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Consider pollution control devices for EtO rules


May 1, 2009

Tip of the month

Consider pollution control devices for EtO rules

Hospitals in the compliance soup of the Environmental Protection Agency’s (EPA) new rule mandating only full loads run in ethylene oxide (EtO) sterilizers—unless a physician or other authority determines it medically necessary to run a partial load—may be interested in an alternative approach.

Some readers have reported that the EtO regulation is onerous because their hospitals rarely have enough gear to run a full load in the sterilizer. An option may be to use an air pollution control device (APCD) that filters EtO waste gas, as outlined by the EPA in a brochure about the regulation at www.epa.gov/ttn/atw/area/sterilizersb.pdf.

“Hospitals which route [EtO] to an air pollution control device are in compliance with the rule requirements,” the EPA states in the brochure.

The agency has found that collectively, hospital EtO sterilizers account for a significant source of pollution, a fact that inspired the new rule. As many as 1,600 of the nation’s 5,800 hospitals may be affected.

If your sterilizer existed before November 6, 2006, you have until June 26 to file an “initial notification of compliance status” with the EPA. This notification will explain which compliance path you plan to take: the management practice of monitoring full loads and logging them or the use of an APCD. Newly constructed sterilizers must send in initial notification within 180 days of startup.

In the initial notification, the EPA requires hospitals to certify one of the following:

  • The hospital sterilizes full loads of items with common aeration time except under medically necessary circumstances
  • The hospital operates sterilizers with an add-on -APCD required by a state or local regulation and follows -APCD manufacturer recommendations
  • The hospital operates sterilizers with an add-on -APCD (but is not subject to a state or local requirement to do so), venting EtO emissions from each sterilizer to the -APCD, operating the -APCD during all sterilization processes, and following -APCD manufacturer recommendations

To read the EPA’s full EtO regulation, go to www.epa.gov and search for the term “FRL-8512-1.”

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