Olympus asked FDA to loosen its belt on cleaning guidelines for endoscope devices

Olympus TJF-Q180V duodenoscope--Courtesy of Olympus Australia

Olympus is facing more pushback over endoscopes tied to drug-resistant superbug outbreaks at U.S. hospitals, as new reports show the company asked the FDA to soften its guidelines on cleaning procedures for the products.

As Bloomberg reports, the FDA published a draft of nonbinding recommendations in 2011 to help devicemakers prove that their cleaning methods were up to snuff and make sure directions given to hospital staff were adequate. Companies, individuals and medical societies weighed in on the proposal as part of the regulatory process, including Olympus, the leading maker of the devices. Instead of overseeing the cleaning process for duodenoscopes on its own, the company suggested shouldering the responsibility with separate groups that make the cleaning equipment.

Olympus and other manufacturers would "identify the worst case conditions" under which the device would need to be cleaned, and then companies that make the cleaning systems would test how effective the process is on behalf of the manufacturer, Olympus said in its comment letter. Under the company's plan, endoscope makers would then test the devices' material durability and compatibility to see how well it stood up to cleanings. The company also suggested changing the wording of the FDA's guidance, saying devices "may" rather than "will" need to be disassembled in order to be completely cleaned.

The agency has still not finalized its new guidelines for the devices but is "working diligently to get the final reprocessing guidance out as soon as possible," spokeswoman Leslie Wooldridge told Bloomberg.

Meanwhile, the FDA continues to face backlash from patients and lawmakers over duodenoscope devices implicated in the recent drug-resistant superbug outbreaks in California and Washington. The agency revealed last week that it had not approved the Olympus scope linked to the superbug outbreak at UCLA Medical Center, even though the company has marketed the device since 2010. Regulators had cleared earlier versions of the device, and Olympus "determined" the new model did not need separate approval, company spokesman Mark Miller told Bloomberg.

A new application for the device is still pending, and regulators have encouraged providers to "inform patients of the benefits and risks" associated with endoscopic retrograde cholangiopancreatography procedures with duodenoscopes, which are threaded through the mouth, throat and stomach or the top of the small intestine to drain fluids from blocked pancreatic or biliary ducts. But the FDA is not pulling the devices because it could lead to a shortage, as the products are used in half a million procedures in the U.S. each year.

Olympus is also facing backlash from patients and families who were affected by the recent superbug outbreaks. Last month, a Los Angeles patient who underwent surgery with a duodenoscope at UCLA Medical Center sued the company's U.S. unit, claiming Olympus did not provide doctors with adequate cleaning instructions for its Q180V scope. The widow of a Seattle-area man who was infected with a superbug at Virginia Mason Medical Center also filed suit against Olympus and the hospital, seeking damages and an injunction that would force Virginia Mason officials to inform other patients and families involved in the outbreak.

- read the Bloomberg story
- here's Olympus' comment letter (PDF)

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