title: Product Failures in Respirators and Consumables: Analysis of Field Safety Notices of 2005-2013 Publicized by the Federal Institute for Drugs and Medical Devices in Germany.
abstract: The current European system governed by the three EC directives 93/42/EEC (Medical Device Directive), 98/79/EC (In-Vitro Diagnostic Directive) and 90/385/EEC (Active Implantable Medical Device Directive) regulates marketing and post-market surveillance of medical devices in the European Economic Area (EEA). In cases of incidents raising the field safety corrective actions (FSCA), manufacturers have to inform the responsible Competent Authority (CA; in Germany this 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 respirators and consumables directly required for their function, whereas devices for anesthesia and gas delivery were excluded. FSCA and FSN of 2005-2013 publicized by BfArM for the included products were analyzed with respect to the MEDDEV 2.12-1 rev. 8. In total, 60 FSCA were publicized. German and English FSN were found in 59/53 cases, respectively. FSN were clearly characterized as FSN in 44/38 cases and declaration of the type of action in 45/44 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/7 and 43/40 cases, respectively. Detailed information regarding FSCA and product malfunction was found in all cases. Information on product related risks with previous use of affected devices was provided in 42/38 cases. In 53/53 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness in the organization were found in 27/24 cases. Contact data were provided in 53/48 cases, respectively. Confirmation that a CA was informed was found in 28/26 cases and in 19/15 cases a customer confirmation was included. The identified risks were: total loss of function (19/16), short circuit (1/1) and burn (3/3), and inhalation of foreign particles (1/1) which might cause severe risk to patients and users. The most frequent FSCA were product modifications and customer information. The data suggest that there is an annually increasing number of FSCA on devices included in our study. 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 a CA was informed, and missing customer confirmation. Due to the importance of FSN for reduction of product related risks in FSCA, the type and content of FSN should be further improved.
authors.affiliation: 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.affiliation: Drug Regulatory Affairs, Pharmaceutical Institute, University Bonn, An der Immenburg 4, 53121, Bonn, Germany.
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Siekmeier
mesh_terms: D004868:Equipment Failure / Q000706:statistics & numerical data*; D004864:Equipment and Supplies / Q000706:statistics & numerical data; D005858:Germany; D019983:Guideline Adherence; D006801:Humans; D011358:Product Surveillance, Postmarketing; D012140:Respiratory Tract Diseases / Q000628:therapy; D012449:Safety; D006113:United Kingdom; D012122:Ventilators, Mechanical / Q000706:statistics & numerical data*
keywords: Directive 93/42/EEC; MEDDEV 2.12-1 rev. 8; Medical devices; Respirators