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Biomed Sci Instrum. 2007;43:302-5.

Medical device incident investigation.

Author information

1
Baretich Engineering, Inc., P.O. Box 469, Fort Collins. CO 80522-0469, USA.

Abstract

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.

PMID:
17487098
[Indexed for MEDLINE]

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