Discover the Critical Insights on EO Sterilization and Safer Alternatives

Ethylene oxide (EO) is a widely used sterilization method for both commercial and healthcare applications. Approximately half of all single-use medical devices are sterilized using EO in large-scale facilities before reaching patients.1 However, the rising concern over EO's toxic emissions has prompted stricter regulations and legal actions due to the health risks posed to workers and nearby communities.2,3,4

Key Concerns of EO Sterilization

  • Health Risks: Exposure to EO increases the risk of cancer and reproductive issues5,6
  • Environmental Impact: EO emissions contribute significantly to air pollution7,8
  • Patient Safety: Residual EO on devices after sterilization poses potential health risks9
  • Operational Inefficiency: Lengthy aeration times required after EO sterilization slow down processes

EPA's Regulatory Actions

The U.S. Environmental Protection Agency (EPA) has implemented a two-pronged approach to tackle EO exposure:10

  1. Stricter emissions limits for sterilization facilities
  2. Enhanced protections for workers and residents near EO manufacturing plants

A Paradigm Shift Toward Safer Sterilization Methods

Molecular image of hydrogen peroxide on an abstract purple background

Hydrogen Peroxide Gas Plasma (HPGP) presents a promising alternative to EO, notably in these areas:

  • Safety: HPGP breaks down into harmless water vapor and oxygen, posing no health or environmental risks.11
  • Efficiency: Shorter sterilization cycle times improve operational efficiency.12,13
  • Effectiveness: HPGP is versatile and effective in sterilizing a wide range of medical devices.13

 

Explore the White Paper

ASP’s white paper delves deeper into the hazards associated with EO sterilization, its environmental impact, and the shift toward safer alternatives like HPGP. By adopting these advanced sterilization methods, healthcare facilities can enhance patient and staff safety while maintaining environmental responsibility.


Access the white paper and gain valuable insights into the path forward for medical device sterilization.

References

  1. FDA, U. F. (2024, May 13). Sterilization for Medical Devices. Retrieved from FDA Sterilization for Medical Devices: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices

  2. Goldman, D. (2024, May 14-20). Ethylene Oxide Litigation Expands to California. The National Law Review

  3. Hawthorne, M. (2024, April 15). From discovery of a powerful chemical to shutting down Sterigenics: 160 years of ethylene oxide. Retrieved from Chicago Tribune News: https://www.chicagotribune.com/2019/10/16/fromdiscovery-of-a-powerful-chemical-to-shutting-down-sterigenics-160-yearsof-ethylene-oxide/

  4. Reuter, E. (2024, May 6). EtO causes cancer. Device sterilizers are scrambling to find alternatives. Medtechdive.

  5. EPA. (2016, December 1). U.S. Environmental Protection Agency IRIS Executive Summary Ethylene Oxide. Retrieved from IRIS Ethylene Oxide CASRN 75-21-8: https://cfpub.epa.gov/ncea/iris/iris_documents/documents/subst/1025_summary.pdf

  6. OSHA, O. S. (2002). OSHA Fact Sheet: Ethylene Oxide. Retrieved from OSHA Fact Sheet: https://www.osha.gov/sites/default/files/publications/ethyleneoxide-factsheet.pdf

  7. Sreejith, L. S. (2020). Residual Ethylene Oxide in Medical Devices: Effects and Estimation Methods, an Overview. Trends in Biomaterials and Artificial Organs, 7-12

  8. U.S. Department HHS. (2022). Toxicological Profile of Ethylene Oxide. Agency for Toxic Substances and Disease Registry

  9. CDC ATSDR, C. f. (2024, May 24). ATSDR MMG Ethylene Oxide. Retrieved from CDC ASTDR MMG: https://www.atsdr.cdc.gov/mhmi/mmg137.pdf

  10. Reuter, E., & Lucas, S. (2023, November 27). Why medical device companies are worried about the EPA’s planned sterilization regs. Medtechdive

  11. Rutala, W. A., Weber, D. J., & (HICPAC), H. I. (2019, May). Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Update: May 2019. Retrieved from Centers for Disease Control and Prevention (CDC) : https://www.cdc.gov/infection-control/media/pdfs/Guideline-Disinfection-H.pdf

  12. Boiano, J., & Steege, A. (2015). Ethylene Oxide and Hydrogen Peroxide Gas Plasma Sterilization: Precautionary Practices in U.S. Hospitals. Zentralsterilisation (Wiesb), 262-268

  13. CDC Guide HPGP. (2024, May 23). Disinfection and Sterilization Guideline: Hydrogen Peroxide Gas Plasma. Retrieved from Guideline for Disinfection and Sterilization in Healthcare Facilities (2008): https://www.cdc.gov/infection-control/hcp/disinfection-sterilization/hydrogen-peroxide-gas-plasma-file-name.html

Author

Ryan Lewis

Ryan Lewis MD, MHA, MPH

Senior Director Medical Affairs, Medical Safety, ASP

AP-2401286-1