Medical Device Ethylene Oxide Sterilization

For this reason following sterilization the item must undergo aeration to remove residual eto.

Medical device ethylene oxide sterilization. Ethylene oxide gas eog sterilization procedure was regarded as the last candidate of sterilization pro cedure due to toxic gas residue. A comparison of gamma e beam x ray and ethylene oxide technologies for the industrial sterilization of medical devices and healthcare products. 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. For 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.

Guidelines have been promulgated regarding allowable eto limits for devices that depend on how the device is used how often and how long in order to pose a minimal risk to patients in normal product use 814. 1 2017 august 31. Eto is absorbed by many materials. Sterilization facilities must meet epa emissions limits to operate.

The variables and their relevance on process optimization ar. Ethylene oxide sterilization is an important sterilization method that manufacturers widely use to keep medical devices safe. First under the pilot program sterilization facilities that sterilize single use medical devices using fixed chamber ethylene oxide sterilization processes in which the device is placed in a. The fda will continue in its efforts to reduce over reliance on ethylene oxide for medical device sterilization.

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 advantages and disadvantages as well as its recommended uses are explored in this review article. Our actions including the launch of our innovation challenge and the master file pilot are illustrative of this commitment. Eto toxicity has been established in a variety of animals.