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A symposium on plasma for direct clinical use was held in September 2015 by the European directorate for the quality of medicines and healthcare (EDQM) in order to consider changes to the Council of Europe guide to the preparation, use and quality assurance of blood components monographs on plasma components.
The programme reviewed use of plasma in various settings, novel components, adverse reactions, manufacturing and quality monitoring issues.
The main requirement identified was that plasma should be made available to support early transfusion in the trauma/massive haemorrhage setting. Further guidance on component manufacturing and reviewing of quality monitoring requirements will also be addressed.
A working group has been established to review component monographs and other advice in the guide relating to plasma components, with the aim of providing optimal components to support clinical management of patients requiring plasma.Le texte complet de cet article est disponible en PDF.