Background The risk of exogenous infections from endoscopic procedures is often cited as almost negligible (1 infection in 1.8 million procedures); however, this risk is based on older literature and does not seem to match the number of infectious outbreaks due to contaminated duodenoscopes reported after endoscopic retrograde cholangiopancreatography (ERCP). Using Dutch data, we aimed to estimate the minimum risk of duodenoscope-associated infection (DAI) and colonization (DAC) in patients undergoing ERCP. Methods A systematic literature search identified all DAI outbreaks in the Netherlands reported between 2008 and 2019. Included cases were confirmed by molecular matching of patient and duodenoscope cultures. Risk ratios were calculated based on the total number of ERCPs performed during the study period. Results Three outbreaks were reported and published between 2008 and 2018, including 21 confirmed DAI cases and 52 confirmed DAC cases. The estimated number of ERCPs performed during the same period was 181 209–227 006. The calculated minimum estimated DAI risk was approximately 0.01 % and the minimum estimated DAC risk was 0.023 %–0.029 %. Conclusions The estimated risk of DAI in Dutch ERCP practice was at least 180 times higher than previously published risk estimates. The actual risk is likely to be (much) higher due to underreporting of infections caused by multidrug-resistant organisms and sensitive bacteria. Greater awareness by healthcare personnel involved in endoscopy and endoscope cleaning is required, as well as innovative technical solutions to contain and ultimately eliminate DAIs.

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Background To mitigate duodenoscope contamination, recent design enhancements have primarily focused on the distal tip. However, the working channels remain unchanged, which may be linked to biofilm formation. We assessed the persistence of microorganisms, indicative of biofilm formation, in reprocessed duodenoscopes in a non-clinical endoscopic retrograde cholangiopancreatography (ERCP) simulation setting. Methods Three new duodenoscopes were over-soiled in non-clinical ERCP simulations followed by reprocessing. After 40 tests, the Pseudomonas aeruginosa strain in the soil (Pa-type 1) was switched to a different P. aeruginosa strain (Pa-type 2) for 20 subsequent tests. Cultures of the tip and working channel were acquired after high level disinfection and overnight storage. Results One duodenoscope showed persistent growth of P. aeruginosa from the fifth test until the end of the study. Pa-type 1 remained present until the end of the study in the cultures of this duodenoscope, even after discontinuation of exposure to that specific strain. The other two duodenoscopes only showed incidental contamination. Conclusion Persistent contamination by Pa-type 1 was seen in one out of three duodenoscopes after exposure to supraphysiological levels of gut microorganisms. No clear explanation was found for this persistent contamination as exposure and handling were identical and no abnormalities of this particular duodenoscope were identified by borescope inspection.

Background: The likelihood of endoscopy-associated infections (EAIs) is often referenced from a paper published in 1993 by Kimmery et al1 in which a risk of 1 exogenous infection for every 1.8 million endoscopies (0.00006%) is proclaimed. Even though Ofstead et al2 pointed out in 2013 that this was at least an underestimation by 6-fold because of erroneous assumptions and mathematical errors, the original calculation is still often referred to. In the past decade, multiple outbreaks of multidrug-resistant microorganisms (MDROs) related to contaminated duodenoscopes have been reported worldwide. This leads to the assumption that the former risk calculation is indeed incorrect. Objective: We calculated the duodenoscope-associated infection (DAI) risk for the Dutch ERCP practice. Methods: We searched and consolidated all Dutch patients reported in the literature to have suffered from a clinical infection linked to a contaminated duodenoscope between 2008 and 2018. From a national database, the number of ERCPs performed per year in The Netherlands were retrieved. Actual numbers were available from 2012 to 2018. Numbers from 2008 to 2011 were estimated and assumed to be equal to 2012. Results: In 2008–2018, 3 MDRO outbreaks in Dutch hospitals were reported in the literature, with 21 patients suffering from a clinical infection based on a microorganism proven to be transmitted by a duodenoscope. In that period, ∼203,500 ERCP procedures were performed. Hence, for every 9,690 procedures, 1 patient developed a clinically relevant infection (DAI risk, 0.010%). Conclusions: The risk of developing a DAI is at least 30–180 times higher than the risks that were previously reported for all types of endoscopy-associated infections. Importantly, the current calculated risk of 0.010% constitutes a bare minimum risk of DAI because endoscope-related infections are underreported. Apart from DAI risk, a patient is also at risk of becoming colonized with a microorganism through contaminated endoscopes but without developing symptoms of clinical infection. These data call for consorted action of medical practitioners, industry, and government agencies to minimize and ultimately eliminate the risk of exogenous endoscope-associated infections and contamination. As a first step, the FDA recently recommended that healthcare facilities and manufacturers begin transitioning to duodenoscopes with disposable components.3Funding: NoneDisclosures: None

Background Despite compliance to extensive reprocessing protocols, duodenoscopes have been linked to outbreaks of susceptible and multi-drug resistant organisms (MDRO) due to persistent duodenoscope contamination. Duodenoscope-associated infections (DAIs) based on transmission of susceptible microorganisms are likely to be underreported due to detection bias. Case presentation We describe the retrospective detection of a DAI case caused by a susceptible microorganism which at the time of clinical infection was not recognized as such. During 2017 and 2018, duodenoscopes were cultured on a daily basis due to research activities. While analyzing this data, it was found that a duodenoscope had been contaminated with Enterobacter cloacae complex over a period of 3 months. We checked whether patients treated with this duodenoscope had developed infections and found one patient with an E. cloacae cholangitis 3 months after the ERCP (Endoscopic retrograde cholangiopancreaticography) procedure. The isolates on the duodenoscope and in the patients’ blood culture were indistinguishable by amplified fragment length polymorphism (AFLP). By classical multi-locus sequence typing (MLST), both strains were of the same (but novel) sequence type. Application of whole genome MLST showed 93 (out of 3757) allelic differences. Conclusion This case report describes a plausible link between a contaminated duodenoscope and a patient infection with E. cloacae. Transmission of susceptible E. cloacae was highly suspected from AFLP and MLST results; by WGS, 93 allelic differences were found which proves closely related strains. This report shows that DAIs by susceptible microorganisms can be easily missed and therefore its true prevalence remains underscored.