January 15, 2016 | | Comments 0
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All Olympus duodenoscopes recalled, replaced with approved FDA model

Olympus Corp., the biggest seller of duodenoscopes in the nation, announced a recall of all its scopes on January 15. The recall was issued a day after a Senate committee report linked Olympus products to 142 antibiotic-resistant infection (ARI) cases.

Duodenoscopes are flexible cameras that are inserted into a patient’s mouth or digestive tract to diagnose cancers, and are used in over 500,000 procedures a year. Recent investigations found that a flaw in the scope’s design made it near impossible to fully disinfect, exposing patients to ARIs and resulting in 25 outbreaks in three years and four countries.

Olympus is the largest of the three companies listed in the Senate Committee on Health, Education, Labor, and Pensions report, controlling 85% of the American duodenoscope market. Olympus voluntarily issued the recall after the Food and Drug Administration (FDA) cleared the company’s new safety modifications to its TJF-Q180V model duodenoscope. 

“We have made it a top priority to improve the safety of duodenoscopes and help protect patients from bacterial infections associated with these medical devices,” said William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, in a press release. “The Olympus TJF-Q180V’s new design, as well as the new annual inspection program, is intended to reduce the risk of fluid leakage into the elevator channel, which in turn can reduce patient exposure to bacteria and other potential infections.”

Olympus says it will call every facility using the scopes and provide them with a free replacement for their recalled devices. There are around 4,400 TJF-Q180V models currently in use in America and Olympus hopes to have them all replaced or modified by August 2016. In the short term, healthcare facilities may continue to use unmodified TJF-Q180Vs, but are urged to meticulously follow the manufacturer’s reprocessing instructions.

 

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Filed Under: National NewsPatient Safety

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About the Author: Brian Ward is an Associate Editor at HCPro working on accreditation, patient safety, and quality news.

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