摘要
本文列出医用耗材说明书中存在的内容不完整、内容不规范、变更不及时及进口产品缺少中文标识等问题,从法规层面、监管层面、行业层面和使用者层面剖析问题产生的原因,提出加强医用耗材说明书法规体系建设,完善医用耗材说明书分类管理,强化医用耗材说明书使用管理等措施。
The problems of medical supplies instructions were listed,such as incomplete and no-standardized contents,updated no timely and the lack of a Chinese label instructions of imported products.The causes of the problems were analyzed systematically from law levels,regulatory level,industry level and user level.The countermeasures had been investigated,to improve the regulatory system of medical consumables instructions,to recommend the instructions classification system and to strengthen medical supplies instructions usage management.
出处
《解放军医院管理杂志》
2013年第7期669-671,共3页
Hospital Administration Journal of Chinese People's Liberation Army
关键词
医用耗材
说明书
问题及对策
medical supplies
instructions
problems and countermeasures
