Department of Radiation Oncology, Vall d'Hebron University Hospital Campus, Barcelona, Spain.
Department of Medical Physics and Radiation Protection, Vall d'Hebron University Hospital Campus, Barcelona, Spain.
Clin Transl Oncol. 2024 Dec;26(12):3142-3149. doi: 10.1007/s12094-024-03539-9. Epub 2024 Jun 3.
The increasing complexity of radiation treatments can hinder its clinical success. This study aimed to better understand evolving risks by re-evaluating a Failure Mode and Effects Analysis (FMEA) in lung SBRT.
An experienced multidisciplinary team conducted an FMEA and made a reassessment 3 years later. A process map was developed with potential failure modes (FMs) identified. High-risk FMs and their possible causes and corrective actions were determined. The initial FMEA analysis was compared to gain a deeper perspective.
We identified 232 FMs. The high-risk processes were plan approval, target contouring, and patient evaluation. The corrective measures were based on stricter standardization of plan approval, pre-planning peer review, and a supporting pretreatment checklist, which substantially reduced the risk priority number in the revised FMEA. In the FMEA reassessment, we observed that the increased complexity and number of patients receiving lung SBRT conditioned a more substantial presence of human factors and communication errors as causal conditions and a potential wrong dose as a final effect.
Conducting a lung SBRT FMEA analysis has identified high-risk conditions that have been effectively mitigated in an FMEA reanalysis. Plan approval has shown to be a weak link in the process. The increasing complexity of treatments and patient numbers have shifted causal factors toward human failure and communication errors. The potential of a wrong dose as a final effect augments in this scenario. We propose that digital and artificial intelligence options are needed to mitigate potential errors in high-complexity and high-risk RT scenarios.
放疗的复杂性日益增加可能会阻碍其临床成功。本研究旨在通过重新评估肺部 SBRT 的失效模式和影响分析（FMEA），更好地了解不断变化的风险。
一个经验丰富的多学科团队进行了 FMEA，并在 3 年后进行了重新评估。制定了一个过程图，确定了潜在的失效模式（FM）。确定了高风险 FM 及其可能的原因和纠正措施。将初始 FMEA 分析进行了比较，以获得更深入的了解。
我们确定了 232 个 FM。高风险的过程是计划审批、靶区勾画和患者评估。纠正措施基于计划审批的更严格标准化、预规划同行评审和支持预处理清单，这大大降低了修订后的 FMEA 中的风险优先数。在 FMEA 重新评估中，我们观察到，接受肺部 SBRT 的患者的复杂性和数量增加，使得人为因素和沟通错误作为因果条件，以及潜在的错误剂量作为最终影响的可能性更大。
进行肺部 SBRT 的 FMEA 分析已经确定了高风险的情况，这些情况在 FMEA 的重新分析中已经得到了有效缓解。计划审批已被证明是该过程中的一个薄弱环节。治疗和患者数量的增加使因果因素转向人为失误和沟通错误。在这种情况下，错误剂量作为最终影响的可能性增加。我们建议，需要数字和人工智能选项来减轻高复杂性和高风险 RT 场景中的潜在错误。
