Ethylene Oxide Sterilization Of Medical Devices

The fda is aware that the medline industries medical device ethylene oxide sterilization facility in waukegan il has been closed since december 13 2019 as was announced by the lake county.

Ethylene oxide sterilization of medical devices.

872 two eto gas mixtures are available to replace eto chlorofluorocarbon cfc mixtures for large capacity tank supplied sterilizers. The use of eto evolved when few alternatives existed for sterilizing heat and moisture sensitive medical devices. It is a relatively cold sterilization technique and offers high compatibility with most materials used in the manufacture of medical devices such as plastics polymers metals and glass. And is a well established and scientifically.

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. However favorable properties table 6 account for its continued widespread use. Through the use of a vacuum based process eo sterilization can efficiently penetrate surfaces of most medical devices and its lower temperature makes it an ideal process. Ethylene oxide eo sterilization is the most common industrial sterilization technique for medical devices.

Ethylene oxide gas has been used since the 1950s for heat and moisture sensitive medical devices. While ethylene oxide sterilization is a necessary part of the manufacturing process for many medical. Ethylene oxide also known as eo or eto is a low temperature gaseous process widely used to sterilize a variety of healthcare products such as single use medical devices. 1 2017 august 31.

The eto carbon dioxide co 2 mixture consists of 8 5 eto and. Within the past 15 years a number of new low temperature sterilization systems e g hydrogen peroxide gas plasma peracetic acid immersion ozone have been developed and are being used to sterilize medical devices. These standards help ensure levels of ethylene oxide on medical devices are within safe limits.