The International Haemovigilance Network Database for the Surveillance of Adverse Reactions and Events in Donors and Recipients of Blood Components: technical issues and results.

BACKGROUND AND OBJECTIVES: The International Haemovigilance Network's ISTARE is an online database for surveillance of all adverse reactions (ARs) and adverse events (AEs) associated with donation of blood and transfusion of blood components, irrespective of severity or the harm caused. ISTARE aims to unify the collection and sharing of information with a view to harmonizing best practices for haemovigilance systems around the world. MATERIALS AND METHODS: Adverse reactionss and adverse events are recorded by blood component, type of reaction, severity and imputability to transfusion, using internationally agreed standard definitions. RESULTS: From 2006 to 2012, 125 national sets of annual aggregated data were received from 25 countries, covering 132.8 million blood components issued. The incidence of all ARs was 77.5 per 100 000 components issued, of which 25% were severe (19.1 per 100 000). Of 349 deaths (0.26 per 100 000), 58% were due to the three ARs related to the respiratory system: transfusion-associated circulatory overload (TACO, 27%), transfusion-associated acute lung injury (TRALI, 19%) and transfusion-associated dyspnoea (TAD, 12%). Cumulatively, 594 477 donor complications were reported (rate 660 per 100 000), of which 2.9% were severe. CONCLUSIONS: ISTARE is a well-established surveillance tool offering important contributions to international efforts to maximize transfusion safety.

Quality validation of data in national haemovigilance systems in Europe: report of a survey on current state of practice.

European Union member states must have national haemovigilance reporting of serious adverse reactions and events. We sent national competent authorities an email questionnaire about data validation. Responses were received from 23/27 countries. Nine previously had no national haemovigilance system. In 13 (57%), the serious adverse reactions and events can be verified. Coverage of blood establishments is documented in 20 systems (87%) and of hospitals in 15 systems (65%). Although all member states have implemented haemovigilance systems, there are currently wide variations in data quality assurance, not allowing comparisons between countries.

Haemovigilance: an effective tool for improving transfusion practice.

Haemovigilance is a tool to improve the quality of the blood transfusion chain, primarily focusing on safety. In this review we discuss the history and present state of this relatively new branch of transfusion medicine as well as some developments that we foresee in the near future. The top 10 results and conclusions are: (1) Haemovigilance systems have shown that blood transfusion is relatively safe compared with the use of medicinal drugs and that at least in Europe blood components have reached a high safety standard. (2) The majority of the serious adverse reactions and events occur in the hospital. (3) The majority of preventable adverse reactions are due to clerical errors. (4) Some adverse reactions such as anaphylactic reactions often are not avoidable and therefore have to be considered as an inherent risk of blood transfusion. (5) Well-functioning haemovigilance systems have not only indicated how safety should be improved, but also documented the success of various measures. (6) The type of organisation of a haemovigilance system is of relative value, and different systems may have the same outcome. (7) International collaboration has been extremely useful. (8) Haemovigilance systems may be used for the vigilance and surveillance of alternatives for allogeneic blood transfusion such as cell savers. (9) Haemovigilance systems and officers may be used to improve the quality of aspects of blood transfusion other than safety, such as appropriate use. (10) Haemovigilance systems will be of benefit also for vigilance and surveillance of the treatment with other human products such as cells, tissues and organs.

[Review of the main haemovigilance systems in the world]. / Revue des principaux systèmes d'hémovigilance dans le monde.

Since 2002, major progress has occurred worldwide in the context of haemovigilance and significant improvement of the blood chain has come out as a result. Nevertheless different scenarios exist throughout the European Union and outside of Europe: the systems are mandatory or voluntary, notification is required for recipients, donors, processes or activities in the broad context of blood component transfusion. Differing from country to country, notification is mandatory for all adverse reactions or only for serious ones; and so it is with adverse events. Under-reporting is generally considered to be the most important single problem. But there is no doubt that haemovigilance will continue to help improve quality and safety of blood transfusion.

[Blood surveillance in Europe]. / L'hémovigilance en Europe.

The organisation of haemovigilance in Europe is quite heterogeneous between the different member states of the European Union, which requires an exchange of information between the different systems through the creation of the European Haemovigilance Network. This article presents, firstly, the various regulatory and administrative levels where the European policy in this matter is decided, and secondly, the different situations of haemovigilance organisation in the main European countries.