Abstract:Objective To provide a reference for improving the quality of infusion/ syringe pumps, and strengthen the management for
the production enterprises. Methods Statistics, analysis and discussion was performed on the current supervision status and national
medical devices sampling inspection results in 2016, especially these non-compliance items and reasons, and the potential quality
risk points were explored and researched. Results There were 6 test items appeared to be substandard products in the statutory
standards test, and the “interruption of the power supply” was the highest incidence of substandard products, reaching at 75.0%. The
results of the exploration and research indicated that many of registered product standards/product technical requirements were not
quoted YY0709-2009, and the overall quality of “protection against bolus volumes and occlusion” was not high enough, there were
potential safety issues. Conclusion In view of the existing problems of such products, recommendations will put forward to the
manufacturers, and thus the overall quality of products will be improved to protect people’s safety.
张克,陈甜甜,范书健,刘铮. 输液泵/注射泵质量评价与分析[J]. 中国医疗设备, 2018, 33(3): 87-90.
ZHANG Ke, CHEN Tiantian, FAN Shujian, LIU Zheng. Quality Evaluation and Analysis for Infusion/Syringe Pumps. China Medical Devices, 2018, 33(3): 87-90.