The overall goal of this SBIR effort is to develop for commercialization a new nonflammable, cost-effective, low atmospheric impact sterilant gas as a demonstrated and approved sterilizing agent for hemodialyzers and related equipment. The new sterilant gas should be marketable worldwide and should allow use of existing ethylene oxide (EO) sterilizing equipment, thus reducing costs of medical care. The new gas has been given the trade name IoxideTM . The cost of treating renal disease in the U.S. is constantly increasing. The total number of dialysis patients in the U.S. is currently about 290,000, and is expected to rise to about 520,000 by 2010. Medicare alone is already paying out about $11 billion per year for treatment of dialysis patients. Many dialysis membrane materials and other materials used in sensitive medical equipment degrade under the conditions of steam or gamma radiation sterilization. Currently explosive 100% ethylene oxide is being used to sterilize many dialyzers and other sensitive medical equipment, which increases the cost of sterilization. Cost-effective technologies are needed to reduce the cost of hemodialysis, as well as many other medical procedures. In Phase II, the low levels of residual Ioxide components in hemodialyzer materials will be verified; compatibility with a wide selection of materials used in sensitive medical equipment will be measured; a shelf-life will be determined; the suitability of catalytic oxidizers with Ioxide will be established; pilot production will be arranged; and the new sterilant will be demonstrated in sterilization of medical equipment. Residuals will be measured by thermal offgassing of components from hemodialyzers sterilized with Ioxide. Compatibilities will be determined by exposing material specimens to the new sterilant with subsequent visual inspection, size and weight measurements, and surface analysis. A minimum shelf life will be determined by maintaining Ioxide in typical storage containers over the project period. Small catalytic oxidizers will be operated with the new sterilant and their outgas analyzed to establish their suitability for use. Arrangements will be made with a chemical manufacturer to produce a pilot run of Ioxide. The pilot run will provide enough of the new sterilant for demonstrations of sterilization of medical equipment at one or more facilities.
