Ibanez-Rosello Blanca, Bautista-Ballesteros Juan Antonio, Bonaque Jorge, Celada Francisco, Lliso Françoise, Carmona Vicente, Gimeno-Olmos Jose, Ouhib Zoubir, Rosello Joan, Perez-Calatayud Jose
Radiotherapy Department, La Fe University and Polytechnic Hospital, Valencia, Spain.
Radiotherapy Department, Lynn Cancer Institute, Boca Raton, Florida, USA.
J Contemp Brachytherapy. 2016 Dec;8(6):518-524. doi: 10.5114/jcb.2016.64745. Epub 2016 Dec 20.
Esteya (Nucletron, an Elekta company, Elekta AB, Stockholm, Sweden) is an electronic brachytherapy device used for skin cancer lesion treatment. In order to establish an adequate level of quality of treatment, a risk analysis of the Esteya treatment process has been done, following the methodology proposed by the TG-100 guidelines of the American Association of Physicists in Medicine (AAPM).
A multidisciplinary team familiar with the treatment process was formed. This team developed a process map (PM) outlining the stages, through which a patient passed when subjected to the Esteya treatment. They identified potential failure modes (FM) and each individual FM was assessed for the severity (S), frequency of occurrence (O), and lack of detection (D). A list of existing quality management tools was developed and the FMs were consensually reevaluated. Finally, the FMs were ranked according to their risk priority number (RPN) and their S.
146 FMs were identified, 106 of which had RPN ≥ 50 and 30 had S ≥ 7. After introducing the quality management tools, only 21 FMs had RPN ≥ 50. The importance of ensuring contact between the applicator and the surface of the patient's skin was emphasized, so the setup was reviewed by a second individual before each treatment session with periodic quality control to ensure stability of the applicator pressure. Some of the essential quality management tools are already being implemented in the installation are the simple templates for reproducible positioning of skin applicators, that help marking the treatment area and positioning of X-ray tube.
New quality management tools have been established as a result of the application of the failure modes and effects analysis (FMEA) treatment. However, periodic update of the FMEA process is necessary, since clinical experience has suggested occurring of further new possible potential failure modes.
埃斯特亚（瑞典斯德哥尔摩医科达公司的核通公司生产）是一种用于治疗皮肤癌病变的电子近距离放射治疗设备。为了确立适当的治疗质量水平，按照美国医学物理学家协会（AAPM）TG - 100指南提出的方法，对埃斯特亚治疗过程进行了风险分析。
组建了一个熟悉治疗过程的多学科团队。该团队绘制了一个过程图（PM），概述了患者接受埃斯特亚治疗时所经历的各个阶段。他们识别出潜在失效模式（FM），并针对每个单独的FM评估其严重程度（S）、发生频率（O）和未被检测到的可能性（D）。制定了一份现有质量管理工具清单，并经协商重新评估了FM。最后，根据风险优先数（RPN）及其严重程度（S）对FM进行排序。
识别出146个FM，其中106个RPN≥50，30个严重程度（S）≥7。引入质量管理工具后，只有21个FM的RPN≥50。强调了确保施源器与患者皮肤表面接触的重要性，因此在每次治疗前由另一个人复查设置情况，并进行定期质量控制以确保施源器压力的稳定性。安装中已经在实施的一些基本质量管理工具是用于皮肤施源器可重复定位的简单模板，有助于标记治疗区域和X射线管的定位。
通过应用失效模式与效应分析（FMEA）治疗建立了新的质量管理工具。然而，由于临床经验表明可能会出现更多新的潜在失效模式，因此有必要定期更新FMEA过程。
