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国务院发布的《医疗器械监督管理条例》已于2000年4月1日起施行规定县级以上药品监督管理部门行使区域内监督管理职权,在医疗器械的监督工作中一次性输液器的质量检测是涉及面大、任务重的一项工作。而县(市)级目前还没有认可的检测机构。我市医疗机构目前使用的一次性输液器有近20个厂家和品牌,假冒、过期常有发现,临床上严重的热原反应也时有发生。为了加强一次性输液器的抽检,我
The Regulations on the Supervision and Administration of Medical Devices promulgated by the State Council came into force on April 1, 2000, stipulating that drug regulatory authorities above the county level should exercise the power of supervision and management in the region. In the supervision of medical devices, the quality inspection of disposable infusion sets is Involving a large, heavy task of a job. The county (city) level has not yet recognized testing agencies. Medical institutions in our city currently used disposable infusion set has nearly 20 manufacturers and brands, counterfeit, often found outdated, clinically severe pyrogen reaction also occur from time to time. In order to strengthen the disposable infusion pump sampling, I