FDA blocks select Japanese-made Olympus medical devices from US imports over quality violations

The U.S. Food and Drug Administration (FDA) has issued to health care providers a letter announcing import alerts on select Olympus Medical Systems Corporation devices manufactured in Japan. The subsidiaries as well as Olympus manufacture the affected devices.

This action follows the agency’s finding of outstanding violations of Quality System regulations at Olympus’s Aizu manufacturing facility, despite Olympus’s efforts to remedy earlier deficiencies.

The FDA also sent out the import alert to all the email service subscribers of MedWatch — the FDA Safety Information and Adverse Event Reporting Program. US and Global News is subscribed to the email service.

Under Import Alert No. 89-04, the FDA will refuse entry into the United States of the following categories of Olympus devices:

• Ureterorenoscopes used for diagnostic and therapeutic procedures in the urinary tract
  
• Bronchoscopes used in respiratory tract examinations and interventions
  
• Laparoscopes employed in abdominal and pelvic therapeutic and diagnostic procedures
  
• Automated endoscope reprocessors intended for reprocessing various endoscopes

The FDA advises health care providers to:

• Verify model numbers against those listed in Import Alert 89-04 to determine if devices in use are affected (on the Import Alert page, use the Find feature of your browser/app to search for and arrive at the Japan part of the page) or refer to the table below for Unique Device Identifiers (UDI) as well as model numbers of the affected devices

• Continue using in-service devices only if they show no damage or leak-test failures
  
• Follow all manufacturer labeling, cleaning and reprocessing instructions and establish routine inspection and maintenance schedules in accordance with those instructions
  
• Discuss with patients the benefits and risks of procedures involving these devices rather than postponing or canceling care outright
  
• Submit prompt reports of any adverse events or malfunctions through MedWatch to help the FDA monitor device safety.

This import alert builds on previous FDA actions—including Warning Letters and prior import alerts—when certain facilities were found noncompliant with current good manufacturing practice (CGMP) requirements and several reporting requirements, particularly in connection with what the FDA identifies as the most serious recall type.

The FDA says it is actively working with Olympus to accelerate corrective measures and is prepared to pursue further regulatory or enforcement actions if necessary. Health care providers will be updated should new information on these devices become available, says the FDA.

To aid device identification, the FDA’s Unique Device Identification (UDI) system links each device’s label to a centralized database. Providers may consult the FDA’s AccessGUDID portal for detailed UDI information and instructions on recognizing UDIs on device labels.

Health care personnel are encouraged to report any device-related adverse events or suspected malfunctions to MedWatch. Device manufacturers and user facilities remain obligated under Medical Device Reporting regulations to file mandatory reports, and facility staff should follow their institution’s internal reporting protocols.

Providers with questions about the import alert or the Letter to Health Care Providers may contact the FDA’s Division of Industry and Consumer Education (DICE) at 1-888-INFO-FDA.

Featured photo shows FDA Laboratory Building 62 (Engineering and Physics), which houses the Center for Devices and Radiological Health. The FDA campus is located at 10903 New Hampshire Ave., Silver Spring, MD 20993. Image source: FDA Bldg 62 – Exterior. Public domain image by the FDA.