22 research outputs found

    Critical pathway for deceased tissue donation: a novel adaptative European systematic approach

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    Vía crítica; Donantes de tejidos; Obtención de tejidoCritical pathway; Tissue donors; Tissue procurementVia crítica; Donants de teixits; Obtenció de teixitsA ‘Critical pathway for deceased tissue donation’ was developed by the European Committee on Organ Transplantation of the Council of Europe (CD-P-TO) with the aim of providing a common systematic approach to the deceased tissue donation process. Definitions of tissue donors according to the donation stage have been developed so that they can be adapted to different local scenarios. This critical pathway can be used retrospectively to evaluate the potential of tissue donation, assess performance in the tissue donation process and identify areas for improvement. It sets the basis to build indicators to compare organizations, regions and countries. The critical pathway can also be used prospectively to promote good practices in tissue donation programmes aimed at covering the tissue transplantation needs of patients

    Haemovigilance:current practices and future developments

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    Haemovigilance is the systematic surveillance of adverse events in the transfusion chain, and encompasses activities that contribute to the safety and quality in the process of blood donation and transfusion. From the start in the early 1990s, haemovigilance has put emphasis on different adverse reactions and incidents in recipients and subsequently in donors, pointing to vulnerabilities in the transfusion chain and areas for prevention. More recently, the monitoring of efficacy and efficiency of transfusion practice has been introduced in the concept of haemovigilance. The purpose of this review is to present an overview of the current status and future developments of haemovigilance. Haemovigilance is part of the quality systems of the blood collection establishments, transfusion laboratories and the transfusion institutions. The monitoring, investigation and analysis of adverse events generates relevant data for the quality cycle of these systems, driving continuous improvement in transfusion practice. Recommendations based on haemovigilance findings have led to changes in clinical guidelines and policies. Despite the progress haemovigilance has made, further developments are needed. Current challenges lie in the field of the establishment of haemovigilance systems in low resource settings, the international harmonisation of definitions and the prevention of underreporting. In addition, the causal relationship between the transfusion and the reaction is often unclear. Biomarkers may aid in the imputability assessment and their role in the diagnosis of transfusion reactions needs to be further investigated. Future developments are expected in automated reporting, the use of big data and increased shareability of international data, contributing to a better understanding of the causal mechanisms and risk factors, and to prevention of adverse events. Haemovigilance is an evolving discipline and will continue to contribute to improving the safety of blood donation and transfusion

    Analyse der Tätigkeiten kardiovaskulärer Gewebebanken in Deutschland in den Jahren 2007 bis 2010

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    __Background:__ Especially in complicated aortic valve endocarditis, infections of the aorta by mycotic aortic aneurysms and prosthetic infections, or as part of the Ross procedure, the use of allogeneic heart valve transplants remains important. The production of such allografts in Germany is the task of cardiovascular tissue banks (CVTB). __Materials and methods:__ During an analysis of the years 2007-2010, basic data on donor numbers, production, and distribution as well as the technical conditions of not only the four participating CVTB (Bad Oeynhausen, Berlin, Kiel, Munich) but also data from the CVTB Rotterdam as an external reference were recorded. __Results:__ The German CVTB delivered an average of 44 aortic and 95 pulmonary allografts per year to clinical users. By incorporating the annually imported valve allografts, the demand in Germany approximately averages 220 heart valve allografts per year. The heart tissue was harvested from approximately 100 multiorgan donors, 45 cardiovascular deaths, and 80 domino donors annually. __Discussion:__ The participating cardiovascular tissue banks have comparable technical and administrative requirements and are able to produce tissue preparations according to the rules of Good Professional Practice in accordance with § 3 (3) AMWHV to assess their quality, whereby harmonization of microbiological monitoring and antibiotic treatment is still necessary

    Physical examination of potential tissue donors: results of a risk management procedure to identify the critical elements of the physical examination

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    To identify critical elements of physical examination (PE) of potential tissue donors that could help to improve the safety of tissue transplantation. Physical signs were identified that can indicate the presence of a contraindication mentioned in EU Directive 2006/17/EC and that can theoretically be detected at PE. A risk assessment was designed, according to the Failure Mode and Effects Analysis model. Signs were scored on several aspects, taking into account various control measures, either required in the EU Directive or additional non-required measures. 106 signs associated with general and tissue-specific contraindications were identified. Signs of advanced infection with HIV, hepatitis B/C and syphilis (n = 13, 12.3%) can be omitted, since these contraindications will be detected by the required serological testing. With the required control measures, risk priorities are unacceptably "high" for 17.3% of the signs. For 64.5% of the signs, additional control measures are possible, which result in acceptable risk priorities for all signs. This risk management procedure identified the minimal necessary content of PE in potential tissue donors. Furthermore, risks associated with tissue donation were elucidated and possible risk control measures were identified as well as their impact on the safety of tissue transplantation

    Haemovigilance: current practices and future developments

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    Haemovigilance is the systematic surveillance of adverse events in the transfusion chain, and encompasses activities that contribute to the safety and quality in the process of blood donation and transfusion. From the start in the early 1990s, haemovigilance has put emphasis on different adverse reactions and incidents in recipients and subsequently in donors, pointing to vulnerabilities in the transfusion chain and areas for prevention. More recently, the monitoring of efficacy and efficiency of transfusion practice has been introduced in the concept of haemovigilance. The purpose of this review is to present an overview of the current status and future developments of haemovigilance. Haemovigilance is part of the quality systems of the blood collection establishments, transfusion laboratories and the transfusion institutions. The monitoring, investigation and analysis of adverse events generates relevant data for the quality cycle of these systems, driving continuous improvement in transfusion practice. Recommendations based on haemovigilance findings have led to changes in clinical guidelines and policies. Despite the progress haemovigilance has made, further developments are needed. Current challenges lie in the field of the establishment of haemovigilance systems in low resource settings, the international harmonisation of definitions and the prevention of underreporting. In addition, the causal relationship between the transfusion and the reaction is often unclear. Biomarkers may aid in the imputability assessment and their role in the diagnosis of transfusion reactions needs to be further investigated. Future developments are expected in automated reporting, the use of big data and increased shareability of international data, contributing to a better understanding of the causal mechanisms and risk factors, and to prevention of adverse events. Haemovigilance is an evolving discipline and will continue to contribute to improving the safety of blood donation and transfusion

    Dynamics of HbA<sub>1c</sub> during 8 weeks post whole blood donation (Tosoh G8).

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    <p>Horizontal dotted lines represent the Tosoh G8 one-tailed RCV (-4.28%) calculated for SI units. <i>A</i>: 23 non-diabetic blood donors after 475 mL whole blood donation. A low maximum % reduction in HbA<sub>1c</sub> correlated with an early time point in the study, a high maximum % reduction in HbA<sub>1c</sub> correlated with a late time point (Spearman r = -0.668; <i>P</i> = 0.0005). <i>B</i>: Individual changes of HbA<sub>1c</sub> in 23 non-diabetic blood donors. The orange lines represent non-diabetic blood donors with low ferritin (<30 μg/L). <i>C</i>: 17 blood donors with type 2 diabetes after 475 mL whole blood donation. A low maximum % reduction in HbA<sub>1c</sub> correlated with an early time point in the study, a high maximum % reduction in HbA<sub>1c</sub> correlated with a late time point (Spearman r = -0.547; <i>P</i> = 0.015). <i>D</i>: Individual changes of HbA<sub>1c</sub> in 17 blood donors with type 2 diabetes. The orange lines represent blood donors with type 2 diabetes with low ferritin (<30 μg/L).</p

    Whole Blood Donation Affects the Interpretation of Hemoglobin A<sub>1c</sub>

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    <div><p>Introduction</p><p>Several factors, including changed dynamics of erythrocyte formation and degradation, can influence the degree of hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) formation thereby affecting its use in monitoring diabetes. This study determines the influence of whole blood donation on HbA<sub>1c</sub> in both non-diabetic blood donors and blood donors with type 2 diabetes.</p><p>Methods</p><p>In this observational study, 23 non-diabetic blood donors and 21 blood donors with type 2 diabetes donated 475 mL whole blood and were followed prospectively for nine weeks. Each week blood samples were collected and analyzed for changes in HbA<sub>1c</sub> using three secondary reference measurement procedures.</p><p>Results</p><p>Twelve non-diabetic blood donors (52.2%) and 10 (58.8%) blood donors with type 2 diabetes had a significant reduction in HbA<sub>1c</sub> following blood donation (reduction >-4.28%, <i>P</i> < 0.05). All non-diabetic blood donors with a normal ferritin concentration predonation had a significant reduction in HbA<sub>1c</sub>. In the non-diabetic group the maximum reduction was -11.9%, in the type 2 diabetes group -12.0%. When eligible to donate again, 52.2% of the non-diabetic blood donors and 41.2% of the blood donors with type 2 diabetes had HbA<sub>1c</sub> concentrations significantly lower compared to their predonation concentration (reduction >-4.28%, <i>P</i> < 0.05).</p><p>Conclusion</p><p>Patients with type 2 diabetes contributing to whole blood donation programs can be at risk of falsely lowered HbA<sub>1c</sub>. This could lead to a wrong interpretation of their glycemic control by their general practitioner or internist.</p></div
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