Eliminate risk of patient
infection due to ineffective
duodenoscope reprocessing

Innovative, single-use design enhances safety

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 is now calling for duodenoscopes with innovative designs to enhance safety, including scopes with disposable components or fully disposable duodenoscopes.¹

The EXALT^TM Model D Single-Use Duodenoscope completely eliminates the concern for device cross-contamination and the risk of patient-to-patient infection due to ineffective reprocessing.*

_{*As defined by the American Society for Gastrointestinal Endoscopy.}

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.

FDA keeping a close eye on duodenoscope safety

The FDA continues to closely scrutinize duodenoscope cross-contamination, with more safety communications issued on duodenoscopes than any other medical device since 2013. The FDA now states that all hospitals and endoscopy facilities should transition to fully disposable duodenoscopes or those with disposable components to reduce the risk of patient infection – while recognizing that disposable scope components, like single-use endcaps, may lower but not eliminate infection risks.¹

Read latest FDA statement

Single-use duodenoscopes 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. Yet, while disposable components like endcaps may lower the risks of infection, only single-use duodenoscopes – like EXALT Model D – completely eliminate post-ERCP infection risks as a result of cross-contamination from 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 2022 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 contamination^2,3,4

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.

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15 studies

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13,112 patient-ready duodenoscopes

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15.3% contamination rate

FDA mandated surveillance studies^5,6

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

High-concern
organisms

Up to 6% of properly collected samples tested positive for high-concern organisms, which cause infectious diseases.^1,5,6

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Low-concern
organisms

Up to 8.2% of properly collected samples tested positive for enough low-concern organisms to indicate a reprocessing failure.^5,6

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