为了更好地使用外来器械及植入物,我院自2009年4月对外来器械及植入物管理的普遍现状及困难进行讨论,分析使用中存在的主要问题,提出相应的整体质量管理对策。现报道如下。1外来器械及植入物使用管理存在的问题1.1准入混乱未严格遵守国务院第276号令《医疗器械监督管理条例》的 In order to make better use of foreign instruments and implants, our hospital since April 2009 to discuss the general status and difficulties of foreign instruments and implants management, analysis of the main problems in use, put forward the corresponding overall quality management strategies . Report as follows now. 1 foreign instruments and implants management problems 1.1 access to confusion does not strictly comply with the State Council Decree 276 “Medical Device Supervision Regulations”