Research of Reliability Evaluation Index of PET-CT Based on FEMCA
CHEN Ying1, SUN Yuqi2, YANG Hai3
1. Department of Medical Equipment, Shanghai Sixth People’s Hospital East Campus, Shanghai 201306, China;
2. School of Public Health, Fudan University, Shanghai 200032, China;
3. Department of Human Resourcing, Shanghai Sixth People’s Hospital, Shanghai 200233, China
Abstract：Objective Taking clinical PET-CT as the research object, this study established the key indicators of reliability evaluation and
the key impact components through the research and application of FMECA. Methods The study invited senior technical support engineers
or nuclear medicine technical managers from six PET-CT manufacturing enterprises and four senior clinical engineers to have a brain storm
and formulatedspecialized FMECA procedure for medical equipment industry. Combined with technical features and management practice,
the structure of PET-CT system was decomposed into 7 subsystems, 22 key components and 44 possible fault modes were enumerated.
Results The research optimized the traditional FMECA evaluation index-SOD, it added “Repairability” into the index system. RPN and
RPN×R was calculated and ranked for each fault to verify the validity of the procedure. Conclusion Our study
established reliability evaluation index and method for PET-CT, and innovated the traditional FMECA evaluation index. It provided
template for FMECA in medical equipment industry, and also provided reference information for improving the reliability of PET-CT.
陈颖1，孙雨骐2，杨海3. 基于FMECA的PET-CT可靠性评价指标研究[J]. 中国医疗设备, 2019, 34(8): 28-31.
CHEN Ying1, SUN Yuqi2, YANG Hai3. Research of Reliability Evaluation Index of PET-CT Based on FEMCA. China Medical Devices, 2019, 34(8): 28-31.
