The French Hæmovigilance System

Abstract

Haemovigilance was part of the reform of the French transfusion system. The haemovigilance network is now operational with approximately 4600 transfusion incidents reported annually. Immediate incidents observed within 8 days after transfusion account for 85% of the reports. A cause cannot be identified in 41% of these, usually concerning minor clinical incidents with transient fever and/or shivers. An allergic reaction is described in 31% of transfusion reactions. Immunological conflicts account for 18% and bacteria associated transfusion reactions for 6%. The importance of bacteria associated transfusion reactions, the first identified cause of death associated with transfusion is one of the findings of haemovigilance. Improvement in the haemovigilance systems aims at obtaining better descriptions of transfusion incidents, standardisation of severity and imputability assessment and definitions of denominators such as the actual number of recipients. Delayed incidents will ultimately provide a true vision of post transfusion immunisation and infection The improvement of haemovigilance now considered as part of transfusion medicine practice is a continuous process.

SHOT–A Voluntary System for the Reporting of Serious Hazards of Transfusion in the UK

“…2 The overall goal is to make clinical care safer for patients requiring transfusion and to demonstrate to the public, patients and professionals, the safety of existing transfusion systems. 3 It can be approached in a number of different ways, as illustrated by the variety of systems which have been developed in different countries in recent years.…”

“…3 It can be approached in a number of different ways, as illustrated by the variety of systems which have been developed in different countries in recent years. 2,4,5 Issues which must be considered when devising a scheme of national hemovigilance or surveillance include the following:…”

“…There is a legal obligation on all health care personnel to report any unexpected or undesirable effect of transfusion. 2 Thus, a large body of data is generated which not only comprises serious adverse outcomes of transfusion but also encompasses minor events and those which eventually turn out to be completely unassociated with transfusion. This contrasts with the much more restricted confidential and anonymous SHOT scheme in the UK.…”

Transfusion‐Associated Septic Reactions

“…[2][3][4] In these reports, only the more severe or potentially life-threatening septic reactions are reported. It is the opinion of this author that such reports represent only one end of the clinical spectrum of septic transfusion reactions.…”

“…2 Similarly, the French hemovigilance system reported that bacterial contamination was responsible for 5 of the 33 deaths attributed to transfusion in 1996 and 1997. 3 In the United States, the bacterial contamination study, known as BaCon, recently provided evidence that septic transfusion reactions also occur regularly in the United States. 4 Although septic transfusion reactions are apparently more common with platelet products, which are stored at 22 ± 2°C, they are also associated with the inadvertent transfusion of bacterially contaminated red blood cells, plasma, cryoprecipitate, and albumin.…”