March 06, 2009 | | Comments 0
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Air pollution control devices may help with upcoming EPA notification

The EPA put a new rule into effect in December that requires hospitals with ethylene oxide (EtO) sterilizers to run full loads.

Partial loads may be run if medically necessary, and in all cases, hospitals must document every sterilizer load and, when loads aren’t full, note the medical reasons. The EPA mandates initial notification of compliance status for existing sterilizers by June 27, 2009.

An EPA brochure on the subject indicates one of the key compliance methods is the use of an air pollution control device (APCD) for the exhausting of ethylene oxide waste gas. You can see from the brochure that having such apparatus is an acceptable strategy under certain conditions, which precludes the whole challenge of having to schedule full loads of materials for an EtO sterilizer.

The brochure also indicates the consideration for less-than-full loads that are processed based on medically necessary circumstances. The brochure goes on to define medically necessary circumstances as an instance in which the protection of human health is at risk. The EPA further indicates that this determination can be made by a number of folks, including hospital administrators, physicians, and even central services staff.

That said, the overarching requirement is to implement a management practice to sterilize full loads of items having a common aeration period. However, in granting the medically necessary exception, I do believe that the EPA would be looking to see that partial loads are the exception rather than standard practice.

So, I guess the choices are to:

  • Pursue the APCD route if you do not already have such equipment (which I can only imagine is quite expensive)
  • Adopt the management practice of full loads (with occasional exceptions for partials)
  • Discontinue the use of the EtO sterilizer (which I suspect is the true endgame for this process)

If you have questions, I think the best place to start would be to contact the EPA regional office at the number listed on the brochure. There area a great many hospitals that will be struggling with this over the next little while, and I suspect there might end up being specific regional concerns if you don’t touch base with the EPA early in the process.

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Filed Under: Environmental protection


Steve MacArthur About the Author: Steve MacArthur is a safety consultant with The Greeley Company in Danvers, Mass. He brings more than 30 years of healthcare management and consulting experience to his work with hospitals, physician offices, and ambulatory care facilities across the country. He is the author of HCPro's Hospital Safety Director's Handbook and is contributing editor for Briefings on Hospital Safety. Contact Steve at

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