BIOBank ensures all tissue bank activities listed in article L.1243-2 of the public health code (authorisation since 29 September 2003), from tissue collection to issuance of safe grafts. These steps include, inter alia, the biological selection of donors and the proper transformation of the bone grafts. All these operations are done in accordance with the Good Practice rules of Tissue Banks set by the ANSM (French National Safety Agency for Health Products) decision on 27 October 2010, transposing the European Directives into French regulations.
As for all French tissue banks, the BIOBank’s activities are subjected to an authorisation issued by the ANSM. Bone grafts are grouped into families according to their shapes (anatomical, geometrical, granules, powders, plates) which are subject to a single marketing authorisation issued by the ANSM. Biobank has also an export authorisation issued by the ANSM for its grafts.
BIOBank grafts come from femoral heads harvested exclusively from living donors during hip arthroplasties. As such, the tissue is removed during a surgery in the operating room, guaranteeing optimal quality and asepsis. All samples are obtained in France only by orthopaedic surgeons within approved health care establishments.