医用口罩质量控制与应急管理

Quality control and emergency management of medical masks

目的 分析口罩、医用口罩结构、材质要求、设计开发、性能指标、质量控制要求以及应急供应现状.方法 比较医疗器械法规对原材料、灭菌工艺、变更的要求以及一次性使用医用口罩、医用外科口罩、医用防护口罩等自吸过滤口罩的性能要求和实际应用.结果 医用口罩应对用量突增情况,受到储量小、灭菌加工周期长等因素的制约,原料、工艺变更、灭菌方式对医用口罩过滤效率等固有性能产生不利影响,需评估其带来的应用风险.结论 医用口罩、医用防护服等防护器械应加大以国家储备为主的应急机制,建议按照临床实际用途确切规范产品技术指标和适用范围,对该类产品的应急生产能力、质量控制能力进行日常考核.

Objective To analyze the structure of masks and medical masks, and material requirements, design confirmation, performance indexes, quality control requirements and emergency supply status of medical masks. Methods The requirements of medical device regulations for raw materials, sterilization process and changes of them, and the performance requirements and practical application of self-inhalation filter masks such as disposable medical masks, medical surgical masks and medical protective masks were compared. Results Confronting the sudden increase in its use, medical mask was restricted by factors such as small reserves and long sterilization processing cycle. Raw materials, process changes and sterilization methods had adverse effects on the inherent properties of medical masks, such as filtration efficiency. The application risks thus incurred should be evaluated. Conclusion Protective devices such as medical masks and medical protective clothing, etc. should strengthen the emergency mechanism based on national reserves. It is suggested that the technical indexes and application scope of the products be exactly standardized according to the actual clinical use, and the emergency production capacity and quality control capacity of such products should be checked on a daily basis.