Historically, steam autoclaves or dry-heat sterilizers, have played the predominant role for sterilizing devices, equipment, and supplies in hospitals and industry. This method of sterilization is less popular today due to the desire for faster sterilization cycle times and the increased use of heat sensitive equipment. There is a pressing need for low temperature methods for sterilizing medical equipment that are rapid, safe, and cost effective. This Phase I study has successfully demonstrated a low temperature, chemical vapor-based sterilization method. The method has numerous attributes including the ability to package the items to prevent recontamination after the sterilization step has been applied. The sterilizer is easy to install, has been fully automated, and offers a high level of safety. A thorough analysis indicates that the device has a high potential to be manufactured at a cost acceptable to the target end users. The Phase II development effort will focus on the design and validation of a practical device to meet the needs of non-hospital end-users, such as healthcare offices, dental offices, clinics, ambulatory care centers, and non-hospital facilities. The sterilization market is growing in these areas, as more medical procedures are performed outside of a conventional hospital setting.
