- What is an Automated Endoscope Reprocessor?
- FDA's Evaluation
- Validating AER Reprocessing Effectiveness
- AER Validation Testing Status
- Related FDA Actions
- Additional Resources
What is an Automated Endoscope Reprocessor?
Automated Endoscope Reprocessors (AERs) are important devices widely used in the health care setting to reprocess endoscopes, such as duodenoscopes, and endoscope accessories, to decontaminate them between uses. AERs are designed to kill microorganisms in or on reusable endoscopes by exposing their outside surfaces and interior channels to chemical solutions. AERs are Class II devices cleared through the premarket notification [510(k)] pathway.
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 duodenoscopes.
We continue 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.
|Company name (alphabetical order)||AER model name||Validation test results|
|AEROFLEX Automatic Endoscope Reprocessor||Adequate|
|Custom Ultrasonics||System 83 Plus Washer/Disinfector*||Adequate|
|System 83 Plus - 2*||Adequate|
|System 83 Plus™ - 9*||Adequate|
|Advantage Plus Pass Thru Endoscope Reprocessing System||Adequate|
|CER Optima models (CER-1 and CER-2)||Adequate|
|Steris Corporation||System 1E Liquid Chemical Sterilant Processing System||Adequate|
|System 1 endo Liquid Chemical Sterilant Processing System||Adequate|
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.
** 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 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 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 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.
- UPDATE: Use of Custom Ultrasonics' System 83 Plus Automated Endoscope Reprocessors (AERs) for Reprocessing of Certain Duodenoscopes: FDA Safety Communication (April 10, 2018)
- Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication (August 4, 2015)
- Industry Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (PDF - 955KB)