欧美导尿管产品监管技术要求的比较研究及对策  

Comparative Study of FDA and EU Technical Regulations on Catheters

作　　者：李非[1,2] 马艳彬 迟戈 

机构地区：[1]辽宁省食品药品监督管理局技术审评中心,沈阳110003 [2]沈阳药科大学

出　　处：《中国药事》2011年第2期190-194,共5页Chinese Pharmaceutical Affairs

摘　　要：目的比较研究欧美导尿管产品有关技术法规的具体要求,以合理制定并提高我国的导尿管产品的安全性。方法对美国、欧盟等国家和地区的一次性使用导尿管产品安全性和有效性技术要求进行标准和法规的具体比较,并与我国的现有要求进行对比分析。结果与结论我国尚缺乏对导尿管产品的材料及涂层的监管,而材料和涂层是引发留置导尿感染的重要因素之一,故应加强对导尿管的材料化学性能要求和生物学评价,增加对导尿管涂层的技术要求。Objective To study the technical regulation on catheters,thus improve the safety of catheters in China.Methods Based on regulation and standards in FDA and EU,an analysis is carried out on the safety and efficacy of catheters for single use,and compared with regulation in China.Results and Conclusion The regulation of catheters in China lacks of supervision on materials and coatings,which have vital impacts on catheter associated urinary tract infection（CAUTI）.To improve the safety of catheters,chemical analysis and biocompatibility should be enhanced for catheter materials,and technical requirements should be added for catheter coatings.

关 键 词：导尿管 留置导尿感染 材料化学性能 生物学评价 涂层 

分 类 号：R955[医药卫生—药学] R197.31