[Safety of in-vitro diagnostics used in transfusion medicine. Experience of the BfArM until end 2005].

The European Directive 98/79/EC on in-vitro diagnostic medical devices (IVD) stipulates the marketing and post marketing surveillance of IVD in the European Economic Area. In cases of incidents and field corrective actions related to IVD, manufacturers have to inform the responsible Competent Authorities. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible Competent Authority for most IVD. Only a small subset of IVD for immune hematological and infectiological testing, as well as tissue typing specified in Annex II of the Directive, is under the responsibility of the Paul-Ehrlich-Institute (PEI). Until the end of 2005 the BfArM received a total of 653 notifications regarding IVD. From these 48 related to IVD used for diagnostics in transfusion medicine and tissue typing which are subject of this study. The investigated products included reagents (tests, calibrators and controls) used for immune hematological analysis as far as they are not under the responsibility of the PEI, analyzing instruments used for immune hematological testing, liquid handling systems for sample preparation and a small subset of analysing instruments and reagents for tissue typing. Most of the reports originated from manufacturers (n=27, 56.3%) and Competent Authorities (n=20; 41.7%) whereas other sources played only minor roles. Product failures were confirmed by the investigations of the manufacturers in 36 (75%) of the reported incidents. Reagents were frequently subject of manufacturing errors and biological contaminations, whereas analysing instruments were typically affected by software errors. In consequence, corrective actions were performed in the large majority of cases (n=37; 77.1%). These included customer information, product recalls, changes in production or quality management and software upgrades (the latter predominantly in cases of failures of analysing instruments). Our data suggest that the governmental system for marketing surveillance is an established tool to ensure product safety for IVD used in transfusion medicine.