Ethylene oxide how does it work

ETO has been linked to spontaneous abortion, genetic damage, nerve damage, peripheral paralysis, muscle weakness, and impaired thinking and memory. Alkylation, or the replacement of a hydrogen atom with an alkyl group, within cells prevents normal cellular metabolism and replication.

The excellent microbicidal activity of ETO has been demonstrated in several studies , , , , , and summarized in published reports. For this reason B. Like all sterilization processes, the effectiveness of ETO sterilization can be altered by lumen length, lumen diameter, inorganic salts, and organic materials. ETO is used in healthcare facilities to sterilize critical items and sometimes semicritical items that are moisture or heat sensitive and cannot be sterilized by steam sterilization.

Skip directly to site content Skip directly to page options Skip directly to A-Z link. Infection Control. Section Navigation. Our laboratory testing and product and packaging testing services provide Customers with validation support and microbial testing, ensuring medical devices processed with EO perform as expected for the life of the product, and packaging maintains the sterility of the device until its point of use.

Our Sustainable EO services provide Customers with strategies to reduce the EO sterilant used in the sterilization process to achieve the prescribed sterility assurance level. The program includes innovative approaches to EO sterilization, such as cycle design, validation strategy, and process challenge device design, all focused on the delivery of an efficient and effective process for sterilization of healthcare products.

View our TechTeam Resources to learn more about the ethylene oxide sterilization process. Ethylene oxide sterilization uses a 3-part gas process which includes pre-conditioning, sterilization, and aeration. Trace levels of EO may remain on product after processing and product may require prolonged aeration to reduce to permissible levels.

A study was carried out to compare the impact, if any, of EO concentration on product EO residual levels determined in accordance with ISO Learn more about our global offering, which includes electron beam, gamma, X-ray, and ethylene oxide technologies.

This TechTip provides a summary of minimizing over-processing by understanding how to establish an appropriate internal process challenge device. Skip to content. Facebook page opens in new window Twitter page opens in new window YouTube page opens in new window Linkedin page opens in new window.

Ethylene oxide, the gas used in all Andersen Products sterilisers, is one of the most effective sterilant available on the market. It has more than 60 years of existence in the medical and pharmaceutical sectors.

But how does it work exactly? The simple answer is that ethylene oxide rips apart cell membranes, causing microorganisms to die. Ethylene oxide is a colorless, flammable gas.

When ethylene oxide reacts with different chemicals it undergoes a process called alkylation. Alkylation is a chemical reaction where a hydrogen atom is replaced with a hydroxyethyl radical. On November 25, , the FDA announced that 46 applications were received and 12 participants selected for the challenges.

Refer to each challenge page for details on the selected participants and next steps. Meeting materials are available on the Advisory Committee Meeting Announcement page. One recommendation from the advisory committee meeting is for device manufacturers to begin, as soon as possible, reducing the amount of paper such as the labeling and instructions for use manuals that is included in the sterile device package. An ethylene oxide sterilized medical device must be sealed in a carefully designed gas-permeable package that enables the ethylene oxide gas to enter.

When the sterilization load encompassing all the materials inserted into the sterilizer chamber with the device includes a large amount of paper with the device, it hinders the ethylene oxide getting to the device and generally means that more ethylene oxide is required.

Because of this, the FDA is encouraging device manufacturers to move to electronic materials where feasible and safe for device users. We are committed to working with industry to make this change. This voluntary program is intended to allow companies sterilization providers that sterilize single-use medical devices using fixed chamber ethylene oxide EtO to submit a Master File when making certain changes between sterilization sites or when making certain changes to sterilization processes that utilize reduced EtO concentrations.

Under this voluntary program, manufacturers PMA holders of Class III devices subject to premarket approval that are affected by such changes may reference the Master File submitted by their sterilization provider in a postapproval report in lieu of submission of a PMA supplement.