title: The revision of the European blood directives: A major challenge for transfusion medicine.
abstract: OBJECTIVE
  Using both patient-focused and donor-focused perspectives, to review the current EU blood directives, in order to derive proposals, in principle, for what should evolve during the revision process of these directives.
  
  
  METHODS
  Review of the EU blood directives in the light of scientific literature, related reports from the Directorate General Health and Consumers (DG SANTÉ), and from the Council of Europe (CoE).
  
  
  RESULTS
  The analyses led us to present the main following proposals: developing voluntary unpaid donations: the directives should consider taking into consideration ethically acceptable forms of compensation consistent with altruistic donation (including plasma donations for fractionation); current expertise: more extensive utilization of the expertise of blood establishments and their consultants should be considered; donor selection: an evidence-based approach for basing donor deferral criteria on sound scientific evidence should be promoted; donor reactions: measures to prevent donor reactions and to make donations safer for the donors should also be included; quality control: The quality control requirements should relate to the Council of Europe Blood Guide specifications: these should become minimum standards (as is the case with monographs of the European Pharmacopeia), facilitating regular update of blood component lists and related specifications and compliance with the specifications; haemovigilance: because of reporting difficulties (e.g. lack of number of blood products transfused), the effectiveness of haemovigilance has so far been limited. This should lead appropriate bodies to investigate alternative or complementary ways to help improve patient safety, taking into consideration, in principle, patient blood management and the appropriate use of blood products. Furthermore, donor vigilance, which is still absent from the current directive should be included in a revised directive.
  
  
  CONCLUSIONS
  These proposals for revising the current EU blood directives (if taken into account and given appropriate regulatory formulation) should help to optimize patient safety and donor care, progress the compliance with the ethical principles for donors and improve the efficiency of the healthcare systems dedicated to transfusion medicine.
authors.affiliation: European Blood Alliance, Plesmanlaan 125, 1066 CX Amsterdam, The Netherlands. Electronic address: gilles.follea@efs.sante.fr.
authors.forename: G
authors.initials: G
authors.lastname: Folléa
authors.affiliation: European Blood Alliance, Plesmanlaan 125, 1066 CX Amsterdam, The Netherlands. Electronic address: k.aranko@europeanbloodalliance.eu.
authors.forename: K
authors.initials: K
authors.lastname: Aranko
mesh_terms: D000533:Altruism; D001771:Blood Banks / Q000331:legislation & jurisprudence / Q000592:standards; D001782:Blood Donors / Q000941:ethics / Q000331:legislation & jurisprudence / Q000600:supply & distribution; D058731:Blood Safety / Q000592:standards; D001803:Blood Transfusion / Q000331:legislation & jurisprudence / Q000592:standards; D017848:Blood-Borne Pathogens / Q000302:isolation & purification; D046148:Donor Selection / Q000331:legislation & jurisprudence / Q000592:standards; D005062:European Union; D066275:Health Information Exchange; D006801:Humans; D007390:International Agencies / Q000458:organization & administration; D021141:Nucleic Acid Amplification Techniques; D017410:Practice Guidelines as Topic; D011785:Quality Assurance, Health Care / Q000458:organization & administration; D011786:Quality Control; D064826:Transfusion Medicine / Q000331:legislation & jurisprudence / Q000379:methods / Q000458:organization & administration / Q000592:standards*; D014838:Volunteers
keywords: Blood; Blood components; Blood products; Blood transfusion; Directives européennes du sang; EU blood directives; Médecine transfusionnelle; Produits sanguins; Produits sanguins labiles; Public healthcare; Sang; Santé publique; Transfusion medicine; Transfusion sanguine