FDA clears Olympus duodenoscope with design modifications

The U.S. Food and Drug Administration on Friday cleared Japan’s Olympus Corp’s duodenoscope with changes to the device’s design and labeling, intended to help reduce the risk of bacterial infections.

Olympus, the world’s biggest maker of duodenoscopes, will voluntarily recall its original model being used in health care facilities to fix them as quickly as possible, the regulator said. (1.usa.gov/1Smn8p8)

The FDA in August asked healthcare facilities using these and other reusable medical devices to meticulously follow the cleaning instructions to avoid the spread of antibiotic-resistant bacteria, or superbugs.

Duodenoscopes are flexible tubes snaked down a patient’s throat to diagnose or treat disorders of the gastrointestinal tract. Physicians perform about 500,000 such procedures every year in the United States.

The complex design of these devices – used to drain fluids from blocked pancreatic and biliary ducts – has been linked to increased risks of superbug infections even when cleaning instructions are followed correctly.

Other companies that sell duodenoscopes in the United States include Fujifilm Holdings Corp and Pentax Medical, a unit of Hoya Corp.

(Reporting by Ankur Banerjee and Rosmi Shaji in Bengaluru; Editing by Saumyadeb Chakrabarty)

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