. Two patients treated by UCLA died of CRE and 7 were injured. The outbreak was linked to infected and improperly cleaned duodenoscopes, and spotlighted their long-standing role in spreading the disease throughout the nation, from Seattle to Philadelphia. In fact, cases linked to the specialized endoscope have been reported for many years, and the FDA was aware of the problem, but only now are efforts to tackle the problem gaining momentum.
Because duodenoscopes, used to visualize the esophagus, stomach and duodenum (the first part of the small intestine), are difficult to clean, some hospitals are purchasing multiple scopes out of caution, at a cost of up $40,000 apiece. Accessories can be added to the device to remove tumors, gallstones or other disturbances.
The federal Centers for Disease Control, American Gastroenterological Association and Association for Professionals in Infection Control and Epidemiology have put out guidelines on preventing duodenoscope infections. Some hospitals are using alternative cleaning techniques involving gasification, but its high cost make it an unappealing option.
"These new protocols, however, render the duodenoscope inaccessible for 24 hours, 48 hours, or more. This has caused hospitals that have experienced CRE outbreaks from Olympus duodenoscopes to purchase even more Olympus duodenoscopes," Lieu wrote the letter.
"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," Lieu continued. He also asked if Olympus would consider donating scopes to hospitals "until the design or cleaning problems have been resolved."
The Olympus scope indicted in the safety scare was never cleared by the FDA following a 2010 redesign. However the agency is not withdrawing the device from the market because it is used in 500,000 ERCP procedures per year. As such, the risk of contracting ERCP is very low.
Meanwhile the FDA is working with duodenoscope manufacturers, Olympus, Pentax Medical and Fujifilm on a redesign. It has scheduled a meeting of its Gastroenterology and Urology Devices Advisory Panel in May to further investigate the issue.
- read the letter