Dive Brief:
- New emissions standards for medical device sterilizers will be pushed back by two years, according to a proclamation issued Thursday by President Donald Trump.
- The new emissions standards, finalized by the Environmental Protection Agency last year, would have tightened emissions limits for ethylene oxide, a cancer-causing chemical used to sterilize medical devices, starting in April 2026.
- The EtO rule places “severe burdens” on commercialization facilities and the current timeline would likely force certain sterilization facilities to close, disrupting the supply of medical equipment, according to the proclamation.
Dive Insight:
Under the second Trump administration, the EPA said in March it planned to reconsider emissions standards for facilities that sterilize medical devices. At the time, the agency said it would consider a two-year exemption for affected facilities while the EPA goes through the rulemaking process.
Trump’s proclamation last week moves forward the administration’s deregulatory agenda. To change or overturn the EPA’s final rule, the administration would need to propose new regulations.
The EPA’s final rule applies to facilities that sterilize medical equipment, such as syringes, surgical tools and implants, before they are used in hospitals. The intent was to reduce EtO emissions by 19 tons per year and ensure no individual would be exposed to EtO levels that correspond to a lifetime cancer risk of greater than 1 in 10,000, the EPA’s limit for maximum acceptable risk.
The new emissions standards were in response to the EPA’s 2016 determination that EtO is carcinogenic. However, the rule faced pushback from the medical device industry. AdvaMed, one of the medtech industry’s largest lobbying groups, said the chemical is used to sterilize about half of medical devices sold in the U.S. and that there were no viable alternatives for sterilizing certain types of devices.
In response, the EPA extended the compliance deadline for the rule to two to three years after the effective date, with tighter deadlines for larger sterilizers than smaller facilities.
AdvaMed did not immediately respond to MedTech Dive’s request for comment on the White House’s proclamation.
The proclamation lists medical device sterilization facilities that will be exempt from compliance with the rule for two years, including BD, Sterigenics, Cosmed Group and Medtronic.
Even if the rule is delayed, medical device sterilizers must still navigate state requirements. For example, California has emissions control requirements that vary based on the size of the facility, and Georgia’s Environmental Protection Division ordered BD to pause sterilization in 2019 after a facility experienced an eight-day valve leak.
