a. Department of Radiation Oncology丨 b. Department of Medical Engineering, Affiliated Suzhou Hospital of Nanjing Medical
University, Suzhou Jiangsu 215001, China
Abstract:Objective To use failure modes and effects analysis (FMEA) method to evaluate the dose daily stability (DDS) deviation of
medical linear accelerator, optimize the troubleshooting process and improve the quality assurance and quality control. Methods The
DDS found in the clinic showed an increasing trend of deviation, and the risk assessment plan was initiated. According to FMEA, the
maintenance flow chart and the failure modes (FM) were created. For each failure mode, the values of occurrence (O), severity (S)
and detection (D) were quantitatively evaluated, and the score of risk priority number (RPN) was obtained. According to the score,
human factors, measurement tools, accelerator components and other FMs were determine whether it was the cause of deviation and
corrected it. Results According to the RPN score results, the human factors and measurement tool reasons were eliminated in stages.
Through four maintenance and three replacements of spare parts, the ionization chamber fault was determined. During the period,
the stability deviation was less than 2%, no downtime and treatment interruption occurred, and the stability deviation of final dose
decreased and remained within 0.5%. Conclusion The application of FMEA method can reasonably evaluate relevant risks, reduce
the impact on clinical work, and provide guarantee for quality assurance and quality control of DDS.
管建a,李成a,沈丹青a,吴传锋a,王晓禹b,胡睿a. FMEA法在加速器剂量日稳定性偏差风险排查中的应用研究[J]. 中国医疗设备, 2021, 36(7): 48-51.
GUAN Jiana,LI Chenga,SHEN Danqinga,WU Chuanfenga,WANG Xiaoyub,HU Ruia. Application Study of FMEA Method in Risk Investigation of
Dose Daily Stability Deviation of Accelerator. China Medical Devices, 2021, 36(7): 48-51.