There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.

The established method for sterilization has a long history of being safe and effective which is demonstrated through multiple FDA guidance’s and additional sources. The novel sterilization method is a mean of sterilization that has not been reviewed and determined to effectively sterilize a device for its intended use1. The use of ethylene oxide is the most common sterilization method since it does not damage the components of the device. The following materials are likely to be sterilized with ethylene oxide:

  • Metal
  • Glass
  • Plastics
  • Resin
  • Multiple layer devices
  • Devices with hard-to-reach places2

Research and literature show that approximately fifty percent of all sterilized medical devices are sterilized with ethylene oxide in the United States today2. Before the device makes it to market the FDA analyzes the 510K submissions to determine if the proposed sterilization method is safe, effective, and complies with the voluntary consensus stands recognized by the FDA. The standards for ethylene oxide are ANSI AAMI ISO 11135:2014 and ANSI AAMI ISO 10993-7:2008(R)20122. These standards help describe how to develop, validate, and control the sterilization process for medical devices utilizing ethylene oxide.

One of the main goals of the FDA is to determine that a device is safe and effective, the FDA and state health departments regularly inspect facilities that utilize ethylene oxide on medical devices. If the device sterilization methods are changed after the premarket approval for the device, a revision of the premarket approval will be required. If your company needs assistance with sterilization or premarket approval for your medical device, EMMA International is here to help. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.

1FDA (January 2016) Submissions and Review of Sterility Information in Premarket Notification Submission for Devices Labeled as Sterile, retrieved on June 13, 2022, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-information-premarket-notification-510k-submissions-devices-labeled

2FDA (June 2022) Sterilization for Medical Devices, retrieved on June 13 2022 from  https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices?utm_source=FDALinkedin

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

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