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Purpose <p>Ethylene oxide (EtO), a commonly used sterilant for medical devices, is a known carcinogen that leaves carcinogenic residuals. Recent regulatory changes encourage medical device manufacturers to consider non-carcinogenic sterilants, including chlorine dioxide (ClO<sub>2</sub>) sterilization. Although medical device manufacturers often request ClO<sub>2</sub> residual testing, there is a lack of literature exploring ClO<sub>2</sub> residual toxicity. This research bridges this gap by proposing testing criteria and assessing the toxicity of chlorite, chlorate, and chloride residuals post ClO<sub>2</sub> sterilization.</p> Methods <p>We developed criteria using data from guidelines published by the United States Environmental Protection Agency and the World Health Organization. We completed a descriptive analysis of ion chromatography testing of different medical devices sterilized by ClO<sub>2</sub>, including a device indicated for incidental contact, a device to treat corneal abrasions, a smoking cessation inhaler, a device to treat embolisms, polychlorotrifluoroethylene bottles, and prefilled syringes.</p> Results <p>Results showed that the residual levels from each device tested were below toxicity limits of &lt; 6.83&#xa0;mg/device or &lt; 0.8&#xa0;mg/L for chlorite and &lt; 70.65&#xa0;mg/device or &lt; 0.7&#xa0;mg/L for chlorate. Chloride, a naturally occurring element considered non-toxic, was not included in the analysis.</p> Conclusion <p>These results support ClO<sub>2</sub> sterilization as a viable, non-toxic alternative to EtO for medical device manufacturers and contract sterilizers. Future research is needed to determine residual toxicity criteria for high-contact medical devices intended for long-term use.</p>

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Chlorine Dioxide Medical Device Sterilization: Residual Toxicity Testing

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月2日

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  • Paul Lorcheim,
  • Emily Lorcheim,
  • Tessa Van Ee

摘要

Purpose

Ethylene oxide (EtO), a commonly used sterilant for medical devices, is a known carcinogen that leaves carcinogenic residuals. Recent regulatory changes encourage medical device manufacturers to consider non-carcinogenic sterilants, including chlorine dioxide (ClO2) sterilization. Although medical device manufacturers often request ClO2 residual testing, there is a lack of literature exploring ClO2 residual toxicity. This research bridges this gap by proposing testing criteria and assessing the toxicity of chlorite, chlorate, and chloride residuals post ClO2 sterilization.

Methods

We developed criteria using data from guidelines published by the United States Environmental Protection Agency and the World Health Organization. We completed a descriptive analysis of ion chromatography testing of different medical devices sterilized by ClO2, including a device indicated for incidental contact, a device to treat corneal abrasions, a smoking cessation inhaler, a device to treat embolisms, polychlorotrifluoroethylene bottles, and prefilled syringes.

Results

Results showed that the residual levels from each device tested were below toxicity limits of < 6.83 mg/device or < 0.8 mg/L for chlorite and < 70.65 mg/device or < 0.7 mg/L for chlorate. Chloride, a naturally occurring element considered non-toxic, was not included in the analysis.

Conclusion

These results support ClO2 sterilization as a viable, non-toxic alternative to EtO for medical device manufacturers and contract sterilizers. Future research is needed to determine residual toxicity criteria for high-contact medical devices intended for long-term use.