Evaluation of a novel, rapid-acting, sterilizing solution at room temperature

Test data are presented for a novel chemical germicide formulation capable of sterilizing reusable medical devices in 30 minutes at 20 degrees C in an open tray. The tests conducted with this rapid-acting sterilizing solution (RSS) included sporicidal, mycobactericidal, and virucidal studies performed in accordance with Association of Official Analytical Chemist International or Environmental Protection Agency published guidelines, by using RSS stressed for as long as 7 days. Sporicidal assays were performed at 20 degrees C with a 30-minute exposure time by using both Clostridium sporogenes and Bacillus subtilis spores dried on porcelain penicylinders or suture loops (n = 60 carriers per treatment). For comparison, identical carriers were exposed to a commercial glutaraldehyde-based sterilizing solution stressed to a maximum-use time of 14 days and exposed per manufacturer's requirements (10 hours at 25 degrees C). The RSS sterilized 100% of the carriers of both spore types. The glutaraldehyde solution demonstrated 100% sterilization of C sporogenes -treated carriers but had difficulty sterilizing B subtilis spore-laden carriers (ie, no sterilization of suture loops and only 57% sterilization of porcelain penicylinders). Similarly, Mycobacteria bovis and selected fungal and viral agents were exposed to stressed solution for 5 minutes or less at 20 degrees C. In each case, the resulting log decrease in viable microorganisms significantly supported a claim for rapid high-level disinfection. Based on these data, RSS demonstrates high-level disinfection in 5 minutes and sterilization in 30 minutes at 20 degrees C.