A Survey And Research Of Some Quality Issues On Single-Use Device

Objective:The quality and disposal of Single-Use Medical Devices (SUD) appeal increasing community attention with their growing clinical application. In this dissertation, the major causes of the current occurrence of adverse events on SUD are analyzed on the basis of their quality condition researches. Consulting the investigation of SUD recycling management in U.S., propose suggestions on it that fits for China's national conditions.Contents:(1)Collect the information on China's recently development of SUD and the management pattern on it in both China and US.(2)The situation of adverse events on SUD is searched by means of survey letters on almost 300 manufactures of SUD. The causes of such adverse events and the drawbacks in disciplines are analyzed meanwhile.(3)The treatments of SUD after use in US and UN are searched to explore the management patterns that fit for China.Methods:Comparative Analysis, induction and deduction, expert survey, literature research, research letters.Conclusions:People's health can be secured more surely with the clinical use of SUD. In order to control the quality conditions of SUD and to reduce adverse events, it is necessary to strengthen the control of raw materials, to inplement GMP system all-round,to add process monitoring on quality control system, to establish a complete standard system,to promote product testing methods, etc. The annually consumption of SUD is enormous because of the big population of China. China would benefit from the application of recycling management on SUD much.