Eliminate cross contamination due to ineffective reprocessing.
Reduce infection risk.
EXALTTM Model D Single-Use Duodenoscope / Infection Prevention
Reducing duodenoscope infection risk
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.
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.
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.
13,112 Patient-ready duodenoscope
15.25% Contamination rate
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 recommendations for duodenoscopes
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.
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.