Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 May;113(5):e35567.
doi: 10.1002/jbm.b.35567.

Diffusion of Hydrogen Peroxide Through Medical Grade Poly(Ether)urethane: Analyzing Mechanisms of Sorption and Transport to Support Sterilization With Vapor Phase Hydrogen Peroxide

Affiliations

Diffusion of Hydrogen Peroxide Through Medical Grade Poly(Ether)urethane: Analyzing Mechanisms of Sorption and Transport to Support Sterilization With Vapor Phase Hydrogen Peroxide

Ioan P I Gitsov et al. J Biomed Mater Res B Appl Biomater. 2025 May.

Abstract

The United States Food and Drug Administration (FDA) recently announced an update to their 510(k) medical device sterility guidance to include vapor phase hydrogen peroxide (VH2O2) as an established 'Category A' sterilization process. This places VH2O2 in the same category as ethylene oxide (EO or EtO), which has demonstrated user and patient safety as well as microbiocidal effectiveness through scientific literature and FDA-recognized consensus standards. For some implantable medical devices, the sterilant chemistry must diffuse through the polymers of construction to access sealed parts of the finished assembly to achieve an appropriate sterility assurance level. Diffusion of EO through materials has been well established over decades of successful use. However, the ability of VH2O2 to diffuse through materials of construction has not been demonstrated. In this work, we measured the diffusivity and permeability of VH2O2 for a series of increasing durometer poly(ether)urethanes (PEUs) commonly used in the construction of single-use medical devices. The diffusion coefficients were 1 × 10-8 cm2/s for PEU75D, 2 × 10-8 cm2/s for PEU55D, and 5 × 10-8 cm2/s for PEU80A. The permeabilities were calculated to be 4.7 × 10-6 cm2/s and 1.3 × 10-5 cm2/s for PEU55D and PEU80A, respectively. For a typical cardiac or neuromodulation lead, the PEU80A wall thickness is on the order of 0.013 cm, resulting in penetration of hydrogen peroxide into the sealed construction in less than 10 min, a timeframe that is a fraction of the total sterilization cycle time.

Keywords: diffusion; ethylene oxide; industrial sterilization; medical devices; vapor phase hydrogen peroxide.

PubMed Disclaimer

References

    1. B. McEvoy and R. Eveland, “Vaporized Hydrogen Peroxide: A Well‐Known Technology With a New Application,” Biomedical Instrumentation & Technology 54, no. s1 June (2020): 74–79, https://doi.org/10.2345/0899‐8205‐54.s3.74.
    1. “Hydrogen Peroxide,” https://www.echa.europa.eu/documents/10162/590965ca‐33e7‐43a0‐a109‐3a914....
    1. “Community Engagement on Ethylene Oxide (EtO),” https://www.epa.gov/hazardous‐air‐pollutants‐ethylene‐oxide/forms/commun....
    1. “EPA Proposes New Standards to Protect Public Health, Reduce Exposure to Ethylene Oxide Pollution,” https://www.epa.gov/newsreleases/epa‐proposes‐new‐standards‐protect‐publ....
    1. “FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization,” https://www.fda.gov/news‐events/press‐announcements/fda‐facilitates‐broa....

LinkOut - more resources