EXALT infectino Prevention
EXALT™ Model D

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Healthcare professionals / Gastroenterology / EXALTTM Model D Single-Use Duodenoscope / Infection Prevention

 

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Supporting Infection Prevention

Duodenoscope reprocessing is in a state of transition. Moving to single-use is good way to eliminate the infections related to improperly reprocessed duodenoscopes. 
 

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.

EXALT FDA safety graphic

Subsequently the FDA mandated post-market surveillance studies to monitor the effectiveness of reprocessing.

  
EXALT FDA timeline graphic
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
*Olympus 522 site : https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=354&c_id=3726 
*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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