We propose to continue the development of a new process for sterilizing heat sensitive medical instruments at room temperature in less than 30 times. An advantage of this technique is that the active component of the liquid sterilant is both created and destroyed at the point of use. Accordingly, the sterilant does not require handling or disposal by the user. In phase II we will incorporate several design improvements identified in phase I for enhanced sterilization performance and enhanced physical performance. We will evaluate athe sporicidal activity of the sterilant according the standard protocols established by the FDA and EPA for qualifying a new sterilant for commercial and medical use. This will include tests with spores on AOAC carriers, tests with spores in suspension, and tests with spore inoculated medical instruments. We will use an outside FDA/EPA approved laboratory to assess the toxicity of the sterilant use dilution. We will analyze the post rinse residue for the presence of the sterilant and measure the toxicity of the sterilant residue if any is detected. Finally, we will perform materials compatibility testing to assess the influence of the sterilant on the materials of construction and functionality of reusable medical devices.
A number of medical instruments cannot withstand the temperatures required for sterilization in an autoclave. These include rigid and flexible endoscopes (such as angioscopes, gastroscopes, colonscopes, uretheoscopes, bronchoscopes, laparoscopes), dental instruments, and microsurgical tools.
