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In order to help the analysis of adverse effects of transfusion, factsheets have been written by working groups of the French agency for the safety of health products ANSM. Each factsheet deals with a blood transfusion side effect and is composed of five parts, including pathophysiological mechanisms, diagnostic criteria, management recommendations, etiologic investigations and rules for filing the notification form to ANSM. Since 2006, 11 factsheets have been published on the French haemovigilance network website. The major characteristics of the two last sheets published "post-transfusion purpura" and "non erythrocyte incompatibility reaction" are presented, followed by the updated card for "allergy". These factsheets give relevant guidelines allowing better evaluation of recipients' adverse reactions, particularly their diagnosis, severity and accountability. They also could initiate studies among European and international haemovigilance networks.

A working group of the French National Hemovigilance Committee has been in charge of heightening awareness of Transfusion-Associated Circulatory Overload (TACO) among physicians and nurses. This multidisciplinary group has produced the present document that focuses on epidemiological data provided by the French haemovigilance network, physiopathology, diagnosis, treatment and specific actions that could prevent or minimize the risk of TACO.

Safety in the field of transfusion medicine has greatly improved in France. The risk of viral transmission has decreased by a factor greater than 1500 within the last 20 years. In comparison, the risk related to ABO error has decreased only by half. The reporting of critical incidents, which occur at any step of the transfusion procedure is now mandatory in France and is subject to an in-depth analysis, using methods close to that used in aviation safety. The goal of these analyses is to better understand human factors in order to implement more adequate prevention measures.

Due to regulations, hospital blood banks have to equip them with a computer-based information system. This system facilitates the management of the blood bank and ensures the safety of the storage, issuing and traceability of the blood and blood components. It permits to create a medical file for each transfused patient, which contains the characteristics of the blood components transfused and the immunohematological status of the patient, received by electronic data interchange from the blood establishment. Thus, from the assistance to the prescription of blood transfusion to the issuing and traceability of the blood components, the computer-based information system is the guarantee of the transfusion security in a hospital blood bank.

Pulmonary oedema after transfusion of blood products may be hydrostatic (transfusion-associated circulatory overload [taco]) or exsudative (transfusion-related acute lung injury [trali]). Both conditions have been recognized as major hazards to transfusion recipients. Risk characterization is necessary to improve safety and to monitor trends in the national blood transfusion system. A collaborative multidisciplinary working group of the French National Hemovigilance Committee has proposed an analysis framework for case definitions and classification. The method relies on internationally used definitions and is adapted to the codification procedures used in the french transfusion incident reports electronic data management.

Since 1985, a Council Resolution defines a new approach to technical harmonization and standards. The directives resulting from this new approach establish the essential safety requirements with which products put on the market must conform, and which should therefore enjoy free movement throughout the European Union, owing to a presumption of conformity. However, if the manufacturer is responsible for the conformity of its product in terms of safety, it is the end-user who must make sure that its requirements for a specific use or a considered application are satisfied and that the product meets its needs. It is the objective of the procedure of validation, which calls upon protocols of qualification intended to show the aptitude of a material, a system, a device, of an installation, to meet the requirements of specified quality and safety. This concept of qualification applies to the data-processing software of the hospital blood banks. Only the stage of operational qualification will be developed here. It involves scenarios made up of test files which make it possible to check the electronic data interchanges between the hospital blood bank and the blood establishment (transmission of the results of analysis, transmission of the data of traceability), as well as the functions of assistance to the issuing of the labile blood products.

Les œdemes pulmonaires survenant pendant ou apres une transfusion figurent parmi les accidents graves les plus frequents, dans le systeme francais d'hemovigilance. Ils comportent les œdemes hemodynamiques (transfusion-associated circulatory overload [TACO]) et les œdemes lesionnels (transfusion-related acute lung injury [TPALI]). Les TACO representent actuellement une cause majeure de deces lors d'une transfusion en France. Les donnees d'hemovigilance sur le TRALI montrent qu'ils sont de plus en plus notifies. Dans la serie francaise, aucun TRALI n'est survenu apres transfusion de plasma poole SD. Un logigramme permettra de classer de maniere plus reproductible les œdemes pulmonaires dans la base e-fit.

Resume La necessite d’adapter les pratiques de gestion des concentres erythrocytaires en blocs operatoires et reanimations a l’evolution du cadre legislatif reglementaire a genere une demarche collective d’amelioration des pratiques. Reunis sous l’impulsion des coordonnateurs regionaux d’hemovigilance de la Drass Ile-de-France, des representants de prescripteurs de transfusions, correspondants d’hemovigilance de huit hopitaux de l’Assistance publique–Hopitaux de Paris et representants de l’EFS Ile-de-France, en presence de representants de l’Agence francaise de securite sanitaire des produits de sante (Afssaps), ont coordonne une evaluation des pratiques locales des activites transfusionnelles des blocs operatoires et services de reanimation devant se mettre en conformite. Chaque hopital a ensuite propose des actions d’amelioration locales, validees par les instances regionale et nationale. Nous presentons cette demarche originale de travail collectif d’evaluation des pratiques aboutissant a des propositions d’amelioration pour repondre a une mise en conformite reglementaire tout en gerant au mieux les flux de produits sanguins sans mettre en jeu la securite transfusionnelle.

The urinary polyamines putrescine (PU) and spermidine (SPD) were measured for 67 patients with lymphomas: 49 non-Hodgkin (NHL) and 18 Hodgkin's disease (HD). Monthly repeat measurements were obtained over an average follow-up period of 12.5 months. For NHL, a good association was observed between polyamine levels and the severity of the stage; the distribution of values between nodular and diffuse forms was also significantly different. No such correlations were seen for HD. The evolution of PU values in time has been shown to reflect disease activity for NHL. Non-specific fluctuating PU values were found in the case of HD. In the case of 20 patients with NHL undergoing chemotherapy, comparison of polyamine levels before and after chemotherapy allowed differentiation between the population of complete responders to treatment and those with only partial or no response.

The OPR was studied in 203 patients with squamous cell carcinoma of the head and neck at the time of diagnosis, before any specific treatment. The mean initial OPR value was significantly higher in cancer patients than in 63 healthy controls: 5.29 +/- 3.09 vs. 2.63 +/- 1.07; P less than 0.001. There was no significant difference by anatomic site, but the OPR was significantly lower in stage I-II disease than in stage III-IV: 5.10 +/- 3.85 vs. 3.23 +/- 1.99, P less than 0.001. An initial OPR under or over 6 seems to be an important prognostic factor: at 2 years, 51% of patients with an OPR less than 6 were alive vs. only 24.5% of those with an OPR greater than 6, P less than 0.001. The difference was also noted in patients with stage III-IV disease (mean survival: 16 months vs. 7 months, P less than 0.001) and in 89 of the patients who received chemotherapy (mean survival 16 months vs. 6 months, P less than 0.001) whatever the response to chemotherapy. The OPR index, which explores nutritional and acute phase reactant proteins, seems to reflect the host-tumor relationship. Its initial value is strongly related to prognosis at 2 years.