In vitro pyrogen test - A new test method for solid medical devices

Francesca Mazzotti, Julia Beuttler, Richard Zeller, Ulrich Fink, Stefanie Schindler, Albrecht Wendel, Thomas Harlung, Sonja Von Aulock

Research output: Contribution to journalArticle

Abstract

Medical devices manufactured for implantation into humans must be free of any contamination with viable bacteria. However, remnants of dead bacteria and bacterial components alone may induce an inflammatory immune response. Pyrogen tests for such inflammatory contaminations are generally performed either by determining the content of lipopolysaccharide in rinsing solutions of batch samples by limulus amoebocyte lysate assay, by injecting the rinsing solutions into rabbits or by implanting batch samples into rabbits and measuring change of body temperature. In this study, we show that the in vitro pyrogen test (IPT), which measures the release of the inflammatory cytokine IL-1βin fresh or cryopreserved human whole blood, can be used to assess the pyrogenic contamination of implantable medical devices. This test was used to check neurosurgical implants, namely aneurysm clips, as a proof of principle. Owing to the direct contact of the test material with the blood cells, this test does not require rinsing procedures, which have variable efficacy. The use of human blood ensures the detection of all substances that are pyrogenic for humans and reflects their relative potency. The safety of the products as delivered could be confirmed. The effects of sterilization and depyrogenization procedures on intentional pyrogenic contaminations of samples could be followed. This new application of the already internationally validated method promises to replace further rabbit pyrogen tests. It generates extremely sensitive results with an extended range of detectable pyrogenic contaminants.

Original languageEnglish (US)
Pages (from-to)276-282
Number of pages7
JournalJournal of Biomedical Materials Research - Part A
Volume80
Issue number2
DOIs
StatePublished - Feb 1 2007
Externally publishedYes

Keywords

  • Human
  • Lipopolysaccharide
  • Medical device
  • Pyrogen testing
  • Whole blood

ASJC Scopus subject areas

  • Ceramics and Composites
  • Biomaterials
  • Biomedical Engineering
  • Metals and Alloys

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  • Cite this

    Mazzotti, F., Beuttler, J., Zeller, R., Fink, U., Schindler, S., Wendel, A., Harlung, T., & Von Aulock, S. (2007). In vitro pyrogen test - A new test method for solid medical devices. Journal of Biomedical Materials Research - Part A, 80(2), 276-282. https://doi.org/10.1002/jbm.a.30922