Cold sterilization technology for delicate medical instruments has lagged behind the demand of current medical practices. Due to recent FDA recalls there is only one FDA cleared product for liquid chemical sterilization available. Many high level disinfecting agents are available but they tend to be environmentally compromising, hazardous to the work place and expensive. We have developed a pellet or powder sterilization method that will allow larger and more numerous instrumentation to be sterilized at a fraction of the present cost. Phase I data demonstrated that this product (Enzocide42) is rapidly biocidal against fungi, viruses, bacteria and bacterial spores, but is neither toxic nor mutagenic to higher organisms. In combination with sonication, 45 degrees liquid heating and Enzocide42 it is possible to effectively kill all microbial organisms including dehydrated spores on surgical apparatus. Phase I data established conditions for cold sterilization but the 6 month Phase I period was not extensive enough to fully characterize a disinfection chemistry and sterilization methodology. The Phase II proposal will evaluate: sterilization of surgical instruments using the Enzocide42 sterilizing methodology; efficacy of the Enzocide42 biocide on specific pathogens; Enzocide42 toxicological properties; materials compatibility and steady state concentrations of Enzocide42 active constituents. These studies should allow the marketing of a high level disinfectant and sterilization method that will be half the cost of resterilization (or disinfection) procedures for delicate instruments, such as endoscopes, resulting in substantial medical/hospital cost containment.
