However, only recently has its use significantly emerged, based on its range of applications in the field of new medical device development and sterilization. Safety and health topics ethylene oxide occupational. Aami, arlington, va, 2009 27 asnzs 4187 2, reprocessing of reusable medical devices in health service organizations 28. Ebeam, xray and ethylene oxide technologies for the. Ethylene oxide rapidly breaks down when released to the environment.
In europeethylene oxide has beenused for many years to disinfest foodstuffs, disinfect hides, and, morerecently, to sterilize medical supplies. Aami, arlington, va, 2009 27 asnzs 4187 2, reprocessing of reusable medical devices in. Dose establishment and verification iso 1172 2012 sterilization of healthcare products radiation part 2. The four essential parameters operational ranges are. Ethylene oxide eto or eo sterilization plays an important role in an effective healthcare infection control program because of its reliability and gentleness. Ethylene oxide is highly effective, as it penetrates all porous materials, and it can penetrate through some plastic materials and films. Ethylene oxide sterilization is an important sterilization method that manufacturers widely use to keep medical devices safe. Request pdf ethylene oxide sterilization of medical devices. Stringent regulations require you to validate sterilization processes and stepbystep guidelines are needed to develop and implement a suitable validation program. It is a colorless, poisonous gas that attacks the cellular proteins and nucleic acids of microorganisms. Demonstration of the effectiveness of an ethylene oxide sterilization cycle is achieved through the validation process. Microbiological aspects of ethylene oxide sterilization. Ethylene oxide also known as eo or eto processing is widely used for the sterilization of healthcare devices and instruments. Mar 01, 2009 a new sterilization process under development relies on oxides of nitrogen, and principally, nitrogen dioxide.
The paper discusses radiationbased gamma, electron beam, xray and gasbased ethylene oxide sterilization processes and the regulations, controls and best. Sterility ethylene oxide is widely used in the medical industry to sterilize consumables or products. Ethylene oxide sterilization of medical devices american hospital. If adequate controls of the sterilising process and storage are carried out, sterilisation by ethylene oxide is considered to be safe for new plastics and clean equipment. Final air toxics rules for ethylene oxide emissions from commercial sterilization and fumigation operations 11151994 and 11291999 fact sheets. Ethylene oxide eo sterilization is used for gas compatible devices of all types and configurations for both terminal sterilization as well as sterilization of reusable devices. Ethylene oxide treatment is generally carried out between 30 c and 60 c with relative humidity above 30% and a gas concentration between 200 and 800 mgl. National institute for occupational safety and health niosh, may 11, 2000. Principles and application of ethylene oxide gas sterilization. Ethylene oxide definition of ethylene oxide by merriamwebster.
Chronic exposure to ethylene oxide is also mutagenic. Ethylene oxide is a threeringed epoxy compound with the structural formula. This presentation will go through the history, background, and requirements to perform an appropriate ethylene oxide sterilization validation. Treatment of product prior to the sterilization cycle to attain a predetermined temperature and relative humidity throughout the load. We are manufacturers and suppliers of a wide range of eto sterilizer gas sterilizers, ethylene oxide gas sterilizers and sterilizers. Reed iciuniversity of liverpool joint laboratory, bioengineering unit, po box 147, liverpool l69 3bx, uk.
Eo is considered the sterilization method with the broadest application available for medical products due to its ef ectiveness at lower temperatures and its general compatibility with a diversity of materials, resins and product types, including. Effectiveness of ethylene oxide for sterilization of. Lso provides contract eo sterilization services for both purposes, as well as eo validation services. Eto sterilization can take up to 12 hours due to its slow action upon microorganisms, and lengthy processing and aeration time. Sterilizing units, ethylene oxide world health organization. Sterilization validation and routine operation handbook. It is most commonly used to sterilize instruments with long lumens such as endoscopes and all materials that have. Ethylene oxide gas sterilization of medical devices. National institute for occupational safety and health niosh, may 1994. Validation is the total process starting with commissioning, followed by performance qualification. Having experience with ethylene oxide emissions and sterilizer applications, anguil recognized several unique challenges associated with this project. The national library of medicine hazardous substance database. Pdf on may 1, 2008, anne d lucas and others published ethylene oxide sterilization validation and routine operations handbook find. Note that 3m has established the firm exclusion of ethylene oxide decontamination methods for use with 3m ffrs, because ethylene oxide is an inhalationroute carcinogen, and any potential offgassed ethylene oxide residuals would be directly inhaled by the wearer.
Aami, arlington, va, 2009 26 aami tir28 product adoption and process equivalence for ethylene oxide sterilization. However, only recently has its use significantly emerged, based on its range of applications in the field of new medical device development. However, only recently has its use significantly emerged, based on its range of applications in the field of. Ethylene oxide technologies for the industrial sterilization of medical devices and. Understanding ethylene oxide sterilization youtube. Decontamination methods for 3m filtering facepiece.
Ethylene oxide eto is produced in large volumes and is primarily used as an intermediate in the production of several industrial chemicals, the most notable of which is ethylene glycol. It is most commonly used to sterilize instruments with long lumens such as endoscopes and all materials that have to be sterilized but cannot withstand higher. Forlarge scale sterilization tworather different pro cesses havebeendevisedonthe continent ofeurope andin theunitedstates. Effectiveness of ethylene oxide for sterilization of dental. May 2019 10 of 163 disinfection can nullify or limit the efficacy of the process. Minimum dose required to achieve the specified sal what is the sterilisation dose that will be established 25 kgy15 kgyother single or multiple batches used for qualification. Eo sterilization assures that a safe and sterile product will be delivered to the market each and every time. Currently the overwhelming demand for eto comes from the chemical industry, where it is a very.
Ethylene oxide sterilization 1 calculation of initial gas. Because ethylene oxide is a gas, most is expected to be released to the air where it reacts with water vapor and sunlight and breaks down within a few days. For decades medical device manufacturers have sterilized their products using ethylene oxide eto, radiation gamma or ebeam, or heat steam or dry processes. Dec 06, 2016 ethylene oxide eo sterilization is the most common industrial sterilization technique for medical devices. Because it is a strained ring, ethylene oxide easily participates in a number of addition reactions that. So elevating temperature can provide benefits such as reduced product contact time with ethylene oxide, which may result in lower eo residue levels and hence shorter aeration times. Other sterilization options, such as ethylene oxide eo, hydrogen peroxide h 2 o 2, and radiation, may expose the drug products to elevated temperatures over. Ethylene oxide gas has been utilized as an alternative method for sterilization of dental handpieces, as it is less corrosive than steam. Perioperative services competency assessment vanderbilt. Ethylene oxide eto or eo the future of gas sterilization. Ethylene oxide occupational safety and health administration. Provides an immediately dangerous to life or health document that includes acute toxicity data for ethylene oxide. Ethylene oxide definition is a colorless flammable toxic compound c2h4o used especially in synthesis as of ethylene glycol and in sterilization and fumigation. Learn about the anatomy of the ethylene oxide sterilization process and find more details on topics such as parametric release and performance qualification.
Ethylene oxide eo is known to be gentle on instruments and highly penetrating. Iso sterilization of health care products package specifies the requirements for the development, validation and routine control of ethylene oxide sterilization process for medical devices and other healthcare products. Ethylene oxide eto sterilization following cleaning and highlevel disinfection implementing eto gas sterilization is costly and the process may not be readily available in or accessible to all health care facilities. Guideline for disinfection and sterilization in healthcare.
The main side effect of using eo as a sterilization agent is that it can leave a residue on the devices being processed. However, its effectiveness for sterilization of the internal components of dental handpieces has not been established. It is very water soluble and solutions of as little as 4% in water are flammable. Heat sensitive items can b e damaged by steam sterilization. This report examines control methods and systems for ethylene oxide sterilization in hospitals. Ethylene oxide eto cas 75218 physical hazards ethylene oxide eto is an extremely flammable and reactive material which is a gas at room temperature. First, the catalytic oxidizer had to be able to control both the high concentration, low air volume exhaust from the sterilization chambers vacuum pump, as well as the low concentration, high. Qualification of ethylene oxide and gamma sterilisation.
Proposed air toxics standards for hospital sterilizers 10192006 and 12202007. 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. This is a type of flammable and explosive gas that is used for the sterilization of medical equipment and devices. Ethylene oxide definition of ethylene oxide by merriam. Ethylene oxide is the best practical guide available for. Polymer resinbased products singleuse medical devices. Pdf ethylene oxide sterilization validation and routine. Sterilizing combination products using oxides of nitrogen.
Treatment comprising conditioning if used exposure to ethylene oxide in a sealed chamber, removal of ethylene oxide and flushing if used. Pdf on may 1, 2008, anne d lucas and others published ethylene oxide sterilization validation and routine operations handbook find, read and cite all the research you need on researchgate. This paper describes the progress in terms of eo sterilization and concludes that it remains a promising field to explore and develop. Ethylene oxide gaseog sterilization procedure was regarded as the last candidate of sterilization procedure due to toxic gas residue. Control technology for ethylene oxide sterilization in hospitals dhhs niosh publication no. Read articles from industry publications to learn more about contract sterilization considerations for medical devices and pharmaceuticals. Sterilization byethylene oxide suitable for widespread use in small hospitals or isolated units. Ethylene oxide will dissolve in water, but most of it will quickly evaporate to the air. Full text get a printable copy pdf file of the complete article 796k, or click on a page image below to browse page by page. Why use ethylene oxide eo for sterilizing medical devices. Ethylene oxide eo is a wellknown sterilizing agent. Quizlet flashcards, activities and games help you improve your grades. We break our eo service offering into two groups, small batch.
Ethylene oxide, called oxirane by iupac, is an organic compound with the formula c 2 h 4 o. Axss brand xs series ethylene oxide gas sterilizers are fully automatic devices that sterilize, either resistant to heat or not, any kind of plastic, rubber, sensitive, metal, mechanic or electromechanic medical, surgical materials and laboratory equipment by. The process involves exposing products to ethylene oxide gas under vacuum in a sealed chamber. Overview of ethylene oxide residuals overview sterilizing medical devices with ethylene oxide eo is a common practice primarily due to its extensive material compatibility. Eto sterilizer machine, eto sterilizer from ambica boiler. Because moist heat sterilization procedures are simple and no toxic residues. Eto is a colorless gas that is flammable and explosive. Recent technological advances have greatly reduced the cycle time of eog sterilization, due to the development of aeration processes optimization.
Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. Ethylene oxide emissions standards for sterilization. Sterilizing with nitrogen dioxide pharmaceutical technology. Ethylene oxide is a colorless and flammable gas with a faintly sweet odor. Commissioning demonstrates that the sterilization equipment intended for. Guidelines for validation of propylene oxide pasteurization overview propylene oxide ppo is a registered fumigant in the us for reduction of bacteria, yeasts, and mold on raw nut meats, etc. A method for the preservation of arterial homo and heterografts. It is also used as a fumigant in certain agricultural products and as a sterilant for medical equipment and supplies. Ethylene oxide is a gas sterilant used to sterilize items that cannot tolerate steam sterilization. Validation of an ethylene oxide sterilization cycle demonstration of the effectiveness of an ethylene oxide sterilization cycle is achieved through the validation process. Niosh notes safeguards to prevent explosion risk in industrial ethylene oxide sterilization processes.
Provides information about explosion risks associated with ethylene oxide sterilization processes and what can be done to eliminate these risks. Ethylene oxide eto is a common gas used for low temperature sterilization. Guideline for disinfection and sterilization in healthcare facilities 2008 last update. Ethylene oxide commercial sterilization and fumigation operations neshap. Qualification of ethylene oxide and gamma sterilisation processes. Ethylene oxide sterilization in hospital practice ncbi.
Ethylene oxide sterilization for medical devices fda. Ethylene oxide sterilizers are used to sterilize heat and moisture sensitive devices that would be damaged by pure steam or liquid chemical sterilization. Safe and effective use of ethylene oxide sterilization. The use of eto evolved when few alternatives existed for sterilizing heat and moisturesensitive medical devices. Guidelines for validation of propylene oxide pasteurization. Nitrogen dioxide no 2 gas can provide manufacturers of parenteral drug products with a truly room temperature means of sterilizing the external surfaces of singledose drug containers that are intended for use in a sterile field. Like all sterilization processes, the effectiveness of eto sterilization can be altered by lumen length, lumen diameter, inorganic salts, and organic materials.