Problem analysis and supervision strategy for infusion/syringe pumps / 医疗卫生装备

ABSTRACT

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.