FDA Encourages Vaporized Hydrogen Peroxide Medical Device Sterilization: Reducing Reliance on Ethylene Oxide (EtO)

The path towards utilizing vaporized hydrogen peroxide as a sterilization agent within the medical device and pharmaceutical industries is clear. Recently, Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) recognized a new international consensus standard on the use of low temperature vaporized hydrogen peroxide (VH2O2) as a sterilization agent for medical devices. The standard, ISO 22441:2022, Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices, comes amidst an intense regulatory climate where agencies have been advocating for safe and effective alternative sterilization modalities to help reduce the dependency on ethylene oxide (EtO).  On January 8, 2024, FDA also released a news release further supporting it’s position endorsing the effectiveness of Vaporized Hydrogen Peroxide Sterilization and actively encouraging stakeholders to seek EtO alternative sterilization modalities. EtO, while an effective sterilization agent, is a dangerous and known carcinogenic compound and environmental pollutant.  While its role in the terminal sterilization of medical devices and other healthcare supplies and components will continue to be relied upon, it is important for stakeholders to assess whether or not their medical devices or products can be sterilized using an alternative sterilization modality that delivers adequate sterilization while being significantly safer for the operators and our environment. As companies continue to push for and promote environmental, social, and governance (ESG) type policies, the door has never been more open for companies to explore and choose a safe and more environmentally friendly sterilization solution for medical devices and pharmaceutical products.

In summary, 1) FDA has officially recognized vaporized hydrogen peroxide as an Established Category A sterilization modality for medical devices, 2) ISO 22441:2022 is now the official sterilization standard for use of vaporized hydrogen peroxide as a sterilization modality, and 3) USP <1229.11> further outlines the usage of vaporized hydrogen peroxide as a sterilization modality. Contact us to learn more about how vaporized hydrogen peroxide sterilization (VH2O2) is a safe and effective sterilization method not only for your medical device or pharmaceutical product, but for the environment as well.

1. ISO 22441:2022, Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices 
2. FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide For Medical Device Sterilization; Agency Continues to Encourage Ethylene Oxide Sterilization Alternatives. FDA News Release. January 8, 2024. Updated March 14, 2024.
3. https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-new-standards-recognition-support-innovation-medical-device-sterilization
4. United States Pharmacopeia. 43-NF 38, General Chapter <1229.11> Vapor Phase Sterilization. Bethesda, MD: United States Pharmacopeia; Accessed August, 2023.