An effective sterilization process depends on the temperature, gas concentration, exposure time, and relative humidity (An et al., 2005). I agree to the Longest Operation Times for Maximized Yields Ethylene oxide is used as a fumigant for spices, seasonings, and foodstuffs and as an agricultural fungicide. The medical device is prepared and exposed to EtO in a sealed chamber, which may be up to 100% EtO at sub-atmospheric pressures (Dorman-Smith, 1997). EtO is a strong alkylating agent (Bruck and Mueller, 1988), and it may cause concern for hemolytic reactions (An et al., 2005). While it is occasionally used in the pure form, EtO is usually used in diluted mixtures. It is soluble in water to 10°C, and it forms polyglycols in the presence of bases. Any potential association between ethylene oxide and cancer is linked only to chronic exposure. Delicate, heat-sensitive medical devices that incorporate plastics and electronics could be warped or otherwise damaged by steam sterilization. There may be some sensitivity to humidity, such as hydrophilic coatings, but there are typically solutions to this type of problem. In a study by Ries et al. Based on available data, we do not expect ethylene oxide levels in the air around facilities to be high enough to cause immediate health effects. It is considered to be one of the most versatile chemical intermediates owing to its high reactivity. Can you please explain? Components that were sterilized using EtO showed significantly less surface damage and delamination than gamma-radiation-sterilized components. Should we be concerned about chilcren playing outside. Toxic Eo residues or by-products (ethylene chlorohydrin, and the less toxic ethylene glycol) can also stay on medical devices and desorb during their clinical use (Page, 1993). The latter produces results that would tend to represent a dose greater than or equal to one that the patient might receive, and is the recommended method for evaluating permanent contact devices. Other ethylene oxide derivatives are used in household cleaners and personal care items such as cosmetics and shampoos. A number of independent reviews have raised substantive concerns about EPA’s IRIS program generally and its findings with respect to ethylene oxide specifically. Some of the limitations related to EO may also relate to polymers’, Lúcio Flávio de Magalhães Brito, Douglas Magagna, in, Steven M. Kurtz PhD, Matthew Zagorski MS, CPP, in, UHMWPE Biomaterials Handbook (Third Edition), Sterilisation and cleaning of metallic biomaterials, Exergetic, Energetic and Environmental Dimensions, Sterilization of joint replacement materials. Comment We are not aware of data suggesting that EtO is associated with effects such as birth defects or autism. However, due to potential hazards of EO to patients, staff, and the environment, regulations have tended to decrease its use in several countries and may even ban it within a few years or decades. After an EO process is complete, employees must take appropriate precautions to avoid exposure to EO gas, e.g., use of respirators when working in the vicinity of product that has not been fully aerated to dissipate the gas. See additional categories of questions and answers. The NATA takes about 3 years to produce. Ethylene oxide was first reported in 1859 by the French chemist Charles-Adolphe Wurtz, who prepared it by treating 2-chloroethanol with potassium hydroxide. EtO is also known as “epoxitane” or “dimethylene oxide.” It is a colorless gas and reacts with several chemicals, such as alcohols, amines, organic acids and amides. In contrast, rim cracking was found in 19% of the acetabular components that were gamma-radiation sterilized in air. The main advantages of this low-temperature chemical sterilisation process are its effectiveness, its reliability and more especially its compatibility with most materials, including all metals, ceramics and most polymers. Later an efficient direct oxidation of ethylene by air was invented by Lefort in 1931 and in 1937 Union Carbide opened the first plant using this process. Besides the main reaction, several side reactions take place, all of which result in the production of carbon dioxide, which is then separated in a subsequent process [81]. There may be low EO absorbency, but very slow desorption in some types (e.g., PTFE), but not in PVDF. Based on a limited number of retrieval studies, the clinical experience with EtO-sterilized UHMWPE components has thus far been favorable [13,29]. Disadvantages of the technique include long processing and aeration times (owing to the amount of time required for penetration into complex or tortuous device pathways), which can substantially increase costs for devices that require a quick turnaround. The percentage of ethylene converted to ethylene oxide in the body is unknown, but expected to be low. It is extremely flammable and explosive and is used as the main ingredient in the manufacturing of thermobaric weapons.