Careful donor selection and implementation of tests of appropriate sensitivity and specificity are of paramount importance for minimizing the risk of transmitting infectious diseases from donors to corneal allograft recipients. Reported cases of viral transmission with corneal grafts are very unusual. Nevertheless potential virus transmission through the engraftment cannot be ruled out. According to European Guideline 2006/17/EC, screening for antibodies for Hepatitis B core antigen (anti HBc) is mandatory, and when this test is positive, some criteria must be established before using corneas. Despite the continuous progress in screening tests, donors carrying an occult hepatitis B infection (OBI) can cause transplant-transmitted hepatitis B. To date, Nucleic Acid Testing (NAT) is not an obligatory assay in corneal tissue setting neither in our country nor in the rest of European countries. Herein, we report three cornea donors that were rejected with the diagnosis of OBI through the testing of sensitive NAT and the serological profile of Hepatitis B virus. The aim of this report is to emphasize the need to include NAT in new reviews of EU Tissues and Cells Directives in order to increase level of security in tissue donation as well as not to reject a high number of donors with isolated profile of anti HBc in geographical areas with high prevalence of Hepatitis B, that could be rejected without a true criterion of Hepatitis B infection.
The recent introduction as a minimum test required in The Guide to Safety and Quality Assurance for Organs, Tissues and Cells (Council Europe) and the Directive 2004/23/EC applied to donation, procurement, testing, processing, preservation, storage and distribution of human cells and tissues make necessary the implementation of these markers in all European Tissue Establishments. In this study we have analyzed the impact in tissues discard by introducing anti-HBc in a European Tissue Establishment in a country with a high prevalence of HBV infection. The adoption of this exclusion criteria in this region results in acceptably rejection rates among tissue donors, although some studies are needed on basis a risk assessment to determine the eligibility for clinical use.
Specular microscopy can provide a non-invasive morphological analysis of the cornea endothelial cell layer. A variety of analysis programs are available to determine corneal endothelial quality. The flex-center endothelial analysis method (Konan Inc) is a newer technique including the outermost digitized cells and thus increases the number of cells for analysis. The aim of this study is to analyze whether the new flex-center method, increases the possibilities of corneal endothelium evaluation before implants. For this purpose 67 corneas were studied by both methods at the Eye Bank of the Tissue Establishment of Córdoba. Although we have found differences in the resulting of number of cells in the area analysed, no significant differences were found with respect to the endothelial cell count, coefficient of variation cell area, and the percentage of hexagonal cells recorded. Based on this data, both methods can be used satisfactorily in eye banking.
Quality control and standardized preservation methods are essential in the field of transplantation. The International Organization for Standardization (ISO) has established a common set of manufacturing, trade and communications standards that are applicable worldwide and that provide the basis of a quality plan for Tissuebreak Banks.The Sectorial Tissue Banking (STB) of the Regional Blood Transfusion Center (RBTC) of Córdoba (Spain) is a non-profit-making tissue bank, established in 1992 to provide tissues for surgical procedures to the hospitals in a regional area. In 1998, the STB as a part of the RBTC embarked upon the path of becoming ISO-certified: after two years of the implementation of the project, STB attained ISO 9002 certification, thus becoming one of the first tissue banks in Europe to achieve this qualification. In this paper we describe the process of becoming ISO-certified, to demonstrate the positive impact that it has had on our entire organization.The assistance of an outside consultant who provided the necessary information for implementing an ISO quality management system was required. The initial improvement was: a well-defined quality manual to address all elements of the ISO 9002 standard, an improved document control system, detailed standard operating procedures (SOPs) and improved employees training processes. A quality committee team and developed quality indicators were created. The internal quality auditing program was established by the selection of employees from a cross-section of the organization, who were trained in internal auditing processes. A formal corrective action system was developed and implemented to facilitate process improvement. The consultant conducted a pre-certification audit, and one month later the certification audit was performed.In conclusion, the implementation of an ISO quality program in the STB has helped our center to establish a control process in the manufacturing of products and services to meet the expectations of our customers, by providing components and services that comply with the national regulatory standards and requirements.
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