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

PUBLISHED: Apr 11, 2018
Relevant to: Ambulatory Care, Clinical Lab, Critical Access Hospitals, Hospitals

The US Food and Drug Administration (FDA) is notifying health care facilities that Custom Ultrasonics has completed validation testing of the System Plus AERs with specific duodenoscopes. The 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.

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, link provided below, 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.

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