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 FDA is concerned about the future availability of medical devices and possible medical device shortages. sterilization as a no-residual, safe alternative to ethylene oxide sterilization. Brown, Janet. 6 0 obj However, the last two decades have seen an emergence of alternative sterilization options.5 ,1 ,6 Alternatives include:The following chart describes advantages and disadvantages of the sterilization methods1,7,8,9,10:While ethylene oxide is effective in the sterilization of plastics, and the benefits of using a single sterilant with high product compatibility makes a strong argument for the continued use of EtO, the following chart also demonstrates there are alternative sterilization methods available for almost every plastic without the added risk of ethylene oxide11:Medical device and product sterilization is essential to maintain the safety and health of patients undergoing medical interventions. Ethylene Oxide "Gas" Sterilization. On This Page. The site does not accept responsibility for errors or omission in content. It is a colorless, poisonous gas that attacks the cellular proteins and nucleic acids of microorganisms. The industry standard of using CFCs was then further altered in 1989 with the passing of the Montreal Protocol, which was signed and ratified by all UN member nations, in the effort to reduce the depletion of the ozone layer. Ethylene oxide has been in commercial use for approximately 90 years. 2014 NATA Emissions Updates (as of August 22, 2018. Further, heat is often used with ethylene oxide sterilization, and radiation can also generate heat during the sterilization process. The closure of the Sterigenics plant in Illinois briefly led to “We can’t just stop using it,” said Nancy Foster, vice president of quality and patient safety at the American Hospital Association. Based on a gas diffusion process, Ethylene Oxide (EO or ETO) is capable of sterilizing and rendering products free of viable microorganisms. Lead a discussion with your value analysis/clinical integration team about sterilization. 1 0 obj Just as the Clean Air Act and the Montreal Protocol were passed to protect our environment and precipitated a burst of innovation, new policy changes to safeguard the health of our population should surely encourage a healthy shift in commercial disposable sterilization practices.1. There may be opportunities to lower emissions by using materials that are less difficult to penetrate. endobj St. Joseph was able to eliminate 100% of its use of ethylene oxide by substituting it with a hydrogen peroxide sterilization system. �/a� 2���u Ӽ�G�3*��}���$#zY�cyy��/U��� stream 19 Jun 2012.https://www.medicalplasticsnews.com/news/technology/a-guide-to-nitrogen-dioxide-gas- 10. endobj stream Modification of colour, taste, odour and texture of foodstuffs may occur (Kroeller, 1966) but many materials can be fumigated without appreciable change in these properties. In this environment, ethylene oxide is the most commonly used sterilization method (50%), followed by gamma radiation (40%), and then other less commonly used methods1. %PDF-1.7 Nov 2002. Ethylene Oxide Sterilant Alternatives City of Los Angeles BACKGROUND Ethylene oxide (EtO) is widely used by health care institutions as a sterilant because of its potency in destroying pathogens. Ethylene Oxide Sterilization . Miller, Robert. In December 2016, the United States EPA also classified ethylene oxide as carcinogenic to humans4. <> 15. “Focus on sterilization and high-level disinfection in a healing environment.”Heathcare Design, Jan 2008.14. 5 0 obj Right now, ethylene oxide sterilizes devices in cardboard, which requires a lot of the gas, he said. Sterility occurs when an EO gas molecule reacts with and destroys the microbial DNA. A few facilities use pure EtO, but the vast majority employ a “12/88” mixture of Et0 and Chloroflourocarbon (CFC 1), primarily to improve safety. 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