Breathing Easy: EPA Cracks Down on Harmful Emissions from Medical Device Sterilizers

US: The Environmental Protection Agency (EPA) is taking steps to reduce the potential health risks associated with long-term exposure to Ethylene oxide (EtO), a clear gas used to sterilize medical equipment. The Environmental Protection Agency (EPA) has recently unveiled a series of proposals with the goal of reducing Ethylene oxide (EtO) emissions from commercial sterilization facilities by 80% every year.

To achieve this goal, the EPA is advocating for a reduction in the concentration of EtO used to sterilize medical devices during each cycle, from the current level to 500 milligrams per liter. While some facilities have already made strides to lower their emissions, others have been using up to twice as much EtO as needed for sterility assurance.

The aim is to enforce the new standards for all 86 commercial sterilizers. However, Pease did not specify the number of facilities yet to comply with the regulations. The facilities will now have to implement advanced monitoring measures for pollution controls and report their results to the EPA biannually.

In addition, the agency has proposed an interim decision to augment safety measures for individuals living around these facilities and working inside them. These measures will incorporate technical controls, like emissions capture technology, to lessen worker exposure. The staff would also be required to put on protective gear when EtO is detected. To meet the standards for sterility assurance, the quantity of EtO used for medical device sterilization would also decrease.

The Environmental Protection Agency (EPA) is gearing up to increase its regulation of EtO. In 2020, the EPA implemented new reporting requirements for 31 facilities using EtO for medical device sterilization. The agency also released a list of high-risk sterilization facilities, based on lifetime cancer risk in nearby residential areas.

Recently, the EPA proposed stringent standards for chemical plants producing Ethylene oxide. With approximately 100 facilities using EtO to sterilize about 20 billion medical devices annually, medical device sterilizers have been facing lawsuits associated with EtO exposure. In January 2021, Sterigenics settled over 870 Ethylene oxide cases, tied to alleged emissions from its previous location in Willowbrook, Illinois, by paying $408 million.