Sterilization Guidelines
Introduction to Sterilization Methods
Medical device sterilization is essential to ensuring patient safety and preventing infections. Three methods dominate today's landscape: Ethylene Oxide (EtO) sterilization, a low-temperature gas process suited to heat- and moisture-sensitive devices; radiation sterilization via E-Beam or Gamma, which uses ionizing radiation to eliminate microorganisms without leaving chemical residue; and plasma sterilization (hydrogen peroxide plasma), a chemical method effective for temperature-sensitive materials.
Source: FDA – Sterilization Methods Overview
Why EtO is a Concern?
Environmental and regulatory pressure on EtO is mounting. The U.S. EPA has tightened EtO emission regulations following its classification as a carcinogen, and the European Union has imposed its own restrictions, pushing manufacturers toward alternatives. The trend is accelerating on both sides of the Atlantic: the EU's Medical Device Regulation (MDR) now sets stricter safety requirements for EtO exposure in healthcare settings, and in November 2024 the FDA issued guidance directing Class III medical devices away from EtO sterilization while preserving continued patient access to sterilized products.
Source: EPA – Ethylene Oxide Emission Standards
Source: FDA – Transition Policy for EtO Sterilization
Alternatives to EtO for Catheters
Three technologies are emerging as EtO alternatives, each with its own tradeoffs. Electron Beam (E-Beam) sterilization is fast and residue-free, though penetration depth can be limited. Gamma radiation penetrates deeply and is widely used, but may degrade certain polymers. Plasma (hydrogen peroxide) sterilization runs at low temperature but demands close attention to material compatibility. Material selection matters just as much as the method itself: certain TPUs, PEBA, and nylons resist E-Beam and gamma radiation well enough to support non-EtO sterilization, and manufacturers are also redesigning packaging and Sterile Barrier Systems (SBS) to maintain sterility without EtO.
Source: MedTech Dive – Advancements in Alternative Sterilization
Source: AdvaMed – Material Considerations in Medical Device Sterilization
A Safer, More Sustainable Choice – DynaFlex
At DynaFlex, we are committed to advancing EtO-free sterilization solutions for medical devices. Our EverGlide+ and EverGlide MED Dyna2 additives are E-beam stable, offering manufacturers a reliable alternative to traditional sterilization methods.
Discover how our materials can support your transition to safer and more sustainable sterilization solutions. Contact us today to learn more!
