摘要
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产品之一.而医疗器械检验是确保医疗器械产品安全性和有效性的重要手段.该研究根据GB 19082-2009《医用一次性防护服技术要求》,对 2021-2022 年贵州省医疗器械检测中心抽检的 230 批次医用一次性防护服样品的检验结果(检验项目包括外观、结构、抗渗水性、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、抗静电性、环氧乙烷残留量及微生物项目)进行分析,发现不合格项目为外观、断裂强力和抗静电性,并进一步探讨了不合格项目形成的原因,提出加强对企业的法规宣传培训、重视企业内部培训、加强企业自身检验能力建设及加强监管部门监管能力建设等对策,为医疗器械生产企业提高产品质量意识和保障产品质量提供参考.
Abstract
Disposable medical protective clothing is one of the important protective products to ensure that medical personnel are not contaminated by potential infectious pollutants,and medical device testing is an important means to ensure the safety and effectiveness of products.In this study,according to GB 19082-2009"Technical Requirements for Medical Disposable Protective Clothing",with the analysis of the inspection results of 230 batches of medical disposable protective clothing samples sampled by Guizhou Medical Device Testing Center from 2021-2022(inspection items including appearance,structure,water resistance,anti synthetic blood penetration,surface moisture resistance,breaking strength,breaking elongation,filtration efficiency,anti-static performance,residual ethylene oxide,and microbiological items),it was found that the unqualified items were appearance,breaking strength,and anti-static performance.In addition,the reasons for the formation of unqualified projects were further explored,and the measure such as strengthening regulatory publicity and training for enterprises,valuing internal training,strengthening the construction of their own inspection capabilities,and strengthening the supervision capacity of regulatory departments were proposed,providing reference for medical device production enterprises to improve product quality awareness and ensure product quality.
维普
万方数据