FDA warns endoscope maker Olympus over quality system, device reporting issues

The US Food and Drug Administration (FDA) announced this week it has sent warning letters to Olympus Medical Systems Corporation and its subsidiary, Aizu Olympus, in recent months for good manufacturing practice issues and medical device reporting failures for some of their endoscopes. The agency says it is working with the company, which is one of the primary suppliers of endoscopes for the US market, to ensure they are in compliance.

On 10 January, FDA’s Center for Devices and Radiological Health (CDRH) noted that the warning letters are the latest in a series of compliance actions taken against Olympus’s endoscopes and endoscope accessories. The agency also noted its actions taken since 2015 to address inadequate endoscope reprocessing.

“CDRH has been involved in extensive and ongoing efforts with Olympus to address compliance issues related to the reprocessing of endoscopes,” said CDRH Director Jeff Shuren. “However, as described in the recent warning letters, Olympus is not in compliance with [medical device reporting] MDR reporting and quality system requirements.”

“During recent inspections, CDRH 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,” he added. “In addition, Olympus did not develop MDR procedures, and did not submit MDRs within the required timeframes.”

In November, FDA sent a warning letter to Olympus subsidiary Aizu Olympus in Fukushima, Japan stating it failed to establish and maintain procedures for validating the device design for its endoscopes. It was also cited for failing to ensure manufacturing process validations and ensure that the design history record (DHR) for its endoscopes was properly maintained.

About a month later, FDA sent another warning letter to Olympus in Tokyo, Japan, that it had failed to follow the agency’s MDR requirements for its endoscopes. It specifically pointed to a recall of the company’s Uretero-Reno Fiberscope and Uretero-Reno Videoscope devices that failed to follow proper protocols.

“Your firm failed to submit an MDR for each of the referenced complaints within the required 30-calendar day timeframe,” FDA said. “As a result of these complaints, your firm conducted recall Z-2518-2018, for the Uretero-reno fiberscope URF-P6, where it was established that such events could result in potential perforation of a patient’s organs.”

In 2015, the agency published an updated guidance to require premarket review of reprocessing validation data for certain critical devices. The following year, Congress gave it additional authority under the 21^st Century Cures Act to determine that a reprocessed endoscope is not substantially equivalent to the predicate device if the manufacturer provides inadequate information about the reprocessed product.

“CDRH has issued warning letters to manufacturers and safety communications to the public and health care providers and held a public Advisory Committee meeting seeking information on how to effectively reprocess medical devices,” said Shuren. “In addition, CDRH has facilitated improvements in innovative design of the next generation of these devices, has worked with manufacturers to transition to devices with features that eliminate the need for reprocessing, and has worked with manufacturers to modify and validate their reprocessing instructions.”

The center said that inadequate reprocessing of medical devices poses a relatively low risk, and health care providers should follow labeling and reprocessing instructions to clean and reprocess devices and accessory components properly.

“CDRH does not recommend that procedures are canceled or delayed without discussion of the benefits and risks between the health care provider and patient,” said Shuren. “CDRH encourages prompt reporting of adverse events to help us identify and better understand the risks associated with reprocessed medical devices.”

FDA warns endoscope maker Olympus over quality system, device reporting issues

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