Innovative, single-use design enhances patient safety

EXALT™ Model D eliminates the risk of patient-to-patient infection due to ineffective reprocessing*

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

EXALT Model D Single-Use Duodenoscope reduces onerous methods of reprocessing reusable duodenoscopes – eliminating cross-contamination concerns and patient-to-patient infection risks due to ineffective reprocessing.*

Complex cleaning processes increase post-ERCP infection risk

From pre-cleaning to drying, there can be more than .00 distinct steps to reprocessing a reusable duodenoscope^2,3 – all of which introduce the opportunity for patient crosscontamination. Only a disposable duodenoscope like EXALT Model D eliminates the risks of cross-contamination associated with ineffective reprocessing.

Expand your ERCP toolkit with EXALT Model D and eliminate infection risks due to ineffective reprocessing

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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 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

Since 2013, there have been:

16 FDA safety communications
9 guideline updates
5 IFU updates
6 product recalls/removals

Read latest FDA statement

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 risk of infection, only single-use duodenoscopes – like EXALT Model D – eliminate post-ERCP infection risks as a result of cross-contamination from ineffective reprocessing.

Benefit*	EXALT Model D	Single-Use Endcaps
Eliminates patient infection risks due to ineffective reprossessing⁴	Yes	No
Eliminates duodenoscope reprocessing training and compliance⁵	Yes	No
Decreases reprocessing wastes such as disinfecting consumables⁶	Yes	No
Enhances infection prevention efforts aligning with 2022 FDA Safety Communication**	Yes	Yes

Meta-analysis of reusable duodenoscope contamination^7-9

A meta-analysis of 15 studies found that neither double high-level disinfection (HLD) norethylene oxide (EtO) gas sterilization eliminated the risk of contamination in reusable duodenoscopes that were considered patient ready.

15 studies

13,112 patient-ready duodenoscopes

15.3% contamination rate

*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

1. U.S. Food and Drug Administration. Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication. Issued April 5, 2022. Updated June 30, 2022. https://www.fda.gov/medical-devices/safety-communications/use-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication

2. U.S. Food and Drug Administration. The FDA Provides Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings: FDA Safety Communication. Issued December 10, 2018. https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm628020.htm

3. Ofstead CL, Buro BL, Hopkins KM, Eiland JE, Wetzler HP, Lichtenstein DR. Duodenoscope-associated infection prevention: A call for evidence-based decision making. Endoscopy International Open. 2020;08(12):E1769-E1781. doi:https://doi.org/10.1055/a-1264-7173

4. Bang JY, Hawes R, Varadarajulu S. Equivalent performance of single-use and reusable duodenoscopes in a randomised trial. Gut. 2021;70:838–844.

5. Ofstead CL, Buro BL, Hopkins KM, Eiland JE, Wetzler HP, Lichtenstein DR. Duodenoscope-associated infection prevention: a call for evidence-based decision making. Endosc Int Open. 2020;8:E1769–E1781.

6. Ofstead CL, Quick MR, Eiland JE, Adams SJ, et al. A glimpse at the true cost of reprocessing endoscopes: results of a pilot project. International Association of Healthcare Central Service Material Management. May 2017.

7. U.S. Food and Drug Administration. Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication. August 2015. https://www.fdanews.com/ext/resources/files/08-15/081015-duodenoscopes-fda.pdf?1520541508

8. U.S. Food and Drug Administration. Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication. Issued February 19, 2015. http://wayback.archive-it.org/7993/20170722213105/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm

9. ScienceDirect. Rate and impact of duodenoscope contamination: A systematic review and meta-analysis - Issued August 2020. https://www.sciencedirect.com/science/article/pii/S2589537020301954

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

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