Medical device incident investigation
Baretich, M.F.
Biomedical Sciences Instrumentation 43: 302-305
2007
ISSN/ISBN: 0067-8856 PMID: 17487098 Document Number: 607797
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.
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