|Aix Scientifics® Clinical Research Organisation|
European Donor Haemovigilance system (EDoH)
The term 'haemovigilance' (haeme = blood) refers to measures for control and quality assurance of blood donation and transfusion. It will be recorded and reported, where failures or product damages appear. In a narrower sense, haemovigilance is the mandatory reporting of serious reactions and incidents to the competent authority. In a broader sense it includes the recording and analysis of the whole, also less serious incidents, including errors that only could lead to serious reactions and incidents. Ultimately, the effort is invested to identify sources of error and to correct them.
In the years 2009/2010, the working group haemapheresis vigilance (AGHV) of the section Preparative and Therapeutic Haemapheresis of the German Society for Transfusion Medicine and Immune Haematology (DGTI eV) developed a concept for a web-based record system of complications that arise in the course of haemaphereses.
In January 2012 the European Donor Haemovigilance System, developed by Aix Scientifics®, was placed on the Internet and has since been available to all interested apheresis centres, initially under a seven-year study [see ClinicalTrials.gov: NCT01576237]. Currently, apheresis centres participate in Belgium, Germany, Austria, and Switzerland. The system is multilingual and participation of further countries is possible and desirable.
To date, over 25,000 puncture, citrate, circulatory, donor compliance and technical problems in plasma, platelet, leukocyte (stem cell, granulocyte, monocyte), erythrocyte and multi-component apheresis and whole blood donations were collected.
The participating centres can automatically evaluate their data and compare their results with the results of all other centres (benchmarking) based on the more advanced 'Standard for Surveillance of Complications Related to Blood Donation' of the International Society of Blood Transfusion (ISBT) and the International Haemovigilance Network (IHN) and on the standards of the AGHV. However, a single centre cannot see data from any other centre.
Download published online : H.G. Heuft, et al. (2016) Donor Safety in Haemapheresis