Introduction to Sterilization Methods
Medical device sterilization is essential to ensuring patient safety and preventing infections. Several sterilization methods are commonly used, including:
​
-
Ethylene Oxide (EtO) Sterilization: A low-temperature gas sterilization method widely used for heat- and moisture-sensitive medical devices.
-
Radiation Sterilization (E-Beam, Gamma): Uses ionizing radiation to eliminate microorganisms without leaving chemical residues.
-
Plasma Sterilization (Hydrogen Peroxide Plasma): A chemical sterilization method effective for temperature-sensitive materials.
Source: FDA – Sterilization Methods Overview
Why EtO is a Concern?
EtO sterilization has faced growing regulatory scrutiny due to environmental and health concerns:
​
-
Environmental & Regulatory Challenges
-
The U.S. Environmental Protection Agency (EPA) has tightened EtO emission regulations due to its classification as a carcinogen.
-
The European Union (EU) has also imposed restrictions, pushing for alternatives in medical device sterilization.
-
Source: EPA – Ethylene Oxide Emission Standards
​
-
FDA & EU Regulatory Trends
​​
-
In November 2024, the FDA issued guidance on transitioning Class III medical devices away from EtO sterilization while ensuring continued patient access to sterilized products.
-
The EU Medical Device Regulation (MDR) includes stricter safety requirements for EtO exposure in healthcare settings.
Source: FDA – Transition Policy for EtO Sterilization
Alternatives to EtO for Catheters
​
-
Comparison of Alternative Sterilization Technologies
-
Electron Beam (E-Beam) Sterilization: Fast, residue-free, but penetration depth may be limited.
-
Gamma Radiation: Deep penetration, widely used, but may degrade certain polymers.
-
Plasma (Hydrogen Peroxide) Sterilization: Low-temperature alternative, but material compatibility is critical.
-
Source: MedTech Dive – Advancements in Alternative Sterilization
​
-
Material Selection & Process Adjustments
-
Some polymer materials (e.g., certain TPUs, PEBA, and nylons) are more resistant to E-beam and gamma radiation, making them suitable for non-EtO sterilization.
-
Manufacturers are redesigning packaging and Sterile Barrier Systems (SBS) to ensure sterility in EtO-free methods.
-
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!
​
​
