Chlorine Dioxide Medical Device Sterilization: Residual Toxicity Testing

Ethylene oxide is a known carcinogen that leaves carcinogenic residuals. Recent regulatory changes encourage medical device manufacturers to consider non-carcinogenic sterilants, including chlorine dioxide sterilization.

Although medical device manufacturers often request chlorine dioxide residual testing, there is a lack of literature exploring chlorine dioxide’s residual toxicity. This white paper bridges that gap by proposing testing criteria and assessing the toxicity of chlorite, chlorate and chloride residuals post chlorine dioxide sterilization. The results support chlorine dioxide sterilization as a viable, non-toxic alternative to ethylene oxide for medical device manufacturers and contract sterilizers.

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The study was originally published in the Journal of Medical and Biological Engineering and authored by Paul Lorcheim, Emily Lorcheim and Tessa Van Ee.

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