title: Residual risk and retrospective analysis of transfusion-transmitted bacterial infection reported by the French National Hemovigilance Network from 2000 to 2008.
abstract: BACKGROUND
  Regarding blood safety, transfusion-transmitted bacterial infection (TTBI) remains the most frequent infectious risk. The incidence of these episodes needs to be assessed and updated frequently to accurately manage this risk.
  
  
  METHODS
  TTBIs were reported by the French network of local correspondents in each hospital and blood center. The regional coordinator managed the investigation. A multidisciplinary expert group from the French National Agency of Medicine and Health Products Safety (ANSM) analyzed each TTBI according to a standardized scale of imputability and severity. Only cases with likely or certain imputability are reported in this study.
  
  
  RESULTS
  In France, 18.0 × 10(6) red blood cell (RBC) products, 1.94 × 10(6) platelet concentrates (PCs), and 2.44 × 10(6) fresh-frozen plasma units were transfused throughout 2000 to 2008. The incidence of TTBI was 2.45, 24.7, and 0.39 per million blood components (BCs), PCs, and RBCs, respectively. For PCs, the incidences of severe (vital threat or death) and fatal TTBI were 13.4 and 5.14 per million, respectively. PCs were responsible for 87% of TTBIs. A total of 66.7% of the implicated bacteria were Gram positive, most of them belonging to the normal skin flora. A total of 33.3% of the other implicated bacteria were Gram negative.
  
  
  CONCLUSIONS
  The French hemovigilance system provides an accurate estimate of the TTBI incidence during a period with diversion and improving skin disinfection but without bacterial detection screening. This tool would be able to evaluate further additional safety procedures like bacterial screening and pathogen reduction technology.
authors.affiliation: Direction of Advanced Therapies, Human Products and Vaccines, French National Agency of Medicine and Health Products Safety-ANSM (ex Afssaps), Saint-Denis, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Lafeuillade
authors.forename: François
authors.initials: F
authors.lastname: Eb
authors.forename: Nadra
authors.initials: N
authors.lastname: Ounnoughene
authors.forename: Rachel
authors.initials: R
authors.lastname: Petermann
authors.forename: Gérald
authors.initials: G
authors.lastname: Daurat
authors.forename: Gérard
authors.initials: G
authors.lastname: Huyghe
authors.forename: Mai-Phuong
authors.initials: MP
authors.lastname: Vo Mai
authors.forename: Cyril
authors.initials: C
authors.lastname: Caldani
authors.forename: Danielle
authors.initials: D
authors.lastname: Rebibo
authors.forename: Pierre
authors.initials: P
authors.lastname: Weinbreck
mesh_terms: D016470:Bacteremia / Q000097:blood / Q000453:epidemiology / Q000382:microbiology / Q000635:transmission*; D001431:Bacteriological Techniques; D058731:Blood Safety / Q000706:statistics & numerical data*; D017848:Blood-Borne Pathogens; D005602:France / Q000453:epidemiology; D016905:Gram-Negative Bacterial Infections / Q000097:blood / Q000453:epidemiology / Q000382:microbiology / Q000635:transmission; D016908:Gram-Positive Bacterial Infections / Q000097:blood / Q000453:epidemiology / Q000382:microbiology / Q000635:transmission; D006801:Humans; D015994:Incidence; D047589:Leukocyte Reduction Procedures; D019221:Mandatory Reporting; D018962:Phlebotomy / Q000379:methods; D012189:Retrospective Studies; D012306:Risk; D012720:Severity of Illness Index; D063189:Symptom Assessment; D065227:Transfusion Reaction