Hemovigilance: Definition and Overview of Current Hemovigilance Systems

Abstract

SUMMARyHemovigilance, as a safety concept, appeared in the beginning of the 1990s. Its primary aim is to assure the surveillance of blood transfusion, to collect data on (serious) sequelae of blood transfusions, to inform health policy to improve transfusion standards, to assist in the formulation of guidelines in the field of transfusion and to increase the safety and quality of the entire transfusion process.Two different “poles” of systems exist. In France, where hemovigilance was rendered mandatory by law in 1994, the system is centralized and nationwide, with a legal obligation to notify in written form each and every side effect related to blood transfusion. In the UK, hemovigilance is a national voluntary scheme between professionals (SHOT, Serious Hazards of Transfusion). Learning from the lessons generated by the British and French systems enables the introduction, in other countries, of models representing “hybrids” of the two systems.Within the European Union, the recent European Blood Directive requires hemovigilance in each Member State; its provisions have to be transposed into national legislations within two years. In order to ally efforts at the Community level it would make sense to appeal to existing initiatives in this field that have proven that efficient cooperation is possible: the European Haemovigilance Network (EHN) has played a major role in bringing this important matter forward and in developing it into an efficient tool intended to increase safety and quality in European blood transfusion.