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.
 

Endoscope Reprocessing & Technology Advances in ERCP for the Practicing Gastroenterologist

EXALT Model D

Coming Soon

A replay of our webcast featuring Kenneth Binmoeller, MD and Betty McGinty, RN, CGRN, CER as they discuss the history of duodenoscope cross-contamination and moving to single-use duodenoscope technologies.

  

Duodenoscope reprocessing and safety communications

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

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

Interim Results*

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
*Data reflects the July 2019 interim data posted on the FDA 522 Post-market Surveillance Studies websites for the Sampling and Culture Studies performed by Olympus, Pentax and Fujifilm. These numbers may change as additional interim results become available or a final report is issued.  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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