title: Safety of reagents for infection testing: results of the market surveillance by the Federal Institute for Drugs and Medicinal Devices until end 2006.
abstract: The European Directive 98/79/EC on in vitro diagnostic medical devices (IVD) stipulates the marketing and post market surveillance of IVD in the European Economic Area. In cases of issues and field corrective actions, the manufacturers have to inform the responsible Competent Authorities (CA). In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible CA for most IVD, with a small subset of IVD for immune hematological and infection testing as well as tissue typing as specified in Annex II of the Directive, being within the responsibility of the Paul-Ehrlich-Institute (PEI). In this study, all issues regarding reagents for infection testing, but not laboratory analyzers, reported to the BfArM between begin 1999 and end of 2006 were analyzed in respect to the source of report, the underlying product defects, and the performed corrective actions. Within the observation period a total of 888 reports on IVD were received of which 90 related to the IVD for infection testing included in our study. Reports were predominantly received from manufacturers (55) and Competent Authorities (29). Affected products were most frequently those for serological analysis (42) and culturing techniques (36), whereas molecular biological tests played only a minor role (12). Investigations of the manufacturers were able to identify the underlying root causes of product failures in 68 cases (75.6%). In 16 cases (17.8%) the root cause remained unclear and in 6 cases (6.6%) a product failure was excluded or a user error was the underlying cause. Most frequently product failures were caused by material defects (25), production errors (11), microbial contamination (6), and labelling errors (5). Manufacturers issued corrective measures in 73 cases (81.1%). Based on the underlying root causes of product failures, these were predominantly (multiple entries) customer information (71), recall (58), modifications in production or quality management (50), modifications of the raw materials (17), and modifications of the instructions for use (12). The results and experience obtained since 1999 suggest that the system for post marketing surveillance of IVD is an established tool to ensure product safety even though the current system can be further optimised.
authors.affiliation: Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany. r.siekmeier@bfarm.de
authors.forename: R
authors.initials: R
authors.lastname: Siekmeier
authors.forename: J
authors.initials: J
authors.lastname: Halbauer
authors.forename: W
authors.initials: W
authors.lastname: Mientus
authors.forename: D
authors.initials: D
authors.lastname: Wetzel
mesh_terms: D001424:Bacterial Infections / Q000175:diagnosis; D002138:Calibration; D003470:Culture Media; D003955:Diagnostic Tests, Routine / Q000592:standards; D005858:Germany; D006077:Government Agencies; D006801:Humans; D007202:Indicators and Reagents / Q000009:adverse effects / Q000592:standards*; D007239:Infections / Q000175:diagnosis*; D007883:Legislation, Medical; D011358:Product Surveillance, Postmarketing; D012449:Safety
chemical_list: D003470:Culture Media; D007202:Indicators and Reagents