|Aix Scientifics® Clinical Research Organisation|
The term 'haemovigilance' (haeme = blood) refers to measures to control and quality assurance of blood donation and transfusion. These will be recorded and reported, where failures or product damages appear. In a narrower sense heemovigilance is the mandatory reporting of serious incidents to the competent authority. In a broader sense it includes the recording and analysis of all, also less serious incidents, including errors that only could lead to serious incidents. Ultimately, the effort is invested to identify sources of error and to correct them.
In the years 2009/2010, the working group Haemapheresis (AGHV) of the section Preparative and Therapeutic Haemapheresis of the German Society for Transfusion Medicine and Immune (DGTI eV) developed ideas for a record system of complications that arise in the course of haemaphereses.
In February 2012 the Haemovigilance System, developed by Aix Scientifics®, was placed on the Internet and is since been available to all interested transfusion centres, initially under a five-year study [see ClinicalTrials.gov: NCT01576237]. Currently, transfusion centres participate in Germany, Austria and Switzerland. The system is multilingual and participation of other countries is possible and desirable.
To date, over 19,000 puncture, citrate, circulatory, donor compliance and technical problems in plasma, platelet, leukocyte (stem cell, granulocyte, monocyte), erythrocyte and multicomponent 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 standards regarding 'Complications Related to Blood Donation' of the International Society of Blood Transfusion (ISBT) and the International Haemovigilance Network (IHN). However, a single centre can not see data from any other centre.