Baretich Matthew F
Baretich Engineering, Inc., P.O. Box 469, Fort Collins. CO 80522-0469, USA.
Biomed Sci Instrum. 2007;43:302-5.
FDA Medical Device Reporting regulations require investigation and reporting of certain device-related incidents. Medical device incident investigation is also a key component of risk management for healthcare delivery organizations. However, the fundamental objective of incident investigation is to identify the root cause of an incident and mitigate the risk (probability x severity) of recurrence.
美国食品药品监督管理局（FDA）的医疗器械报告规定要求对某些与器械相关的事件进行调查和报告。医疗器械事件调查也是医疗服务提供机构风险管理的关键组成部分。然而，事件调查的根本目标是确定事件的根本原因，并降低事件再次发生的风险（概率×严重程度）。
