Haemovigilance - how we monitor the safety of blood and blood components

Haemovigilance comprises a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in blood donors or recipients and the epidemiological follow-up of donors. A serious adverse event is defined as an unintended occurrence associated with the collection, testing processing, storage and distribution of blood or 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 a donor or in a patient associated with the collection or transfusion of blood components that is fatal, life-threatening, disabling or incapacitating, or which results in or prolongs hospitalisation or morbidity.

From 8 November 2005, blood establishments and hospital blood banks have been required to notify the UK Competent Authority (the MHRA) of any serious adverse events and serious adverse reactions. Please see our section on 'Reporting serious events and serious adverse reactions related to blood and blood components' for further information.

From 8 November 2005, hospital blood banks have been required to confirm compliance with the requirements of the Regulations by submitting an annual Compliance Report to the MHRA.