Hypersensitivity reactions to blood components: document issued by the allergy committee of the French medicines and healthcare products regulatory agency.

These guidelines represent a consensus among experts on hypersensitivity reactions occurring after transfusion of blood components. They cover recognition, investigation, treatment, and prevention of such reactions. Implemented in France under the auspices of the French Medicines and Healthcare Products Regulatory Agency (AFSSAPS) and based on current knowledge, research, and experience, they aim to provide effective and easily teachable means of further improving the quality of hemovigilance databases, promote interest in this field, and help identify possible mechanisms and at-risk patient groups.

[Who are the recipients of labile blood products? A multicenter nation-wide study--a "donation day." Blood banks, health facilities]. / Qui sont les receveurs de produits sanguins labiles (PSL)? Une étude nationale multicentrique - un jour donné. Etablissement de transfusion sanguine (ETS) - établissements de santé (ES).

During the years 1994-2001, a progressive decrease of the number of blood units transfused has been reported in France. In contrast, since 2002, there is an increasing number of blood units issuing (+7.6% between 2001 and 2006) and this must be investigated. On behalf of the French Society of Blood Transfusion, the "Recipients" working group promoted a nation wide survey with the support of the regional blood transfusion centres. This survey was aimed at describing the profiles of the transfused patients: socio-demographical patterns, and reasons of the blood transfusion (main and associated diagnoses). A cross-sectional survey was designed. All the patients who received a blood unit during a specific day were considered as the population of the study. They were identified by the regional transfusion centres by means of the "individual issuing form". Survey forms were fully filled for 90% of the patients. It has been considered as a good answer rate. Seven thousand four hundred and twenty-two blood units, delivered to 3450 patients were analyzed. Three groups of pathologies were found as a reason of transfusion: haematology-oncology (52.70% of the prescriptions) with 892 patients (27.8%) for haematological malignancies; surgical procedures (23.99%); intensive care and medicine procedures (21.92%). More than 50% of the recipients are 70 years old and more. This result is explained by the age distribution of inpatients. In a context of lack of donors and consequently difficulties to provide patients with optimal number of blood units, this study is helpful. Variability of blood unit issuings must be detected, analyzed and monitored in real time by the actors of the transfusion process, using computerized dashboards: the blood units provider (in order to adjust the strategy of blood units provision) and the health care establishment as well as care blood components prescribers (reasons of blood transfusion and evaluation of practices).

[Blood transfusion and bacterial risk]. / Transfusion sanguine et risque bactérien.

Initial hemovigilance data confirm the incidence and severity of transfusion reactions due to the bacterial contamination of blood components (TRBCs). With 18 deaths reported through the French hemovigilance network over the past five years, bacterial risks represent one of the major immediate complications of BC transfusion. BC contamination may lead to more or less severe TRBCs, depending on their origin: bacteria growth, the BC itself or unknown origin. Although the rate of donated blood or BC contamination is known (0.5% and 0.05%, respectively), it is still difficult to assess the actual incidence of TRBCs, as it is difficult to identify and relate them to transfusion. Likewise, a better knowledge of bacteria, symptoms, and outcome is required to improve prevention methods. Better prevention can reduce BC contamination and proliferation of bacteria at each stage of blood transfusion. Methods of detecting BC contamination are still under investigation. Through continuous education of hemovigilance participants in identifying and dealing with TRBCs, as well as drawing up procedures to perform inquiries and specific bacterial analyses, case reporting can be further improved, in order to achieve more efficient prevention.

[Blood transfusion and bacterial risk]. / Transfusion sanguine et risque bactérien.

Initial hemovigilance data confirm the incidence and severity of transfusion reactions due to the bacterial contamination of blood components (TRBC). With 18 deaths reported through the French hemovigilance network over the past 5 years, bacterial risks represent one of the major immediate complications of blood components (BC) transfusion. BC contamination may lead to more or less severe TRBC, depending on their origin: bacteria growth, the BC itself or unknown origin. Although the rate of donated blood or BC contamination is known (0.5% and 0.05%, respectively) it is still difficult to assess the actual incidence of TRBC, as it is difficult to identify them and relate them to transfusion. Likewise, better knowledge of bacteria, symptoms and outcome is required to improve prevention methods. Better prevention can reduce BC contamination and proliferation of bacteria at each stage of blood transfusion. Methods to detect BC contamination are still under investigation. Through continuous education of hemovigilance actors in identifying and dealing with TRBC, as well as drawing up procedures to perform inquiries and specific bacterial analyses, case reporting can be further improved in order to achieve more efficient prevention.

[Fresh frozen plasma: a pilot study of the context of utilization and the indications]. / Plasma frais congelé: étude pilote du contexte d'utilisation et des indications.

The aim of this pilot study was to assess the feasibility of a tolerance study of qualified (secured by quarantine or solvent-detergent-treated) fresh frozen plasma (FFP) in real conditions of use. We included all patients receiving qualified FFP during a one-month observation period in three french hospitals (Besançon, Brest, Lyon). The 192 FFP transfusion episodes corresponded to 111 patients. Only two thirds of all prescriptions corresponded to indications mentioned in the ministerial order of december 1991. Forty-two episodes consisted of FFP only; in the 150 remaining episodes, at least one product (mostly labile blood products) had been injected within 24 hours before or after the plasma injection. The free interval between FFP transfusion and the nearest associated product was usually less than three hours. Only one side effect was notified. This pilot study points out the difficulties of a tolerance study of qualified FFP in real conditions of use. It also raises the necessity to clarify current indications of FFP.

[Control of the bacterial risk of transfusion in France in 2013]. / Maîtrise du risque bactérien transfusionnel en France en 2013.

Bacterial contamination of blood products (BP) remains the most important infectious risks of blood transfusion in 2013. Platelet concentrates (PC) are the blood products the most at risk, whether CPA or MCPS. In France, the residual risk has been steadily declining since 1994. For the platelets, the frequency of transfusion reaction due to bacterial contamination (TRBC) is now about at one per 50,000 CP distributed. The number of deaths has remained stable since 1994 with one death per year (300,000 distributed CP). The progressive decrease in the number of cases of TRBCs is the result of steady improvement of practices and prevention methods at all stages from collection to the transfusion of BP. But if all these improvements have significantly reduced the incidence of TRBCs, mortality is not changed with the CP and the reduction of this risk is a priority for the French Blood Establishment (EFS). Detection methods of CP contaminated or pathogen inactivation are two approaches available and can provide a significant reduction (for the former) or deletion (for seconds) of the risk of transfused contaminated CP. Currently, the choice is in favor of the detection of bacteria. New detection "rapid tests" methods were added to the panel of candidates and are being evaluated. Inactivation of pathogens remains the safest prospect of eliminating this adverse effect of transfusion. Implementation of one method for bacterial detection is probably a transitional measure.

[Pneumatic tube system for blood products transport]. / Dispositif pneumatique pour le transport des produits sanguins labiles.

Blood product transport from blood bank to the patient care areas of hospitals is a key step in the transfusion process. The pneumatic tube system is now widely used in hospitals. Strict performance specifications must be respected to guarantee blood safety: robustness, easy to use and respect the constraints imposed to blood products. To secure the disposal of blood products ordered to a carrier (delivery step), a security device must be deployed (video camera, barcode reading, fax, chip), allowing in particular to limit the risk of addressing error when sending (in the case of device with several arrival stations) or picked up by the wrong carrier.

[What to do in case of adverse event in recipient at the French National Blood Service?]. / Conduite à tenir en cas d'effet indésirable receveur à l'établissement français du sang.

One of the main goals of haemovigilance is to gather and analyze adverse events in recipients of blood products in order to improve blood safety. The French National Blood Service has a specific role in the management of immediate adverse events: to alert to quarantine the potentially dangerous blood products from the same donation(s), to provide blood testing for the etiologic assessment and to give transfusion advice to patients. The updating of the recipient's computer file allows a better monitoring for both immediate and delayed adverse events. Finally, the French National Blood Service's correspondent of haemovigilance is responsible for donor's inquiries, especially in cases of transfusion related to bacterial contamination, severe allergy, suspicion of transfusion acute related lung injury and viral seroconversion. The management effectiveness for adverse events requires a strong collaboration between all members of the haemovigilance network.

[Factsheets: support in the analysis of recipients' adverse reactions]. / Fiches techniques: aide à l'analyse des effets indésirables receveurs.

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.

[The management of post donation information: a fundamental element of blood safety]. / La gestion des informations post-don: un élément fondamental de la sécurité transfusionnelle.

Post donation information management is a fundamental axis of haemovigilance in terms of blood safety. It requires an organization ensuring a permanent reactivity, a good sensitization of French National Blood Service professionals and needs also a strong awareness of blood donors. Previous identification of stakeholders to warn during these kinds of alerts is essential to avoid the use of any blood product presenting a potential risk. The recent implementation of a consensual internal document aims to target the reinforcement of a homogeneous decision-making process, combining blood product self-sufficiency and above all recipient safety.