EVOTECH® endoscope cleaner and reprocessor (ECR) simulated-use and clinical-use evaluation of cleaning efficacy

Abstract

BackgroundThe objective of this study was to perform simulated-use testing as well as a clinical study to assess the efficacy of the EVOTECH® Endoscope Cleaner and Reprocessor (ECR) cleaning for flexible colonoscopes, duodenoscopes, gastroscopes and bronchoscopes. The main aim was to determine if the cleaning achieved using the ECR was at least equivalent to that achieved using optimal manual cleaning.MethodsSimulated-use testing consisted of inoculating all scope channels and two surface sites with Artificial Test Soil (ATS) containing 108 cfu/mL of Enterococcus faecalis, Pseudomonas aeruginosa and Candida albicans. Duodenoscopes, colonoscopes, and bronchoscopes (all Olympus endoscopes) were included in the simulated use testing. Each endoscope type was tested in triplicate and all channels and two surface sites were sampled for each scope. The clinical study evaluated patient-used duodenoscopes, bronchoscopes, colonoscopes, and gastroscopes (scopes used for emergency procedures were excluded) that had only a bedside flush prior to being processed in the ECR (i.e. no manual cleaning). There were 10 to 15 endoscopes evaluated post-cleaning and to ensure the entire ECR cycle was effective, 5 endoscopes were evaluated post-cleaning and post-high level disinfection. All channels and two external surface locations were sampled to evaluate the residual organic and microbial load. Effective cleaning of endoscope surfaces and channels was deemed to have been achieved if there was < 6.4 μg/cm2 of residual protein, < 1.8 μg/cm2 of residual hemoglobin and < 4 Log10 viable bacteria/cm2. Published data indicate that routine manual cleaning can achieve these endpoints so the ECR cleaning efficacy must meet or exceed these to establish that the ECR cleaning cycle could replace manual cleaningResultsIn the clinical study 75 patient-used scopes were evaluated post cleaning and 98.8% of surfaces and 99.7% of lumens met or surpassed the cleaning endpoints set for protein, hemoglobin and bioburden residuals. In the simulated-use study 100% of the Olympus colonoscopes, duodenoscopes and bronchoscopes evaluated met or surpassed the cleaning endpoints set for protein, and bioburden residuals (hemoglobin was not evaluated).ConclusionsThe ECR cleaning cycle provides an effective automated approach that ensures surfaces and channels of flexible endoscopes are adequately cleaned after having only a bedside flush but no manual cleaning. It is crucial to note that endoscopes used for emergency procedures or where reprocessing is delayed for more than one hour MUST still be manually cleaned prior to placing them in the ECR.

Australian infection control in endoscopy consensus statements on carbapenemase‐producing Enterobacteriaceae

“…Alfa et al reported that automated cleaning resulted in 98.8% of surfaces and 99.7% of lumens meeting or surpassing cleaning end-points for protein, hemoglobin, and bioburden residuals. 38 Similar results have been reported with other automated cleaning machines. 39 The mandating of automated cleaning remains under review.…”

Recent Update of Gastrointestinal Endoscope Reprocessing

“…Evaluation of the EVOTCH system documented the attainment or surpassing of cleaning endpoints for protein, hemoglobin, and bioburden residuals for 98.8% of the surfaces and 99.7% of lumens in the clinical study. It also demonstrated the attainment or surpassing of cleaning endpoints for protein and bioburden residuals for 100% of endoscopes and bronchoscopes in the simulated-use study 34. Assessment of the cost-efficiency of the ECR approaches in an actual practice setting demonstrated a significantly shorter time of endoscope reprocessing and reduced cost compared with manual cleaning followed by automated reprocessing.…”

Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011

“…Recent independent company-sponsored studies also demonstrate significant clearance of protein and other bioburden. 49 Another reprocessor and disinfectant combination was recently cleared with labeling for high-level disinfection after attenuated washing and brushing (OERPro; Olympus America, Center Valley, Pa). These technologies and those still to come warrant further well-designed, peer-reviewed studies by using commercially available machines in clinical settings.…”