Failure Mode and Effects Analysis Application in External Beam Radiotherapy

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.