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DOE OSTI · 3366950

Direct comparison of gamma, electron beam and X-ray radiation effects on the polymers of a pulsed lavage device

Abstract

Gamma radiation used for sterilization of medical devices is challenged by cobalt-60 supply and commercial capacity. To maintain a robust radiation sterilization marketplace for the rapidly growing single-use medical device industry, investigation of potential alternatives to gamma technology, such as electron beam (e-beam) and X-ray technology, is critical. In this work, we directly compare the effects of radiation source and absorbed dose level on the polymeric materials and function of a commercial pulsed lavage device used for wound care. Product functionality, polymer mechanical, and polymer optical properties were evaluated using standard methods and input from the device manufacturer. Test results show that functionality of the product was not inhibited by radiation although the battery in the device exposed to X-ray exhibited greater voltage loss compared to batteries in products exposed to gamma or e-beam. Statistically significant differences between gamma and e-beam exposure and between gamma and X-ray exposure were also observed for product appearance in terms of yellowness index of several of the polymers considered. Overall, the results of this study support the viability of e-beam and X-ray radiation technologies as alternatives to cobalt-60 gamma technology for sterilization of the single-use pulsed lavage medical device investigated.

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BibTeXRIS

Li, Donghui [Pacific Northwest National Laboratory (PNNL), Richland, WA (United States)], Bisel, Tucker T. [Pacific Northwest National Laboratory (PNNL), Richland, WA (United States)], Cooley, Scott K. [Pacific Northwest National Laboratory (PNNL), Richland, WA (United States)], Murphy, Mark K. [Pacific Northwest National Laboratory (PNNL), Richland, WA (United States)], Ni, Yelin [Pacific Northwest National Laboratory (PNNL), Richland, WA (United States)], Spencer, Mychal P. [Pacific Northwest National Laboratory (PNNL), Richland, WA (United States)], Fifield, Leonard S. [Pacific Northwest National Laboratory (PNNL), Richland, WA (United States)] (ORCID:0000000274325356), Pharr, Matt [Texas A & M Univ., College Station, TX (United States)], Hasan, Md Kamrul [Texas A & M Univ., College Station, TX (United States)], Staack, David [Texas A & M Univ., College Station, TX (United States)], Huang, Min [Texas A & M Univ., College Station, TX (United States)], Pillai, Suresh D. [Texas A & M Univ., College Station, TX (United States)], Nichols, Larry [Steri-Tek, Fremont, CA (United States)], Parker, Rodney [Stryker Instruments, Kalamazoo, MI (United States)], Gustin, Erick [Stryker Instruments, Kalamazoo, MI (United States)]. 2026-10-01. Direct comparison of gamma, electron beam and X-ray radiation effects on the polymers of a pulsed lavage device. https://doi.org/10.1016/j.radphyschem.2026.114002

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