医用分子筛制取氧气在临床使用的监管问题

SUPERVISION ISSUES ON THE CLINICAL USE OF THE MOLECULAR SIEVE OXYGEN

分子筛制氧是医疗机构自己通过分子筛制氧设备制造氧气直接用于临床患者治疗,目前暂没有进行GMP认证、也不需要获得药品注册号和药品生产许可证,对分子筛制氧在临床使用的监管缺失已经演变成为了多年未决的热点问题。通过分析医用分子筛制取氧气在临床上使用存在的问题,阐述了加强医用分子筛制取医用氧气管理的建议。

Healthcare institutes apply molecular sieve oxygen on patient treatment, which is not certified by GMP and there is no drug registration number or manufacture license. The Lack of supervision to the clinical use of the molecular sieve oxygen has become unsolved hotspot these years. Through analyzing clinical application problems of molecular sieve oxygen, proposes suggestions on reinforce management.