Large Single Center Comparison Of Novel and Reusable Duodenoscopes Show Similar Contamination Rates That Do Not Correlate With Clinical Infection.

Abstract

Introduction: There are limited data comparing the contamination rates of reusable and novel duodenoscopes with disposable components. The clinical implications of novel duodenoscope bacterial contamination are also unknown. This study aimed to evaluate the rate of pathogenic bacterial contamination of novel and reusable duodenoscopes and assess the clinical implications for patients exposed to contaminated duodenoscopes.

Methods: We conducted an observational study of the bacterial contamination of reusable duodenoscopes and novel duodenoscopes with disposable caps (which do not have disposable elevators). Following identification of positive cultures from duodenoscopes, corresponding patient charts were reviewed for blood culture data or evidence of sepsis by quick sequential organ failure assessment (qSOFA) and systemic inflammatory response syndrome (SIRS) criteria.

Results: The contamination rate of reusable duodenoscopes was 0.80% (95% CI -0.05, 1.65%). The contamination rate of novel duodenoscopes was 0.0%.The contamination rates were not significantly different (p = 0.141). In reusable duodenoscopes, > 1 colony-forming unit (CFU) of gram-negative rods was identified in 4 positive cultures. None of the patients exposed to a positive culture had an existing infection nor developed bacteremia or sepsis after ERCP.

Discussion: Our data suggest bacterial contamination rates of novel duodenoscopes with disposable caps and reusable duodenoscopes are similar. The low contamination rates in this study support consistent high-level disinfection practices regardless of duodenoscope generation.