The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities.
The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations.
“Olympus’ highest priority is providing patients and users with safe and effective medical devices that comply with all applicable legal and regulatory requirements,” the company said in a statement to Medical Design & Outsourcing. “For that reason, we are committed to working together with FDA to address concerns.”
FDA issued the first letter to Aizu Olympus President and CEO Yasuo Takeuchi on Nov. 2, 2022, following a July 5–8 inspection. The warning letter covers the company’s endoscope and automated reprocessing equipment manufacturing operations in Aizuwakamatsu, Fukushima, Japan.
FDA issued the second letter to Olympus Medical Systems President Tomohisa Sakurai on Dec. 12, 2022, following a Sept. 6-9 inspection. That warning letter covers the company’s gastrointestinal and surgical endoscope manufacturing operations in Hachioji-shi, Tokyo, Japan.
FDA Center for Devices and Radiological Health (CDRH) Director Dr. Jeff Shuren said the agency and Olympus have “extensive and ongoing efforts” to address compliance issues related to the reprocessing of endoscopes.
“However, as described in the recent warning letters, Olympus is not in compliance with MDR reporting and quality system requirements,” Shuren said in a statement. “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. In addition, Olympus did not develop MDR procedures, and did not submit MDRs within the required timeframes.”
More about the warning letter
Olympus makes, among many other products, surgical and gastrointestinal endoscopes and automated endoscope reprocessors. Endoscopes can be reused if appropriately cleaned and disinfected or sterilized to remove bacteria that could cause harmful or even fatal infections.
In its warning letter to Olympus Medical Systems, the FDA said the manufacturer conducted a device recall after receiving complaints that its uretero-reno fiberscope and uretero-reno videoscope malfunctioned while in use, but failed to notify the FDA as required by law. According to the FDA, Olympus responded with a promise to improve its MDR reporting process and train staff. The FDA said it could not determine the adequacy of that ongoing effort until its conclusion.
In its warning letter to Aizu Olympus, the FDA identified four potential violations. They included:
- Failure to establish and maintain procedures for validating device design;
- Failure to validate results of a process that couldn’t be fully verified;
- Failure to adequately maintain design history records;
- Failure to develop, maintain and implement written MDR procedures.
The FDA told Aizu Olympus that it could delay premarket approval for Class III devices if the agency determines any quality system regulation violations are reasonably related to those submissions.
Olympus responds
Olympus said in its statement that no corrective action is needed by healthcare providers. They said they should continue to use the company’s products following their Instructions for Use (IFUs).
The company said that it filed the required reports outside of the FDA’s 30-day timeframe. It said it was taking steps to address the FDA’s concerns.
“Comprehensive responses to each warning letter have been submitted to FDA in 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.”
Tokyo-based Olympus is the 20th-largest medical device manufacturer in the world, according to our 2022 Medtech Big 100 rankings. The company reported $6.7 billion in revenue from its medical business for fiscal 2022. The business has nearly 22,000 global employees.
FDA’s focus on reprocessed scope devices
“Compliance with quality system requirements for endoscopes is necessary to ensure these devices are designed, validated, and manufactured in a manner that allows for their safe and effective use, including completion of acceptable reprocessing validation and adequate instructions for use,” Shuren said. “CDRH will continue to ensure that Olympus fully addresses the violations described in the warning letters.”
The FDA said is also working with other medtech manufacturers to ensure the safety of reprocessed medical devices.
“It is important to note that the risk of infection from inadequate reprocessing is relatively low, and healthcare providers should follow the labeling and reprocessing instructions to properly clean and reprocess the devices, including accessory components,” Shuren said. “… CDRH encourages prompt reporting of adverse events to help us identify and better understand the risks associated with reprocessed medical devices.”