Rate and impact of duodenoscope contamination: A systematic review and meta-analysis

Abstract

Background: Multiple infection outbreaks have been linked to contaminated duodenoscopes worldwide. However, the contamination rate of patient-ready duodenoscopes varies highly amongst published studies testing this subject. We aimed to estimate the contamination rate of reprocessed patient-ready duodenoscopes for endoscopic retrograde cholangio-pancreatography (ERCP) based on currently available data.

Methods: We searched the PubMed and Embase databases from January 1, 2010 until March 10, 2020, for citations investigating contamination rates of reprocessed patient-ready duodenoscopes. Studies not assessing other types of endoscopes than duodenoscopes were excluded from the analysis. Study eligibility and data extraction was evaluated by three reviewers independently. A random-effects model (REM) based on the proportion distribution was used to calculate the pooled total contamination rate of reprocessed patient-ready duodenoscopes. Subgroup analyses were carried out to assess contamination rates when using different reprocessing methods by comparing single high-level disinfection (HLD) with double HLD and ethylene oxide (EtO) gas sterilization. Additionally, we investigated the contamination rate between studies conducted following an outbreak compared to non-outbreak-initiated studies.

Findings: We identified 15 studies that fulfilled the inclusion, which included 925 contaminated duodenoscopes from 13,112 samples. The calculated total weighted contamination rate was 15.25% ± 0.018 (95% confidence interval [Cl]: 11.74% - 18.75%). The contamination rate after only using HLD was 16.14% ± 0.019 (95% Cl: 12.43% - 19.85%) and after using either dHLD or EtO the contamination rate decreased to 9.20% ± 0.025 (95% Cl: 4.30% - 14.10%). Studies conducted following an outbreak (n=4) showed a 5.72% ± 0.034 (95% Cl: 0.00% - 12.43%) contamination rate, and non-outbreak-initiated studies (n=11) revealed a contamination rate of 21.50% ± 0.031 (95% Cl: 15.35% - 27.64%).

Interpretation: This is the first meta-analysis to estimate the contamination rate of patient-ready duodenoscopes used for ERCP. Based on the available literature, our analysis demonstrates that there is a 15.25% contamination rate of reprocessed patient-ready duodenoscopes. Additionally, the analysis indicates that dHLD and EtO reprocessing methods are superior to single HLD but still not efficient in regards to cleaning the duodenoscopes properly. Furthermore, studies conducted following an outbreak did not entail a higher contamination rate compared to non-outbreak-initiated studies.

Funding: The authors received no financial support for the research, authorship, and/or publication of this article.

Keywords: AGA, American Gastroenterological Association; AORN, The Joint Commission and The Association of Perioperative Registered Nurses; Bacterial*; CDC, Center for Disease Control and Prevention; CFU, colony-forming units; CRE, carbapenem-resistant Enterobacteriaceae; Cl, confidence interval; Cross infection; Drug Resistance; Duodenoscopes; ERCI, Environmental Risk Communications, Inc.; ERCP, endoscopic retrograde cholangio-pancreatography; Equipment contamination; EtO, ethylene oxide; FDA, Food & Drug Administration; HLD, high-level disinfection; Infection Control; MDR, multi-drug-resistant; MeSH, medical subject headings; Multiple; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; REM, random-effects model; dHLD, double high-level disinfection.

Fig. 1

Flowchart describing the study process and the selection of publications.

Fig. 2

Pooled estimates of contamination rates. Cl: confidence interval.