Medical device incident investigation

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

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.

Publication types

  • Review

MeSH terms

  • Biomedical Engineering / standards*
  • Equipment Failure Analysis / methods*
  • Equipment Failure Analysis / standards*
  • Equipment Failure*
  • Equipment Safety / standards*
  • Mandatory Reporting
  • Product Surveillance, Postmarketing / methods*
  • Product Surveillance, Postmarketing / standards*
  • Risk Management
  • United States