Ethylene oxide sterilization pdf

Ethylene oxide is a threeringed epoxy compound with the structural formula. This standard specifies essential elements in implementing a program for using ethylene oxide to sterilize medical devices in health care facilities, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to health care facility personnel and patients. Ethylene oxide gaseog sterilization procedure was regarded as the last candidate of sterilization procedure due to toxic gas residue. Validation is the total process starting with commissioning, followed by performance qualification. The most recommended sterilization procedure is autoclaving, if the medical device is not sensitive to the heating. Eto is a colorless gas that is flammable and explosive. Sterilization or sterilisation is a term referring to any process that eliminates. Pdf ethylene oxide sterilization validation and routine. Ethylene oxide sterilization for medical devices fda.

Ethylene oxide sterilization in hospital practice ncbi. Ethylene oxide eto or eo the future of gas sterilization. Epa has concluded that ethylene oxide is carcinogenic to humans by the inhalation route of exposure. Eo is considered the sterilization method with the broadest application available for medical products due to its ef ectiveness at lower temperatures and its general compatibility with a diversity of materials, resins and product types, including. Sterile drug products produced by aseptic processing pdf. Worldwide, eo is the primary way to sterilize medical supplies. Ethylene oxide sterilization is an important sterilization method that manufacturers widely use to keep medical devices safe. There also is some evidence linking ethylene oxide exposure to reproductive effects. Validation of an ethylene oxide sterilization cycle demonstration of the effectiveness of an ethylene oxide sterilization cycle is achieved through the validation process. Ethylene oxide sterilization of medical devices american hospital. Sterilizing units, ethylene oxide world health organization. About ethylene oxide sterilization for medical devices and fdas role in assuring that medical devices sterilized with ethylene oxide are safe and effective. Steris is committed to regulatory, quality and safety compliance visit our certification library today to download quality certificates. During an ethylene oxide eo sterilization process, products can.

Ethylene oxide sterilization of medical devices at issue in light of closures and potential closures of certain facilities that use gas ethylene oxide eto to sterilize medical devices prior to their distribution and use, the food and drug administration fda is concerned about the future availability of medical devices and. Recent technological advances have greatly reduced the cycle time of eog sterilization, due to the development of aeration processes optimization. The two most important ethylene oxide sterilization methods are. Bookmark file pdf ethylene oxide product stewardship guidance manual ethylene oxide product stewardship guidance manual how ethylene oxide works in sterilization of critical medical supplies how does ethylene oxide eo work.