Article ID Journal Published Year Pages File Type
3816881 La Presse Médicale 2016 4 Pages PDF
Abstract

SummaryBackgroundA 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.MethodsThe programme reviewed use of plasma in various settings, novel components, adverse reactions, manufacturing and quality monitoring issues.ResultsThe 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.ConclusionA 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.

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