EO Sterilization In Transition: Regulatory Shifts And Industry Impact

By Jessi Dōne, Eurofins Medical Device Services

Ethylene oxide (EO) remains a foundational sterilization method for nearly half of all medical devices, particularly those with complex geometries or heat-sensitive materials. However, the industry is facing a significant shift as new environmental and safety regulations redefine compliance. Recent updates to NESHAP and FIFRA mandate drastic emission reductions and lower worker exposure limits, requiring facilities to overhaul ventilation systems and revalidate sterilization cycles by 2026-2027.

Simultaneously, proposed revisions to ISO 11135 and ISO 10993-7 introduce a risk-based approach to sterilization. These changes emphasize optimized EO usage through biologically based approaches and more stringent residual limits that account for patient body mass—specifically protecting pediatric and neonatal populations. To maintain market access and ensure patient safety, manufacturers must proactively reassess cycle parameters and documentation.