Device profile of the EXALT Model D single-use duodenoscope for endoscopic retrograde cholangiopancreatography: overview of its safety and efficacy

ABSTRACT

Introduction: The management of pancreaticobiliary disorders relies heavily on endoscopic retrograde cholangiopancreatography, which is performed with a duodenoscope. Bacterial colonization of reusable duodenoscopes leading to subsequent infectious outbreaks is well recognized and remains an issue despite efforts to optimize best practices in high-level disinfection. The EXALT Model D duodenoscope (EXALT) (Boston Scientific Corporation, Marlborough, MA) is a single-use device, designed to achieve technical equivalency with reusable devices while eliminating the potential for device-related outbreaks.

Areas covered: This review covers the challenges associated with reprocessing duodenoscopes and the development of duodenoscope-related infections, with an emphasis on the use of single-use duodenoscopes as a potential solution to this issue.

Expert Opinion: Duodenoscope-related infections are an increasingly recognized problem. Infectious outbreaks harm patients, significantly affect providers and medical centers, and can erode patient trust in the health-care system. Single-use duodenoscopes eliminate both the risk of device-related infection transmission and the need for burdensome duodenoscope reprocessing. In clinical evaluations, the EXALT device has demonstrated an equivalent technical performance and provider satisfaction compared to reusable duodenoscopes. Increasing use of this device will clarify how it compares to reusable duodenoscopes in a variety of clinical settings among endoscopists of varying skills levels.

KEYWORDS:

• Duodenoscope
• duodenoscope-related infection
• endoscopic retrograde cholangiopancreatography (ERCP)
• endoscopy
• multidrug-resistant organisms (MDRO)
• single-use duodenoscope

Article highlights

• Bacterial colonization and device-related transmission of infections are known problems associated with the use of reusable duodenoscopes and can occur when breaches in HLD reprocessing protocol are not identified

• The FDA has called for innovation in these devices aimed at reducing or eliminating the infection risk they currently pose.

• The EXALT Model D single-use duodenoscope is a new device designed to eliminate the risk of infection transmission, while performing comparably to existing reusable duodenoscopes in early clinical evaluations.

• ERCPs were technically successful in 95–97% of patients undergoing these procedures performed with the EXALT Model D single-use duodenoscope

• Overall satisfaction with the EXALT Model D single-use duodenoscope by expert endoscopists was 9 out of 10 (on a scale from 1 = unsatisfied to 10 = very satisfied)

• No serious adverse events directly attributable to the use of the EXALT Model D single-use duodenoscope have been reported

Declaration of interest

VR Muthusamy has the following disclosures: Consultant and research support: Boston Scientific and Medtronic; Consultant: Medivators and Interpace Diagnostics; Stockholder: Capsovision; Honoraria: Torax Medical/Ethicon. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.