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FDA Approves Olympus Duodenoscope Modifications
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The FDA today granted 510(k) clearance of design and labeling modifications to the Olympus TJF-Q180V duodenoscope aimed at reducing bacterial infection risks, according to an FDA news release. Olympus will voluntarily recall the original scopes and make repairs “as quickly as possible.”
“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,” William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in the news 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.”
The design modification is a sealing mechanism that provides a tighter seal to reduce potential leakage into the closed elevator channel, which can reduce infection risk as the sealed area cannot be disinfected between uses, according to the news release. Olympus will also begin performing annual inspections of scopes to identify wear and tear on the sealing mechanism or debris at the tip of the scope.
According to a press release from Olympus, the company will begin a corrective action to replace the forceps elevator mechanism with a new forceps elevator design on all original model scopes beginning in early February.
“The company estimates it will be able to correct the mechanism in the approximately 4,400 TJF-Q180V models currently used in health care facilities throughout the country by August 2016,” according to the FDA news release. “While awaiting repair, health care facilities may continue to use the Olympus TJF-Q180V, but they should meticulously follow the manufacturer’s reprocessing instructions.”
Olympus will contact each facility and provide free instructions on obtaining a replacement, which will have a turnaround time of about 4 days, according to the FDA news release. These instructions will be sent by Federal Express today, according to the Olympus press release.
Olympus will also provide an updated operation manual with new information on device inspection before and after procedures now required by health care facilities, and an updated reprocessing manual with new instructions, “including information on the use of Acecide-C High-Level Disinfectant when disinfecting the TJF-Q180V in the OER-Pro and a new chapter (Chapter 6) regarding annual inspections by Olympus service personnel,” according to the Olympus press release. The company plans to implement the corrective action “in all other markets … in the coming months.”