AdvaMed Defends Ethylene Oxide Sterilization

In a letter to the White House, AdvaMed defended the medical sterilization industry’s use of ethylene oxide (EtO) and asked for consideration of several points for the Environmental Protection Agency’s (EPA) proposed regulation of the sterilization process for medical devices.

The EPA is updating its air regulations that limit the amount of EtO certain types of industries release into the outdoor air and new EtO emissions standards for sterilization facilities are now under review at the Office of Management and Budget.

In the letter, AdvaMed highlighted the potential threat to patient care if any facilities shut down, asking the EPA to embrace other solutions to meet emissions targets and to consider the tiny proportion of EtO used in medical device sterilization compared to other sources.

AdvaMed noted that there are no alternative sterilization methods for a substantial portion of medical devices and that other methods would “render unusable certain devices, such as those made of plastic.”