In vitro pyrogen test : a new test method for solid medical devices

Lade...
Vorschaubild
Dateien
2007Mazzotti_JBiomedMaterRes_bearb.pdf
2007Mazzotti_JBiomedMaterRes_bearb.pdfGröße: 165.57 KBDownloads: 1406
Datum
2007
Autor:innen
Mazzotti, Francesca
Beuttler, Julia
Zeller, Richard
Fink, Ulrich
Schindler, Stefanie
Herausgeber:innen
Kontakt
ISSN der Zeitschrift
Electronic ISSN
ISBN
Bibliografische Daten
Verlag
Schriftenreihe
Auflagebezeichnung
DOI (zitierfähiger Link)
ArXiv-ID
Internationale Patentnummer
Angaben zur Forschungsförderung
Projekt
Open Access-Veröffentlichung
Open Access Green
Core Facility der Universität Konstanz
Gesperrt bis
Titel in einer weiteren Sprache
Forschungsvorhaben
Organisationseinheiten
Zeitschriftenheft
Publikationstyp
Zeitschriftenartikel
Publikationsstatus
Published
Erschienen in
Zusammenfassung

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-1β in 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.

Zusammenfassung in einer weiteren Sprache
Fachgebiet (DDC)
570 Biowissenschaften, Biologie
Schlagwörter
pyrogen testing, human, medical device, whole blood, lipopolysaccharide
Konferenz
Rezension
undefined / . - undefined, undefined
Zitieren
ISO 690MAZZOTTI, Francesca, Julia BEUTTLER, Richard ZELLER, Ulrich FINK, Stefanie SCHINDLER, Albrecht WENDEL, Thomas HARTUNG, Sonja von AULOCK, 2007. In vitro pyrogen test : a new test method for solid medical devices. In: Journal of Biomedical Materials Research : A. 2007, 80(2), pp. 276-282. ISSN 1549-3296. eISSN 1552-4965. Available under: doi: 10.1002/jbm.a.30922
BibTex
@article{Mazzotti2007vitro-6960,
  year={2007},
  doi={10.1002/jbm.a.30922},
  title={In vitro pyrogen test : a new test method for solid medical devices},
  number={2},
  volume={80},
  issn={1549-3296},
  journal={Journal of Biomedical Materials Research : A},
  pages={276--282},
  author={Mazzotti, Francesca and Beuttler, Julia and Zeller, Richard and Fink, Ulrich and Schindler, Stefanie and Wendel, Albrecht and Hartung, Thomas and Aulock, Sonja von}
}
RDF
<rdf:RDF
    xmlns:dcterms="http://purl.org/dc/terms/"
    xmlns:dc="http://purl.org/dc/elements/1.1/"
    xmlns:rdf="http://www.w3.org/1999/02/22-rdf-syntax-ns#"
    xmlns:bibo="http://purl.org/ontology/bibo/"
    xmlns:dspace="http://digital-repositories.org/ontologies/dspace/0.1.0#"
    xmlns:foaf="http://xmlns.com/foaf/0.1/"
    xmlns:void="http://rdfs.org/ns/void#"
    xmlns:xsd="http://www.w3.org/2001/XMLSchema#" > 
  <rdf:Description rdf:about="https://kops.uni-konstanz.de/server/rdf/resource/123456789/6960">
    <dc:creator>Mazzotti, Francesca</dc:creator>
    <dc:contributor>Mazzotti, Francesca</dc:contributor>
    <dcterms:issued>2007</dcterms:issued>
    <dc:contributor>Fink, Ulrich</dc:contributor>
    <dc:contributor>Wendel, Albrecht</dc:contributor>
    <dc:date rdf:datatype="http://www.w3.org/2001/XMLSchema#dateTime">2011-03-24T17:30:26Z</dc:date>
    <dcterms:isPartOf rdf:resource="https://kops.uni-konstanz.de/server/rdf/resource/123456789/28"/>
    <dc:contributor>Hartung, Thomas</dc:contributor>
    <foaf:homepage rdf:resource="http://localhost:8080/"/>
    <dc:contributor>Aulock, Sonja von</dc:contributor>
    <dcterms:isPartOf rdf:resource="https://kops.uni-konstanz.de/server/rdf/resource/123456789/52"/>
    <dc:creator>Zeller, Richard</dc:creator>
    <dcterms:abstract xml:lang="eng">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-1β in 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.</dcterms:abstract>
    <dc:contributor>Zeller, Richard</dc:contributor>
    <dcterms:rights rdf:resource="https://rightsstatements.org/page/InC/1.0/"/>
    <dspace:isPartOfCollection rdf:resource="https://kops.uni-konstanz.de/server/rdf/resource/123456789/28"/>
    <dc:creator>Wendel, Albrecht</dc:creator>
    <dc:contributor>Beuttler, Julia</dc:contributor>
    <bibo:uri rdf:resource="http://kops.uni-konstanz.de/handle/123456789/6960"/>
    <dcterms:bibliographicCitation>First publ. in: Journal of Biomedical Materials Research : A ; 80 (2007), 2. - S. 276-282</dcterms:bibliographicCitation>
    <dc:language>eng</dc:language>
    <dc:creator>Fink, Ulrich</dc:creator>
    <dcterms:title>In vitro pyrogen test : a new test method for solid medical devices</dcterms:title>
    <dc:contributor>Schindler, Stefanie</dc:contributor>
    <dc:creator>Hartung, Thomas</dc:creator>
    <dspace:hasBitstream rdf:resource="https://kops.uni-konstanz.de/bitstream/123456789/6960/1/2007Mazzotti_JBiomedMaterRes_bearb.pdf"/>
    <dcterms:hasPart rdf:resource="https://kops.uni-konstanz.de/bitstream/123456789/6960/1/2007Mazzotti_JBiomedMaterRes_bearb.pdf"/>
    <dc:creator>Schindler, Stefanie</dc:creator>
    <dspace:isPartOfCollection rdf:resource="https://kops.uni-konstanz.de/server/rdf/resource/123456789/52"/>
    <dc:creator>Beuttler, Julia</dc:creator>
    <dc:format>application/pdf</dc:format>
    <dc:creator>Aulock, Sonja von</dc:creator>
    <void:sparqlEndpoint rdf:resource="http://localhost/fuseki/dspace/sparql"/>
    <dc:rights>terms-of-use</dc:rights>
  </rdf:Description>
</rdf:RDF>
Interner Vermerk
xmlui.Submission.submit.DescribeStep.inputForms.label.kops_note_fromSubmitter
Kontakt
URL der Originalveröffentl.
Prüfdatum der URL
Prüfungsdatum der Dissertation
Finanzierungsart
Kommentar zur Publikation
Allianzlizenz
Corresponding Authors der Uni Konstanz vorhanden
Internationale Co-Autor:innen
Universitätsbibliographie
Ja
Begutachtet
Diese Publikation teilen