Ethylene Oxide Sterilization for Medical Devices
FDA Innovation Challenges: Identify Sterilization Alternatives and Reduce Ethylene Oxide Emissions
In response to the March 2019 closure of a large device sterilization facility, the FDA is taking steps to ensure that hospitals, health care providers, and patients have access to medical devices that are safely and effectively sterilized.
The FDA is sponsoring two public innovation challenges to encourage new developments in medical device sterilization.
- Read more about Challenge 1: Identify New Sterilization Methods and Technologies
- Read more about Challenge 2: Reduce Ethylene Oxide Emissions
Questions? Send email to CDRH-Innovation-Sterilization@fda.hhs.gov
On this page:
- Why Is Ethylene Oxide Used to Sterilize Medical Devices?
- What Devices Are Sterilized with Ethylene Oxide?
- How Does the FDA Help Ensure that Medical Devices Sterilized with Ethylene Oxide Are Safe?
- EPA's Role in Ethylene Oxide Sterilization
- FDA's Actions to Advance Medical Device Sterilization
- Latest News on Sterigenics and Other Sterilization Facility Closures
- Contact Us
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 (PDF - 386kb).
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.
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).
Before most sterile medical devices are on the market, the FDA reviews premarket submissions to determine if the sterility information (for example, the method the manufacturer is choosing to sterilize their device and validation activities used to show that the device can be effectively sterilized) is in accordance with internationally agreed upon voluntary consensus standards that the FDA recognizes. An important element of our regulatory framework is a robust standards program. The FDA encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their submissions, as conformity to relevant standards streamlines regulatory review and fosters quality. Learn more about the FDA's Recognized Standards Program.
For ethylene oxide sterilization, two voluntary consensus standards (ANSI AAMI ISO 11135:2014 and ANSI AAMI ISO 10993-7:2008(R)2012) describe how to develop, validate, and control ethylene oxide sterilization processes for medical devices and the acceptable levels of residual ethylene oxide and ethylene chlorohydrin left on a device after it has undergone ethylene oxide sterilization. These standards help ensure levels of ethylene oxide on medical devices are within safe limits since long-term and occupational exposure to ethylene oxide has been linked to cancer. Learn more about the risks of ethylene oxide on the National Institutes of Health web page on ethylene oxide.
If a medical device manufacturer changes the method, process, or the facility identified in its original PMA submission for sterilizing its devices, the manufacturer generally needs to submit a PMA supplement so the agency can review these changes and determine if they also meet internationally agreed-upon voluntary standards that the FDA recognizes. For manufacturers that are 510(k) holders, sterilization method, process or site modifications can be assessed with the FDA guidance document: “Deciding When to Submit a 510(k) for a Change to an Existing Device” for determination on whether the sterilization modifications would trigger the need for resubmission.
The FDA also inspects industrial facilities that sterilize medical devices and medical device manufacturing facilities to make sure that they have validated sterilization processes that meet FDA-recognized standards.
State health departments inspect health care facilities that use ethylene oxide to sterilize medical devices. Learn more about guidelines for sterilization in health care facilities on the Centers for Disease Control and Prevention web page.
The Environmental Protection Agency (EPA) reviews and enforces the Clean Air Act regulations for sterilization facilities that emit ethylene oxide to ensure that they protect the public from significant risk. Learn more about the EPA's Regulations for Ethylene Oxide on EPA's website.
The FDA is actively working with sterilization experts, medical device manufacturers, and other government agencies to advance innovative ways to sterilize medical devices with lower levels of currently used agents, and employ new agents or alternatives, while maintaining device safety and effectiveness. In May 2019, the FDA engaged the infection control community at the 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.
In addition, later in 2019, we will announce a public innovation challenge to encourage development of novel sterilization methods, which could include new devices or new modalities that are safe and effective for sterilizing medical devices.
On July 15, 2019, the FDA announced two public innovation challenges:
- 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.
The FDA plans to hold an advisory committee meeting November 6-7, 2019 to discuss how best to advance innovations in medical device sterilization. Additional details about the meeting and how to participate will be provided on the FDA Advisory Committee Calendar web page and in a Federal Register notice prior to the scheduled date.
Since the FDA's Center for Devices and Radiological Health (CDRH) became aware of the closure of Sterigenics' Willowbrook sterilization facility, the FDA has been working with medical device manufacturers to secure alternative locations and methods for the sterilization of devices that were previously processed at Willowbrook.
April 12, 2019 - Smiths Medical
In March 2019, the FDA was notified by health care providers, patients, and Smiths Medical that the closure of the Sterigenics Willowbrook sterilization facility caused a potential device shortage for Bivona tracheostomy tubes. The FDA recognizes how important these essential tracheostomy tubes are to families and health care facilities and is taking steps to assure that sterilized, safe, and effective tubes are available.
The FDA is working with Smiths Medical to secure availability of sterilized Bivona tracheostomy tubes for hospitals, health care providers and patients by helping Smiths Medical transition to another Sterigenics sterilization facility and expedite release of sterilized tubes that still meet the FDA's standards for safety and effectiveness.
Smiths Medical began shipping sterilized Bivona tracheostomy tubes to customers beginning the week of April 22, 2019. Parents, caregivers and health care providers can continue to clean and sterilize these tubes according to the instructions for use that are included with every tube.
March 26, 2019 - Sterigenics and Viant
The FDA's Center for Devices and Radiological Health (CDRH) is aware that on February 15, 2019, the Illinois Environmental Protection Agency (EPA) issued a Seal Order to stop the Sterigenics facility in Willowbrook, Illinois, from sterilizing medical products and other products with ethylene oxide. Learn more about the Environmental Protection Agency's assessment of Sterigenics Willowbrook Facility on U.S. EPA.gov.
Medical devices account for many of the products that the Sterigenics Willowbrook facility sterilizes. The FDA is reaching out to medical device manufacturers to understand which manufacturers are affected by the cessation of operations at this sterilization facility. See a list of devices sterilized at the Sterigenics Willowbrook facility and that may be affected.
The FDA is aware that Viant informed their customers that their Grand Rapids sterilization facility is planning to close later in 2019. See a list of devices sterilized at the Viant facility and that may be affected.
Report Sterilization Site Changes to the FDA
If your products are affected by the stop of operations at the Sterigenic's Willowbrook 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 recently issued the final guidance, Manufacturing Site Change Supplements: Content and Submission (PDF - 185kb), 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 CDRHPremarketProgramOperations@fda.hhs.gov.
- 510(k) Holders: Submitting a new 510(k) is typically not required. 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 (PDF - 1.04MB) when determining if a new 510(k) is required.
Report a Medical Product Supply Issue or Shortage
Supply issues can lead to shortages of medical devices—and can pose a threat to public health by delaying or disrupting critical care for patients. Mitigating product supply issues and working to prevent patient harm from device shortages are important to the FDA.
Planning for and preventing device supply shortages is an important responsibility. The FDA can help anticipate, prevent, or mitigate future shortages by working with device manufacturers that voluntarily provide us with information on potential product supply issues. Learn more about how to report a medical product shortage or supply issue.
To report a medical device shortage or supply issue, email Deviceshortages@fda.hhs.gov or phone 1-800-638-2041 or 301-796-7100.
1 (2017, August 31). A Comparison of Gamma, E-beam, X-ray and Ethylene Oxide Technologies for the Industrial Sterilization of Medical Devices and Healthcare Products. Retrieved March 13, 2019, from http://iiaglobal.com/wp-content/uploads/2018/01/White-Paper-Comparison-Gamma-Eb-Xray-and-EO-for-Sterilisation.pdf
2 Blass, C. (2001). The Role of Poly(vinyl Chloride) in Healthcare. Shawbury, UK: Rapra Technology Limited. Retrieve from https://books.google.com/books?id=vNp3bFNOU_AC&pg=PA47&lpg=PA47&dq=Ethylene oxide sterilization,medical devices, market share&source=bl&ots=oQzply-FBq&sig=ACfU3U0bKGYVubW_3UEj0Kq7G3CpF6SbuQ&hl=en&sa=X&ved=
2ahUKEwiKso3BnuzgAhWFk1kKHeiIC8Q4KBDoATAHegQIARAB#v=onepage&q=Ethylene oxide sterilization,
medical devices, market share&f=false
3 Regulatory Review of the Occupational Safety and Health Administration's Ethylene Oxide Standard, 29 C.F.R § (2005) 1910.1047 https://www.osha.gov/dea/lookback/ethylene_oxide_lookback.pdf.