[The new Blood Law and new principles of transfusion therapy]

The new Blood Law for Self-sufficiency, Stable Supply of Safe Blood Products and Other Transfusion-related Rules was enacted in July 2003. In terms of the safety of blood products, improvement of screening tests and the introduction of the viral nucleic acid amplification test to shorten the so-called window period have markedly reduced the incidence of blood-borne virus transmission, although they cannot completely protect against transfusion-associated adverse reactions. Even with increasing blood safety, there remains an iatrogenic risk of ABO-mismatched transfusions without proper management systems and standard operation procedures. Fresh frozen plasma and plasma derivatives have been and continue to be used much more in Japan compared with the international standard. As a result, the shortage of domestic blood products remains an obstacle to achieving self-sufficiency. The goal of the new law is to provide safe transfusion therapy and achieve self-sufficiency in all blood products including plasma derivatives such as albumin solutions. To reach this goal medical professionals should recognize the necessity for safe and appropriate transfusions and establish new principles for improved transfusion therapy, including standard indications, safe operation procedure guidelines, and a 24-hour management system in each hospital.