Outbreaks associated with duodenoscopes: new challenges and controversies.

Abstract

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. 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. 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.