Application of failure mode and effects analysis in risk management of lung cancer stereotactic radiotherapy process
Objective To explore the application effectiveness of Failure Mode and Effects Analysis(FMEA)in risk man-agement within the process of Stereotactic Body Radiotherapy(SBRT)for lung cancer.Methods A retrospective analysis was conducted on the clinical data of 199 lung cancer patients who underwent SBRT treatment at the Department of Radia-tion Oncology,the First Affiliated Hospital of Soochow University,from February 1,2020,to January 31,2023.The patients were divided into two groups based on the timing of implementing different risk management methods:the con-trol group(February 1,2020,to July 31,2021)with 103 cases,and the observation group(August 1,2021,to January 31,2023)with 96 cases.Patients in the control group underwent conventional radiotherapy quality control risk manage-ment,while patients in the observation group applied risk management based on Failure Mode and Effect Analysis(FMEA).Using the FMEA method to analyze each implementation step in the lung cancer SBRT process,calculate the Risk Priority Index(RPN)to identify key nodes of potential high-risk factors within the process.For high-risk steps with an RPN＞125,prioritize improvement measures.Using t-tests to compare the differences in RPN and positioning errors between the two groups before and after implementing FMEA,and utilizing x2 tests to compare the disparities in the oc-currence rates of adverse events in radiotherapy.Results The observation group's RPN scores for 11 failure modes were significantly lower than those of the control group,and all differences were statistically significant(P＜0.001).The o-verall incidence of four types of adverse events decreased from 10.67％(control group)before implementation to 1.04％(observation group),with a statistically significant difference(x2=8.145,P=0.004).The observation group exhibited significantly lower positioning errors in three directions(left-right,head-foot,and anterior-posterior)compared to those of the control group,with statistically significant differences(t-values were 2.747,4.576 and 4.034,P-values were 0.006,＜0.001 and＜0.001,respectively).Conclusion Incorporating FMEA into the risk management process of lung cancer SBRT can effectively mitigate potential radiotherapy-related risks,decrease the occurrence of adverse events,and enhance clinical safety,as well as improve the precision of radiotherapy delivery.
lung cancerfailure mode and effects analysisrisk priority numberstereotactic body radiation therapyrisk managementsetup error
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