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Failure mode and effects analysis outputs: are they valid?

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  • المؤلفون: Shebl NA;Shebl NA; Franklin BD; Barber N
  • المصدر:
    BMC health services research [BMC Health Serv Res] 2012 Jun 10; Vol. 12, pp. 150. Date of Electronic Publication: 2012 Jun 10.
  • نوع النشر :
    Comparative Study; Journal Article; Research Support, Non-U.S. Gov't; Validation Study
  • اللغة:
    English
  • معلومة اضافية
    • المصدر:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101088677 Publication Model: Electronic Cited Medium: Internet ISSN: 1472-6963 (Electronic) Linking ISSN: 14726963 NLM ISO Abbreviation: BMC Health Serv Res Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: London : BioMed Central, [2001-
    • الموضوع:
      Health Knowledge, Attitudes, Practice* ; Treatment Failure*; Anti-Bacterial Agents/*administration & dosage ; Risk Assessment/*standards; Critical Pathways ; Gentamicins/administration & dosage ; Hospitals, Teaching ; Humans ; Infusions, Intravenous/methods ; Medication Errors/prevention & control ; National Health Programs ; Patient Care Team/standards ; Qualitative Research ; Recurrence ; Reproducibility of Results ; Risk Management ; Time Factors ; United Kingdom ; Vancomycin/administration & dosage
    • نبذة مختصرة :
      Background: Failure Mode and Effects Analysis (FMEA) is a prospective risk assessment tool that has been widely used within the aerospace and automotive industries and has been utilised within healthcare since the early 1990s. The aim of this study was to explore the validity of FMEA outputs within a hospital setting in the United Kingdom.
      Methods: Two multidisciplinary teams each conducted an FMEA for the use of vancomycin and gentamicin. Four different validity tests were conducted: Face validity: by comparing the FMEA participants' mapped processes with observational work. Content validity: by presenting the FMEA findings to other healthcare professionals. Criterion validity: by comparing the FMEA findings with data reported on the trust's incident report database. Construct validity: by exploring the relevant mathematical theories involved in calculating the FMEA risk priority number.
      Results: Face validity was positive as the researcher documented the same processes of care as mapped by the FMEA participants. However, other healthcare professionals identified potential failures missed by the FMEA teams. Furthermore, the FMEA groups failed to include failures related to omitted doses; yet these were the failures most commonly reported in the trust's incident database. Calculating the RPN by multiplying severity, probability and detectability scores was deemed invalid because it is based on calculations that breach the mathematical properties of the scales used.
      Conclusion: There are significant methodological challenges in validating FMEA. It is a useful tool to aid multidisciplinary groups in mapping and understanding a process of care; however, the results of our study cast doubt on its validity. FMEA teams are likely to need different sources of information, besides their personal experience and knowledge, to identify potential failures. As for FMEA's methodology for scoring failures, there were discrepancies between the teams' estimates and similar incidents reported on the trust's incident database. Furthermore, the concept of multiplying ordinal scales to prioritise failures is mathematically flawed. Until FMEA's validity is further explored, healthcare organisations should not solely depend on their FMEA results to prioritise patient safety issues.
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    • الرقم المعرف:
      0 (Anti-Bacterial Agents)
      0 (Gentamicins)
      6Q205EH1VU (Vancomycin)
    • الموضوع:
      Date Created: 20120612 Date Completed: 20121018 Latest Revision: 20231105
    • الموضوع:
      20250114
    • الرقم المعرف:
      PMC3405478
    • الرقم المعرف:
      10.1186/1472-6963-12-150
    • الرقم المعرف:
      22682433