Sterilization Efficacy of Demolizer Technology for Onsite Treatment of Sharps and Other Regulated Medical Waste against <i>Staphylococcus aureus</i>, <i>Escherichia coli</i>, <i>Candida albicans</i>,<i> Mycobacterium phlei</i> and <i>Bacillus subtilis</i> Spores

Abstract

This study was performed to evaluate the efficacy of the Demolizer  technology for the on-site sterilization of low volumes of regulated medical waste. The objective was to demonstrate a minimum of 6 log 10 reduction of the dry heat sterilization process applied by the Demolizer  II system for the representative organisms, Staphylococcus aureus, Escherichia coli, Candida albicans, Mycobacterium phlei, and Bacillus atrophaeus spores (formerly Bacillus subtilis) on simulated medical waste consistent with numerous regulatory standards for medical waste treatment. The system cycle was heat treatment at a minimum temperature of 350˚F and held at or above this temperature for a minimum of 90 minutes. Upon completion of treatment, there was no evidence of growth in the bacterial species after treatment. Given the minimum detection level of 4 CFU/ml, the Demolizer  II system demonstrated a minimum sterilization efficacy of 6.6 log 10 for both S. aureus and E. coli as representative gram-positive and gram-negative bacteria species. Candida albicans (6.7 log 10 CFU/ml), Mycobacterium phlei (9.0 log 10 CFU/ml) and Bacillus subtilis (6.3 log 10 CFU/ml) were completely eliminated after sterilizing representative medical waste in the Demolizer  II system for 90 minutes at a minimum temperature of 350˚F. Also, the Demolizer  II exceeded typical recognized standards for medical waste treatment of a 6 log 10 reduction of Mycobacteria and a 4 log 10 reduction of the appropriate Bacillus endospore.