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.
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