| Literature DB >> 29052751 |
A Pruß1.
Abstract
Transplantation of musculoskeletal tissues is widely used in the treatment of extensive defects of the musculoskeletal system, especially in orthopedics for exchange of prostheses, surgical interventions on the spine and in traumatology for reconstruction after extensive tumor resections. A danger after transplantation is the potential transmission of clinically relevant pathogens. Tissue banks have therefore established a safety level approach for musculoskeletal tissue transplants, which includes donor selection, laboratory testing, tissue procurement, tissue processing, tissue storage and quality assurance. In addition, inactivation procedures were also developed to protect the biological properties of the tissue and to guarantee a high microbiological safety against infections. Quality assurance in accordance with the Ordinance for the Production of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV) and the Transplantation Act Tissue Regulations (TPG-GewV), ensures that the work of tissue banks conforms to the legal requirements. A new aspect is that the introduction of the single European code in April 2017, with which all transplants in Germany must be labelled, ensures the traceability of the tissue transplants after potential infections.Entities:
Keywords: Quality assurance; Safety management; Single European Code; Tissue bank; Tissue transplantation
Mesh:
Year: 2017 PMID: 29052751 DOI: 10.1007/s00113-017-0419-x
Source DB: PubMed Journal: Unfallchirurg ISSN: 0177-5537 Impact factor: 1.000