In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the concern surrounding the use of EtO for medical device sterilization. Questions have been raised as to the safety of the amount that’s been detected in the air around facilities that provide this type of sterilization process. Specifically, we address a number of questions, including:

• How common is EtO for sterilization?
• How does it compare to other methods?
• Why is it used so frequently?
• What are the problems with EtO?
• Do you expect EtO to go away?
• What is the “root cause” of this problem? Could it have been avoided?
• What type of regulatory pathway requires a notification to the FDA for a change of sterilization process?
• What is the FDA’s EtO sterilization pilot program for changing vendors?
• What are the most important takeaways from this issue for medical device manufacturers?

Several references were mentioned during this podcast and you can locate those items by clicking on each one.

• FDA Website: Ethylene Oxide Sterilization for Medical Devices 
• FDA Innovation Challenge: Ethylene Oxide Sterilization for Medical Devices
  • Challenge 1: Identify New Sterilization Methods and Technologies: The goal of this challenge is to encourage the development of new approaches to device sterilization methods or technologies for medical devices that do not rely on ethylene oxide. 
  • Challenge 2: Reduce Ethylene Oxide Emissions: The goal of this challenge is to develop strategies or technologies to reduce emissions to as close to zero as possible from the ethylene oxide sterilization process. 

Listen to this episode and see what you think of the challenges currently surrounding EtO sterilization. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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