The Environmental Protection Agency (EPA) has announced that as of March 1, 2010, a single chamber process is now required for ethylene oxide (ETO) treatment of medical equipment and devices in hospitals and healthcare facilities. Healthcare facilities include nursing homes, diagnostic and major surgery facilities, doctor’s offices, clinics, and other outpatient facilities.

Although ETO is widely used to sterilize the majority of medical supplies such as bandages, sutures, and surgical implements, the EPA has determined that over the long term, ETO may pose both noncancer and cancer risks to hospital workers who are involved with the ETO sterilization process (e.g., loading/unloading ETO chambers and changing/maintaining ETO tanks).

However, the public health benefits associated with the use of ETO to sterilize medical equipment are extremely high. Given the the lack of any feasible replacements for ETO use in sterilizing certain medical equipment and devices, the EPA has determined that it may continue as long as a single chamber treatment process (sterilization and aeration occur in the same chamber) is used. This measure is expected to lower ambient levels of ETO in hospitals and healthcare facilities, reducing potential long-term health risks for hospital and healthcare facility workers. The March 1, 2010, implementation date was first announced by the EPA in 2008, allowing hospitals and medical facilities sufficient time to come into compliance.

Manufacturers of ETO have updated their product labels to state: “After February 28, 2010, a single chamber process is required for ETO treatment (sterilization and aeration are to occur in the same chamber) in hospitals and healthcare facilities.”

Hospitals and healthcare facilities should check their current stock of ETO canisters to see if the labels bear this statement. If the label bears this language, then hospitals should begin using a single chamber for ETO sterilization immediately. If the label DOES NOT bear this language, then hospitals may deplete their current stock of ETO containers and may continue to sterilize medical equipment according to current label instructions until the product bearing the old label language is depleted.

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.

1. Environmental Protection Agency (EPA) [website]. Pesticides: Reregistration. Ethylene Oxide (ETO): Hospitals and Healthcare Facilities Must Use a Single Chamber when Sterilizing Medical Equipment with ETO. Updated March 16, 2010. Available at: http://www.epa.gov/pesticides/reregistration/ethylene_oxide/ethylene_oxide_fs.html. Accessed March 18, 2010.

Posted in News Service
This entry was posted on Thursday, March 18th, 2010 at 12:00 pm.