title: [Consequence of European Directive 2004/23/EC for bone banks in Germany].
abstract: Allogenic bone grafting is an established method in revision surgery of artificial joint replacement and spinal surgery in case of bone defects. In Germany, femoral heads from living donors undergoing total hip replacement are frequently used. These grafts are processed according to the "Guidelines for the management of bone banking" issued by the Federal Medical Board. Bone grafts are drugs according to German law. Local bone banks are excluded from the regulations of the federal law on drugs [Arzneimittelgesetz (AMG) section sign 4a (4)] if certain requirements are fulfilled. The Directive 2004/23/EC of the European Parliament and of The Council on Setting Standards of Quality and Safety for the Donation, Procurement, Testing, Processing, Preservation, Storage and Distribution of Human Tissues and Cells has to be implemented into national law within 2 years. The exception of section sign 4a (4) will no longer be possible. Thus a legal construction has to be found which allows running local bone banks in compliance with the new legal settings. Three conditions will be possible: (1) a single physician procures a graft for another patient of his, (2) grafts are procured in one hospital and are used exclusively in this hospital: a license from the local authorities and a strict quality assessment according to GMP-rules is required, (3) if the grafts are distributed to other hospitals, a license from the local authorities and registration as a drug by the federal authorities are necessary.
authors.affiliation: Gewebebank, Institut für Transfusionsmedizin, Charité -- Universitätsmedizin Berlin.
authors.forename: A
authors.initials: A
authors.lastname: Pruss
authors.forename: H
authors.initials: H
authors.lastname: Knaepler
authors.forename: B-D
authors.initials: BD
authors.lastname: Katthagen
authors.forename: L
authors.initials: L
authors.lastname: Frommelt
mesh_terms: D018586:Bone Banks / Q000331:legislation & jurisprudence / Q000592:standards; D016025:Bone Transplantation / Q000331:legislation & jurisprudence / Q000592:standards; D005062:European Union; D005858:Germany; D017410:Practice Guidelines as Topic; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence / Q000592:standards; D014019:Tissue Donors