[Pulmonary complications of transfusion (TACO-TRALI)]. / Complications pulmonaires de la transfusion (TACO-TRALI).

Pulmonary oedemas occurring during or after a blood transfusion appear as the most frequent serious immediate incidents in the French hemovigilance database. They include transfusion-associated circulatory overload (TACO) and transfusion-related acute lung injury (TRALI). TACO are a major cause of transfusion-related death in France. TRALI are more and more recognized and notified. In no case, pooled fresh frozen plasma (100 donations) treated with solvent-detergent were involved in French TRALI cases. A logigrame will allow hemovigilance officers to better classify pulmonary oedemas in e-fit, the French hemovigilance database.

[Transfusion risk analysis with regard to vCJD in France]. / Evaluation du risque transfusionnel vis-à-vis de la variante de la maladie de Creutzfeldt-Jakob en France.

The latest updates (February 2004 and February 2005) of the analysis of the risk of transmission of the agent of Creutzfeldt-Jakob disease (CJD) by blood and blood products in France firstly reported in 2000, were triggered by the two cases of probable transmission of variant CJD (vCJD) by transfusion reported in the UK, and the notification of two French cases of vCJD who had been blood donors on several occasions before clinical onset. Even though some figures of the quantitative assumption used in the risk analysis have been modified since 2000, the conclusion as regards the risk for blood cellular component is considered unchanged: it can be assumed that one unit of labile blood products will contain more than one infectious unit if the donor is incubating the disease. Therefore, the residual risk of receiving by transfusion one infectious blood unit is depending on the prevalence of subjects incubating the disease in the blood donor population. For this particular aspect, the expected number of clinical vCJD cases to occur in France has been lowered since 2000. However, the worst-case scenario of 300 cases in the next 60 years has been maintained in the risk analysis, leading to the hypothesis that one blood donor per 120,000 could be infectious. In conclusion, the risk of getting one infectious blood unit is considered probable to a level of 1/120,000, but the benefit outweighs the risk if the use of transfusion is restricted to well justified indications and if patients are informed a priori and a posteriori.

[Transfusion incidents reports of grade zero: a national and descriptive analysis upon two years of practical survey]. / Les incidents transfusionnels de grade zéro: analyse descriptive nationale sur deux ans de pratique.

A grade zero transfusion incident is defined as an inappropriate transfusion of blood component due to one or several failures without immediate clinical or biological consequences for the recipient. Two years after the setting up of the mandatory notification of these incidents, Afssaps haemovigilance unit performed a first descriptive national analysis of the data collected in years 2003 and 2004 at the national level. This analysis was based on one part on computarised e-Fit national database and on the other part on investigation results documents and additional surveys set up by the network professionals. From a quantitative point of view, this study reveals differences in notification as well as in the type of analysis from one region to another. Quantitatively, 45% of grade zero transfusion incidents correspond to attribution errors. The site of origin of grade zero incidents is for almost 73% linked to health establishment, clinical unit or hospital blood bank, and for almost 23% linked to blood establishment. Complete analysis has notably shown that 9% of the incidents are due to errors in blood component prescription. This descriptive analysis, which identifies recurrent failure and critical points originating from non-appropriated transfusions, should constitute the starting point of a reflection aiming at optimising and standardising methods of analysis of grade zero transfusion incidents and at elaborating suggestions to better control critical points.

[Viral safety: European and French directives]. / Sécurité virale: les dispositifs européen et français.

The viral safety of IVIg is defined by transposition of European Directives. Directive 89/381/CEE defines plasma-derived medicinal products (pd-MP) which should be registred through a Marketing Authorization (75/318/CEE) and requires specific criteria for donation acceptability and fractionation processing. Recommendations and Notes for Guidance are prepared by the "Biotechnology Working Party" (BWP), Committee for Proprietary Medicinal Products (CPMP) ad hoc group. "Note for Guidance on Virus Validation Studies: CPMP/BWP/268/95" defines, for conventional viruses, the validation study as regards viral elimination /inactivation steps (relevant virus, scale reduction system and statistical interpretation of the results). "Note for Guidance on 'blood products'- CPMP/BWP/269/95" defines the key issues of viral safety: starting material, viral elimination /inactivation steps within the fractionation processing and in process controls. Pd-MP used as excipients are also covered. BWP/CPMP recommends that exclusion criteria only be considered for sporadic, familial or iatrogenic Creutzfeldt-Jakob disease (CJD), while withdrawal should be undertaken, according to the precaution principle, when a donor is suffering from nv-CJD (February 1998). Also, screening tests currently under development for transmissible spongiform encephalopathies are encouraged to be introduced for fractionation products (January 1999). Some donor exclusion criteria for conventional viruses and prions are specific to France. In conclusion, measures taken to ensure pd-MP viral safety are constantly changing. Its evaluation can only be done when considering numerous parameters within a global context.