Failure Mode and Effects Analysis Application in External Beam Radiotherapy

Radiološki vjesnik Pub Date : 2024-05-17 DOI:10.55378/rv.48.1.3

Vedran Manestar, Anita O'Donovan, Sarah Barrett

{"title":"Failure Mode and Effects Analysis Application in External Beam Radiotherapy","authors":"Vedran Manestar, Anita O'Donovan, Sarah Barrett","doi":"10.55378/rv.48.1.3","DOIUrl":null,"url":null,"abstract":"Background: Radiotherapy is a medical procedure with potential high risk to harm patients. In order to reduce that risk and create a workflow safe for patients, prospective analysis tools are used. Failure modes and effect analysis (FMEA) is one such tool, used to evaluate potential risks. As FMEA originated from industry, there is a constant effort to adjust FMEA methodology for use in radiotherapy. This has caused a variety of approaches and inhomogeneous practices. Purpose: To investigate the current practice of FMEA in external beam radiotherapy and to propose a more standardised approach. Materials and Methods: The search was performed in PubMed, Ovid and Embase databases, resulting in 312 articles retrieved. Using PRISMA methodology the number of unique articles meeting inclusion and exclusion criteria was reduced to a total of 35, containing 38 analyses. The data on FMEA methodology implemented, scope of analysis, expert team composition, number of failure modes (FM) detected, relative priority number (RPN) threshold, number of FM exceeding the threshold, minimum, maximum and mean RPN, RPN calculation method and risk mitigation strategies were selected as important properties of FMEA. Results: Data retrieved showed large variation in how FMEA is conducted. There is a considerable underreporting of minimum and mean RPN values. Large variations in RPN threshold value selection were also observed. Two different approaches to RPN calculation procedure were reported, and it is unclear what the best practice is. Expert teams were assembled according to the guidelines, but the optimal number of members is unclear. The vast majority of risk mitigation measures were applied directly, without the use of systematic tools. Conclusion: FMEA is a well-established and widely used tool for prospective risk assessment in radiotherapy. As a result of this analysis, recommendations for more standardized approaches were proposed. Possible additional research goals were proposed in order to provide evidence for best practice in some areas of FMEA.","PeriodicalId":500956,"journal":{"name":"Radiološki vjesnik","volume":"125 12","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Radiološki vjesnik","FirstCategoryId":"0","ListUrlMain":"https://doi.org/10.55378/rv.48.1.3","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Radiotherapy is a medical procedure with potential high risk to harm patients. In order to reduce that risk and create a workflow safe for patients, prospective analysis tools are used. Failure modes and effect analysis (FMEA) is one such tool, used to evaluate potential risks. As FMEA originated from industry, there is a constant effort to adjust FMEA methodology for use in radiotherapy. This has caused a variety of approaches and inhomogeneous practices. Purpose: To investigate the current practice of FMEA in external beam radiotherapy and to propose a more standardised approach. Materials and Methods: The search was performed in PubMed, Ovid and Embase databases, resulting in 312 articles retrieved. Using PRISMA methodology the number of unique articles meeting inclusion and exclusion criteria was reduced to a total of 35, containing 38 analyses. The data on FMEA methodology implemented, scope of analysis, expert team composition, number of failure modes (FM) detected, relative priority number (RPN) threshold, number of FM exceeding the threshold, minimum, maximum and mean RPN, RPN calculation method and risk mitigation strategies were selected as important properties of FMEA. Results: Data retrieved showed large variation in how FMEA is conducted. There is a considerable underreporting of minimum and mean RPN values. Large variations in RPN threshold value selection were also observed. Two different approaches to RPN calculation procedure were reported, and it is unclear what the best practice is. Expert teams were assembled according to the guidelines, but the optimal number of members is unclear. The vast majority of risk mitigation measures were applied directly, without the use of systematic tools. Conclusion: FMEA is a well-established and widely used tool for prospective risk assessment in radiotherapy. As a result of this analysis, recommendations for more standardized approaches were proposed. Possible additional research goals were proposed in order to provide evidence for best practice in some areas of FMEA.

查看原文本刊更多论文

故障模式与效应分析在体外放射治疗中的应用

背景：放疗是一种对患者有潜在高伤害风险的医疗程序。为了降低这种风险并为患者创造一个安全的工作流程，需要使用前瞻性分析工具。失效模式和影响分析（FMEA）就是这样一种用于评估潜在风险的工具。由于 FMEA 源于工业领域，因此人们一直在努力调整 FMEA 方法，使其适用于放射治疗。这就造成了方法的多样性和实践的不一致性。目的：调查目前外照射放射治疗中的 FMEA 实践，并提出更标准化的方法。材料与方法：在 PubMed、Ovid 和 Embase 数据库中进行检索，共检索到 312 篇文章。采用 PRISMA 方法，将符合纳入和排除标准的文章数量减少到 35 篇，共包含 38 项分析。FMEA 的重要属性包括：所采用的 FMEA 方法、分析范围、专家团队组成、检测到的故障模式（FM）数量、相对优先级（RPN）阈值、超过阈值的故障模式数量、RPN 的最小值、最大值和平均值、RPN 计算方法和风险缓解策略。结果：检索到的数据显示，在如何进行 FMEA 方面存在很大差异。对最小和平均 RPN 值的报告严重不足。在 RPN 临界值的选择上也存在很大差异。报告了两种不同的 RPN 计算程序，目前尚不清楚最佳做法是什么。专家小组是根据指南组建的，但最佳成员人数尚不清楚。绝大多数风险缓解措施都是直接采用的，没有使用系统工具。结论FMEA 是放疗前瞻性风险评估的一种成熟且广泛使用的工具。通过分析，提出了更多标准化方法的建议。还提出了可能的其他研究目标，以便为 FMEA 某些领域的最佳实践提供证据。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Radiološki vjesnik

自引率

0.00%

发文量