2023-12-29 08:49:07
As of January 2, 2024, the procedures for reporting, by hemovigilance correspondents, adverse effects of moderate severity (known as grade 2, such as vagal discomfort and hematomas) occurring in blood donors are aligned with the procedures European and international. This development allows uniform monitoring of these adverse effects. They continue to be collected, analyzed and monitored by the blood transfusion establishments (ETS) of the French Blood Establishment (EFS) and the Armed Blood Transfusion Center (CTSA). In the event of a potential signal, they are analyzed by the ANSM which can take any necessary measures. For donors, the process of reporting adverse effects, whatever their seriousness and attributability, does not change: they continue to report them to the ETS. Since 2007, healthcare professionals working in blood transfusion centers have been required to report adverse reactions of severity 2 to 4 that occur in blood donors to the national hemovigilance system. Minimal adverse effects, called “grade 1”, did not have to be declared but they were collected, analyzed and monitored by the ETS of the EFS and the CTSA.
Blood donors, for their part, can report adverse effects to the ETS, regardless of the severity of these adverse effects.
After many years of collection and analysis of these declarations and in the light of European work on the subject, the scope of declaration to the national hemovigilance system of adverse effects occurring in blood donors will be simplified from January 2, 2024. and focus on the most serious adverse effects (grades 3 and 4). The majority of grade 2 reports (87%) are vagal discomfort and hematoma at the puncture site without signs of severity and without subsequent complications.
Donors and ETS health professionals will continue to report these effects, such as those of grade 1, to the ETS hemovigilance unit which will evaluate and analyze them.
This decision by the Director General of the ANSM allows harmonization with European and international procedures, for better comparability of data between States, in particular the member States of the European Union.
It also harmonizes the French and European definitions of serious adverse donor effect. The modification will make it possible to take into account the clinical and/or biological manifestations observed in the donor during the donation or following it, as well as possible complications and possible impacts on the daily life of the donor post-donation.
Finally, clarifications are made to the definition of adverse donor effects in general and to the onset times in relation to the donation for which the declaration of an adverse effect is necessary.
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