新疆地区医用一次性防护服质量检测结果分析

Analysis of Quality Detection Results of Disposable Protective Clothing in Xinjiang Autonomous Region

目的:根据2020年抽送检情况对医用一次性防护服类产品进行质量检测结果统计,了解新疆地区生产、流通环节医用一次性防护服质量状况,为医疗器械安全监督管理部门提供科学依据。方法:根据GB 19082-2009标准方法的要求,对新疆地区抽送检的57批次医用一次性防护服,根据相应国家标准对其外观、结构、号型规格、抗渗水性、透湿量、抗合成血液穿透性、表面抗湿性、断裂强力、断裂伸长率、过滤效率、阻燃性能、微生物指标、环氧乙烷残留量等项目进行检验。结果:1批次防护服产品环氧乙烷残留量结果不符合规定;2批次防护服产品透湿量结果不符合规定;1批次防护服产品断裂强力不符合规定;5批次防护服产品规格尺寸不符合规定;2批次防护服产品外观性能不符合规定;4批次微生物指标不符合规定。结论:防护服类产品经检验发现不同性能指标均会出现质量问题,存在一定的安全隐患。建议对原料采购、生产质量控制环节继续加强监管力度,以保障对医护人员的病毒防护安全。

Objective:To provide scientific basis for medical device administration department by investigating the quality of disposable protective clothing in the process of its production and distribution in Xinjiang based on the quality test results of medical disposable protective clothing products according to the situation of sampling inspection in 2020.Methods:The 57 batches of disposable protective clothing for sampling inspection were checked in terms of its appearance,structure,model and specification,water tightness,permeability,anti-synthetase blood penetration,surface moisture resistance,breaking force,breaking elongation,fltration effciency,flame retardation,microbiological indicator and residual ethylene oxide according to the requirements in GB 19082-2009.Results:The residual ethylene oxide in one batch of disposable protective clothing does not meet the standard;the moisture vapor permeability of two batches of disposable protective clothing does not meet the standard;the breaking force of one batch of disposable protective clothing does not meet the standard,the specifications and dimensions of five batches of disposable protective clothing do not meet the standard,the appearance and function of the two batches of disposable protective clothing do not meet the standard;the microbial index of four batches of disposable protective clothing does not meet the standard.Conclusion:There are some quality problems in the disposable protective clothing in terms of different performance indicators,therefore there exist some potential dangers.Suggestion is proposed to further strengthen the supervision and management of disposable protective clothing in the procedures of the purchase of raw material,manufacturing and quality control.