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  5. Information about Automated Endoscope Reprocessors (AERs) and FDA’s Evaluation
  1. Reprocessing of Reusable Medical Devices

Information about Automated Endoscope Reprocessors (AERs) and FDA’s Evaluation

Automated Endoscope Reprocessors (AERs) are important devices widely used in the health care setting to reprocess endoscopes, such as duodenoscopes, and endoscope accessories. AERs are designed to kill microorganisms in or on reusable endoscopes by exposing their outside surfaces and interior channels to high level disinfectant or liquid chemical sterilant solutions. AERs are Class II devices cleared through the premarket notification [510(k)] pathway.

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FDA's Evaluation of Automated Endoscope Reprocessors

The FDA is looking into all critical factors contributing to patient infections associated with exposure to duodenoscopes and how best to mitigate them, including how AERs are used in clinical settings.

The FDA's review of AER safety and effectiveness includes the following actions to help mitigate the risk of patient infection:

  • Collaborating with industry as they modify and validate their reprocessing instructions to enhance the safety margin of the methods used to clean and disinfect endoscopes, specifically manufacturers of AERs that reprocess duodenoscopes as stated in their labeling.
  • Reviewing AER manufacturer validation study protocols and test data as they conduct additional testing with duodenoscopes to demonstrate AER reprocessing effectiveness.
  • Evaluating information from multiple sources, including medical device adverse event reports submitted to the FDA, medical literature, the health care community, and federal partners to analyze the possible association between AERs and the transmission of infectious agents to patients.
  • Analyzing data from validation studies for cleaning and high level disinfection or liquid chemical sterilization.
  • Collaborating with hospitals that experienced infection outbreaks to understand how AERs may be a factor in infectious outbreaks.
  • Communicating recommendations to health care providers and end users to help mitigate the possible risk associated with duodenoscopes reprocessed in AERs.

Validating AER Reprocessing Effectiveness

The FDA, AER manufacturers, and endoscope manufacturers consider the long narrow channels of some duodenoscopes to be particularly challenging areas of the device to reprocess. In addition, the recess around the elevator area also poses challenges to effectively reprocess duodenoscopes.

Due to the potential association between reprocessed duodenoscopes and patient infection, the FDA initially requested validation testing data from all companies that have AERs labeled to reprocess duodenoscopes. In this request, AER manufacturers conducted additional rigorous validation testing with duodenoscopes to evaluate AER reprocessing effectiveness of the recess around the duodenoscope's elevator area. To support adequate high level disinfection or liquid chemical sterilization, testing should demonstrate a 99.9999 percent reduction of the most resistant microbes at several locations on the duodenoscope to prevent infection transmission.

In June 2017, the FDA determined that it is necessary for manufacturers of certain reusable medical devices (including AERs) to include in their premarket notification (510(k)s) instructions for use which have been validated and validation data regarding cleaning, disinfection, and sterilization, for which a substantial equivalence determination may be used. FDA published this list in accordance with the requirements established by the 21st Century Cures Act. These actions are effective on August 8, 2017.

Given duodenoscopes' complex design and rigorous manual cleaning instructions, the FDA recommends that the AER cleaning cycle only be used as a supplement to thorough manual cleaning according to the duodenoscope manufacturer's instructions.

AER Validation Testing Status

In the United States, there are five companies that manufacture AERs labeled to reprocess duodenoscopes currently in use in health care facilities. The table below lists the manufacturers and AER models that have completed the updated high level disinfection or liquid chemical sterilization validation testing with fixed endcap duodenoscopes. Fixed endcap duodenoscopes have a plastic or rubber cap permanently glued to the metal edges around the distal end to prevent tissue injury from the metal edges on the scopes, but when permanently affixed, the endcaps also limit the accessibility to clean the crevices at the distal end.

The FDA recommends hospitals, endoscopy facilities and duodenoscope manufacturers transition away from fixed endcap duodenoscopes to those with more modern design features that facilitate or eliminate the need for reprocessing. Facilities should contact the AER manufacturer for information on validation testing in their AERs with the new duodenoscopes designs.

The FDA continues to work with AER manufacturers to ensure they provide a sufficient safety margin when reprocessing duodenoscopes. The FDA will periodically update the table to notify the public when adequate updated validation test results are complete for other AERs on the market.

Table: Completed status of high level disinfection or liquid chemical sterilization validation testing with duodenoscopes by AER manufacturer and model
Company name (alphabetical order) AER model name Validation test results
ASP
AEROFLEX Automatic Endoscope Reprocessor Adequate
EvoTech ECR Adequate
Custom Ultrasonics System 83 Plus Washer/Disinfector* Adequate
System 83 Plus - 2* Adequate
System 83 Plus™ - 9* Adequate
Medivators Advantage Plus Adequate
Advantage Plus Pass Thru Endoscope Reprocessing System Adequate
DSD Edge Adequate
DSD-201 Adequate
CER Optima models (CER-1 and CER-2) Adequate
Olympus America OER-Pro** Adequate
Steris Corporation Reliance Endoscope Processing System Adequate
System 1E Liquid Chemical Sterilant Processing System Adequate
System 1 endo Liquid Chemical Sterilant Processing System Adequate

Adequate Definition:

Adequate - The Agency completed its review of the manufacturer-provided validation data and test reports, determined that the data achieves acceptable high level disinfection or liquid chemical sterilization of duodenoscopes used in AERs.

* Custom Ultrasonics AERs validated to reprocess only the Olympus TJF-Q180V and the Pentax ED-3490TK duodenoscopes. Testing for use with other duodenoscopes has not been satisfactorily completed.

** Testing for the Olympus closed elevator channel duodenoscope – the TJF-Q180 model, has been found to be adequate. Testing is still in process for the Olympus open elevator channel duodenoscope, the TJF-160VF model.

Related FDA Actions on Automated Endoscope Reprocessors

On April 10, 2018, the FDA authorized Custom Ultrasonics to modify its user instructions and notify its customers that the Custom Ultrasonics' System 83 Plus AER has been validated to reprocess the Olympus TJF-Q180V duodenoscope and the Pentax ED-3490TK duodenoscope models only. Also on April 10, 2018, the FDA issued a Safety Communication (2018) advising health care facilities that Custom Ultrasonics' System 83 Plus AERs may be used for reprocessing of certain duodenoscopes. This Safety Communication is an update of the FDA's August 2016 Safety Communication (2016)  advising health care facilities that on May 6, 2016 Custom Ultrasonics, Inc. issued an urgent medical device recall advising users to stop using the System 83 Plus AERs for reprocessing of all duodenoscopes.

The FDA continues to advise that facilities use alternative methods of reprocessing of duodenoscopes, with the exception of the Olympus TJF-Q180V and the Pentax ED-3490TK. Custom Ultrasonics' System 83 Plus AERs remain in service for the reprocessing of other flexible endoscopes.

Additional Resources

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