How we monitor the safety of blood and blood components

Haemovigilance is the monitoring system for the safety of blood and blood components. It collects information on adverse events or reactions and investigates to identify any safety concerns.

A 'serious adverse event' is defined as any untoward occurrence associated with the collection, testing, processing, storage and distribution of blood and blood components that might lead to death or life threatening, disabling or incapacitating conditions for patients or which results in or prolongs hospitalisation or morbidity.

A 'serious adverse reaction' is defined as an unintended response in donor or in patient associated with the collection or transfusion of blood or blood components that is fatal, life threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity.

How the system works in Ireland

The National Haemovigilance Office (NHO) operates the Irish haemovigilance system. 

We are the Competent Authority for implementing blood and blood components legislation. The NHO assists the HPRA by collecting, collating, and evaluation Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs).

Blood establishments are required to report serious adverse events and reactions to the NHO, who will in turn submit it to us. We then provide annual reports to the European Commission.  

We meet regularly with the NHO to discuss reports and trends.  

Reporting

To report an adverse reaction or adverse event with blood or blood components - report forms are available from the NHO website.

To report adverse reactions associated with blood-derived medicines both the NHO and the HPRA should be notified. You can notify the HPRA online or contact the Pharmacovigilance Section at the HPRA.