Ethylene Oxide Sterilization Of Medical Devices

The eto carbon dioxide co 2 mixture consists of 8 5 eto and.

Ethylene oxide sterilization of medical devices.

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. While ethylene oxide sterilization is a necessary part of the manufacturing process for many medical. 1 2017 august 31. 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.

The use of eto evolved when few alternatives existed for sterilizing heat and moisture sensitive 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. However favorable properties table 6 account for its continued widespread use. These standards help ensure levels of ethylene oxide on medical devices are within safe limits.

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. 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. 872 two eto gas mixtures are available to replace eto chlorofluorocarbon cfc mixtures for large capacity tank supplied sterilizers. 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.

A comparison of gamma e beam x ray and ethylene oxide technologies for the industrial sterilization of medical devices and healthcare products. Ethylene oxide gas has been used since the 1950s for heat and moisture sensitive medical devices. 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.