[Bone banks : The state-of-the-art]. / Knochenbanken : State-of-the-Art.

Bone banks are responsible for the collection, production, testing, packaging, storage and delivery of osseous grafts. In compliance with legal and quality requirements, it is their main task to ensure the biological properties and the microbiological safety of the transplants as well. German legal requirements for bone banking are explained and current standards with respect to donor selection, laboratory tests and tissue processing, as well as labeling are discussed. Production and preparation procedures should include a validated microbiological inactivation method that largely preserves the biological properties of the tissue.

The role of the donor liaison officer at PlusLife (Perth Bone and Tissue Bank Inc.), Western Australia.

Femoral head donation at the time of hip replacement surgery provides a much needed resource of bone allograft to orthopaedic surgeons. Prior to 2005, potential femoral head donors were identified and consented in the hospital setting on the day of surgery. This resulted in over 40 % of donations failing post operatively suggesting that more effort could be given to pre-operative screening resulting in substantial savings in the cost associated with collection and testing of donors who were subsequently failed. The Donor Liaison role was implemented in 2005 to coordinate a Femoral Head Donation program maximising the number of successful donations through pre-operative screening. This study reviews the effectiveness of pre-operative screening of potential femoral head donors at PlusLife from 2002-2012. A retrospective audit of the database was undertaken 2002-2012 and medical/social reasons for pre-operative and postoperative failures were collated into 4 main categories to enable comparison: malignancy, autoimmune conditions, variant Creutzfeldt Jakob disease risk and general medical/social reasons. The number of femoral heads failed post operatively has decreased significantly from 26 % in 2003 to 6 % in 2012. A cost of $121,000 was expended on femoral heads failed post operatively in 2004, as compared to $20,350 in 2012. Donors excluded due to the 4 main categories (medical/social history) were identified pre-operatively in over 80 % of all cases. Preoperative screening of femoral head donors through a coordinated Femoral Head Donation Program is a safe and cost effective method.

[Informed consent to postmortem tissue donation: a catamnestic survey within a year of the donor's death]. / Die muskuloskelettale Gewebespende: Rückblickende Bewertung durch die Angehörigen des Spenders im Jahresabstand nach dem Tod.

UNLABELLED: The authors present data from 36 musculoskeletal donors. Talking to the next of kin plays a key role in the consenting process for tissue donation. We give an overview of our fundamental thoughts and the guidelines developed for the contact with the family and present the results of a catamnestic review. METHODS: One year after procurement, we contacted the consenting persons by telephone for an interview using a semi-standardized questionnaire to evaluate the information given on tissue donation and the emotional processing of the death. RESULTS: 8-18 months after the donation, 26 (72.2 %) consenting persons could be reached and gave a positive feedback with regard to the information and support provided and the consent given by them at that time. DISCUSSION: The telephone contact of physicians from an Institute of Legal Medicine with the family of a deceased is perceived as being helpful in an acute stress situation caused by a sudden death and as an accepted way to ascertain the deceased's last will with regard to a potential musculoskeletal donation. According to the German Transplantation Act asking for musculoskeletal donations is the duty of every physician. Our data show that this does not constitute an additional burden for the relatives, if the question is asked in an appropriate way.

[Perspectives of clinical stem cell therapy in the treatment of musculoskeletal diseases in Germany]. / Perspektiven klinischer mesenchymaler Stammzelltherapie bei muskuloskeletalen Erkrankungen in Deutschland.

AIM: The treatment of large bone defects remains a challenge for the orthopaedic surgeon. Regenerative therapies with the use of mesenchymal stem cells (MSC) may provide an alternative to autogenous bone transplantation, callus distraction or the use of allografts. MATERIAL AND METHODS: On the occasion of an expert workshop of the German Society for Orthopaedic and Trauma Surgery, a literature search regarding studies with the use of MSC was performed to evaluate its potential for future clinical studies. Furthermore, the legislative requirements were examined. RESULTS: Various in vitro and animal studies showed the benefit of MSC in bone regeneration. However, there are sparse data from clinical studies. Due to recent legislative changes there are several regulatory demands to meet if clinical studies are performed with MSC. CONCLUSIONS: For further evaluation of the role of MSC in the treatment of bone defects there is a need for clinical trials. The current paper provides some assistance for the successful application for clinical trials with MSC. Planning and performance of these studies may require early consultation with the regulatory authorities and cooperation of research centres in order to obtain authorisation for the evaluation of MSC. Preclinical data have to be obtained according to good laboratory practice with equivalent protocols that will be used in the clinical trials. In the latter the implementation of the guidelines for good clinical practice are mandatory.

Transplante ósseo: aspectos legais para a reflexão da prática em enfermagem / Bone transplant: legal aspects for reflection in nursing practice

Este estudo de reflexão traça algumas considerações acerca da existência e funcionamento de Banco de Ossos tendo por base a legislação existente no país e a literatura disponível. Destaca aspectos inquietantes relacionados à adequação ética e legal dos serviços às normas que dispõem sobre a realização de transplantes ósseos, bem como da participação do enfermeiro na organização e funcionamento de serviços que executam os procedimentos de captação, processamento, estocagem e distribuição dos tecidos ósseos utilizados em enxertos.

[Consequence of European Directive 2004/23/EC for bone banks in Germany]. / Auswirkungen der EU-Geweberichtlinie 2004/23/EG auf deutsche Knochenbanken.

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.

Safety and FDA regulations for musculoskeletal allografts: perspective of an orthopaedic surgeon.

The Musculoskeletal Transplant Foundation Symposium held in September 2003, in Edinburgh, Scotland provided the opportunity for an orthopaedic surgeon experienced in tissue banking and musculoskeletal allograft transplantation to summarize to orthopaedic colleagues the past and current efforts made by the Food and Drug Administration to ensure the safety of allograft tissues, aspects of tissue banking, concerns of allograft safety and future Food and Drug Administration proposals. The review allows an orthopaedic surgeon an understanding of allograft safety issues and provides information for better informed consent to be obtained by the orthopaedic surgeon from the recipient patient.

[Transplantation and donation of tissues--six years with the new law. Experiences from the tissue bank in Lund]. / Transplantation och donation av vävnader--sex år med nya lagen. Erfarenheter från vävnadsbanken i Lund.

Tissue transplantation is more common than organ transplantation. Legislative changes in 1996 transformed tissue banking and conditions for tissue transplantation in Sweden. After an initial decrease in donated tissue, heart valves are now available in sufficient numbers, but there is sometimes a shortage of valves the right size for pediatric cardiac surgery. Since the new transplantation legislation was implemented there has been an increase in the number of valves from neonatal donation and after sudden infant death. The number of donated corneas does not correspond to the number required for transplantation. A number of tissue coordinators have been established throughout the country and recently some new tissue banks were founded to increase the amount of tissue available for transplantation. The organization of the tissue bank in Lund is described. There is a lack of knowledge about tissue transplantation and donation among health professionals as well as the general public, and more education is warranted.

Musculoskeletal tissue banking in Europe--regulations and quality assurance.

This paper is confined to the use of human musculoskeletal tissue in the treatment of patients. Its focus is on the safety and quality dimension of human tissue transplantation, including the ethical and legal aspects, the regulations and standards from the European perspective, quality assurance and quality management in tissue banking and as a special subject, tissue sterilisation and the validation of sterilisation methods.

Banco de huesos: Obtención, conservación y utilización de injertos oseos esponjos de banco / Bank of bones: Obtaining, conservation and use of esponjos bony grafts of bank

Constituye una guía médica para la atención de pacientes con lesiones oseas. Presenta la organización y metodología de los bancos de huesos, así como las normas para el uso y conservación del material oseo esponjoso...

[Bone banks: medicolegal aspects]. / Banques d'os: aspects médico-légaux.

Heterologous bone grafting has increased considerably due to improved preservation and the development of bone banks. We analyzed the forensic aspects of organ procurement, transformation, processing and preservation specifically related to bone grafts. Topics considered included the organization of the responsible authorities and their activities in the context of ethical medical considerations. The surgeon is often faced with a complex heterogeneous situation without clear legal requirements.