Results of the clinical donor case and quality system case workshops of the European Association of Tissue Banks annual meeting 2009.

The European Association of Tissue Banks (EATB) Donor Case Workshop and Quality System Case workshop are forums held within the program of the EATB Annual Congress. These workshops offer an opportunity to discuss and evaluate approaches taken to challenging situations, regarding donor selection and quality issues, and strengthen the professional tissue banking and regulatory networks across Europe. This report reflects some of the discussion at the congress workshops and also subsequent correspondence between the various individuals who submitted cases for discussion. The cases presented to the workshops demonstrate that the findings, their interpretation, deducted actions and preventive measures in tissue banks are not predictable. The varied responses and lack of consensus corroborate this and clearly indicate that operating procedures cannot comprehensively cover or prepare for all eventualities. For many of the issues raised there is a lack of information in the published literature. The workshops actively engage participants, representing a wide array of international expertise, in an informal, secure and enjoyable setting, which facilitates learning from peers and provides potential solutions to those submitting cases. By publishing a summary of the discussions, we hope to reach a wider audience and to stimulate individuals to undertake full literature reviews or research on some of the discussed subjects.

A pilot to examine the logistical and feasibility issues in testing deceased tissue donors for vCJD using tonsil as the analyte.

Transplanted tissues have transmitted transmissible spongiform encephalopathies and in the UK there have been more cases of variant Creutzfeldt-Jakob disease (vCJD) than elsewhere in the world. A pilot study was undertaken to look at the feasibility of testing for vCJD in deceased donors using tonsillar tissue. This pilot showed that obtaining consent for removal and testing tonsil tissue was feasible. Donor eligibility for inclusion in the pilot was limited to tissue donors from the National Health Service Blood and Transplant, Tissue Services and to donors shared with the Corneal Transplant Service Eye Banks. Obtaining tonsillar tissue in the immediate post-mortem period was limited by the presence of rigor mortis. Tonsillar tissue was suitable for routine analysis for the presence of prion associated with vCJD in deceased tissue donors. Production and processing of tissue was straightforward and a low assay background was obtained from most samples. Since palatine and lingual tonsil tissue can be obtained in pairs it was possible, in the majority of cases, to set aside an intact sample for confirmatory testing if required. In one instance a sample was reactive by Western blot. However, the pattern of reactivity was not typical for that obtained from vCJD patients. Unfortunately the sample was not of sufficient quality for the confirmatory test to provide a conclusive result.

European coding system for tissues and cells: a challenge unmet?

The Comité Européen de Normalisation (European Committee for Standardization, CEN) Workshop on Coding of Information and Traceability of Human Tissues and Cells was established by the Expert Working Group of the Directorate General for Health and Consumer Affairs of the European Commission (DG SANCO) to identify requirements concerning the coding of information and the traceability of human tissues and cells, and propose guidelines and recommendations to permit the implementation of the European Coding system required by the European Tissues and Cells Directive 2004/23/EC (ED). The Workshop included over 70 voluntary participants from tissue, blood and eye banks, national ministries for healthcare, transplant organisations, universities and coding organisations; mainly from Europe with a small number of representatives from professionals in Canada, Australia, USA and Japan. The Workshop commenced in April 2007 and held its final meeting in February 2008. The draft Workshop Agreement went through a public comment phase from 15 December 2007 until 15 January 2008 and the endorsement period ran from 9 April 2008 until 2 May 2008. The endorsed CEN Workshop Agreement (CWA) set out the issues regarding a common coding system, qualitatively assessed what the industry felt was required of a coding system, reviewed coding systems that were put forward as potential European coding systems and established a basic specification for a proposed European coding system for human tissues and cells, based on ISBT 128, and which is compatible with existing systems of donation identification, traceability and nomenclatures, indicating how implementation of that system could be approached. The CWA, and the associated Workshop proposals with recommendations, were finally submitted to the European Commission and to the Committee of Member States that assists its management process under article 29 of the Directive 2004/23/EC on May 25 2008. In 2009 the European Commission initiated an impact assessment on the Workshop proposals and recommendations. In the absence of an agreed pan-European direction various initiatives have continued work using, adopting or adapting their preferred, or existing, methods.

Amniotic membrane transplantation for ocular disease: a review of the first 233 cases from the UK user group.

BACKGROUND: Amniotic membrane transplantation (AMT), as a new tool in the armamentarium of therapies available for ocular surface problems, became widely available in the UK in 1998. This study evaluates the indications for treatment, the surgical procedures used, and the results of a subset of the first AMT cases carried out by the group using this nationally available supply. This user group model provides data which is different from that obtained from uncontrolled case series, or clinical trials, and may be more representative of the outcomes that can be expected when a procedure becomes widely available. METHODS: The first 233 AMTs, performed by the UK user group, were evaluated by audit and outcomes were assessed at 3 months. RESULTS: Of the 233 transplants, there were 126 (54.1%) valid outcome returns: the outcome for persistent epithelial defects was a healed and stable surface in 11/35 (31.4%, 95% CI 16.9 to 49.3); for chemical/thermal injuries, a healed uninflamed eye with clear cornea in 5/18 (27.8%, 95% CI 9.7 to 53.4); for bullous keratopathy a pain-free, stable surface without bullae in 4/18 (22.2%, 95% CI 6.4 to 47.6); for ocular surface reconstruction, an epithelialised uninflamed conjunctiva without scarring in 12/23 (52.2%, 95% CI 30.6 to 73.2); and for limbal stem cell deficiency, a corneal phenotype in 4/7 (57.1%). The operative technique least associated with failure was use of a bandage contact lens at the end of the procedure (OR 0.19, 95% CI 0.06 to 0.59, p = 0.004). Previous treatment with topical steroids was significantly associated with failure (OR 5.70, 95% CI 1.77 to 18.43, p = 0.004). CONCLUSION: Although the outcome criteria used in this study were stringent, and the follow-up duration was short, the results of AMT by this user group were generally less favourable than those of previously reported case series. Controlled clinical trials would improve the quality of evidence for use of amniotic membrane in ocular disease.