Abstract
This study was performed to evaluate the efficacy of the Demolizer? technology for the on-site sterilization of low vo-lumes of regulated medical waste. The objective was to demonstrate a minimum of 6 log10 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 subtilis 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 log10 for both S. aureus and E. coli as representative gram-positive and gram-negative bacteria species. Candida albicans (6.7 log10 CFU/ml), Mycobacterium phlei (9.0 log10 CFU/ml) and Bacillus subtilis (6.3 log10 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 log10 reduction of Mycobacteria and a 4 log10 reduction of the appropriate Bacillus endospore.
Highlights
There was no evidence of growth in the bacterial species after treatment
Regulated medical waste as defined in the OSHA Blood borne Standard includes: liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling contaminated sharps, and pathological and microbiological wastes containing blood or other potentially infectious materials
Treatment of microbial carriers—Microbial inocula contained in five microbial carriers or Bacillus subtilis spore strips contained in glassine envelopes were suspended with thin-wire, metallic clips from each one of three Demolizer II collector rims
Summary
Regulated medical waste as defined in the OSHA Blood borne Standard includes: liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling contaminated sharps, and pathological and microbiological wastes containing blood or other potentially infectious materials. While there is not a uniform standard for sterilization, most states define minimum treatment standards of a 4 log reduction of the appropriate Bacillus endospore indicator for the technology and a 6 log reduction of other important indicators, including a representative Mycobacteria such as Mycobacterium phlei, Mycobacterium fortuitum or Mycobacterium bovis These bacterial strains typically represent the most resistant organisms to heat or chemical sterilization, the techniques most commonly used for medical waste treatment. The objective was to demonstrate a minimum of 6 log 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.
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