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FDA Validation Testing for System 83 Plus Automated Endoscope Reprocessors (AERs)

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System 83 Plus Automated Endoscope Reprocessors (AERs) by Custom Ultrasonics: FDA Safety Communication - Completed Validation Testing


AUDIENCE: Risk Manager, Gastroenterology, Infectious Disease, Pulmonology

ISSUE: The FDA is notifying health care facilities that Custom Ultrasonics has completed validation testing of the System Plus AERs with specific duodenoscopes and FDA has determined that the validation data demonstrate the System 83 Plus can effectively achieve high-level disinfection of the Olympus TJF-180V duodenoscope and the Pentax ED-3490TK duodenoscope. As a result, the System 83 Plus AERs may now be used to reprocess only the Olympus TJF-Q180V duodenoscope and the Pentax ED-3490TK duodenoscope. The System 83 Plus is not validated for the reprocessing of FUJIFILM Medical Systems, U.S.A., Inc. (Fujifilm) duodenoscopes or duodenoscopes with open elevator wire channels.

BACKGROUND: All Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) are used in health care facilities to wash and disinfect flexible endoscopes, including duodenoscopes, and scope accessories between uses. The System 83 Plus AERs include the System 83 Plus, System 83 Plus 2, and the System 83 Plus 9 AERs

RECOMMENDATION: Due to the potential association between reprocessed duodenoscopes and patient infection, the FDA requested validation testing data from all companies that have AERs labeled to reprocess duodenoscopes. The Agency created a website to provide the public with up-to-date information about AERs and when the Agency has reviewed adequate reprocessing validation for duodenoscopes.

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 manufacturer’s instructions for cleaning other flexible endoscopes.
  • Implement a comprehensive quality control program for reprocessing flexible endoscopes, including:
    • written procedures for monitoring training and adherence to the program
    • documentation of equipment, tests, processes, and quality monitors used during the reprocessing procedure.
  • Ensure that staff 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online:
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch Safety Alert, including a link to the FDA Safety Communication, on the FDA website.

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