Technical data sheets: a tool for analyzing adverse effects in recipients

To assist in the analysis of adverse events occurring in patients receiving labile blood products, fact sheets were developed for hemovigilance liaisons by working groups of the French Agency for the Safety of Health Products (Afssaps), now the French National Agency for Medicines and Health Products Safety (ANSM) on May 1, 2012. Each technical fact sheet describes a recipient adverse reaction in five sections, including its pathophysiology, diagnostic criteria, management, etiological investigation, and specific reporting requirements to the ANSM. Since 2006, 11 fact sheets have been posted on hemovigilance websites in France. The key data from the two most recent fact sheets, “post-transfusion purpura” and “non-erythrocyte immunological incompatibility,” are presented, along with an update to the “allergy” fact sheet and its accompanying documents. These fact sheets provide methodological support, particularly for the diagnostic evaluation of transfusion reactions, their severity, and causality. They also open up new avenues for study and research in transfusion medicine, including within European and international hemovigilance networks.

Author(s): Bazin A, Trophilme C, Py JY, Caldani C, Daurat G, Hauser L, Leconte des Floris MF, Moncharmont P, Pillonel J, Renaudier P, Richomme X, Sailliol A, Boudjedir K, Ounnoughene N, Sandid I, Vo Mai MP, Carlier M

Publishing year: 2012

Pages: 187-94

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