输液泵/注射泵问题分析及监管对策

Problem analysis and supervision strategy for infusion/syringe pumps

目的:分析输液泵/注射泵抽验中发现的问题,为提高输液泵/注射泵产品质量、加强产品质量监督管理提供参考。方法:分析输液泵/注射泵产品监管现状,并对2016年国家医疗器械抽验结果进行统计、分析,以全面评价该类产品的质量及使用情况。结果:该类产品质量水平参差不齐,抽验到样率不高,注册产品标准/产品技术要求未引用YY 0709—2009《医用电气设备第1-8部分:安全通用要求并列标准:通用要求,医用电气设备和医用电气系统中报警系统的测试和指南》情况较多,外部标记、说明书和产品包装不规范问题突出,抽验合格率近几年维持在较低水平。结论:针对该类产品现有问题提出加强抽样队伍建设、统一审评尺度等监管对策,进而增强监管能力,提高产品整体质量水平,保障人民群众用械安全。

Objective To analyze the problems found during the sampling inspection of the infusion and syringe pumps.Methods The present situation of the supervision of medical devices was explored,and statistical analysis was executed on the sampling inspection results of medical devices in 2016 to evaluate completely their quality and application.Results The medical devices had problems in uneven quality,low rate of coverage of sampling inspection,unreferencing YY 0709-2009 Medical Electrical Equipment-Part 1-8:General Requirements for Safety-Collateral Stanalard:General Requirements,Tests and Guidance for Alarm Systems in Medical Eleatriail Equipment and Medical Electrical Systems when registering product standard and technical requirements,external labeling,instruction manual and packaging.The qualification rate for sampling inspection was kept at low level in the past few years.Conclusion The supervision strategy is put forward for medical devices to enhance their overall quality