Safety of in vitro Diagnostics for Hematology and Coagulation Testing – Analysis of the Reports to the German Competent Authority (BfArM)

The European Directive 98/79/EC on in vitro diagnostic medical devices (IVD) stipulates the marketing and postmarketing surveillance of IVD in the European Economic Area. In case 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 in 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, 53 and 34 related to IVD for analysis of coagulation and for hematological testing (without immune hematology), respectively, and were subject of this study. Most of the reports came from manufacturers (n = 69, 79.3%), whereas other sources played only minor roles. Product failures of tests and control materials were frequently caused by manufacturing errors and material defects, whereas analyzers were typically affected by software bugs. Based on the investigations of the manufacturers, product failures were confirmed in most cases, and in consequence corrective actions were performed in 71 cases. The latter included frequently customer information, product recalls, modifications in production or quality management, and software upgrades. Our data suggest that the governmental system for postmarketing surveillance is an established and important tool to ensure the safety of IVD.