Hemovigilance in Germany -: Reports to the Paul-Ehrlich-Institut between January 1995 and December 2002 concerning suspected transfusion reactions

In the past few years, various different hemovigilance networks have been implemented in Europe and North America with the goal of further improving the safety of cellular blood products and fresh frozen plasma. In a way, the German hemovigilance system has a special role since aspects of pharmacovigilance form an important part here. A total of 3,463 suspected cases of transfusion reactions (TR) in connection with cellular blood products and fresh frozen plasma have been reported to the Paul-Ehrlich-Institut (PEI) between 1995 and 2002. Out of these cases, 2,648 reports related to suspected cases of transmissions of virus (1,460 HCV, 922 HBV, and 222 HIV infections). In the majority of the tracking procedures which were carried out, it could be established that the infection of the receiver was not due to the transfusion. After the introduction of donor screening, only 3.9% of the tracking cases reported to the PEI in the observation period led to a 'positive' result. After the introduction of testing by means of HCV-NAT, no further HCV transmissions were reported to the PEI. 81 suspected cases (2.3%) referred to a bacterial/parasite contamination of the blood product while a contamination could be observed in the remaining amount of product in retrospect in only 38 of the cases (46.9%). In 3 cases, it was reported that the infection of the donor was not recognized (Plasmodium falciparum, Yersinia enterocolitica, and Escherichia coli). 13 infections were of lethal outcome. In 5 of these 13 cases, pathogens were found in the bag containing the remaining amount of blood product (Y. enterocolitica, Staphylococcus aureus, Proteus vulgaris, Enterobacter cloacae, and Klebsiella pneumoniae). 756 suspected cases of a noninfectious (immunological) TR were reported to the PEI, including 132 hemolytic TR (comprising 22 reports on inappropriate use, e. g. ABO incompatibility), 362 reports on suspected cases of allergic TR, 4 reports on posttransfusion purpura, 101 reports of suspected transfusion-related acute lung injury (TRALI), in which granulocytic antibodies could be found in 23 cases.