[Are test systems for diagnostics of infectious diseases safe? Experiences of the BfArM based on all notifications received until end of 2005].

The European Directive 98/79/EC for in vitro diagnostic medical devices (IVD) regulates the marketing and post marketing surveillance of IVD in the European Economic Area. Manufacturers have to inform the responsible Competent Authorities about incidents and field corrective actions related to IVD. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible Competent Authority for most IVD, while a small subset of IVD, specified in Annex II of the Directive 98/79/EC for immune hematological and infectiological testing as well as tissue typing, 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 115 related to IVD for analysis of the infection status (reagents, control materials, calibrators, culture media and analyzing equipment). Most of the reports originated from manufacturers (57.4 %), while other sources of reports played only minor roles. Product failures of test reagents, control materials, calibrators as well as culture media were frequently caused by manufacturing errors and biological contamination. Analyzing equipment was typically affected by software malfunction. Through the investigations of the manufacturers product failures were confirmed in most cases and consequently corrective actions were performed in the large majority of incidents. The corrective actions frequently included customer information, product recalls, changes in the production process and/or the quality management or software upgrades for the analyzing equipment. Our data suggest that the existing system for post marketing surveillance is an important tool to ensure product safety of IVD even though it should be further optimized in the future.