Risk Estimate of Duodenoscope-Associated Infections in The Netherlands

Abstract

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.³

Funding: None

Disclosures: None