FDA Issues Safety Reminder on Endoscope Reprocessors

Health care facilities should be using alternatives to System 83 Plus devices

The FDA is reminding health care facilities of Custom Ultrasonics’ May 6 device recall, and is advising users to stop using the company’s System 83 Plus automated endoscope reprocessor (AER) to reprocess duodenoscopes. By now, facilities should have transitioned to alternative methods for the reprocessing of duodenoscopes, according to the agency. System 83 Plus AERs remain in service for reprocessing endoscopes other than duodenoscopes.

The design of duodenoscopes is complex and makes these devices more difficult to clean than most other flexible endoscopes, according to the FDA. Because inadequately reprocessed duodenoscopes have been associated with infections and death, health care facilities should not use Custom Ultrasonics’ System 83 Plus AERs for reprocessing duodenoscopes, the FDA says.

Health care facilities are advised to identify and transition to alternate methods to reprocess duodenoscopes, such as manual high-level disinfection, alternative AERs, liquid chemical sterilization, or other sterilization methods according to the duodenoscope manufacturers’ reprocessing instructions. Regardless of the reprocessing method, hospital staff should manually clean duodenoscopes according to the manufacturer’s instructions.

The FDA continues to recommend the following best practices for all flexible endoscopes:

  • Always clean endoscopes and their accessories thoroughly before high-level disinfection, liquid chemical sterilization, or other sterilization methods.
  • Ensure ready access and promote strict adherence to manufacturers’ instructions for cleaning other flexible endoscopes.
  • Implement a comprehensive quality control program for reprocessing flexible endoscopes, including 1) written procedures for monitoring training and adherence to the program, and 2) documentation of equipment, tests, processes, and quality monitors used during the reprocessing procedure.
  • Ensure that staff members responsible for reprocessing endoscopes understand the importance of their role in reprocessing the device and maintain proficiency in performing required reprocessing tasks.
  • Adhere to general endoscope reprocessing guidelines and practices established by the infection control community and endoscopy professionals.

Source: FDA; August 17, 2016.