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FDA approves Olympus’ redesign of device once linked to infections
Dawn Ouellette Nixon//February 3, 2020
FDA approves Olympus’ redesign of device once linked to infections
Dawn Ouellette Nixon//February 3, 2020//
Listen to this articleThe U.S. Food and Drug Administration cleared Olympus Corporation of the Americas to sell a revised version of a medical device used to examine a patient’s internal organs. Olympus revised the device, called a duodenoscope, after it was linked to outbreaks of a potentially deadly bacteria.
A duodenoscope is used to diagnose problems and perform therapies on the bile ducts, pancreas and duodenum. The FDA warned duodenoscope manufacturers, Olympus, Pentax and Fujifilm in March of 2018 that the companies must improve the safety of the device or the FDA would take additional action, such as injunction and civil money penalties.
The device was linked to carbapenem-resistant enterobacteriaceae, strains of bacteria resistant to most antibiotics used today. Enterobacteriaceae infections are common in health care settings, and were responsible for 13,100 infections and 1,100 deaths in the United States in 2017, according to the CDC, the national public health institute.
Olympus’ new version of the tool features a sterile, disposable distal end cap, according to a news release from the Center Valley-based biotech company.
The new device is designed to be easier to clean, reducing the risk of contamination. Olympus will also perform periodic inspections and maintenance of every duodenoscope.
“Infection prevention is an ongoing mission that we at Olympus are committed to fulfilling,working in partnership with our customers, medical societies, and regulatory authorities to keep patients safe…,” said Kurt Heine, group vice president for endoscopy at Olympus,
