Close-up image of contaminant

Eliminate cross contamination due to ineffective reprocessing.

Reduce infection risk.

EXALTTM Model D Single-Use Duodenoscope / Infection Prevention

 

Reducing duodenoscope infection risk

Despite adherence to rigorous disinfection and reprocessing protocols, multiple infection outbreaks worldwide have been linked to contaminated duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures. As a result, the FDA has called for innovative solutions that make reprocessing easier, more effective or unnecessary. The EXALT Model D Single-Use Duodenoscope completely eliminates the risk of patient infection due to ineffective reprocessing.
 

Complex cleaning processes increase post-ERCP infection risk

From pre-cleaning to drying, there can be more than 100 distinct steps to reprocessing a reusable duodenoscope—all of which introduce the opportunity for patient cross-contamination. Only a disposable duodenoscope like EXALT Model D eliminates the risks of cross-contamination associated with ineffective reprocessing. 

 
Icon of hand wiping with scrubber with words "pre-clean". Icon of leaky curved pipe with words "leak test". Icon of hand cleaning with scrubber with words "manual clean". Icon of eye with words "visual inspection". Icon of viruses under cross-out symbol with letters "HLD". Icon of fan with word "drying"
 

Single-use duodenoscope vs. single-use endcaps

New clinical endoscopy technologies such as single-use endcaps and single-use duodenoscopes are designed to help reduce the risk of cross-contamination due to ineffective reprocessing. However, only single-use or disposable duodenoscopes, like the EXALT Model D, completely reduce the post-ERCP infection risks as a result of cross-contamination due to ineffective reprocessing.

Benefit* Exalt Model D Single-Use Endcaps
Eliminates risk of patient infection due to ineffective reprocessing Yes No
Eliminates duodenoscope reprocessing training and compliance Yes No
Decreases waste from reprocessing such as disinfecting consumables Yes No
Enhances infection prevention efforts aligning with 2019 FDA Safety Communication** Yes Yes

*As compared to reusable duodenoscopes. Assumes full conversion of all ERCP procedures using reusable duodenoscopes to instead using the EXALT Model D Duodenoscope. 

**FDA News Release

  
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Meta-analysis of reusable duodenoscope contamination1

A meta-analysis of 15 studies found that neither double high-level disinfection (HDL) nor ethylene oxide (EtO) gas sterilization eliminated the risk of contamination in reusable duodenoscopes that were considered patient ready.

Test tubes icon with words: 15 studies

15 Studies

People icon with words: 13,112 patient-ready duodenoscope

13,112 Patient-ready duodenoscope

Contaminants icon with words: 15.25% contamination rate

15.25% Contamination rate
   

Physician perspectives

Dr. Kenneth Binmmoeller

FDA duodenoscope recommendations

Dr. Binmoeller talks about the FDA’s recommendation to transition to duodenoscopes with innovative designs that range from disposable endcaps to fully disposable duodenoscopes.

Dr. Kenneth Binmmoeller

Only a single-use duodenoscope completely eliminates reprocessing

Dr. Binmoeller discusses clinical data on duodenoscope double-reprocessing and shares his perspective on the inherently complex and ineffective processes for disinfecting reusable duodenoscopes.

   
 

FDA reccomendations for duodenoscopes

 
infection prevention graphic

FDA safety communications

The FDA has issued more safety communications on duodenoscopes than any other medical device since 2013 and recommends healthcare facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce the risk of patient infection.

Read statement

   
   

FDA Mandated surveillance studies2,3,4

Due to a growing concern over the post-ERCP infection risks with reusable scopes, the FDA mandated post-market surveillance studies to monitor the effectiveness of duodenoscope reprocessing. 

  

High-concern
organisms

5.0% (1 out of 20) of properly collected samples tested positive for high-concern organisms, which cause infectious diseases

high risk org gaphic
infection prevention low risk org graphic

Low-concern
organisms

4.4% of properly collected samples tested positive for enough low-concern organisms to indicate a reprocessing failure

   
   

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