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EFHSS- Questions & Answers- Q000-142
What is an Ethylene SterilizerFollow Up]
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From:    Date: 9 April 2002
Subject: What is an Ethylene Sterilizer

WHAT IS AN ETHYLENE STERILIZER

From: Wim Renders   Date: 10 April 2002
Subject: Re: What is an Ethylene Sterilizer

Dear,

I think your question is about an ethylene oxide sterilizer.

I quote the training manual of ASHCSP:

  • "ethylene oxide sterilizer: A sterilizer with locked chamber and humidity control used to sterilize instruments, supplies, and other items that cannot withstand high heat or humidity.
  • ethylene oxide: EtO; a gaseous sterilant used for instruments and supplies that cannot withstand high heat or humidity.
    EtO is a colorless gas that has properties that make it an ideal sterilant for heat-sensitive medical devices. EtO gas will kill all known microorganisms by means of a process called alkylation, a chemical reaction that interferes with the metabolism of all types of microbial life, including bacterial spores. EtO is noncorrosive and nondamaging to plastics and rubber and is an effective sterilant at temperatures and pressures that are tolerated by these heat-sensitive items. The gas readily penetrates commonly used packaging materials and diffuses rapidly to contact all surfaces of items.
    EtO sterilization does have some disadvantages. First, the process takes many hours due to the need for lengthly exposure and aeration periods. Second, it is more expensive than steam sterilization, due to the cost of purchasing and maintaining the equipment itself, the cost of necessary ventilation systems and other safety measures, and the cost of the gas. Third, EtO in its pure form is extremely flammable. To minimise fire and explosion hazards, special precautions must be taken in its storage and use. For this reason, 100 % EtO is available only in small cartridges. Fourth, due to the toxicity of EtO, sterile items must be aerated for a specified time to allow residues to escape. If EtO sterilized items are not properly aerated, patients and staff can be exposed to toxic levels of the gas and suffer both short-term effects (such as chemical burns) and long-term effects.
    There are serious health hazards with inhaling EtO gas. OSHA has designated EtO a potential carcinogen (it may cause cancer), and there is concern that it may cause birth defects as well. In addition, acute overexposure to concentrations above 500 ppm may cause dizziness, respiratory distress, nausea, vomiting and headache. Rigorous ventilation and other engineering controls must be scrupulously observed to prevent excessive exposure to the gas.
    Because of the toxicity and health hazards, EtO sterilization should only be used to process devices that will not withstand steam sterilization."

Questions 11, 111, 112 and 139 can give you a good idea of the discussion that's taking place about the possibility of replacing EtO sterilization in the hospitals by other less toxic methods as gasplasma (see the ASP website, our industrial partner) or by outsourcing EtO sterilization. Questions 139, 136, 131, 127, 122, 89, 79 and 77 are also treating different aspects of EtO sterilization.

I hope this information will help you further,
Kind regards,
Wim Renders


EFHSS  European Forum for Hospital Sterile Supply