title: Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology.
abstract: The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing and post-market surveillance of medical devices in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform the responsible Competent Authority, which is the Federal Institute for Drugs and Medical Devices (BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of medical devices exclusively serving for diagnostics or treatment in pulmonology (e.g. nebulizers, oxygen concentrators, pulse oximeters, lung function analyzers, and non-active devices for treatment). FSCA and FSN publicized by BfArM in 2005-2013 were analyzed in respect to the MEDDEV 2.12-1 rev 8. In total 41 FSCA were publicized for the included products. German and English FSN were found in 36/35 cases, respectively. FSN were clearly characterized as FSN in 22/20 cases and declaration of the type of action was found in 27/26 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/8 and 26/24 cases, respectively. Detailed information regarding FSCA and product malfunction were found in 27/33 and 36/35 cases, respectively. Information on product related risks with previous use of the affected product was provided in 24/23 cases. In 34/34 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness were found in 10/14 cases. Contact data were provided in 30/30 cases. Confirmation that the Competent Authority was informed was found in 12/14 cases and in 19/18 cases a customer confirmation was included. The obtained data suggest that there is an increasing annual number of FSCA and most FSN fulfill the criteria of MEDDEV 2.12-1 rev 8. However, there are differences between German and English FSN, e.g. regarding the distribution to persons needing awareness, missing statement that the Competent Authority was informed and missing customer confirmation. Due to the importance of FSN for reduction of product related risks in FSCA type and content of FSN should be further improved.
authors.affiliation: c/o Prof. Dr. Schweim; Drug Regulatory Affairs, Pharmaceutical Institute, University Bonn, An der Immenburg 4, 53121, Bonn, Germany, juergenH79@googlemail.com.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Hannig
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Siekmeier
mesh_terms: D004864:Equipment and Supplies / Q000009:adverse effects*; D006801:Humans; D061214:Patient Safety; D015272:Pulmonary Medicine / Q000295:instrumentation*