Change is coming—Ethylene Oxide (EO) Sterilization must accommodate for carcinogenicity concerns

Updated: Sep 4, 2020

The inherent carcinogenic nature of ethylene oxide (EO) through sterilization emissions has led to the search for alternative sterilization methods and changes to the current EO sterilization method in recent years. However, the search for alternatives remains challenging because of thermodynamic and efficacy issues. EO sterilization processes occur at <55°C, which means almost all medical device sterilization occurs without compromising the device's integrity. Moist heat sterilization alternatives reach temperatures of up to 132°C and thus compromise plastic devices easily. Other alternatives (e.g., gamma, e-beam, X-ray, nitrogen dioxide, and vaporized hydrogen peroxide) not only cause cracking, crazing, and discoloring, but also do not penetrate to the hardest to sterilize locations like EO. Therefore, the efficacy of EO remains the largest in the US, with over 20 billion devices sterilized each year. 

However, the issue remains that EO has carcinogenic effects, and for that reason, companies are searching for ways to reduce the concentration of EO used in their sterilization processes to lower their emissions. To date, companies have shown that concentrations at and lower than 300mg/L is lethal enough to kill the Most Resistant Organism (MRO), Bacillus atrophaeus. Changing the EO sterilization concentrations appears to be the most sustainable way to keep this method viable for years to come. Moreover, it will reduce the need for changes to ISO 10993-7, which focuses on residual EO on medical devices. This process will take time to restructure, but "by looking at a holistic approach of the packaging, product, and process, this "old" method of sterilization can become new again."

Click here to view the full article from "Oliver". For more information about EO sterilization and safety, visit the United States Environmental Protection Agency's website.




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