Abstract：Objective To investigate the problems of the medical device adverse event reports through the reports’ quality evaluation.
Methods The non probabilistic sampling and probability sampling were used to investigate the reports according to the injure
severity. The typical investigation of the death reports, the major investigation of the serious injury reports, and the stratified sampling
of the general reports were used in this progress. Results A total of 1571 medical device adverse event repots were received in the
third quarter 2016, the sample proportion was 10%, the number of the sampling was 160, and the stratified sampling average error
was 0.0229. Conclusion Some measures were put forward to improve the reporting quality gradually in this paper, which would
provide effective data and foundation for analysis and evaluation of adverse event reports of medical devices, and make the risk
control of medical devices more scientific.
杨飞，钟蕾，刘东红. 医疗器械不良事件报表质量评估抽样方案研究与探讨[J]. 中国医疗设备, 2018, 33(5): 165-169.
YANG Fei, ZHONG Lei, LIU Donghong. Research on the Sampling Scheme of the Medical Device Adverse Event Reports’ Quality Evaluation. China Medical Devices, 2018, 33(5): 165-169.
