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Healthcare professionals / Gastroenterology / EXALTTM Model D Single-Use Duodenoscope / Infection Prevention
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Supporting Infection Prevention
Dr. Kenneth Binmoeller – What Led Him to Single-Use Solutions?
Hear from Dr. Binmoeller, in his own words, as he discusses infections traced to duodenoscope cross-contamination, results from surveillance studies, and FDA recommendations.
Highlighted Topics:
- - The history of “super-bug” infections traced to duodenoscope cross-contamination
- Results from an FDA surveillance study
- Studies outlining “real-world” data
Dr. Kenneth Binmoeller discusses:
The FDA’s recommendation to transition to duodenoscopes with innovative designs that range from disposable endcaps to fully disposable duodenoscopes.
Are you familiar with the difference between a fully single-use duodenoscope and new technologies utilizing single-use endcaps?
Duodenoscope reprocessing and safety communications
There have been more FDA safety communications on duodenoscopes than any other medical device since 2013.
Subsequently the FDA mandated post-market surveillance studies to monitor the effectiveness of reprocessing.
Up to 5.0% of properly collected samples tested positive for high-concern organisms, which cause diseases
Up to 4.4% of properly collected samples tested positive for enough low concern organisms to indicate a reprocessing failure
*Fujifim 522 site: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=353&c_id=3725
*Pentax: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=355&c_id=3727
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