Statement on Final EPA Rule on Ethylene Oxide Emissions Standards for Sterilization Facilities

By Soumi Saha, Senior Vice President, Government Affairs, Premier Inc.

Premier is equally dedicated to weighing environmental responsibilities with our ability to sustain patient care across the country and is encouraged that the Environmental Protection Agency (EPA) has modified its proposal in the final ethylene oxide sterilization rule to better strike this balance. By adjusting the compliance timeline and permitting the staggering of facilities based upon size as called for by Premier, EPA has acknowledged the need to protect and enhance environmental stewardship in the communities we serve while preventing medical device shortages and downstream impact to patient care.

Moving forward, Premier urges sterilizers and manufacturers of sterile devices to proactively and voluntarily share information with the Food and Drug Administration (FDA) regarding anticipated supply disruptions during improvements to their facilities so the healthcare supply chain can better prepare for any potential shortages and impact to patient care.

Given the intense supply chain pressures our nation has faced during the pandemic, enabling true domestic resiliency requires us to think cohesively about how national standards and regulations support that goal. Premier is pleased that EPA recognized this need.