Ethylene Oxide Sterilization Of Medical Devices

A comparison of gamma e beam x ray and ethylene oxide technologies for the industrial sterilization of medical devices and healthcare products.

Ethylene oxide sterilization of medical devices.

The use of eto evolved when few alternatives existed for sterilizing heat and moisture sensitive medical devices. These standards help ensure levels of ethylene oxide on medical devices are within safe limits. 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. While ethylene oxide sterilization is a necessary part of the manufacturing process for many medical.

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. 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. Although medical devices can be sterilized by several methods ethylene oxide is the most common method of sterilization of medical devices in the u s. 872 two eto gas mixtures are available to replace eto chlorofluorocarbon cfc mixtures for large capacity tank supplied sterilizers.

The eto carbon dioxide co 2 mixture consists of 8 5 eto and. 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. Ethylene oxide eo sterilization is the most common industrial sterilization technique for medical devices. 1 2017 august 31.

However favorable properties table 6 account for its continued widespread use. And is a well established and scientifically. 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.