Literature shows that about fifty percent 1, 2, 3 of all sterile medical devices in the U.S. How Does the FDA Help Ensure that Medical Devices Sterilized with Ethylene Oxide Are Safe? 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). What Devices Are Sterilized with Ethylene Oxide? 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. 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.įor 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. Ethylene oxide sterilization is an important sterilization method that manufacturers widely use to keep medical devices safe. 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). FDA Innovation Challenge 2: Reduce Ethylene Oxide EmissionsĮthylene Oxide Why Is Ethylene Oxide Used to Sterilize Medical Devices?.FDA Innovation Challenge 1: Identify New Sterilization Methods and Technologies.Ethylene Oxide Sterilization Facility Updates.Report Sterilization Site Changes to the FDA.Sterilization Master File Pilot Programs.FDA's Actions to Advance Medical Device Sterilization.EPA's Role in Ethylene Oxide Sterilization.How Does the FDA Help Ensure that Medical Devices Sterilized with Ethylene Oxide Are Safe?.What Devices Are Sterilized with Ethylene Oxide?.Why Is Ethylene Oxide Used to Sterilize Medical Devices?.Learn more about FDA's Sterilization Master File Pilot Programs. 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. 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 considering this pilot program due to global supply chain constraints and to support sterilization supply chain resiliency. 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. When ultraviolet light strikes human skin, it triggers the production of vitamin D, which promotes the growth of bones and teeth.August 2022 Update: FDA Press Statement: FDA Continues Efforts to Support Innovation in Medical Device Sterilization Though ultraviolet light can damage health, it can also maintain or improve health. Electric arc lamps can also generate ultraviolet light to heat furnaces for melting and to enable motion-picture projectors to show movies. Light from tanning lamps contains ultraviolet A and ultraviolet B. In addition to natural light from the sun, artificial Recent research, however, has also implicated ultraviolet A as a possible cause of skin cancer. History of sunburn and repeated overexposure to ultraviolet radiation. Because ultraviolet A is weaker than ultraviolet B, scientists long blamed ultraviolet B as the sole culprit in causing skin cancer in persons with a Ultraviolet A and ultraviolet B, on the other hand, do penetrate the ozone layer in attenuated form and reach the surface of the planet. Therefore, it poses no threat to human, animal or plant life on earth. Ultraviolet C: One of the three types of invisible light rays (together with ultraviolet A and ultraviolet B) given off by the sun.Īlthough ultraviolet C is the most dangerous type of ultraviolet light in terms of its potential to harm life on earth, it cannot penetrate earth's protective ozone layer.
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