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

Abstract

The European Directive 98/79/EC on in vitro diagnosticmedical devices (IVD) stipulates the marketing and postmarketingsurveillance of IVD in the European EconomicArea. In case of incidents and field-corrective actions relatedto IVD, manufacturers have to inform the responsiblecompetent authorities. In Germany, the Federal Institutefor Drugs and Medical Devices (BfArM) is the responsiblecompetent authority for most IVD. Only a smallsubset of IVD for immune hematological and infectiologicaltesting as well as tissue typing specified in Annex IIof the Directive is in the responsibility of the Paul-Ehrlich-Institute (PEI). Until the end of 2005, the BfArM receiveda total of 653 notifications regarding IVD. From these, 53and 34 related to IVD for analysis of coagulation and forhematological testing (without immune hematology),respectively, and were subject of this study. Most of thereports came from manufacturers (n = 69, 79.3%), whereasother sources played only minor roles. Product failuresof tests and control materials were frequentlycaused by manufacturing errors and material defects,whereas analyzers were typically affected by softwarebugs. Based on the investigations of the manufacturers,product failures were confirmed in most cases, and inconsequence corrective actions were performed in 71cases. The latter included frequently customer information,product recalls, modifications in production or qualitymanagement, and software upgrades. Our data suggestthat the governmental system for postmarketingsurveillance is an established and important tool to ensurethe safety of IVD.