Sterilization for Medical Devices
Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide).
August 2022 Update: FDA Press Statement: FDA Continues Efforts to Support Innovation in Medical Device Sterilization
June 2022 Radiation Sterilization Update: The FDA is considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized using radiation, including gamma radiation.
The FDA is considering this pilot program due to global supply chain constraints and to support sterilization supply chain resiliency. If implemented, this program would help medical device manufacturers advance alternative ways to sterilize their approved medical devices, including changing radiation sources, in a least burdensome regulatory approach.
The FDA is working actively with sterilization experts, medical device manufacturers, and other government agencies to advance alternative ways to sterilize medical devices, including using lower levels of currently used sterilizing agents and using new sterilizing agents or alternatives, while maintaining device safety and effectiveness.
Learn more about FDA's Sterilization Master File Pilot Programs.
On this page:
- Ethylene Oxide
- FDA's Actions to Advance Medical Device Sterilization
- Report Sterilization Site Changes to the FDA
- Medical Device Supply Chain Issues
Related pages:
- Ethylene Oxide Sterilization Facility Updates
- FDA Innovation Challenge 1: Identify New Sterilization Methods and Technologies
- FDA Innovation Challenge 2: Reduce Ethylene Oxide Emissions
Ethylene Oxide
Why Is Ethylene Oxide Used to Sterilize Medical Devices?
Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide). Ethylene oxide sterilization is an important sterilization method that manufacturers widely use to keep medical devices safe. Learn more about sterilization methods in the Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance.
For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process. Medical devices made from certain polymers (plastic or resin), metals, or glass, or that have multiple layers of packaging or hard-to-reach places (for example, catheters) are likely to be sterilized with ethylene oxide.
What Devices Are Sterilized with Ethylene Oxide?
Literature shows that about fifty percent1,2,3 of all sterile medical devices in the U.S. are sterilized with ethylene oxide. The types of devices that are sterilized with ethylene oxide range from devices used in general health care practices (for example, wound dressings) to more specialized devices used to treat specific areas of the body (for example, stents).
How Does the FDA Help Ensure that Medical Devices Sterilized with Ethylene Oxide Are Safe?
June 2022 Radiation Sterilization Update: The FDA is considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized using radiation, including gamma radiation.
The FDA is considering this pilot program due to global supply chain constraints and to support sterilization supply chain resiliency. If implemented, this program would help medical device manufacturers advance alternative ways to sterilize their approved medical devices, including changing radiation sources, in a least burdensome regulatory approach.
The FDA is working actively with sterilization experts, medical device manufacturers, and other government agencies to advance alternative ways to sterilize medical devices, including using lower levels of currently used sterilizing agents and using new sterilizing agents or alternatives, while maintaining device safety and effectiveness.
Learn more about FDA's Sterilization Master File Pilot Programs.
On this page:
- Ethylene Oxide
- FDA's Actions to Advance Medical Device Sterilization
- Report Sterilization Site Changes to the FDA
- Medical Device Supply Chain Issues
Related pages:
- Ethylene Oxide Sterilization Facility Updates
- FDA Innovation Challenge 1: Identify New Sterilization Methods and Technologies
- FDA Innovation Challenge 2: Reduce Ethylene Oxide Emissions
Ethylene Oxide
Why Is Ethylene Oxide Used to Sterilize Medical Devices?
Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide). Ethylene oxide sterilization is an important sterilization method that manufacturers widely use to keep medical devices safe. Learn more about sterilization methods in the Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance.
For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process. Medical devices made from certain polymers (plastic or resin), metals, or glass, or that have multiple layers of packaging or hard-to-reach places (for example, catheters) are likely to be sterilized with ethylene oxide.
What Devices Are Sterilized with Ethylene Oxide?
Literature shows that about fifty percent1,2,3 of all sterile medical devices in the U.S. are sterilized with ethylene oxide. The types of devices that are sterilized with ethylene oxide range from devices used in general health care practices (for example, wound dressings) to more specialized devices used to treat specific areas of the body (for example, stents).
How Does the FDA Help Ensure that Medical Devices Sterilized with Ethylene Oxide Are Safe? Boston Scientific March 18, 2020 Becton, Dickinson & Company (BD) September 11, 2020 Steris Corporation October 25, 2021 Oscor, Inc. December 17, 2021 Medtronic, Inc. February 17, 2022
FDA Innovation Challenges
On July 15, 2019, the FDA announced two public innovation challenges to encourage development of novel sterilization methods, which could include new devices or new modalities that are safe and effective for sterilizing 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.
On November 25, 2019, the FDA announced that 46 applications were received and 12 participants selected for the challenges. Refer to each challenge page for details on the selected participants and next steps.
Advisory Committee Meetings
On November 6-7, 2019, the FDA held a meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee to discuss how best to advance innovations in medical device sterilization. Meeting materials and other event materials are available on the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee Meeting web page.
One recommendation from the advisory committee meeting is for device manufacturers to begin, as soon as possible, reducing the amount of paper (such as the labeling and instructions for use manuals) that is included in the sterile device package. An ethylene oxide sterilized medical device must be sealed in a carefully designed gas-permeable package that enables the ethylene oxide gas to enter. When the sterilization load (encompassing all the materials inserted into the sterilizer chamber with the device) includes a large amount of paper with the device, it hinders the ethylene oxide getting to the device and generally means that more ethylene oxide is required. Because of this, the FDA is encouraging device manufacturers to move to electronic materials where feasible and safe for device users. We are committed to working with industry to make this change.
In May and November 2019, the FDA engaged the infection control community at the CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC) meeting to update the public on the FDA's work and engagement with industry on sterilization modalities with devices that are normally sterilized using ethylene oxide.
Report Sterilization Site Changes to the FDA
If your products are affected by the stop of operations at a sterilization facility and you are planning to use an alternative facility to sterilize your products:
- Premarket Approval (PMA) Holders: You should submit a 180-day site change supplement. However, the FDA intends to review such PMA supplements within 30 days. The FDA issued a final guidance, Manufacturing Site Change Supplements: Content and Submission, that PMA holders can refer to for more information about site change supplements. If you have questions about your PMA device or need help with submitting a site change supplement, contact [email protected].
- 510(k) Holders: Submitting a new 510(k) is typically not required for this type of change. You should document qualification activities supporting this change in your internal files. However, the FDA recommends that affected 510(k) holders refer to the FDA's guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff when determining if a new 510(k) is required.
Medical Device Supply Chain Issues
Contact the FDA about a medical device supply chain issue.
Read More:
- Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility (March 26, 2019)
- Statement on concerns with medical device availability due to certain sterilization facility closures (October 25, 2019)
- Preventing Medical Device Shortages by Ensuring Safe and Effective Sterilization in Manufacturing (July 15, 2019)
1 A Comparison of Gamma, E-beam, X-ray and Ethylene Oxide Technologies for the Industrial Sterilization of Medical Devices and Healthcare Products (2017, August 31).
2 Blass, C. (2001). The Role of Poly(vinyl Chloride) in Healthcare. Shawbury, UK: Rapra Technology Limited.
3 Regulatory Review of the Occupational Safety and Health Administration's Ethylene Oxide Standard, 29 C.F.R § (2005) 1910.1047