Quality Control in Hospital Bone Banking

The use of allogenic bone transplantation is nowadays a standard orthopaedic procedure. It is widely used for reconstruction of bone defects that arise from trauma (Friedlaender 1987), infection, resection of bone tumours (Mankin et al. 1996) or it is used in spinal fusion (Raizman et al. 2009) and as impaction grafting in revision of total joint arthroplasty (Slooff et al. 1996). Although autologous bone is generally preferred because of its osteoconductive and osteoinductive activity, autologous bone is often not sufficiently available and comes with donor site morbidity (Summers & Eisenstein 1989). Therefore allogenic bone grafts are often used in orthopaedic procedures. These bone allografts are provided by an orthopaedic bone bank. It might be financially attractive for a hospital to manage its own local hospital bone bank, especially if they perform many procedures in which bone allograft is used. The main advantage of managing a hospital bone bank however, is the easy accessibility to and availability of bone allograft. The bone allografts in a hospital bone bank are femoral heads obtained from suitable patients who underwent total hip replacement surgery. Management of an orthopaedic bone bank is a complex process. The bone bank procedure has to meet the requirements of the national law and European guidelines 2004/23/EC and 2006/86/EC. This law states the technical requirements for coding, processing, preserving, storing, and distributing of human tissue and cells. Human tissue should be traceable and serious side effects and incidents with human tissue and cells should be reported. The bone bank procedure should be carefully described in an extensive protocol. Neither in the Netherlands, nor in any other European country, there are official guidelines for the organization and management of an orthopaedic bone bank. Our bone banking procedure protocol is based on guidelines of The American Association of Tissue Banks (AATB 1993), the criteria of the Council for Blood Transfusion of the Netherlands Red Cross (Richtlijn Bloedtransfusie 2004), the recently merged Netherlands Bone Bank Foundation (NBF) and Bio Implant Services (BIS); (NBF-BIS Foundation 2010) and the guidelines of the European Association of Musculoskeletal Transplantation (EAMST). The latter has been discontinued because of diverging European legislation. This bone bank protocol extensively describes the procedure, which includes a thorough questionnaire for donor selection, extensive serological, bacteriological and histopathological examination, as well as standard procedures for registration, processing, preservation, storage and distribution of bone allografts (Zwitser et al. 2010). In this chapter we describe our local hospital bone banking