T C Penna1, C A Ferraz. 1. Department of Biochemical and Pharmaceutical Technology, School of Pharmaceutical Science, University of São Paulo, Brasil.
Abstract
OBJECTIVES: To evaluate the efficacy of a multistep cleaning method using a cleaner and a chemical disinfectant on blood-contaminated angiographic catheters and spinal needles intended to be sterilized by hydrogen peroxide gas plasma. METHOD: A mixture of radiopaque iodine contrast, bovine blood (plus ethylenediaminetetraacetic acid), and a suspension of Bacillus subtilis spores was used to simulate catheterization and needle use. The mixture was a 1:1 proportion of contrast and blood, inoculated so that there was a final concentration of B subtilis spores of 1.0x10(6) colony-forming units (CFU)/mL. The inoculated devices were cleaned using a hydrogen peroxide solution at a concentration of 1.5+/-0.5 percent by weight, followed by distilled water with enzymatic detergent. After drying, the devices were sterilized with hydrogen peroxide gas plasma. RESULTS: The initial B subtilis spore concentration inoculated into catheters and needles varied from 2.12x10(4) to 2.74x10(7) CFU/mL. The residual load of B. subtilis spores after cleaning varied from zero (no count) to a maximum of 200 CFU/device. The multistep cleaning procedure was responsible for an average 5log10 reduction of B. subtilis spores in the catheter and needle lumens. CONCLUSIONS: The hydrogen peroxide and enzymatic detergent aqueous solutions were shown to be efficacious when used as part of a multistep cleaning method. The low level of microbial contamination prior to sterilization with hydrogen peroxide gas plasma assured that the intended sterility assurance level was reached.
OBJECTIVES: To evaluate the efficacy of a multistep cleaning method using a cleaner and a chemical disinfectant on blood-contaminated angiographic catheters and spinal needles intended to be sterilized by hydrogen peroxide gas plasma. METHOD: A mixture of radiopaque iodine contrast, bovine blood (plus ethylenediaminetetraacetic acid), and a suspension of Bacillus subtilis spores was used to simulate catheterization and needle use. The mixture was a 1:1 proportion of contrast and blood, inoculated so that there was a final concentration of B subtilis spores of 1.0x10(6) colony-forming units (CFU)/mL. The inoculated devices were cleaned using a hydrogen peroxide solution at a concentration of 1.5+/-0.5 percent by weight, followed by distilled water with enzymatic detergent. After drying, the devices were sterilized with hydrogen peroxide gas plasma. RESULTS: The initial B subtilis spore concentration inoculated into catheters and needles varied from 2.12x10(4) to 2.74x10(7) CFU/mL. The residual load of B. subtilis spores after cleaning varied from zero (no count) to a maximum of 200 CFU/device. The multistep cleaning procedure was responsible for an average 5log10 reduction of B. subtilis spores in the catheter and needle lumens. CONCLUSIONS: The hydrogen peroxide and enzymatic detergent aqueous solutions were shown to be efficacious when used as part of a multistep cleaning method. The low level of microbial contamination prior to sterilization with hydrogen peroxide gas plasma assured that the intended sterility assurance level was reached.