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January 2, 2019

AGA insights on combating duodenoscope contamination

In December, the FDA provided interim results of duodenoscope reprocessing studies and found higher-than-expected contamination rates even after reprocessing. 

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AGA’s Center for GI Innovation and Technology (CGIT) is collaborating with industry and other interested groups to find solutions to work toward zero device-associated infections. Raman Muthusamy, MD, AGAF, FACG, FASGE, and Michael Kochman, MD, who are leading CGIT’s efforts on this important patient-safety issue, read the FDA study with great interest and provide the following insights.

It’s clear that the potential for inadequate reprocessing of duodenoscopes is real and continues to exist. In fact, it could be more frequent than previously thought. Data from the FDA study suggests that the rate is about three times what was reported by Andrew Ross and Virginia Mason a few years ago, for pathogenic and non-pathogenic bacteria.

Potential solutions to this extraordinarily complex problem include:

    • Improving existing reprocessing methods including cleaning high-level disinfection and potentially sterilization.
    • Automating reprocessing steps that are currently manually performed and simplifying the process.
    • Developing single-use parts to existing duodenoscopes, including the distal tip and elevator mechanism.
    • The introduction of efficacious and cost-effective disposable devices.

CGIT is working with the FDA, CDC, other regulatory bodies and industry to increase the safety of the devices to avoid device related transmissible infections and maintain access and efficacy of the procedures.

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