Washing and disinfection efficacy of a newly developed endoscope disinfection device CM-5, which was certificated as a medical device by the Health, Labor and Welfare Ministry of Japan in May 2010, was examined in the following two points. That is, 1) antimicrobial and antiviral efficacy of strong acid electrolyzed water (SAEW) produced by CM-5, and 2) washing and disinfection efficacy of CM-5 under the conditions of clinical use. In the study of 1) in which 20 strains of 18 bacterial species, 3 fungal species, and 4 strains of 3 viral species were used, SAEW needed <5 min and <60 sec to kill Bacillus subtilis and Clostridium sporogenes, both of which are spore forming bacteria, respectively, and <30 sec to kill Cryptococcus neoformans, which is a capsulated fungus. Against any other pathogens, SAEW needed only < 5 to 15 sec to kill them. In the study of 2), each pathogen from 14 strains of 13 bacterial species, 3 fungal species, and 3 strains of 2 viral species was attached to both the inside and outside of an endoscope, and then the contaminated endoscope was subjected to the treatment of disinfection process of CM-5. As a result, efficacy against Helicobacter pylori was not evaluated because no H. pylori were detected even before the treatment. Against any other pathogens, the treatment of CM-5 exerted potent disinfectant efficacy enough to eliminate bacteria and fungi with 6 logarithmic reductions. In addition, no viruses were isolated after the treatment.
Considering the preliminary washing for endoscope as described in the “guideline for disinfection of endoscope”, the endoscope disinfectant device CM-5 is most likely effective for clinical use.
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