STP898: Sterility and Pyrogenicity Issues of Synthetic Vascular Grafts

    Helmus, MN
    Senior consultant for biomaterials, Arthur D. Little, Inc., Cambridge, MA

    Botan, EA
    Senior engineers, Bard Cardiosurgery Division, C. R. Bard, Inc., Billerica, MA

    Malone, JM
    Professor of surgery and research assistantchief of vascular surgery, College of Medicine, University of ArizonaTucson Veteran's Administration Medical Center, Tucson, AZ

    Botzko, KM
    Reading, MA

    Reinert, RL
    Professor of surgery and research assistantchief of vascular surgery, College of Medicine, University of ArizonaTucson Veteran's Administration Medical Center, Tucson, AZ

    Bevans-Lynch, R
    Senior engineers, Bard Cardiosurgery Division, C. R. Bard, Inc., Billerica, MA

    Brendel, K
    Professor and assistant professor, College of Medicine, University of Arizona, Tucson, AZ

    Duhamel, RC
    Professor and assistant professor, College of Medicine, University of Arizona, Tucson, AZ

    Snyder, RW
    Vice-president—research, Advanced Vascular Technologies, Inc., Webster, TX

    Pages: 14    Published: Jan 1986


    Abstract

    Common sterilization techniques, validation methods, and the physical and biologic effects of sterilization on synthetic vascular graft materials are reviewed. Pyrogenicity issues are discussed. A series of endotoxin-contaminated polyester externally supported grafts were tested in a canine model to assess the clinical significance of pyrogen contamination. Systemic pyrogenicity was observed, but gross thrombus formation was unaffected. The pathogenesis of graft infections are then reviewed.

    Keywords:

    sterility, bacteria, pyrogen, endotoxin, vascular graft, thrombus, thrombus free surface


    Paper ID: STP33295S

    Committee/Subcommittee: F04.04

    DOI: 10.1520/STP33295S


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