The U.S. Food and Drug Administration has issued two warning letters to a prominent endoscope manufacturer for violations, including failure to adhere to medical device reporting (MDR) requirements and quality systems regulations.
The FDA’s Center for Devices and Radiological Health (CDRH) issued the letters on Jan. 10 to Olympus Medical Systems Corp. and a subsidiary, Aizu Olympus Co. Ltd., following facility inspections. Reuters reported the violations were found during inspections of facilities located in Japan.
The MDR requirements and quality system regulations violations encompassed endoscopes and scope accessories, including gastrointestinal and surgical scopes and automated endoscope reprocessors (AER), according to the FDA.
In a statement to Medical Design & Outsourcing, Olympus said its “highest priority” is providing safe and effective devices for patients.
CDRH emphasized that the risk of infection from inadequate reprocessing is relatively low, and the agency does not recommend patients cancel or delay procedures without first discussing it with their healthcare providers.
CDRH has undertaken “extensive and ongoing efforts” to address compliance issues with Olympus related to endoscope reprocessing, the agency said in its announcement. Recent inspections found Olympus did not meet requirements to ensure device quality and performance, including adequate testing or documentation of the assembly process, according to the FDA.
Additionally, it did not develop MDR procedures nor submit MDRs within the required timeframe. Prompt reporting of adverse events helps officials “identify and better understand the risks associated with reprocessed medical devices.”
MDRs are critical, the FDA added, “to ensure that any infections or reprocessing failures associated with these devices are appropriately communicated to and evaluated by CDRH to assure appropriate actions are taken to prevent potential patient injury.”
Similarly, compliance with quality system regulations for endoscopes ensures they “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.”
This is the latest communication and action taken by CDRH regarding infections related to reprocessed endoscopes and underscores its ongoing work “facilitating improvements in innovative design of the next generation of these devices.” The agency’s aim is to both work with manufacturers to transition to devices with features that eliminate the need for reprocessing as well as modify and validate reprocessing instructions.