The Food and Drug Administration (FDA) has issued a list of supplemental duodenoscope reprocessing measures to further reduce the risk of infection and increase the safety of these medical devices.
The FDA urges that staff responsible for reprocessing duodenoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the device, and maintain proficiency in performing these reprocessing tasks. The agency also recommends the following supplemental measures to further help reduce the risk of infection transmission associated with use of duodenoscope:
- Microbiological Culturing
- Ethylene Oxide Sterilization
- Use of a Liquid Chemical Sterilant Processing System
- Repeat High-Level Disinfection
In addition to these supplemental measures, the FDA recommends strictly adhering to the manufacturer’s reprocessing instructions and following these best practices:
- Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using AER. Raise and lower the elevator throughout the manual cleaning process to allow brushing of both sides.
- Implement a comprehensive quality control program for reprocessing duodenoscopes. Your reprocessing program should include written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.
- Refer to the Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes: 2011 disclaimer icon consensus document for evidence-based recommendations for endoscope reprocessing.
For more information call (888) 463-6332 or visit FDA.gov.