Hämovigilanz von Blutkomponenten Meldungen an das Paul-Ehrlich-Institut vom 1.1.1995 bis zum 15.11.1998: Meldungen an das Paul-Ehrlich-Institut vom 1.1.1995 bis zum 15.11.1998

In Germany cellular blood products are a licensed medicinal product. In the following we would like to present the reporting procedure, analysis and evaluation of suspected cases from spontaneously recorded data. During the time period from 1.1.95 until 1.1. 98 a total of 1488 suspected adverse events were reported in connection with cellular blood products and fresh plasma. In 1270 (85.34%) of these case reports viral transmissions were implicated, in 187 (12.56%) immunological transfusion reactions and in 31 (2.06%) bacterial infections. The case reports concerning viral transmission were further evaluated in a look-back-procedure according to the guidelines of the „Arbeitskreis Blut”, a working party on acute issues arising in the transfusion medicine area. In 864 (68%) of the 1270 cases the causality of the blood product could be excluded by re-testing the donor. In 118 cases (9.3%) infectious donors were subsequently identified; 21 were HIV-, 81 HCV- and 16 HBV transmissions. The reports were decoded according to year of treatment to differentiate those cases that occurred before the introduction of mandatory donor screening from those that occurred afterwards. 51 transmissions arose from the time prior to screening for viral antibodies. A total of 67 cases (3 HIV, 48 HCV, 16 HBV) can be traced back to the diagnostic window of each infection. In Germany transfusion reactions are most likely to be underreported compared to France or theUnited Kingdom. The frequency of infections that arose from cellular blood products is comparable to the remaining risk described in scientific literature.