Sam Brusco, Associate Editor01.12.23
The U.S. Food and Drug Administration (FDA) recently issued two warning letters to endoscope maker Olympus Medical Systems and its subsidiary Aizu Olympus Co. after facility inspections.
The warning letters concern violations in medical device reporting (MDR) requirements and quality system regulations for endoscopes and endoscope accessories, including surgical and gastrointestinal (GI) endoscopes and endoscope reprocessors.
These warning letters are the latest in the history of FDA’s compliance actions against Olympus related to MDR and quality system requirements.
FDA determined Olympus didn’t meet requirements to assure quality and performance of devices, such as adequate testing and documentation of the device assembly process. Further, the agency said Olympus didn’t develop MDR procedures and didn’t submit MDRs in the required timeframes.
Correct MDR reporting is crucial to ensure any infections or reprocessing failures associated with the devices are communicated and evaluated so appropriate actions can be taken to prevent potential patient injury. Compliance with quality system requirements for endoscopes is crucial to ensure the endoscopes are made with acceptable reprocessing validation and adequate instructions for use.
FDA is working to ensure Olympus fully addresses the violations in the warning letters. The agency doesn’t recommend procedures are canceled or delayed without discussion of benefits and risks between the healthcare provider and patient.
The warning letters concern violations in medical device reporting (MDR) requirements and quality system regulations for endoscopes and endoscope accessories, including surgical and gastrointestinal (GI) endoscopes and endoscope reprocessors.
These warning letters are the latest in the history of FDA’s compliance actions against Olympus related to MDR and quality system requirements.
FDA determined Olympus didn’t meet requirements to assure quality and performance of devices, such as adequate testing and documentation of the device assembly process. Further, the agency said Olympus didn’t develop MDR procedures and didn’t submit MDRs in the required timeframes.
Correct MDR reporting is crucial to ensure any infections or reprocessing failures associated with the devices are communicated and evaluated so appropriate actions can be taken to prevent potential patient injury. Compliance with quality system requirements for endoscopes is crucial to ensure the endoscopes are made with acceptable reprocessing validation and adequate instructions for use.
FDA is working to ensure Olympus fully addresses the violations in the warning letters. The agency doesn’t recommend procedures are canceled or delayed without discussion of benefits and risks between the healthcare provider and patient.
