摘要
目的:对医用一次性防护服产品的企业研发生产、监管部门技术审评以及产品使用提出建议。方法:采用综合分析方法,探究医用一次性防护服产品现状,总结目前监管部门审评经验,进行综合分析研究。结果与结论:在新型冠状病毒肺炎疫情中,医用一次性防护服有效降低了交叉感染风险,保障了医务人员生命安全。经过综合分析企业研发现状及监管人员在技术审评中的关注要点,探寻出监管部门技术审评、企业研发生产、产品分级及相应技术要求细化完善等方面的改进空间,并提出合理化建议。
Objective:To put forward some suggestions on the R&D and production,technical reviews and use of medical disposable protective clothing.Methods:The current status of medical disposable protective clothing and experience of the current regulatory authorities were comprehensively analyzed and studied by using analytical methods and comprehensive methods.Results and Conclusion:In the COVID-19 outbreak,medical disposable protective clothing could effectively reduce the risk of cross-infection and ensure the life safety of medical staff.Based on the comprehensive analysis of the present situation of enterprise R&D and the key points of supervisors'concerns in the technical review,this paper explored the room for improvement of technical reviews of the supervision department,enterprise R&D and production,product classifications and the refinement and perfection of the corresponding technical requirements and put forward reasonable suggestions.
作者
李耀华
李思
Li Yaohua;Li Si(Center for Medical Device Evaluation,NMPA,Beijing 100081,China)
出处
《中国药事》
CAS
2021年第1期50-57,共8页
Chinese Pharmaceutical Affairs
