Interaction of preservation methods and radiation sterilization in human skin processing, with particular insight on the impact of the final water content and collagen disruption. Part I: process validation, water activity and collagen changes in tissues cryopreserved or processed using 50, 85 or 98% glycerol solutions.

Current regulatory requirements demand an in-depth understanding and validation of protocols used in tissue banking. The aim of this work was to characterize the quality of split thickness skin allografts cryopreserved or manufactured using highly concentrated solutions of glycerol (50, 85 or 98%), where tissue water activity (aw), histology and birefringence changes were chosen as parameters. Consistent aw outcomes validated the proposed processing protocols. While no significant changes in tissue quality were observed under bright-field microscopy or in collagen birefringence, in-process findings can be harnessed to fine-tune and optimize manufacturing outcomes in particular when further radiation sterilization is considered. Furthermore, exposing the tissues to 85% glycerol seems to derive the most efficient outcomes as far as aw and control of microbiological growth.

European quality system for tissue banking.

AIM: The aims of this project were to analyze the factors that influence quality and safety of tissues for transplantation and to develop the method to ensure standards of quality and safety in relation to tissue banking as demanded by European Directive 2004/23/EC and its technical annexes. It is organized in 4 Working Groups, the objectives of each one being focused in a specific area. STANDARDS: The Guide of Recommendations for Tissue Banking is structured into 4 parts: (1) quality systems that apply to tissue banking and general quality system requirements, (2) regulatory framework in Europe, (3) standards available, and (4) recommendations of the fundamental quality and safety keypoints. REGISTRY: This Working Group handled design of a multinational musculoskeletal tissue registry prototype. TRAINING: This Working Group handled design and validation of a specialized training model structured into online and face-to-face courses. The model was improved with suggestions from students, and 100% certification was obtained. AUDIT: The Guide for Auditing Tissue Establishments provides guidance for auditors, a self-assessment questionnaire, and an audit report form. The effectiveness and sustainability of the outputs were assessed. Both guides are useful for experienced tissue establishments and auditors and also for professionals that are starting in the field. The registry prototype proves it is possible to exchange tissues between establishments throughout Europe. The training model has been effective in educating staff and means having professionals with excellent expertise. Member states could adapt/adopt it. The guides should be updated periodically and perhaps a European organization should take responsibility for this and even create a body of auditors.

Subsidence of the stem after impaction bone grafting for revision hip replacement using irradiated bone.

Loss of bone stock is a major problem in revision surgery of the hip. Impaction bone grafting of the femur is frequently used when dealing with deficient bone stock. In this retrospective study a consecutive series of 68 patients (69 hips) who had revision of a hip replacement with femoral impaction grafting were reviewed. Irradiated bone allograft was used in all hips. Radiological measurement of subsidence of the stem, incorporation of the graft and remodelling was carried out and showed incorporation of the graft in 26 of 69 hips (38%). However, there was no evidence of trabecular remodelling. Moderate subsidence of 5 mm to 10 mm occurred in ten hips (14.5%), and massive subsidence of > 10 mm in five (7.2%). The results of this study are less favourable than those of others describing studies of revision of the femoral stem using impaction bone grafting. The absence of the characteristic changes of graft remodelling noted in other series raises the question as to whether irradiated bone graft may be a significant factor influencing the post-operative outcome.

Confirmation of cadaveric blood sample identity by DNA profiling using Short Tandem Repeat (STR) analysis.

Blood samples collected from deceased tissue donors for mandatory transfusion microbiology testing may be taken either at the time of tissue donation, or residual samples may be retrieved from hospital laboratories where they were originally used for ante-mortem tests. In the latter case, sample labelling may not conform to the required standard, which stipulates that three independent identifiers be provided. If no alternative adequately labelled sample is available for testing the donated tissues may have to be discarded, which can adversely affect tissue sufficiency. An alternative method to ensure that the blood sample to be tested is from the intended deceased donor is to confirm the identity of the blood sample by Deoxyribonucleic Nucleic Acid (DNA) Short Tandem Repeats (STR) analysis, then comparing the DNA profile with the DNA from the donated tissues. If the two DNA profiles are identical, probability calculations can demonstrate the chance of the two samples of DNA being from the same or different individuals. The authors have used this approach to salvage deceased tissue donations.

Directional correlation in direct and sequential double ionization of model atoms.

We discuss directional dependence in the time development of spatial wavefunctions, which includes jet formation, for two-electron model atoms exposed to intense laser fields. Two competing scenarios for double ionization are evident: (1) both electrons emerge simultaneously from the core region and on the same side of the nucleus, and (2) the electrons detach on opposite sides but not simultaneously. The importance of the electron-electron repulsion contribution to the competing processes is investigated for various laser intensities.