Department of Practice and Policy, The School of Pharmacy, University of London, London, UK.
J Patient Saf. 2009 Jun;5(2):86-94. doi: 10.1097/PTS.0b013e3181a6f040.
To test the reliability of failure mode and effect analysis (FMEA) within a hospital setting in the United Kingdom.
Two multidisciplinary groups were recruited, within 2 hospitals from the same National Health Services (NHS) Trust, to conduct separate FMEAs in parallel on the same topic. Each group conducted an FMEA for the use of vancomycin and gentamicin. The groups followed the basic FMEA steps, which included mapping the process of care; identifying potential failures within the process; determining the severity, probability, and detectability scores for these failures; and finally making recommendations to decrease these failures.
Both groups described the process with 5 major steps: starting vancomycin or gentamicin, prescribing the antibiotics, administering the antibiotics, monitoring the antibiotics, and finally stopping or continuing the treatment. Although each group identified 50 failures, only 17 (17%) of them were common to both. Furthermore, the severity, detectability, and risk priority number scores for both groups differed markedly resulting in their failures being prioritized differently.
Failure mode and effect analysis is a useful tool to aid multidisciplinary groups in understanding a process of care and identifying errors that may occur. However, the results of this study call into question the reliability of the FMEA process that was tested. The 2 groups identified similar steps in the process of care but different potential failures with very different risk priority numbers. Such discrepancies make it impossible to identify reliably those failures that should be prioritized and thus where money, time, and effort should be allocated to avoid these failures. Health care organizations should not solely depend on FMEA findings to improve patient safety.
测试失效模式与影响分析（FMEA）在英国医院环境中的可靠性。
在同一国民保健服务（NHS）信托的 2 家医院中招募了 2 个多学科小组，对同一主题平行进行独立的 FMEA。每个小组都对万古霉素和庆大霉素的使用进行了 FMEA。两组都遵循基本的 FMEA 步骤，包括绘制护理流程；识别流程中潜在的失效；确定这些失效的严重程度、发生概率和可检测性评分；最后提出减少这些失效的建议。
两组都描述了 5 个主要步骤的过程：开始使用万古霉素或庆大霉素、开抗生素处方、给予抗生素、监测抗生素，最后停止或继续治疗。尽管每组都确定了 50 个失效，但只有 17 个（17%）是双方共有的。此外，两组的严重程度、可检测性和风险优先数评分差异显著，导致他们对失效的优先级排序也不同。
失效模式与影响分析是一种有用的工具，可以帮助多学科小组理解护理过程并识别可能发生的错误。然而，这项研究的结果对所测试的 FMEA 过程的可靠性提出了质疑。这两组确定了护理过程中的相似步骤，但潜在的失效不同，风险优先级数也非常不同。这种差异使得无法可靠地确定那些应该优先考虑的失效，从而无法确定在哪里投入资金、时间和精力来避免这些失效。医疗保健组织不应该仅仅依靠 FMEA 的结果来提高患者的安全性。
