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EFHSS - Questions & Answers - Low Temperature Sterilization - Q00345
Gas plasma sterilizer recommendations
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From:    Date: 24 October 2003, 14:45 [GMT]
Subject: Gas plasma sterilizer recommendations

Dear Sir,

I'm going to buy Low Temperature Sterilizer but I can't decide between EO Sterilizer and Plasma sterilizer. Who know abot these products please give me detail.

Thanks for your kindly

Jame Donne

From: Josy Holdener (Switzerland)   Date: 25 October 2003, 06:59 [GMT]
Subject: Re: Gas plasma sterilizer recommendations

Dear Jame,

Please see the answers Q00011 and Q00112 given by Pete Bobb and the many related Q/A under the Category "Low Temperature Sterilization".
If you don't find the answer you are looking for, please try again.

Kind regards
Josy Holdener

From: Wim Renders (Belgium)   Date: 25 October 2003, 12:13 [GMT]
Subject: Re: Gas plasma sterilizer recommendations

Dear,

Answers on questions Q00323, Q00140, Q00139, Q00112, Q00111, Q00077, Q00030, Q00016, Q00011 and Q00007 will help you further.

Good luck,
Wim Renders

From: Wim Renders (Belgium)   Date: 31 October 2003, 21:41 [GMT]
Subject: Re: Gas plasma sterilizer recommendations

Dear,

Hereby my opinion: In the first place whenever possible use steam sterilization!

Ethylene oxide (EO) is toxic both for the operator and for the patient and it is as well an environmental hazard. As a result an installation is expensive as a number of security precautions has to be taken. Moreover, the medical device (m.d.) which needs to be sterilized cannot be put into the EO sterilizer without the necessary care. A number of precautions apply such as the fact that ethylene oxide should be able to reach all surfaces which need to be sterilised, the m.d has to be dry and afterwards it should be possible to aerate it long enough. It is not becausse a m.d. has been through an EO cycle that it is also sterile! For all these and other reasons EO is used less and less in a hospital. Hydrogen peroxide gasplasma does not have the toxic disadvantages of EO. But once again a number of restrictions apply: product compatibility cf. cellulose, cotton and a restriction in lumina which can be sterilized. An advantage is that when a problem with moisture occurs the cycle is cancelled. One has to take into account these restrictions when making a choice in order to avoid unpleasant surprises. In the past there were a lot of questions regarding the controllability, reproducibility and toxicity of low temperature steam formaldehyde processes. These should have substantially improved with the new sterilizers. And maybe also sterilization by means of ozone (FDA approval) can be offering new possiblities.

During the EFHSS - MSUD congress 2004 in Turkey a very interesting afternoon will be devoted to low temperature sterilization.

Best regards,
Wim Renders

From:    Date: 25 November 2003, 14:02 [GMT]
Subject: Re: Gas plasma sterilizer recommendations

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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