Sterility and Pyrogenicity Issues of Synthetic Vascular Grafts

MN Helmus; EA Botan; R Bevans-Lynch; JM Malone; RL Reinert; KM Botzko; K Brendel; RC Duhamel; RW Snyder

doi:10.1520/STP33295S

SYMPOSIA PAPER Published: 01 January 1986

STP33295S

Sterility and Pyrogenicity Issues of Synthetic Vascular Grafts

Source

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.

Author Information

Helmus, MN

Arthur D. Little, Inc., Cambridge, MA

Botan, EA

Bard Cardiosurgery Division, C. R. Bard, Inc., Billerica, MA

Malone, JM

Tucson Veteran's Administration Medical Center, Tucson, AZ

Botzko, KM

, Reading, MA

Reinert, RL

Tucson Veteran's Administration Medical Center, Tucson, AZ

Bevans-Lynch, R

Bard Cardiosurgery Division, C. R. Bard, Inc., Billerica, MA

Brendel, K

College of Medicine, University of Arizona, Tucson, AZ

Duhamel, RC

College of Medicine, University of Arizona, Tucson, AZ

Snyder, RW

Advanced Vascular Technologies, Inc., Webster, TX

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Details

Developed by Committee: F04

Pages: 236–249

DOI: 10.1520/STP33295S

ISBN-EB: 978-0-8031-4966-3

ISBN-13: 978-0-8031-0462-4

Sterility and Pyrogenicity Issues of Synthetic Vascular Grafts

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