Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation · 2026
[Development and Empirical Study of an FMEA-Based Risk Management Model for CBCT Equipment].
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Yang Jie, Ren Xiaomin, Tang Ronggao
Аннотация
OBJECTIVE: To construct a failure mode and effects analysis (FMEA) model for risk management of cone- beam computed tomography (CBCT) equipment and improve the level of equipment management.
METHODS: The lean management tool FMEA was used for full-process management evaluation. A total of 15 CBCT devices were selected, and four types of failure modes, including technical performance, environmental interference, system software, and operation norms, were identified. A total of 58 failure modes were confirmed, of which 10 were classified as high-risk effective interventions were carried out on the high-risk items, and a questionnaire survey was conducted to evaluate the effectiveness of the interventions.
RESULTS: The χ 2 test and t-test were performed using SPSS 29.0. After the intervention, the mean risk priority number (RPN) for all four failure mode categories decreased significantly. The differences in both RPN values and work quality scores before and after the intervention were statistically significant.
CONCLUSION: The FMEA model can be used for refined and scientific risk management of cone-beam CT equipment, effectively enhancing the operational capacity of medical equipment and improving the quality of clinical services.
METHODS: The lean management tool FMEA was used for full-process management evaluation. A total of 15 CBCT devices were selected, and four types of failure modes, including technical performance, environmental interference, system software, and operation norms, were identified. A total of 58 failure modes were confirmed, of which 10 were classified as high-risk effective interventions were carried out on the high-risk items, and a questionnaire survey was conducted to evaluate the effectiveness of the interventions.
RESULTS: The χ 2 test and t-test were performed using SPSS 29.0. After the intervention, the mean risk priority number (RPN) for all four failure mode categories decreased significantly. The differences in both RPN values and work quality scores before and after the intervention were statistically significant.
CONCLUSION: The FMEA model can be used for refined and scientific risk management of cone-beam CT equipment, effectively enhancing the operational capacity of medical equipment and improving the quality of clinical services.