The European Blood Directive--its role in blood safety.
New EC legislation ensures a high level of quality and safety of blood and blood components, whatever the intended purpose, throughout the community. Though the initial intention was to strengthen regulatory oversight in the field of blood transfusion services, the Directive 2002/98/EC also has strong implications for the collection and testing of plasma for fractionation. Within the legal framework, as set out by Directive 2002/98/EC, mandatory minimal requirements are laid down by the Commission in further " daughter " Directives, with the assistance of a committee. While allowing some flexibility to the member states to find their specific solutions and regulatory mechanisms in transposition of the Directive, the new legislation advances the approximation of the provisions, thus strengthening the blood supply in the EC. This is an important step towards the ultimate goal to further improve the quality and safety of blood and blood components and to contribute to the confidence of the patients in a safe blood supply in the EC.
Seitz
R
R
Division of Haematology/Transfusion Medicine, Paul-Ehrlich-lnstitut, Langen, Germany. seira@pei.de
D001769:Blood; D001771:Blood Banks / Q000331:legislation & jurisprudence* / Q000592:standards; D001782:Blood Donors; D001803:Blood Transfusion / Q000331:legislation & jurisprudence* / Q000592:standards; D005060:Europe; D006291:Health Policy; D006801:Humans; D017053:Infection Control / Q000331:legislation & jurisprudence* / Q000379:methods