Medical device incident investigation.
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.
Baretich
Matthew F
MF
Baretich Engineering, Inc., P.O. Box 469, Fort Collins. CO 80522-0469, USA.
D001698:Biomedical Engineering / Q000592:standards*; D004868:Equipment Failure; D019544:Equipment Failure Analysis / Q000379:methods* / Q000592:standards*; D004869:Equipment Safety / Q000592:standards*; D019221:Mandatory Reporting; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000592:standards*; D012308:Risk Management; D014481:United States