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

Alfa MJ, DeGagne P, Olson N, Fatima I - BMC Infect. Dis. (2010)

Bottom Line: 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.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 cleaning In 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).

View Article: PubMed Central - HTML - PubMed

Affiliation: Diagnostic Services of Manitoba, 409 Tache Avenue, Winnipeg, MB R2H 2A6, Canada. malfa@sbgh.mb.ca

ABSTRACT

Background: The 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.

Methods: Simulated-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 microg/cm2 of residual protein, < 1.8 microg/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 cleaning

Results: In 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).

Conclusions: The 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.

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A summary of the simulated-use testing to assess the reduction in E. faecalis, P. aeruginosa and C. albicans after ECR cleaning. All results represent the average and standard deviation for three replicate experiments. S1 and S2 represent samples from 1 cm2 surface sites on the insertion tube and control head, respectively. L1, L2, L4 represent samples taken from the suction-biopsy, air-water and elevator guidewire channels, respectively. [Note; there were no Auxiliary water channels (L3) on the endoscopes used for simulated-use testing.]
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Figure 2: A summary of the simulated-use testing to assess the reduction in E. faecalis, P. aeruginosa and C. albicans after ECR cleaning. All results represent the average and standard deviation for three replicate experiments. S1 and S2 represent samples from 1 cm2 surface sites on the insertion tube and control head, respectively. L1, L2, L4 represent samples taken from the suction-biopsy, air-water and elevator guidewire channels, respectively. [Note; there were no Auxiliary water channels (L3) on the endoscopes used for simulated-use testing.]

Mentions: Figure 2 provides a summary of the removal of bioburden stratified by organism tested. Although the impact of the detergent may partly explain why P. aeruginosa was the most susceptible to removal, the data for the other two test organisms demonstrated that there was significant removal of microorganisms from both lumens and surfaces as neither E. faecalis or C. albicans were affected by the detergent yet they were effectively removed by the ECR cleaning (4 to 7 Log10 reduction in bioburden).


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

Alfa MJ, DeGagne P, Olson N, Fatima I - BMC Infect. Dis. (2010)

A summary of the simulated-use testing to assess the reduction in E. faecalis, P. aeruginosa and C. albicans after ECR cleaning. All results represent the average and standard deviation for three replicate experiments. S1 and S2 represent samples from 1 cm2 surface sites on the insertion tube and control head, respectively. L1, L2, L4 represent samples taken from the suction-biopsy, air-water and elevator guidewire channels, respectively. [Note; there were no Auxiliary water channels (L3) on the endoscopes used for simulated-use testing.]
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2914053&req=5

Figure 2: A summary of the simulated-use testing to assess the reduction in E. faecalis, P. aeruginosa and C. albicans after ECR cleaning. All results represent the average and standard deviation for three replicate experiments. S1 and S2 represent samples from 1 cm2 surface sites on the insertion tube and control head, respectively. L1, L2, L4 represent samples taken from the suction-biopsy, air-water and elevator guidewire channels, respectively. [Note; there were no Auxiliary water channels (L3) on the endoscopes used for simulated-use testing.]
Mentions: Figure 2 provides a summary of the removal of bioburden stratified by organism tested. Although the impact of the detergent may partly explain why P. aeruginosa was the most susceptible to removal, the data for the other two test organisms demonstrated that there was significant removal of microorganisms from both lumens and surfaces as neither E. faecalis or C. albicans were affected by the detergent yet they were effectively removed by the ECR cleaning (4 to 7 Log10 reduction in bioburden).

Bottom Line: 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.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 cleaning In 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).

View Article: PubMed Central - HTML - PubMed

Affiliation: Diagnostic Services of Manitoba, 409 Tache Avenue, Winnipeg, MB R2H 2A6, Canada. malfa@sbgh.mb.ca

ABSTRACT

Background: The 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.

Methods: Simulated-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 microg/cm2 of residual protein, < 1.8 microg/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 cleaning

Results: In 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).

Conclusions: The 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.

Show MeSH
Related in: MedlinePlus