Coding of tissue preparations with eurocode in Germany.

A safe look back of products requires their unique identification. Blood products are encoded in Germany with Eurocode since 1987. EU Directives 2004/23/EC und 2006/86/EC demanded unique identification and safe look back procedure also for tissues and cells.

CT Lesion Model-Based Structural Allografts: Custom Fabrication and Clinical Experience.

Background: Patients requiring knee and hip revision arthroplasty often present with difficult anatomical situations that limit options for surgery. Customised mega-implants may be one of few remaining treatment options. However, extensive damage to residual bone stock may also be present, and in such cases even customised prosthetics may be difficult to implant.

"Eurocode International Blood Labeling System" enables unique identification of all biological products from human origin in accordance with the European Directive 2004/23/EC.

Due to their limited availability and compatibility, biological products must be exchanged between medical institutions. In addition to a number of national systems and agreements which strive to implement a unique identification and classification of blood products, the ISBT 128 was developed in 1994, followed by the Eurocode in 1998. In contrast to other coding systems, these both make use of primary identifiers as stipulated by the document ISO/IEC 15418 of the International Organization for Standardization (ISO), and thus provide a unique international code.

No influence of collagenous proteins of Achilles tendon, skin and cartilage on the virus-inactivating efficacy of peracetic acid-ethanol.

The risk of transmitting human pathogenic viruses via allogeneic musculoskeletal tissue transplants is a problem requiring effective inactivation procedures. Virus safety of bone transplants was achieved using peracetic acid (PAA)-ethanol sterilisation. Proteins are known to have an adverse effect on the virus-inactivating capacity of PAA.

Distraction forces on repaired bucket-handle lesions in the medial meniscus.

Background: Numerous studies have investigated the biomechanical properties of meniscal repair techniques. One of the most commonly discussed parameters is the failure load in the axis of insertion, although little is known about the distraction forces actually occurring at repaired bucket-handle lesions.

Hypothesis: There are clinically relevant distraction forces on repaired meniscus bucket-handle lesions.

A method for the determination of the residual chloroform in defatted cancellous bone transplants.

The removal of fat from cancellous bone tissue promotes the clinical healing of the transplant and improves the penetration of chemical sterilisation media into the tissue. Treatment using chloroform/methanol (2:1, 2 h) is frequently used as a defatting procedure. Eight rinses with methanol followed by two rinses with aqua ad iniectabilia (20 min each, with ultrasonic effect) ensure depletion in the level of chloroform from defatted cancellous bone to a concentration below 25 ppm (limit value).

The establishment of a network of European human research tissue banks.

This is a report of a workshop held on the establishment of human research tissue banking which was held in Levi, Finland 21-24 March 2002. There were 21 participants from 7 European countries. This meeting was attended by representatives from academia, research tissue banks and from the Biotech and Pharmaceutical Industries.

Clinical efficacy and compatibility of allogeneic avital tissue transplants sterilized with a peracetic acid/ethanol mixture.

In the course of the past 20 years a quantity of approximately 60,000 allogeneic avital tissue grafts sterilized with the peracetic acid-ethanol method (PES) were transplanted successfully. Based on a retrospective report of clinical experience of the years 1997-2001 on the overall scope of tissue grafts manufactured by the Tissue Banks of the University Hospital Charité and the German Institute for Cell and Tissue Replacement, the clinical efficacy and side effects of 18.3% (3.

Peracetic acid-ethanol treatment of allogeneic avital bone tissue transplants--a reliable sterilization method.

Objectives: Based on the European Standard EN 1040, the validation guidelines of the German Federal Institute for Drugs and Medical Devices and CPMP guidelines we tested the antimicrobial effectiveness of a peracetic acid-ethanol sterilization procedure (PES) in allogenic avital bone transplants.

Study Design: Delipidated human bone spongiosa cubes (15 x 15 x 15 mm) served as tissue. Three enveloped viruses (human immunodeficiency virus type 2, pseudorabies virus, bovine virus diarrhoea virus) and three non-enveloped viruses (hepatitis A virus, poliovirus, porcine parvovirus) were used.

Good preservation of initial mechanical properties in lipid-extracted, disinfected, freeze-dried sheep patellar tendon grafts.

Patellar tendon allografts can be used for anterior cruciate reconstruction to avoid morbidity of autografts on the donor side. Secondary processing of allografts is important for reducing immunological reactions, bacterial contamination and improving storage. We analyzed the effects of processing on the mechanical properties of patellar tendon grafts in 20 sheep.

Reconstruction of the frontal calvarian continuity in a child using a freeze-preserved autogenous bone graft.

Today, extended craniofacial defects in childhood can be treated by using modern techniques of bone banking and osteosynthesis, of particular importance when the restoration needs to consider calvarial growth. This is a report of an 8-year-old boy whose right frontal bone was removed during primary multidisciplinary trauma care. The bone was stored at a tissue bank using sterilization and freeze-dried preservation.

Effect of gamma irradiation on human cortical bone transplants contaminated with enveloped and non-enveloped viruses.

In the production of bone grafts intended for transplantation, basic safety measures to avoid the transmission of pathogens are selection and serological screening of donors for markers of virus infections. As an additional safety tool we investigated the effect of gamma irradiation on the sterility of human bone diaphysis transplants and evaluated its impact on the virus safety of transplants. Model viruses were included in the study to determine the dose necessary to achieve a reduction factor for the infectivity titres of at least 4 log(10) at a temperature of -30+/-5 degrees C.