Related Experiment Videos
Efficacy of high-level disinfectants for reprocessing GI endoscopes in simulated-use testing
R L Foliente1, B J Kovacs, R M Aprecio
1Division of Gastroenterology and Department of Microbiology, Loma Linda University School of Medicine, California, USA.
Background:
There has been recent public concern regarding the adequacy of current practices for flexible endoscope reprocessing. High-level disinfection is defined by the Food and Drug Administration (FDA) as a minimum of 6-log reduction of mycobacteria under a worst-case scenario. Several agents are currently approved by the FDA, but published data on their relative efficacies against mycobacteria are lacking. The objective of this study was to determine the efficacy of these agents for high-level disinfection.
Methods:
In simulated-use testing, video endoscopes (5 colonoscopes and 5 duodenoscopes) were each inoculated with 9.0 x 10(7) colony-forming units of Mycobacterium chelonae. Cleaning was performed by using a standardized protocol. Each endoscope was then subjected to chemical disinfection with Cidex (2.0% glutaraldehyde) at 20 degrees C for 20 minutes, Sporox (7.5% hydrogen peroxide) at 20 degrees for 30 minutes, and Steris 20 (0.2% peracetic acid) at 50 degrees C to 56 degrees C for 12 minutes using the Steris System 1 processor. Although not FDA-approved, tests were also conducted by using 70% isopropyl alcohol at 20 degrees C for 20 minutes. These results were compared with disinfection with ethylene oxide gas. All channels were sampled for M chelonae before and after manual cleaning and after disinfection.
Results:
Cleaning alone resulted in an average log reduction of 3. Cidex, Sporox, Steris 20, ethylene oxide gas, and isopropyl alcohol, in combination with manual cleaning, each achieved a 6-log or greater reduction of the mycobacterial inoculum. No organisms were recovered from any channel after reprocessing with ethylene oxide and Steris 20.
Conclusions:
Commercially available high-level disinfectants are equally efficacious for reprocessing flexible GI endoscopes when used in conjunction with cleaning and in accordance with recommended guidelines.
Insights
Flexible GI endoscope reprocessing with FDA-approved high-level disinfectants effectively eliminates mycobacteria when combined with cleaning. All tested agents achieved the required 6-log reduction, ensuring patient safety.
Area of Science:
- Microbiology
- Infectious Disease Control
- Medical Device Reprocessing
Background:
- Public concern exists regarding flexible endoscope reprocessing efficacy.
- High-level disinfection requires a minimum 6-log reduction of mycobacteria.
- Limited comparative data on FDA-approved agents' efficacy against mycobacteria.
Purpose of the Study:
- To evaluate the efficacy of FDA-approved high-level disinfectants for flexible GI endoscope reprocessing.
- To compare the mycobactericidal activity of Cidex, Sporox, and Steris 20.
- To assess the effectiveness of reprocessing protocols against Mycobacterium chelonae.
Main Methods:
- Simulated-use testing on colonoscopes and duodenoscopes inoculated with Mycobacterium chelonae.
- Standardized manual cleaning followed by chemical disinfection with glutaraldehyde, hydrogen peroxide, or peracetic acid.
- Comparison with ethylene oxide gas and isopropyl alcohol disinfection; microbial sampling before and after reprocessing.
Main Results:
- Manual cleaning alone achieved an average 3-log reduction of mycobacteria.
- All tested high-level disinfectants (Cidex, Sporox, Steris 20), ethylene oxide, and isopropyl alcohol achieved ≥6-log reduction post-cleaning.
- Ethylene oxide and Steris 20 resulted in complete organism eradication.
Conclusions:
- Commercially available high-level disinfectants are equally effective for flexible GI endoscope reprocessing.
- Effective reprocessing requires combining chemical disinfection with thorough cleaning.
- Adherence to recommended guidelines ensures the efficacy of endoscope disinfection.