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Sicherheitsstandards bei der Verwendung muskuloskelettaler Allografts

Safety standards for the use of musculoskeletal allografts

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Arthroskopie Aims and scope

Zusammenfassung

Die Transplantation muskuloskelettalen Gewebes dient der Behandlung ausgedehnter Defekte des muskuloskelettalen Systems, v. a. bei Prothesenwechseloperationen, sportmedizinischen Eingriffen und Rekonstruktionen nach ausgedehnten Tumorresektionen. Die Hauptgefahr nach einer Transplantation besteht in der potenziellen Übertragung klinisch relevanter Infektionserreger. In den mit der Herstellung muskuloskelettaler Gewebetransplantate beauftragten Gewebebanken hat sich daher ein Sicherheitsstufenkonzept etabliert, das aus Spenderauswahl, Labortestung, Gewebegewinnung und -verarbeitung und Qualitätssicherung besteht. Des Weiteren wurden Verfahren entwickelt, die einerseits die biologischen Eigenschaften des Gewebes schützen und andererseits zu einer hohen Infektionssicherheit führen. In Deutschland werden hierfür validierte chemische und thermische Inaktivierungsverfahren mit Erfolg angewendet. Die ordnungsgemäße Qualitätssicherung gemäß Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV) und Transplantationsgesetz(TPG)-Gewebeverordnung sichert die gesetzeskonforme Arbeit von Gewebebanken.

Abstract

The transplantation of musculoskeletal tissues is widely used in orthopedics, sports medicine, traumatology and reconstruction after extensive tumor resection. The main risk after transplantation is the potential transmission of clinically relevant pathogens. Tissue banks have therefore established a safety level approach for the manufacture of musculoskeletal tissue transplants which includes donor selection, laboratory testing, tissue procurement, tissue processing and quality assurance. In addition, procedures have been developed to protect the biological properties of the tissue and to guarantee a high microbiological safety. In Germany validated chemical and thermal inactivation procedures have been successfully applied. A correct quality assurance in accordance with the Pharmaceuticals and Active Substances Production Act (AMWHV) and Transplantation Act (TPG) for tissue regulation ensures that tissue banks work within the law.

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Interessenkonflikt

Der korrespondierende Autor weist auf folgende Beziehung hin: er erhält ein Beraterhonorar von der Firma telos H + V Marburg.

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Authors and Affiliations

  1. Univ.-Gewebebank, Institut für Transfusionsmedizin, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Deutschland

    A. Pruß & U. Kalus

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  1. A. Pruß
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  2. U. Kalus
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Correspondence to A. Pruß.

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Pruß, A., Kalus, U. Sicherheitsstandards bei der Verwendung muskuloskelettaler Allografts. Arthroskopie 25, 30–35 (2012). https://doi.org/10.1007/s00142-011-0677-5

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  • DOI: https://doi.org/10.1007/s00142-011-0677-5

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