Haemovigilance is the process of monitoring the safety of blood and blood components from collection of the pre-transfusion sample to completion of the transfusion process.
The National Haemovigilance Office (NHO) was established in 1999 by the Department of Health to operate a national haemovigilance system. As such, while the IMB is the Competent Authority for implementation of legislation relating to blood and blood components, the NHO will provide assistance to the IMB through the continued collection, collation and evaluation of Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs), as provided for in national legislation.
Reporting establishments are considered to have complied with their reporting requirements if they submit details of SARs and SAEs to the NHO, who will in turn submit relevant data to the IMB. In its role as Competent Authority, the IMB will forward the annual reports of SARs and SAEs received to the European Commission.
The NHO and the IMB meet regularly to discuss cumulative data and reporting trends.
Further information and report forms are available from the NHO
Blood-derived Medicinal Products
The IMB is the Competent Authority for medicinal products (including blood-derived medicinal products) and is responsible for the national pharmacovigilance system for collection and evaluation of information relevant to the benefit-risk balance of medicinal products. Suspected adverse reactions associated with blood-derived medicinal products should be notified to the IMB, in addition to NHO reporting requirements. For further information on adverse reaction reporting, see product safety or contact the Pharmacovigilance Section at the IMB.
Accreditation of Blood Banks
S.I. No. 360 of 2005 requires that all hospital blood banks gain ISO 15189 accreditation by the 8th of November 2008. The Irish National Accreditation Board (www.inab.ie) is the accrediting body for ISO 15189 in Ireland. As, ISO 15189 does not fully meet the requirements of the Blood Directives in the areas of Traceability and Haemovigilance, an Expert Group on Blood and Blood Components was established to provide guidance for ensuring that hospital blood banks comply with the requirements of Article 14 (Traceability) and Article 15 (Notification of Serious Adverse Reactions and Events) of Directive 2002/98/EC.
The ‘Minimum Requirements for Blood Bank Compliance with Article 14 (Traceability) and Article 15 (Notification of Serious Adverse Reactions and Events) of EU Directive 2002/98/EC’ document was prepared by this group in order to provide such guidance. Further information is available on www.inab.ie