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Copyright © 2008

People, Places, Processes & Products that Influence the Supply Chain

INSIDE THE CURRENT ISSUE

July 2007

Having My say

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The benefits of 100 percent EO sterilization

by Susan Flynn, technical service specialist, 3M Sterilization Assurance

• What should I choose as the method of low temperature sterilization
   for my hospital?

• What are my choices?

• What factors should I be considering?

• What are the tradeoffs?

These are just some of the most important questions that cross the mind of a hospital administrator when he or she is looking to purchase a new low temperature sterilization system. While it is safe to say that there are many choices in the market that provide a solid efficacy and safety profile, a closer examination will bring the benefits of a 100 percent ethylene oxide sterilization system to the forefront, making it a front-runner among other types of systems. Let’s take a closer look.

Background

What is ethylene oxide (EO)? A gas at room temperature, EO is bactericidal, fungicidal and sporicidal, making it an ideal agent for sterilizing medical and surgical devices, especially for those devices and instruments sensitive to high temperature and/or moisture. Outside of healthcare, ethylene oxide is an important industrial chemical intermediate that is utilized in the manufacturing of surfactants, polyester polymers and antifreeze, an automotive coolant.

As a sterilant, what is ethylene oxide’s mechanism of action? Ethylene oxide sterilizes by the process of alkylation. By alkylating the DNA and other components of bacteria and fungi, ethylene oxide disrupts their life cycle. The very properties that make ethylene oxide a great sterilization agent, however, also make it hazardous. The questions in the administrator’s mind should center around: patient and operator safety; efficacy of the sterilants being considered; device compatibility; and acquisition and operating costs.

Safety profile: A 50 year history

It is important to note that ethylene oxide boasts a fifty-year history of use in the healthcare industry. When compared to mixed gas systems, 100 percent EO sterilizers offer safety features such as single-dose cartridges and negative-pressure chambers that minimize the potential for gas leaks and worker exposure. In addition, the use of ethylene oxide as a sterilant is well regulated. The Occupational Safety and Health Administration (OSHA) has regulations in place, OSHA 29 CFR 1910.1047, that help ensure the safety of all workers who work with ethylene oxide.

It is also important to note that because all sterilizing agents are potentially harmful to humans, the extensive set of existing regulations around the use of EO, when implemented appropriately, should help put the minds of administrators and technicians at ease.

Efficacy and material compatibility

With proper installation and maintenance, a 100 percent ethylene oxide system remains one of the safest sterilization systems in the market. Recent survey results indicate that efficacy is the most important factor in the decision to purchase a new low temperature sterilization system. Over the last 50 years, ethylene oxide has been established as the "gold standard" of efficacy for low-temperature sterilization and also provides the greatest penetrability and medical device material compatibility. It does not require any special packaging materials, such as polypropylene wraps or polyolefin pouches, as other systems often do. Ethylene oxide can penetrate all common packaging materials and device lumens and is compatible with most medical materials. The "trade-off" of having such high material penetrability, however, is the residual ethylene oxide in the materials sterilized. To minimize staff and patient exposure, adequate aeration time is required, making the cycle time of ethylene oxide systems longer than that of other low temperature sterilants.

Cost analysis

For a hospital administrator looking to purchase a new sterilization system, cost impact is of utmost importance. Both acquisition/installation costs and daily operating costs, including sterilant, monitoring products and wrapping materials, should be considered. 100 percent ethylene oxide’s initial equipment cost can be lower which, combined with a typical operating cost per cubic foot advantage, can lead to significant savings.

Conclusion

Low-temperature sterilization systems continue to evolve. Even with newer technological advancements that have led to faster sterilization processes, the 100 percent ethylene oxide system still remains one of the best options, providing proven efficacy, greater material compatibility and penetrability, along with a solid safety profile. While there is a place for other types of systems, and some can deliver faster cycle and turnaround times, their limitations in materials compatibility make 100 percent ethylene oxide systems a worthy consideration for any hospital administrator looking to purchase new sterilization equipment.