[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.

[Cost-effectiveness of a local bone bank based on thermodisinfection according to § 20 b and c AMG and alternatives]. / Zulassung einer lokalen Knochenbank nach § 20 b und c AMG und Einführung einer Thermodesinfektion: Lohnt sich der Aufwand?

INTRODUCTION: The German tissue law creates a different and more difficult situation for German musculoskeletal tissue banks. The objective aim of the new regulations was an increased safety and a reduction of viral and non-viral disease transmissions. In the authors' case, the government officials demanded a thermodisinfection for human femur heads. As a consequence of the requirements we aimed at an analysis of the cost-effectiveness of an admission according to § 20 b and c "Arzneimittelgesetz" (AMG) and implementation of the "lobator bonebank system™". METHOD: We calculated the working hour requirements for all medical staff involved in the tissue procedure. Additional costs were the current consumptions of two freezers (cooling power - 80 °C) for one year, the current consumption of one thermodisinfection process, the material cost of one disinfection and documentation set, expenses for laboratory examinations and the non-recurrent expenses for the admission according to § 20 b and c AMG and the "lobator bonebank system". Non-recurrent expenses were calculated for five years according to 610 tissue donations. We compared the overall costs for one processed femur head with the charges of an industrial chemical treating and irradiation. RESULTS: Expenses for medical doctors were 14.13 € and for nurses 3.71 €. Energy costs were 15.20 € for each stored femur head. Costs for the disinfection and documentation sets were 105.15 €, laboratory expenses were 107.25 €. The non-recurring fee for the admission according to § 20 b and c AMG was 2650 €, the cost for the lobator-sd2 was 12 495 €. The overall expenses for one disinfected femur head were 274.82 € compared to 535.23 € in a tissue service. CONCLUSION: To comply with legal requirements, operating expenses of the new tissue act increased. Nevertheless we could still prove the cost-effectiveness of a local bone bank in Germany.

[Approval of a bone bank: an institution's experience]. / Zulassung einer klinikeigenen Knochenbank : Ein Erfahrungsbericht.

The new tissue laws of 2007 created a completely new situation for German musculoskeletal tissue banks. The objective of the new regulations in the recent German tissue act is to improve safety by reducing the risk of transmission of viral and nonviral diseases. Since 2007 tissue banks have to declare their intention to continue providing allografts to the local authorities until August 2011 based on the guidelines of the Federal Medical Association (Bundesärztekammer 2001) and according to § 144 of the Pharmaceutical Products Act (Arzneimittelgesetz). The Orthopedic University Clinic in Ulm applied for registration according to § 20 b and c of the Pharmaceutical Products Act in 2010. After submitting all the required documents, government officials controlled the equipment, distribution of responsible personnel, location of operating theatres and the laboratory and quality assurance documentation. After alluding to the lack of validation for the use of a hemoculture medium for testing ringer lactate solutions, permission according to § 20 b and c was granted with the obligation to transfer all serological and microbiological testing of tissue donors to another laboratory with its own approval under § 20 c of the Pharmaceutical Products Act.

Temporal bone bank: complying with European Union directives on human tissue and cells.

BACKGROUND: Availability of allograft tympano-ossicular systems (ATOS) provides unique reconstructive capabilities, allowing more radical removal of middle ear pathology. To provide ATOS, the University of Antwerp Temporal Bone Bank (UATB) was established in 1988. ATOS use was stopped in many countries because of safety issues concerning human tissue transplantation. Our objective was to maintain an ATOS tissue bank complying with European Union (EU) directives on human tissues and cells. METHODS: The guidelines of the Belgian Superior Health Council, including EU directive requirements, were rigorously applied to UATB infrastructure, workflow protocols and activity. Workflow protocols were updated and an internal audit was performed to check and improve consistency with established quality systems and changing legislations. The Belgian Federal Agency of Medicines and Health Products performed an inspection to examine compliance with national legislatives and EU directives on human tissues and cells. A sample of important procedures was meticulously examined in its workflow setting next to assessment of the infrastructure and personnel. RESULTS: Results are reported on infrastructure, personnel, administrative workflow, procurement, preparation, processing, distribution, internal audit and inspection by the competent authority. Donors procured: 2006, 93 (45.1%); 2007, 64 (20.6%); 2008, 56 (13.1%); 2009, 79 (6.9%). The UATB was approved by the Minister of Health without critical or important shortcomings. The Ministry accords registration each time for 2 years. CONCLUSIONS: An ATOS tissue bank complying with EU regulations on human allografts is feasible and critical to assure that the patient receives tissue, which is safe, individually checked and prepared in a suitable environment.

The effect of the EU tissues and cells directive on bone banking in Denmark: a case study.

As a result of the EU Tissues and Cells Directive (2004/23/EC), therapeutic tissue banking is currently being restructured throughout Europe. The stated objectives are to enhance a safe and stable supply of bone and tissue in Europe and to facilitate internal exchange. We conducted an interview study to explore the effect of the Directive on Danish bone banks in terms of (1) organizational restructuring, (2) supply and range of exchange, (3) economic costs. We found that the Directive stimulated extensive re-organization of bone banks with a substantial adjoining workload; that it is doubtful whether it will increase supply and range of exchange; and that the transposition of the Directive is associated with considerable extra cost. Additionally, we found that elements in the documentation of safety were fabricated by surgeons to avoid what was seen as unnecessary questioning of potential donors.

[Logistics and European laws on allogeneic tissue transplantation]. / Logistik und europäische Gesetze für allogene Gewebetransplantate.

European rules stipulate quality and safety requirements on recruitment, testing, preserving, and distributing human tissues for application in patients in order to obtain a high level of health safety. In order to avoid transmissible diseases in tissue transplantation, specific requirements for all individual groups of tissues of human origin were defined. European Member States need to implement these directives in order to obtain a high level of health protection in human application. Precise instructions for tissue institutes regarding organization, management, documentation, and quality controls are required. Adverse effects have to be registered by these institutions. Costs need to be contained and therefore uniform administrative directives will engineer the modern techniques of communication. A uniform European code is needed for easy traceability of human tissues. The directive respects the basic human rights as laid down in the Charter of Fundamental Rights of the European Union.

[Influence of European regulations on quality, safety and availability of cell and tissue allografts in Germany]. / Einfluss europäischer Regulativa auf Qualität, Sicherheit und Verfügbarkeit allogener Zell- und Gewebetransplantate in Deutschland.

The transplantation of allogenic tissue (bone, cartilage, tendon, skin, amnion and special preparations such as demineralised bone matrix and acellular dermis) is an important component of the treatment of bone and soft tissue defects, particularly in traumatology and orthopaedic, reconstructive and plastic surgery. In Germany, the requirement for such tissue transplants is met by supply from local tissue banks (in particular bone banks) and a small number of regional and national tissue banks. These banks operate on the basis of the "Guidelines for Bone Banks" laid down by the German Chamber of Physicians, and of the German Drug Law (AMG). The 2004/23/EG guidelines issued by the European Parliament and ratified on 31/3/2004 define the quality and safety standards for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. These guidelines will have a major impact on all aspects of tissue banking and transplantation. In particular, the new guidelines will remove the possibility for local tissue banks to operate outside of national drug laws ( section sign 4 a [4]). The currently in draft law on "Quality and Safety of Human Tissues and Cells" ("Tissue Law") of the Federal Health Ministry seems to be heading in this direction, but it also includes possibilities for the continuation of local banks. An additional European guideline draft "Proposal for the regulation of advanced therapeutic medical products" is currently under discussion. This paper assesses the impact of these new pieces of legislation on the quality, safety and availability of human cell and tissue transplants in terms of the current situation and future prospects in Germany.

[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.