title: [The blood donors' haemovigilance in France].
abstract: This work aim to present the descriptive analysis of serious adverse reactions in donors (dSAR's), which were notified in 2010 and 2011 in the French national haemovigilance database "e-FIT" (Internet secured haemovigilance reporting system). Some data, which are necessary for this analysis, also come from the regional haemovigilance coordinators' reports (RHC). The other parts of haemovigilance in the context of donation, without donors adverse reactions, such as post-donation information (PDI), adverse events occurred in the blood collection steps of the transfusion chain and epidemiology are not subject to this work analysis. This work shows that the quality of the data gradually improved since the setting up of the notification system of dSAR's. These data are particularly rich in learning lessons, but are still improving. It allows us to confirm that donor's safety, blood components quality, while preserving the blood components self-sufficiency in France, remains a priority. For these reasons, it is important to continue this haemovigilance awareness and to implement necessary actions that would be required for the protection of the donor's health and comfort during donation.
authors.affiliation: Agence nationale de sécurité du médicament et des produits de santé (ANSM), direction des thérapies innovantes des produits issus du corps humain et des vaccins (BIOVAC), 143/147, boulevard Anatole-France, 92385 Saint-Denis cedex, France. nadra.ounnoughene@ansm.sante.fr
authors.forename: N
authors.initials: N
authors.lastname: Ounnoughene
authors.forename: I
authors.initials: I
authors.lastname: Sandid
authors.forename: M
authors.initials: M
authors.lastname: Carlier
authors.forename: M
authors.initials: M
authors.lastname: Joussemet
authors.forename: N
authors.initials: N
authors.lastname: Ferry
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001771:Blood Banks; D001781:Blood Component Removal / Q000009:adverse effects*; D001782:Blood Donors / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D058731:Blood Safety; D005260:Female; D005568:Forms and Records Control; D005602:France / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D008952:Mobile Health Units; D017202:Myocardial Ischemia / Q000453:epidemiology / Q000209:etiology; D010146:Pain / Q000453:epidemiology / Q000209:etiology; D011677:Punctures / Q000009:adverse effects*; D019462:Syncope, Vasovagal / Q000453:epidemiology / Q000209:etiology; D013924:Thrombophlebitis / Q000453:epidemiology / Q000209:etiology; D014946:Wound Infection / Q000453:epidemiology / Q000209:etiology; D055815:Young Adult