Sievänen Harri
Medical Devices Department, National Agency for Medicines, Helsinki, Finland.
Med Device Technol. 2003 May;14(4):26-9.
In many countries, health-care professionals are required to notify relevant authorities about certain incidents that can be linked to properties, performance and usability issues of medical devices. This study examines whether the user-reporting scheme could add to the information that is already available from manufacturer incident reports.
在许多国家，医疗保健专业人员被要求向相关当局通报某些可能与医疗设备的特性、性能和可用性问题相关的事件。本研究探讨用户报告计划是否能补充制造商事件报告中已有的信息。
