Innovate, 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 has called 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. 

Single-use duodenoscopes vs. single-use endcaps

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.

*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

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.

FDA Mandated surveillance studies ^5,6

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.