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. STUDY DESIGN AND 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. CONCLUSION: 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.
Subject(s)
Bacteremia/transmission , Blood Safety/statistics & numerical data , Transfusion Reaction , Bacteremia/blood , Bacteremia/epidemiology , Bacteremia/microbiology , Bacteriological Techniques , Blood-Borne Pathogens , France/epidemiology , Gram-Negative Bacterial Infections/blood , Gram-Negative Bacterial Infections/epidemiology , Gram-Negative Bacterial Infections/microbiology , Gram-Negative Bacterial Infections/transmission , Gram-Positive Bacterial Infections/blood , Gram-Positive Bacterial Infections/epidemiology , Gram-Positive Bacterial Infections/microbiology , Gram-Positive Bacterial Infections/transmission , Humans , Incidence , Leukocyte Reduction Procedures , Mandatory Reporting , Phlebotomy/methods , Retrospective Studies , Risk , Severity of Illness Index , Symptom AssessmentABSTRACT
SUMMARY: The French Hemovigilance Network has been established in 1994 and records all adverse events associated with the transfusion of a labile blood products (LBP) regardless of their severity. From 1994 to 2006 35,423,172 LBP were issued, 85,812 adverse transfusion reactions notified, and 139 cases of transfusion related acute lung injury (TRALI) observed. The LBP most at risk is fresh frozen plasma (FFP), followed by platelets concentrates (PC) and packed red cells (PRC). However, because the use of FFP is not frequent in France, it only accounts for about 10% of TRALI, whereas PRC and PC are involved in the remaining cases. In no case, pooled FFP treated with solvent-detergent were involved. Patients' profiles are peculiar with a high disease burden. Therefore, targeting a prevention policy only on FFP would result in a marginal reduction of TRALI in France.
ABSTRACT
SUMMARY: The Agence Française de Securite Sanitaire des Produits de Santé (Afssaps; French Health Products Safety Agency) is responsible, through its hemovigilance unit, for the organization and the functioning of the national hemovigilance network. In accordance with the French law, it receives all data on adverse transfusion reactions regardless of their severity. With the aim of evaluating the tolerance of two kinds of labile blood products (LBP), pooled platelet concentrates (PP) and apheresis platelet concentrates (APC), we screened the French national database from January 1, 2000 to December 31, 2006. We observed that the number of transfusion incident reports is more than twice as high with APC (8.61:1,000 LBP) than with PP (4.21:1,000 LBP). The difference between these two ratios is statistically significant as shown by chi-square test (e = 21.00 with α = 5%). The risk to suffer adverse reactions of any type, except for alloimmunization, is higher with APC, and the major type of diagnosis related to APC is allergic reaction (1:200 APC issued) even if those allergic reactions are rarely serious. The new French National Hemovigilance Commission should impel a working group evaluating this topic and above all the impact of additive solutions which have been used since 2005 to put forward preventives measures.
