Low-Temperature Sterilization Technologies

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).

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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 states (e.g., California, New York, Michigan) require the use of ETO abatement technology to reduce the amount of ETO being released into ambient air from 90 to 99.9% depending on the state. Third, OSHA regulates the acceptable vapor levels of ETO (i.e., 1 ppm averaged over 8 hours) due to concerns that ETO exposure represents an occupational hazard³¹⁸. These constraints have led to the development of alternative technologies for low-temperature sterilization in the healthcare setting.

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Alternative technologies to ETO with chlorofluorocarbon that are currently available and cleared by the FDA for medical equipment include 100% ETO; ETO with a different stabilizing gas, such as carbon dioxide or hydrochlorofluorocarbons (HCFC); immersion in peracetic acid; hydrogen peroxide gas plasma; and ozone. Technologies under development for use in healthcare facilities, but not cleared by the FDA, include vaporized hydrogen peroxide, vapor phase peracetic acid, gaseous chlorine dioxide, ionizing radiation, or pulsed light.^{400, 758, 853} However, there is no guarantee that these new sterilization technologies will receive FDA clearance for use in healthcare facilities.

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These new technologies should be compared against the characteristics of an ideal low-temperature (<60°C) sterilant (Table 9).⁸⁵¹ While it is apparent that all technologies will have limitations (Table 9), understanding the limitations imposed by restrictive device designs (e.g., long, narrow lumens) is critical for proper application of new sterilization technology.⁸⁵⁴ For example, the development of increasingly small and complex endoscopes presents a difficult challenge for current sterilization processes. This occurs because microorganisms must be in direct contact with the sterilant for inactivation to occur. Several peer-reviewed scientific publications have data demonstrating concerns about the efficacy of several of the low-temperature sterilization processes (i.e., gas plasma, vaporized hydrogen peroxide, ETO, peracetic acid), particularly when the test organisms are challenged in the presence of serum and salt and a narrow lumen vehicle.^{469, 721, 825, 855, 856} Factors shown to affect the efficacy of sterilization are shown in Table 10.

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