Hemovigilance

Health care units must notify the Blood Establishment without delay, and the Blood Establishment must notify Fimea without delay of serious adverse events that may affect the quality and safety of blood or blood components. Similarly, any serious adverse reactions observed in donor or in patient associated with the collection or transfusion of blood or blood components which may be attributed to the quality and safety of the blood or blood components must be notified. Notifications are submitted using the forms validated in the Blood Service Decree (258/2006).

In addition, the Blood Establishments must submit an annual summary of serious adverse reactions and events (SARE) to Fimea by the end of March of the following year. These hemovigilance reports delivered to Fimea that meet the criteria laid down in the Blood Directives will be further reported to the European Commission. The Commission monitors hemovigilance reports from EU Member States and summarises them annually.

Forms (available only in Finnish and Swedish)

Notification by a health care unit to a Blood Establishment of a serious adverse reaction caused by a blood product transfusion and a transfusion of an incorrect blood product (788, notification) (docx)

Notification of a serious adverse reaction, Blood (793, initial notification) (docx, in Finnish)

Notification of a serious adverse reaction, Blood (791, confirmation report) (docx, in Finnish)

Notification of a serious adverse event, Blood (790, initial notification) (docx, in Finnish)

Notification of a serious adverse event, Blood (792, confirmation report) (docx, in Finnish)

Annual summary of serious adverse reactions, Blood (794) (docx, in Finnish)

Annual summary of serious adverse events, Blood (795) (docx, in Finnish)