Single-use Duodenoscopes: Where Are We and Where Are We Going?

Shajan Peter; Ji Young Bang; Shyam Varadarajulu

Disclosures

Curr Opin Gastroenterol. 2021;37(5):416-420. 

In This Article

Abstract and Introduction

Abstract

Purpose of Review: Given the growing concerns about infection transmission from use of contaminated reusable duodenoscopes, technological advancements have been made that vary from modifications of existing designs to development of single-use devices.

Recent Findings: To circumvent mechanical limitations that preclude access to critical areas of a duodenoscope to perform thorough cleaning and disinfection, single-use disposable duodenoscopes have been developed. A thorough assessment of this technology is limited by the minimal published data that is currently available. This opinion assesses the current technical functionality of these devices, potential for further improvements, implications for healthcare economics and the future of gastrointestinal endoscopy.

Summary: Currently available data suggest that majority of endoscopic retrograde cholangiopancreatography procedures can be safely performed using single-use duodenoscopes. The ability to improve technical functionality, incorporate futuristic technology and secure financial reimbursement from insurance carriers will largely define the future prospects of this recent innovation.

Introduction

Infection control and prevention seem to be buzzwords at the dawn of 2021 as the world slowly adapts to the reality of a global COVID-19 pandemic. The Hippocratic principle for hygiene, every disease has its own nature and arises from external causes, holds value even for the discipline of endoscopy where despite best practices in reprocessing techniques there persists substantial risks for infection transmission, particularly for duodenoscopes.

Outbreaks of duodenoscope-related infection (DRI) have been reported with pathogenic organisms that include Klebsiella pneumoniae, Pseudomonas aeruginosa and more recently carbapenem-resistant Enterobacteriaceae (CRE).[1,2] These adverse events involving multidrug resistant organisms have raised serious concerns regarding current standards-of-care. While professional societies have revised existing guidelines for duodenoscope reprocessing techniques, significant limitations persist.[3,4] The Food and Drug Administration (FDA) has published numerous safety communications on this topic and recently mandated that endoscope manufacturers transition away from fixed endcap duodenoscopes to those with features that significantly improve cleaning and disinfection or eliminate the need for reprocessing altogether.[5] Consequently, with objective of eliminating infection transmission associated with use of contaminated reusable duodenoscopes, endoscope manufacturers have moved to develop single-use platforms. This opinion will review the current status and future prospects of this new technology.

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