AHRMM Issues & Legislative (I&L) Committee identifies, reviews and follows the regulatory, environmental, quality of service and standards matters that impact the health care supply chain field. Each I&L Committee member closely monitors an important topic and compiles an update with useful information to help AHRMM members stay ahead of policy issues that affect their work and health care organization.
The following I&L Committee Ethylene Oxide (EtO) Sterilization topic profile was submitted by Joe Jackson, Managing Director, Strategic Healthcare Services, LLC, on July 22, 2020.
The FDA and EPA believe Ethylene Oxide (EtO) to be a carcinogen and poses a public health risk via excessive emissions into the atmosphere from sterilization plants. Several sterilization plants that use EtO have been temporarily closed by Federal Health officials due to public health concerns. Sterilization plant closures have the potential to create a backlog in the supply chain to U.S. hospitals for critical medical devices and supplies. We will report on the status of plant closures and the impact to U.S. hospitals.
Public Health Concerns
- There is a lot controversy in the marketplace regarding the use of the sterilization agent, Ethylene Oxide (EtO).
- The Office of Inspector General (OIG) within the Environmental Protection Agency (EPA) issued a new report regarding EtO safety.
- The OIG said the EPA needs to inform residents who live near the 25 facilities with significant EtO emissions about their elevated estimated cancer risks so they can manage their health risks.
- Most of the EtO news has been centered around plants near Atlanta and Chicago.
- The report was issued March 31, 2020. The EPA has not yet formally notified the 25 communities per the OIG report – presumably due to the COVID-19 pandemic taking center stage.
- It’s reasonable to assume, EtO will come under more intense scrutiny when the EPA notifies those 25 communities.
Sterilization Plant Updates
- Sterigenics obtained a federal judge’s permission to continue operating its Atlanta medtech sterilization plant as usual until litigation with Cobb County is resolved. Learn More.
- Medline's Illinois sterilization plant came back online after being shut down December 13, 2019, due to EO emissions concerns. Learn More.
- Sterigenics to abandon its Illinois plant located in Willowbrook, IL, citing the “unpredictable legislative and regulatory landscape”. Learn More.
- Viant to permanently cease ethylene oxide sterilization at Michigan plant. Learn More.
Impact to U.S. Hospitals
- There is a significant risk in the supply chain should the EPA decide to shutdown additional EtO plants.
- The industry relies heavily on EtO for sterilization needs and there does not appear to a “back-up” plan in place if access to EtO is interrupted.
- Medical device shortages threatening the practice of modern medicine could quickly become a reality if even a handful of commercial ethylene oxide sterilizers cease operations said top FDA officials.
- FDA's advisory committee offered a stark warning that no adequate replacement to the carcinogenic sterilant exists today.
- Ethylene oxide plant closures put U.S. on 'cusp of a major medical logistical failure'.
- Most ethylene oxide sterilization facilities are currently operating at 90% capacity, meaning companies may soon run out of other facilities to move sterilization to in the event of a shutdown because they will not have the excess or extra capacity to handle the additional devices.