Regner M, Osmers A, Hübler M
Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, 01307 Dresden, Deutschland.
Anaesthesist. 2012 May;61(5):452-6. doi: 10.1007/s00101-012-2010-8.
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.
在过去二十年中，医学领域建立了各种警戒系统。其目的是识别关键事件并采取适当的应对措施，从而降低事故发生的可能性，提高患者和使用者的安全性。这些系统的类型差异很大：它们要么局限于个别科室、医院、专科或职业群体，要么在全国范围内发挥作用。医疗产品的立法规定还包括关键事件监测和报告系统，并侧重于涉及医疗产品的事件子集。德国的负责机构是联邦药品和医疗器械研究所，该机构与制造商联系并通知使用者。本文介绍了负责机构的经验。并非所有使用者都意识到有报告义务。有人提议简化报告流程，以提高使用者的报告意愿。此外，建议在所有现有的关键事件报告系统中加入一个链接，该链接可以将使用者引导至特定的报告网站。
