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Ethylene oxide (ETO) has been widely used as a low-temperature sterilant since the 1950s. It has been the most commonly used process for sterilizing temperature- and moisture-sensitive medical devices and supplies in healthcare institutions in the United States. Two types of ETO sterilizers are available, mixed gas and 100% ETO. Until 1995, ethylene oxide sterilizers combined ETO with a chloroflourocarbon (CFC) stabilizing agent, most commonly in a ratio of 12% ETO mixed with 88% CFC (referred to as 12/88 ETO).

For several reasons, healthcare personnel have been exploring the use of new low-temperature sterilization technologies.825, 851 First, CFCs were phased out in December 1995 under provisions of the Clean Air Act.852 CFCs were classified as a Class I substance under the Clean Air Act because of scientific evidence linking them to destruction of the earth’s ozone layer. Second, some s...