title: [Critical incidents with medical products].
abstract: Various vigilance systems have been established in medicine during the last two decades. The aims are the identification of critical incidents and to implement appropriate countermeasures thus decreasing the likelihood of accidents and increasing patient and user safety. The types of systems are very divergent: they are either restricted to individual departments, hospitals, specialist or occupational groups or function nationwide. The legislative provision for medical products also includes critical incident surveillance and reporting systems and focuses on the subset of events with involvement of medical products. The responsible German authority is the Federal Institute for Drugs and Medical Products which contacts manufacturers and informs users. This article describes experiences with the responsible authority. Not all users are aware that an obligation for reporting exists. A proposal is made to simplify the reporting process in order to enhance user willingness for reporting. Additionally, it is suggested that a link should be incorporated into all existing critical incident reporting systems which can forward the user to the specific reporting website.
authors.affiliation: Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, 01307 Dresden, Deutschland. Maic.Regner@uniklinikum-dresden.de
authors.forename: M
authors.initials: M
authors.lastname: Regner
authors.forename: A
authors.initials: A
authors.lastname: Osmers
authors.forename: M
authors.initials: M
authors.lastname: Hübler
mesh_terms: D018685:Anesthetics, Inhalation; D001803:Blood Transfusion / Q000295:instrumentation; D057785:Catheters; D004282:Documentation; D004340:Drug Contamination; D005858:Germany; D006077:Government Agencies; D019981:Health Care Sector / Q000592:standards; D006761:Hospitals; D006801:Humans; D007262:Infusions, Intravenous / Q000295:instrumentation; D007442:Intubation, Intratracheal; D007883:Legislation, Medical / Q000639:trends; D019221:Mandatory Reporting; D061214:Patient Safety; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011785:Quality Assurance, Health Care; D012308:Risk Management; D013647:Task Performance and Analysis; D065227:Transfusion Reaction
chemical_list: D018685:Anesthetics, Inhalation