ObjectiveIncreasing numbers of outbreaks caused by contaminated duodenoscopes used for Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures have been reported, some with fatal outcomes. We conducted a nationwide cross-sectional study to determine the prevalence of bacterial contamination of reprocessed duodenoscopes in The Netherlands.DesignAll 73 Dutch ERCP centres were invited to sample ≥2 duodenoscopes using centrally distributed kits according to uniform sampling methods, explained by video instructions. Depending on duodenoscope type, four to six sites were sampled and centrally cultured. Contamination was defined as (1) any microorganism with ≥20 colony forming units (CFU)/20 mL (AM20) and (2) presence of microorganisms with gastrointestinal or oral origin, independent of CFU count (MGO).ResultsSixty-seven out of 73 centres (92%) sampled 745 sites of 155 duodenoscopes. Ten different duodenoscope types from three distinct manufacturers were sampled including 69 (46%) Olympus TJF-Q180V, 43 (29%) Olympus TJF-160VR, 11 (7%) Pentax ED34-i10T, 8 (5%) Pentax ED-3490TK and 5 (3%) Fujifilm ED-530XT8. Thirty-three (22%) duodenoscopes from 26 (39%) centres were contaminated (AM20). On 23 (15%) duodenoscopes MGO were detected, including Enterobacter cloacae, Escherichia coli, Klebsiella pneumonia and yeasts. For both definitions, contamination was not duodenoscope type dependent (p values: 0.20 and higher).ConclusionIn 39% of all Dutch ERCP centres, at least one AM20-contaminated patient-ready duodenoscope was identified. Fifteen per cent of the duodenoscopes harboured MGO, indicating residual organic material of previous patients, that is, failing of disinfection. These results suggest that the present reprocessing and process control procedures are not adequate and safe.

Duodenoscope design modifications may compromise microbiological safety as illustrated by this outbreak. Extensive pre-marketing validation of the reprocessability of any new endoscope design and stringent post-marketing surveillance are therefore mandatory.

Background and Aims: Contaminated duodenoscopes and linear echoendoscopes (DLEs) pose a risk for infectious outbreaks. To identify DLEs and reprocessing risk factors, we combined the data from the previously published nationwide cross-sectional PROCESS 1 study (Prevalence of contamination of complex endoscopes in the Netherlands) with the follow-up PROCESS 2 study. Methods: We invited all 74 Dutch DLE centers to sample !2 duodenoscopes during PROCESS 1, and all duodenoscopes as well as linear echoendoscopes during PROCESS 2. The studies took place 1 year after another. Local staff sampled each DLE at 6 sites according to uniform methods explained by online videos. We used 2 contamination definitions: (1) any microorganism with !20 colony-forming units (CFU)/20 mL (AM20) and (2) presence of microorganisms with GI or oral origin, independent of CFU count (MGOs). We assessed the factors of age and usage by performing an analysis of pooled data of both PROCESS studies; additional factors including reprocessing characteristics were only recorded in PROCESS 2. Results: Ninety-seven percent of all Dutch centers (72 of 74; PROCESS 1, 66; PROCESS 2, 61) participated in one of the studies, sampling 309 duodenoscopes and 64 linear echoendoscopes. In total, 54 (17%) duodenoscopes and 8 (13%) linear echoendoscopes were contaminated according to the AM20 definition. MGOs were detected on 47 (15%) duodenoscopes and 9 (14%) linear echoendoscopes. Contamination was not age or usage dependent (all P values !.27) and was not shown to differ between the reprocessing characteristics (all P values !.01). Conclusions: In these nationwide studies, we found that DLE contamination was independent of age and usage. These results suggest that old and heavily used DLEs, if maintained correctly, have a similar risk for contamination as new DLEs. The prevalence of MGO contamination of w15% was similarly high for duodenoscopes as for linear echoendoscopes, rendering patients undergoing ERCP and EUS at risk for transmission of microorganisms. (Gastrointest Endosc 2020;92:681-91.) Abbreviations: AER, automated endoscope reprocessor; AM20, any microorganism with !20 CFU/20 mL; CFU, colony-forming units; DLE, duodenoscope and linear echoendoscope; IFU, instructions for use; IQR, interquartile range; MGO, presence of microorganisms with GI or oral origin, independent of CFU count; PROCESS study, Prevalence of contamination of complex endoscopes in the Netherlands; SFERD, Dutch Steering Group for Flexible Endoscope Cleaning and Disinfection. DISCLOSURE: Dr Bruno has had the following relevant financial activities outside the submitted work: consultant for 3M; grant from 3M for an investigator-initiated study; consultant and lecturer for Boston Scientific; grants from Boston Scientific for investigator-initiated studies and industryinitiated studies; consultant and lecturer for Cook Medical; grants from Cook Medical for investigator-initiated studies and industry-initiated studies; grants from Pentax Medical. Dr Vos has had the following relevant fina...

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