Appendix I: International context
The first haemovigilance system in Europe was initiated in France in 1994, in large part as a reaction to the human immunodeficiency virus scandal in the 1980s and early 1990s. Other European countries followed this initiative, notably the SHOT program in the UK in 1996. The French and UK systems are the most mature and continue to provide insightful data and contribute to the global improvement of quality of care. Subsequent to the adoption and implementation of the European Blood Directive (2002/98/EC) and three additional implementing directives (2004/33/EC, 2005/61/EC and 2005/62/EC), nearly all European Union countries, and many other countries internationally, have established haemovigilance systems.
The current haemovigilance systems show significant differences related to what is reported (such as all versus serious adverse events) and how the system is organised (such as voluntary versus mandatory reporting). The majority of the serious adverse reactions and events reported to the systems occurred in hospitals and the majority of preventable adverse reactions are due to human errors. Data from the UK SHOT program has drawn attention to the fact that about 50% of adverse events are due to administrative errors. Various corrective actions and success measures have improved the safety of blood products and quality of transfusion practice. One key example is the use of male only donor plasma, which has resulted in a significant reduction of TRALIs in many countries such as the UK, the Netherlands, France, Canada, Australia and New Zealand.