Dear Jame
I feel it necessary to add some additional discussion points to Wim Renders response to your question. While I cannot disagree with Wim's point about using steam, unfortunately not everything can be processed by this medium. I think, however,some clarity should be applied to the rest of his response.
Ethylene Oxide sterilizers,correctly installed and controlled by appropriately trained personnel following well defined safety procedures,utilising a quality system employing monitoring systems required by both EN and ISO standards, poses NO threat to the operator, the patient or the environment. I think the fact that for a number of years, Wim has used and continues to use EO in his hospital, without as far as I am aware adverse reactions to staff or patients is evidence of the safety of EO.
There is a decline in the use of low temperature sterilization in some European countries but this has more to do with the increase in the use of single use medical devices (some 50% of which incidentally are sterilized with EO!) and the reduction in the reprocessing of single use items in those countries. I fully agree with Wim that medical devices cannot be put into ANY sterilizer,not just EO, without necessary care. The toxicity of EO arising from both acute and long term exposure to low levels of EO is well documented, and as a result appropriate STEL (short term exposure limits) and TWA (time weighted average) levels are defined by the health and safety organisations in many countries. It is however also important to note that both hydrogen peroxide and formaldehyde are also toxic substances covered by health and safety legislation and appropriate exposure limits equal to or even lower than EO are defined.It is also interesting to note that a toxicologic gauge used by NIOSH called IDLH (Immediate Danger to Life and Health) gives the following limits - EO 800 parts per million (ppm) Hydrogen Peroxide 75 parts per million(ppm) Sterilant penetrability and material compatibility are two of the important considerations in choosing a sterilization process. The range of single use medical devices ranging from hypodermic needles to contact lens, angiography catheters to prostheses, provide by industry and processed by Ethylene Oxide provides clear evidence as to its efficacy and safety. There are a lot of hospitals, including Wim's,throughout the world using EO safely and effectively every day. One small question: what is the advise in terms of reprocessing medical devices which were in the chamber of a hydrogen peroxide sterilizer where the cycle aborted due to the presence of moisture.
Pat Dillon
3M -Sterility Assurance Products
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