Haemovigilance is a surveillance system which covers the entire transfusion chain. It records and analyses expected and unexpected adverse event such as donor reactions, quality defects, transfusion reactions, transfusion errors and near misses before, during and after the administration of labile blood products.
The objective of haemovigilance is to prevent the occurrence or repetition of these events and to improve the safety of transfusion therapy.
Early identification, analysis and evaluation provide an up-to-date overall picture of safety in the transfusion chain and of the nature and dimension of the expected risks. Investigation of these events can provide additional information about the causes of avoidable transfusion incidents and show where improvements are necessary and possible.
According to Art. 58 of the Therapeutic Products Act (TPA, SR 812.21), Swissmedic is responsible for monitoring the safety of therapeutic products, including blood and blood products as defined in Art. 4 para. 1 TPA. To this end, it collects and evaluates reports as stipulated in Art. 59 TPA in particular and institutes the necessary administrative actions.