Illinois Hospital Association

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June 10, 2009

Reminder: Initial Notification of Compliance Status with USEPA Ethylene Oxide Sterilization Rule Due June 27, 2009

The USEPA rule on National Emission Standards for Hospital Ethylene Oxide Sterilizers requires a one time certification that hospitals are in compliance. The certification form is due on June 27, 2009. IHA has been notified that very few hospitals have sent in their form. A copy of the form is attached (click here).

Copies must be sent to the Illinois EPA, USEPA Region 5, and the EPA’s Office of Air Quality Planning and Standards. The full addresses are on the form itself.

The rule applies to any hospital ethylene oxide sterilization facility that is an area source of Hazardous Air Pollutants (HAPs). An area source is a stationary source of HAP emissions that emits less than 10 tons per year of a single HAP or less than 25 tons per year of a combination of HAPs.

The required management practices are that hospitals should:

  • Sterilize full loads of items having a common aeration time except where medical necessity dictates less than a full load. The determination of medical necessity can be made by hospital central services staff, a hospital administrator, or a physician;
  • Maintain on-site records of the date and time of each sterilization operation. If less than a full load is sterilized due to medical necessity, it must be recorded; and
  • Keep sterilization records for five years and at least the most recent two years on-site.

    • As an alternative to the above management practices, hospitals that operate sterilization units with air pollution control devices (APCDs) may demonstrate compliance by certifying that they are venting the ethylene oxide emissions from the sterilizer unit to an air pollution control device and that they are operating the control device during all sterilization processes in accordance with the manufacturer’s recommended procedures.

    When filling out question #7 on the Initial Notification of Compliance Status form, note that Illinois does not have specific regulations for ethylene oxide emissions at this time. Therefore, you will need to either check the first or third box certifying that you are in compliance with the required management practices or that your ethylene oxide sterilizers are operated with air pollution control devices.

    For more detailed information, the full text of the USEPA’s rule can be found by clicking here.

    If you have questions, contact Ann Guild at 630-276-5496 or via e-mail at aguild@ihastaff.org.