New EPA Requirements for Sterilizing Medical Equipment to Protect Hospital and Healthcare Facility Workers

After February 25, 2010, hospitals and healthcare facilities should begin using a single-chamber process (sterilization and aeration in the same chamber) to sterilize medical equipment with ethylene oxide (ETO).  Healthcare facilities include nursing homes, diagnostic and major surgery facilities, doctors' offices, clinics, and other outpatient facilities.  This measure is expected to lower ambient levels of ETO, reducing long-term non-cancer and potential cancer risks for workers in hospitals and healthcare facilities.  

During the pesticide reregistration program, EPA found that ETO has the potential to cause adverse health effects to workers who experience long-term (greater than 6 months) inhalation exposure.  For hospital workers involved with the ETO sterilization process (e.g., loading/unloading ETO chambers, changing/maintaining ETO tanks), long-term non-cancer and potential cancer risks are of concern.  Further, the potential cancer risk to all hospital workers resulting from ETO use in hospitals also exceeds the Agency’s level of concern.

In its 2008 Ethylene Oxide Reregistration Eligibility Decision (RED), EPA required the manufacturers of ETO to update their product labels to specify single-chamber technology for use in hospitals and healthcare facilities after February 28, 2010.  Hospitals should check their current stock of ETO canisters to see if the labels already reflect this change.  If the label reflects use of the single-chamber process, then hospitals should immediately begin implementing this process for ETO sterilization.  Facilities with existing stocks bearing a label which does not require a single chamber are encouraged--but not required--to switch to a single-chamber sterilization process.  Also, hospitals may choose to send some of their medical equipment to contract facilities for sterilization to ease their transition to a single-chamber sterilization process.  Contract sterilization facilities are not required to adopt the single chamber process.  Instead, they may elect to have employees wear respirators.

For more information regarding ETO label changes and EPA’s human health risk assessment, please see the Ethylene Oxide Factsheet located under the ETO Use in Hospitals heading at http://www.epa.gov/pesticides/reregistration/ethylene_oxide/.  Also, the 2008 Ethylene Oxide Reregistration Eligibility Decision is available at http://www.epa.gov/pesticides/reregistration/REDs/ethylene-oxide-red.pdf.   The fact sheet is available directly at
http://www.epa.gov/pesticides/reregistration/ethylene_oxide/ethylene_oxide_fs.html.

EPA also has air pollution reduction requirements for hospital sterilizers that use ETO.  Hospitals subject to the air regulation (found at http://www.epa.gov/ttn/atw/eo/fr28de07b.pdf) are required to sterilize full loads of items with common aeration times (unless medically necessary).  For more information, please see the ETO factsheet, “Hospital Sterilizers using Ethylene Oxide –Brief Summary” at http://www.epa.gov/ttn/atw/eo/eopg.html.