• 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.
