Introduction to Ethylene oxide alternative for medical device sterilization
Ethylene oxide alternative for medical device sterilization, The major use of ethylene oxide is as a chemical intermediate in the manufacture of ethylene glycol. Ethylene oxide is also used as a sterilizing agent for medical equipment and a fumigating agent for spices. The acute (short-term) effects of ethylene oxide in humans consist mainly of central nervous system depression and irritation of the eyes and mucous membranes. Finding suitable ethylene oxide alternatives for medical device sterilization is more crucial than ever as federal regulators consider new rules in light of EtO health risks.
Evaluation of Ethylene oxide alternative for medical device sterilization
Ethylene oxide alternative for medical device sterilization, EtO is use to sterilize of half of all medical devices, or about 20 billion units per year. It’s primarily used for new, single-use and reusable devices and equipment. For example EtO is used to sterilize an estimated 95% of all surgical kits. There are currently no EtO alternatives for some products. Of all sterilization methods, EtO is least likely to harm a medical device’s materials or components. Other sterilization methods have limitations on material compatibility and scalability or lack accepted validation measures for sterility assurance.
Radiation sterilization: gamma ray and electron beam (e-beam)
Ethylene oxide alternative for medical device sterilization, The next most common methods of medical device sterilization after EtO are two forms of radiation sterilization: gamma irradiation and electron beam (e-beam) Irradiation. Like EtO, these methods can penetrate product packaging, and can even go further into airtight compartments where EtO can’t reach.
But radiation sterilization methods can damage semiconductors and degrade other electronics in medical devices. Radiation sterilization can also damage or otherwise change the properties of certain polymers and plastics, and discolors clear glass.
What about heat sterilization?
The high temperature of heat sterilization — whether dry heat or steam — makes it suitable only for heat-resistant materials, and the moisture from steam is a deal-breaker for electronics.
Potential ethylene oxide alternatives in development
The four companies working directly with the FDA on new sterilization methods and technologies are focusing on five technologies:
- Supercritical carbon dioxide sterilization (NovaSterilis)
- Nitrogen dioxide sterilization (Noxilizer)
- Accelerator-based radiation sterilization (STERIS)
- Vaporized hydrogen peroxide sterilization (STERIS)
- Vaporized hydrogen peroxide-ozone sterilization (TSO3, a Stryker subsidiary)
The new sterilization methods that don’t use EtO would not only need to be safe and effective, but also meet certain criteria for compatibility, scalability and high throughput. The new approaches would need to be compatible with a large cross-section of materials used for medical devices, packaging and sterile barriers, particularly materials that are compatible with EtO sterilization.
Conclusion
EtO has so far held one or more advantages over chlorine dioxide, hydrogen peroxide and other options. But there are some EtO alternatives available for a wide range of medical devices, and more may be on the way as the FDA works with the medtech industry to ensure the safety of patients, sterilization workers and neighbors of sterilization facilities.
