Hospitals should take note of new requirements from U.S. EPA applicable to ethylene oxide ("EtO") sterilizers. Many facilities rely upon these sterilizers for reusable equipment, instruments and supplies. Ethylene oxide, a toxic, flammable gas, is regulated as a "hazardous air pollutant" or HAP under the Clean Air Act.
Under the new rules, hospitals using one or more EtO sterilizers must do the following before December 29, 20081:
- institute management practices that require, except in limited circumstances, that EtO sterilizers process only full loads having a common aeration time;
- create and keep (for at least 5 years) records of the use of each EtO sterilizer not equipped with an air pollution control device which establish compliance with the management practices standard, above; and
- submit an Initial Notification of Compliance Status to U.S. EPA within 180 days after the final compliance date of December 29, 20082. The Notification must either certify compliance with the management practices standard and recordkeeping requirements, above, or certify that the EtO sterilizer is equipped with an air pollution control device.
The new EtO rule can be found in the Federal Register at 72 FR 73611.