Discussion on Problems and Countermeasures of Clinical Trials of
Medical Devices in Stomatological Hospitals
JU Jiaa, XIN Hongb, ZHANG Huana, HUANG Jinga, YUE Jiaoa, Lin Yaoa, CHENG Lifeia, FENG Bina
a. Department of Pharmacy; b. Department of Medical Equipment, The Third Affiliated Hospital of Air Force Medical University of
PLA, Xi’an Shaanxi 710032, China
Abstract：Objective To explore the application effect of whole-process multi-dimensional quality control mode in clinical trial quality
management of medical devices in stomatological hospitals. Methods By summarizing the problems found in the on-site verification
of clinical trial data in stomatological hospitals, they were classified and sorted out according to pre-clinical trial preparation,
protection of subjects’ rights and interests, clinical trial protocol, clinical trial process, record and report, and the management of
medical devices for trial, and the causes of the problems were analyzed from the perspectives of clinical researchers, sponsors/contract
research organizations, and clinical trial institutions. The problems existing in the clinical trials of medical devices before and after
the implementation of the whole-process multi-dimensional quality control mode in our hospital were sorted out, and the application
effect of the whole-process multi-dimensional quality control mode was evaluated. Results After the implementation of the wholeprocess
multi-dimensional quality control mode, The quality of clinical trials of medical devices was significantly improved. The
incidence of unqualified items was significantly reduced in terms of implementation of trial protocol, adverse event recording,
traceability of test data, and consistency and integrity of data, the difference was statistically significant (P<0.05). Conclusion
The whole-process multi-dimensional quality control mode effectively improves the quality of clinical trials of medical devices in
stomatological hospitals, which is expected to become a new model of clinical trial quality management in stomatological hospitals.
巨佳a，辛红b，张欢a，黄静a，岳姣a，林瑶a，成黎霏a，冯斌a. 口腔专科医院医疗器械临床试验
常见问题及对策[J]. 中国医疗设备, 2023, 38(8): 132-137.
JU Jiaa, XIN Hongb, ZHANG Huana, HUANG Jinga, YUE Jiaoa, Lin Yaoa, CHENG Lifeia, FENG Bina. Discussion on Problems and Countermeasures of Clinical Trials of
Medical Devices in Stomatological Hospitals. China Medical Devices, 2023, 38(8): 132-137.
