Efficacy of high-level disinfectants for reprocessing GI endoscopes in simulated-use testing

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.