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

 

Supporting Infection Prevention

Duodenoscope reprocessing is in a state of transition. The environment, equipment, and guidelines that inform cleaning procedures are constantly changing to address safety concerns and reduce the risk of contamination and infection.
 

Dr. Kenneth Binmoeller discusses "Going Disposable"

Hear from Dr. Binmoeller as he discusses points for adopting single-use duodenoscope technology including clinical, ecological  and cost considerations. 

  

Duodenoscope reprocessing and safety communications

There have been more FDA safety communications on duodenoscopes than any other medical device since 2013.

EXALT safety graphic
  

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

EXALT 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
   

Are you familiar with the difference between a fully single-use duodenoscope and new technologies utilizing single-use endcaps?

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