Eliminate cross contamination due to ineffective reprocessing.
Reduce infection risk.
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 | 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.
Find out how EXALT Model D may help reduce infection risk due to ineffective reprocessing and benefit your facility
Meta-analysis of reusable duodenoscope contamination1
A meta-analysis of 15 studies found that neither double high-level disinfection (HLD) nor ethylene oxide (EtO) gas sterilization eliminated the risk of contamination in reusable duodenoscopes that were considered patient ready.
15 Studies
13,112 Patient-ready duodenoscope
15.25% Contamination rate
Duodenoscope safety communications
The environment, equipment and guidelines that inform cleaning procedures are constantly changing, putting duodenoscope reprocessing into a state of transition.
In Europe, ESGE and ESGENA collaborated in 2019 to produce Position Statement on this topic, stressing that regardless of duodenoscope design, there are two crucial points:13
- Standardized and validated duodenoscope reprocessing should be performed by appropriately trained, dedicated, and competent staff;
- Microbiological surveillance and regular maintenance of duodenoscopes should be performed to identify any problems at an early stage.
In the United States, FDA recommended in 2019 to transition to duodenoscopes with innovative designs that range from disposable endcaps to fully disposable duodenoscopes.1
Physician perspectives
Dr. Kenneth Binmoeller
Going Disposable
Dr. Binmoeller discusses points for adopting single-use duodenoscope technology.
Dr. Kenneth Binmoeller
FDA duodenoscope recommendations
Dr. Binmoeller talks about the FDA’s recommendation to transition to duodenoscopes with innovative designs in the United States that range from disposable endcaps to fully disposable duodenoscopes.
Dr. Kenneth Binmoeller
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 Mandated surveillance studies 2,3,4
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
|
Low-concern
|
EXALT™ Model D
Single-Use Duodenoscope
delivers robust stability, maneuverability
and control in ERCP procedures.
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