FDA Safety Communication: FDA Provides Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings

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    Stephen B. Hanauer, MD, FACG

    Stephen B. Hanauer, MD, FACG
    Chair, ACG FDA Related Matters Committee

    On December 10, the U.S. Food & Drug Administration (FDA) released interim results from post-market surveillance studies on contamination rates with duodenoscopes after reprocessing.

    In 2015, the FDA ordered all three manufacturers of duodenoscopes sold in the U.S.(Fujifilm Medical Systems USA, Inc, Olympus Medical Systems Corporation, Pentax of America), to conduct post-market surveillance studies, so the FDA can better understand how duodenoscopes are reprocessed in real-world settings. Interim results from these studies indicate higher-than-expected contamination rates after reprocessing, with up to 3% of properly collected samples testing positive for enough low concern organisms to indicate a reprocessing failure, and up to 3% of properly collected samples testing positive for high concern organisms. High concern organisms are defined as “organisms that are more often associated with disease, such as E. coli, and Pseudomonas aeruginosa.”

    The FDA recommends facilities and staff strictly adhere to the manufacturer’s reprocessing and maintenance instructions, and follow these best practices:

    • Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an automated endoscope reprocessors (AERs). Raise and lower the elevator throughout the manual cleaning process to allow brushing and flushing of both sides. After cleaning, carefully inspect the elevator recess and repeat cleaning if any soil or debris is visible.
    • 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.
    • Follow the duodenoscope manufacturer’s recommendations for inspection, leak testing, and maintenance of the duodenoscope.
    • Prior to each use, closely inspect and remove from service for assessment, and repair or replace any duodenoscope that shows visible signs of damage, as recommended in the duodenoscope instruction manuals. Examples of damage may include: loose parts, protrusions or abnormal bulging from the endoscope, kinks or bends in tubing, cracks and gaps in the adhesive that seals the device’s distal cap or other signs of wear or damage.
    • During each reprocessing cycle, conduct leak testing and remove from service for assessment, and repair and replace any duodenoscope that shows signs of leakage. Follow the duodenoscope manufacturer’s leak testing instructions for angulating the bending section and elevator during leak testing.
    • As recommended in the duodenoscope instruction manuals, return the duodenoscope to the duodenoscope manufacturer for inspection, servicing, and maintenance of the device at least once per year.

    FDA has previously issued a Safety Communication and provided a detailed list of supplemental duodenoscope reprocessing measures that can be implemented to reduce the risk of infection transmission, such as: microbiological culturing, sterilization, use of a liquid chemical sterilant processing system and repeat high-level disinfection. ACG will continue to work with the FDA on these important patient safety issues, and will update membership when more information is available.

    Stephen B. Hanauer, MD, FACG

    Chair, ACG FDA Related Matters Committee

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