Manufacturer made changes to reduce risk of bacterial infection
MONDAY, Jan. 18, 2016 (HealthDay News) — A newly designed Olympus duodenoscope was approved Friday by the U.S. Food and Drug Administration.
The new device has modifications to reduce the risk of bacterial infections, the FDA said. The original model will be recalled and repaired by Olympus, according to the FDA. Along with design modifications to its device, Olympus made labeling changes. The company also said it will conduct annual inspections of each scope in use to ensure their safety.
“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,” William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in an agency news release.
Olympus estimated approximately 4,400 of these duodenoscopes are currently in use in U.S. health facilities. The company estimated that repairs to these devices will be completed by August 2016. While awaiting repair, health facilities can continue using the devices but must closely follow the manufacturer’s reprocessing instructions.
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