| Quality and Safety in Blood Supply in 2010. | |
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MedLine Citation:
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PMID: 20577599 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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The past two decades saw tremendous achievements in blood safety, which are due to the commitment of blood establishments and industry, progress in technology such as the improvement of serological and NAT screening tests, and stringent regulatory control. Milestones in the legislation were the inclusion of plasma derivatives in the pharmaceutical legislation of the European Community (EC) in the year 1989 and special laws for the blood sector in EC and in member states, such as the Transfusionsgesetz (Transfusion Law) in Germany. The legal frame has to be supplemented by scientific and technical guidance, which is provided on the European level by the European Directorate for the Quality of Medicines and Health Care and by the European Medicines Agency. In the member states, guidelines taking into account the national peculiarities can be elaborated, such as the German hemotherapy guidelines issued by the German Medical Association (Bundesärztekammer) in agreement with the Paul-Ehrlich-Institut. The regulatory control of screening tests, and the introduction of NAT testing lead to a remarkably high degree of safety concerning the most relevant viruses HIV, HBV and HCV. Issues needing further attention are bacterial contamination and transfusion-associated acute lung injury (TRALI). Measures aiming at minimizing risks have to be balanced against their impact on supply. In order to ensure the assured supply with safe blood products, sustained efforts and research are needed as well as a continuous dialogue among blood services, industry, physicians, patients and regulatory authorities. |
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Authors:
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Rainer Seitz; Margarethe Heiden |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2010-5-20 |
Journal Detail:
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Title: Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie Volume: 37 ISSN: 1660-3818 ISO Abbreviation: - Publication Date: 2010 Jun |
Date Detail:
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Created Date: 2010-6-25 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101176417 Medline TA: Transfus Med Hemother Country: - |
Other Details:
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Languages: ENG Pagination: 112-117 Citation Subset: - |
Affiliation:
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Division of Hematology/Transfusion Medicine, Paul-Ehrlich-Institut, Langen, Germany. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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