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Olympus Receives FDA Warning Letters

The company Olympus Medical recently received two letters of warning from the FDA (Food & Drug Administration) regarding safety issues which relate to reprocessing endoscopes, which also involves the cleaning and disinfection of the devices in order that they can be re-used. Throughout inspections which took place in July and September last year (2022), the decision from the FDA was that Olympus failed to provide evidence of adequate testing and recording of the device assembly process.

Additionally, the company failed to meet MDR (medical device reporting) standards, according to a statement issued on January 10th from the director of the FDA’s CDHR (Center for Devices and Radiological Health), Jeff Shuren: “CDRH has been involved in extensive and ongoing efforts with Olympus to address compliance issues related to the reprocessing of endoscopes,” Shuren wrote.
“However, as described in the recent warning letters, Olympus is not in compliance with MDR reporting and quality system requirements.”
These warning letters have been addressed to Aizu Olympus, which is a subsidiary of Olympus Medical Systems and is based in Tokyo.

Olympus Medical create a wide range of devices, included among which are duodenoscopes, bronchoscopes, and urological endoscopes. “During recent inspections, [the FDA] determined that Olympus did not meet requirements to assure the quality and performance of the devices such as adequate testing and documentation of the device assembly process,” Shuren said.

He also faulted Olympus for not developing reporting procedures to ensure the agency is told of “any infections or reprocessing failures connected to the devices.” In a background statement about endoscope sterilization published this week, the FDA wrote that “inadequate cleaning between patient uses can result in the retention of blood, tissue and other biological debris (soil) in certain types of reusable medical devices.” Olympus issued an emailed statement, saying that it is currently working with the FDA: “Comprehensive responses to each Warning Letter have been submitted to FDA on time, and the implementation of appropriate actions to address the FDA’s concerns is progressing on time,” Olympus said. “The company is committed to implementing sustained improvements to its Quality System to ensure that we consistently meet requirements and are in full compliance with regulations.”

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