Outbreaks Associated With Duodenoscopes

New Challenges and Controversies

Zachary A. Rubin; Rekha K. Murthy

Disclosures

Curr Opin Infect Dis. 2016;29(4):407-414. 

In This Article

Abstract and Introduction

Abstract

Purpose of review Recent outbreaks of carbapenem-resistant enterobacteriaceae related to duodenoscopes in the United States and Europe have gained international attention and resulted in new regulations, especially in the United States, affecting healthcare facilities. In this review, we summarize findings from recent duodenoscope-related outbreaks, highlight what is known about the risk of transmission from these devices and discuss controversies about current recommendations to prevent transmission.

Recent findings Between 2013 and 2015, several US and European healthcare facilities reported outbreaks of carbapenem-resistant enterobacteriaceae associated with endoscopic retrograde cholangiopancreatography procedures. Unlike prior outbreaks (attributed to lapses in cleaning and reprocessing), the recent outbreaks occurred in spite of adherence to current reprocessing guidelines. Factors associated with infection transmission include a low margin of safety for gastrointestinal endoscopic procedures and complex design features of duodenoscopes. Outbreaks were halted with enhanced cleaning and surveillance measures or by adopting gas sterilization methods. New guidance from manufacturers and federal agencies has been issued as a result of these recent outbreaks; however, concerns remain that the new measures may not eliminate risks to patients.

Summary Recent duodenoscope-related outbreaks have highlighted the need for a reassessment of current guidelines for endoscope reprocessing and for new design of duodenoscope components. Although we summarize the US experience, this review has global implications for the safe cleaning and disinfection of these instruments.

Introduction

Endoscopic procedures are common medical procedures and are increasing as endoscopes become capable of performing a wider range of procedures. For example, in the United States, there are an estimated 11 million performed annually of which endoscopic retrograde cholangiopancreatography (ERCP) comprises over 670 000.[1] Over 3 million ERCPs were performed between 2010 and 2014.[2] As heat-labile, semicritical devices, endoscopes require at least high-level disinfection (HLD) and are not amenable to current sterilization methods used for surgical instruments.[3]

Endoscope-related outbreaks reported in the past were found to be largely related to lapses in cleaning and HLD steps.[4] Until recent outbreaks, HLD done in accordance with multisociety guidelines and manufacturers' instructions for use (IFUs) were considered adequate to safeguard patients from risk of organism transmission and infection.[5] Recent studies of duodenoscope-related outbreaks at healthcare centers adhering to manufacturer's IFUs and professional guidelines have led the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to reappraise the risks associated with duodenoscopes. The FDA ultimately determined that the complex design of duodenoscopes may impede effective reprocessing and that duodenoscope-related outbreaks are occurring despite adherence to manufacturer's IFUs and professional guidelines.[6]

Prompting further alarm in the media and among the public, duodenoscope-related outbreaks have been linked to multidrug-resistant (MDR) bacterial infections that are associated with high mortality rates.[7,8]

In this review, we describe the recent outbreaks associated with duodenoscopes. We will also discuss the resulting controversies related to standard duodenoscope cleaning and disinfection and recent guidance issued by manufacturers and federal agencies.

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