Failure modes and effects analysis of total skin electron irradiation technique
Failure modes and effects analysis of total skin electron irradiation technique
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DOI：
10.1007/s12094-017-1721-3
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发表时间：
2018-03-01
影响因子：
3.4
通讯作者：
Rosello, J.
中科院分区：
文献类型：
--
作者：
Ibanez-Rosello, B.;Bautista, J. A.;Rosello, J.
全皮肤电子照射（TSEI）是一种放射治疗技术，包括电子均匀的体表照射。这种治疗需要非常严格的技术和剂量测定条件，需要实施多重控制。最近，AAPM 100 任务组报告建议根据其工艺风险调整设施的质量保证计划。一个多学科团队评估了每个工艺步骤的潜在故障模式 (FM)，无论安装中应用了何种管理工具。对于每个 FM，根据共识评估发生率 (O)、严重性 (S) 和可检测性 (D)，从而得出风险优先级编号 (RPN)，从而对 FM 进行排名。随后，检查了与 TSEI 流程相关的所有使用的管理工具，并对 FM 进行了重新评估，以分析这些工具的有效性，并提出新的管理工具来覆盖较大风险的 FM。 确定了 361 个 FM，其中 103 个 FM 最初的 RPN >= 80，41 个 FM 的 S >= 8。考虑到这一点，对质量管理工具 FM 进行了重新评估，只有 30 个 FM 的 RPN >= 80. 对这 30 个 FM 的研究强调，涉及较大风险的 FM 与治疗期间扩散器屏幕的放置和患者的位置有关。该设施的质量保证计划已根据 TG-100 提出的指导方针进行了调整，以适应该治疗过程的风险。然而，临床经验不断揭示新的 FM，因此需要定期进行风险分析。
Total skin electron irradiation (TSEI) is a radiotherapy technique which consists of an homogeneous body surface irradiation by electrons. This treatment requires very strict technical and dosimetric conditions, requiring the implementation of multiple controls. Recently, the Task Group 100 report of the AAPM has recommended adapting the quality assurance program of the facility to the risks of their processes.A multidisciplinary team evaluated the potential failure modes (FMs) of every process step, regardless of the management tools applied in the installation. For every FM, occurrence (O), severity (S) and detectability (D) by consensus was evaluated, which resulted in the risk priority number (RPN), which permitted the ranking of the FMs. Subsequently, all the management tools used, related to the TSEI process, were examined and the FMs were reevaluated, to analyze the effectiveness of these tools and to propose new management tools to cover the greater risk FMs.361 FMs were identified, 103 of which had RPN >= 80, initially, and 41 had S >= 8. Taking this into account the quality management tools FMs were reevaluated and only 30 FMs had RPN >= 80. The study of these 30 FMs emphasized that the FMs that involved greater risk were related to the diffuser screen placement and the patient's position during treatment.The quality assurance program of the facility has been adapted to the risk of this treatment process, following the guidelines proposed by the TG-100. However, clinical experience continually reveals new FMs, so the need for periodic risk analysis is required.