title: Does customer information fulfill MEDDEV criteria in cases of product problems of in vitro diagnostics for infection testing?
abstract: The European Directive 98/79/EC on in vitro diagnostics (IVD) regulates marketing and post market surveillance of IVD in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform responsible competent authority (CA) and public by field safety notices (FSN). We analyzed FSCA and FSN of IVD for infection testing (culture media, reagents, kits, control materials, as well as culture-based analyzers and their general consumables) published by the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn, Germany in 2005-2012 in regard to the European Regulatory Framework of Medical Devices (MEDDEV). One hundred and sixty-nine FSCA were published and German and English FSN were found in 157 and 154 cases, respectively. FSN were clearly characterized as FSN in 110 German and 134 English cases and product names were provided in 157 and 154 cases, respectively. Lot numbers and other information for product characterization were available in 146 and 137 cases, respectively. The information regarding FSCA and product malfunction was provided in 157 and 151 and 144 and 136 cases and that regarding the product related risks with continued use of affected IVD in 116 and 116 cases, respectively. In 156 German and 152 English cases, manufacturers provided the information for risk mitigation, including retesting in 69 and 75 cases, respectively. Requests to pass FSN to persons needing awareness were found in 108 and 87 cases, and contact data were provided in 127 and 131 cases, respectively. We conclude that most FSN fulfilled the MEDDEV criteria. However, type and content of FSN should be improved to ensure a better mitigation of risks due to product failure.
authors.affiliation: Drug Regulatory Affairs, Pharmaceutical Institute, University Bonn, An der Immenburg 4, Bonn, 53121, Germany, juergenH79@googlemail.com.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Hannig
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Siekmeier
mesh_terms: D003141:Communicable Diseases / Q000175:diagnosis*; D003257:Consumer Product Safety; D019719:Diagnostic Equipment / Q000706:statistics & numerical data; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000941:ethics* / Q000592:standards; D017410:Practice Guidelines as Topic; D011933:Reagent Kits, Diagnostic / Q000941:ethics* / Q000592:standards
chemical_list: D011933:Reagent Kits, Diagnostic