对医用一次性防护服监管问题的分析与讨论

Analysis and Discussion on Supervision of Medical Disposable Protective Clothing

作为特殊场合穿用的职业性服装,医用一次性防护服是确保医务人员不受潜在感染性污染物污染的重要防护用品之一。医疗器械监督抽查检验是通过检验技术确保产品安全性和有效性的重要手段。该研究结合医用一次性防护服产品概况、国家强制性标准关键项目解读分析,以及近3年广东省药品监督管理局组织开展的专项抽查检验工作发现的不合格问题进行探讨,以期为医用防护服生产企业提升产品质量及各级药监部门加强监督管理工作提供参考。

As professional clothing for special occasions,medical disposable protective clothing,is one of the important protective articles to ensure that medical personnel are not contaminated by potentially infectious pollutants.The spot-check supervision of medical devices is an important means to improve the safety and effectiveness of products through inspection technology.This article discussed the general situation of medical disposable protective clothing products,the interpretation and analysis of the key items of the national mandatory standards,and the unqualified problems found in the special spot check inspection organized by Guangdong Provincial Drug Administration in recent three years,expecting to provide a reference for improving the product quality of medical protective clothing manufacturers and strengthening the supervision and management of drug regulatory departments.