- 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 requested validation testing data from all companies that have AERs labeled to reprocess duodenoscopes. The FDA requested that AER manufacturers conduct 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. 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|
|Steris Corporation||System 1E 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 November 12, 2015, FDA ordered the manufacturer Custom Ultrasonics, Inc. to recall all its AERs presently on the market (including AER model names "System 83 Plus," "System 83 Plus 2," and "System 83 Plus 9"). FDA also issued a Safety Communication recommending health care facilities transition from Custom Ultrasonics AERs to alternate reprocessing methods as soon as possible.
FDA Correspondence to AER Manufacturers
Custom Ultrasonics, Inc. - Ivyland, Pennsylvania - Letter issued 1-29-2016(PDF - 759KB) Recall Order to Custom Ultrasonics Under Consent Decree of Permanent Injunction(PDF - 90KB) Custom Ultrasonics, Inc. - Ivyland, Pennsylvania - 483 issued 04-24-2015(PDF - 310KB)
- Industry Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (PDF Only) (PDF - 955KB)
FDA Communications on AERs
- FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods: FDA Safety Communication. Updated February 23, 2016.
FDA orders recall under consent decree for all Custom Ultrasonics automated endoscope reprocessors Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication