A prospective, multicenter, clinical study of duodenoscope contamination after reprocessing.

objectiveSeveral clinical procedures utilize duodenoscopes, which are processed for reuse after the procedures are completed. However, infection outbreaks due to improper duodenoscope processing occur frequently. To address this, we aimed to assess the contamination rates of duodenoscopes after reprocessing in nonoutbreak settings. DESIGN AND

settingProspective study in 16 clinical sites in the United States.

methodsWe sampled and cultured reprocessed duodenoscopes following the FDA/CDC/ASM guideline; "Duodenoscope Surveillance Sampling and Culturing - Reducing the Risks of Infection." High-concern (HC) organisms were those highly associated with disease, including gram-negative rods,

resultsWe assessed 859 newer-model (NM) duodenoscopes (TJF-Q180V) and 850 older-model (OM) duodenoscopes (TJF-160F/VF); of these, 35 NM samples (4.1%) and 56 OM samples (6.6%) were contaminated with HC organisms. We detected and classified the HC organisms as gastrointestinal (45.4%), human origin (16.7%), environmental (24.1%), waterborne (13.0%), and unidentified (0.9%).

conclusionsWe detected an overall HC contamination rate of 5.3% in nonoutbreak settings. Although the relationship between endoscopic contamination and the occurrence of infections remains unclear, attempts should continue to be made to further reduce contamination rates. Additional improvements to the manufacturer's instructions for use, human factors during the reprocessing procedure, ongoing training programs, cleanliness of reprocessing environments, and the design of the distal end of the duodenoscope should be considered.