硬脑膜修复材料的临床使用评价和质控标准建立的研究

吴敏1a,黄亚萍1a,黄丹1b,李婷婷2,汪长岭1a

中国医疗设备 ›› 2019, Vol. 34 ›› Issue (3) : 117-121.

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中国医疗设备 ›› 2019, Vol. 34 ›› Issue (3) : 117-121. DOI: 10.3969/j.issn.1674-1633.2019.03.032
医院数字化管理

硬脑膜修复材料的临床使用评价和质控标准建立的研究

  • 吴敏1a,黄亚萍1a,黄丹1b,李婷婷2,汪长岭1a
作者信息 +

Clinical Evaluation and the Establishment of Quality Control Standards for Dural Repair Materials

  • WU Min1a, HUANG Yaping1a, HUANG Dan1b, LI Tingting2, WANG Changling1a
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文章历史 +

摘要

目的 医用耗材的使用在现代医院诊疗中发挥的作用不可或缺,为确保和提高医疗质量,应重视医用耗材采购后的跟 踪管理和质量控制,本文通过个例耗材的研究探讨共性问题。方法 对比三甲医院常用植入性硬脑膜修复材料的临床使用, 建立具有可执行性的检测项目标准。结果 通过对医用耗材临床使用和质控标准评价内容和依据的深入了解和讨论,可针对 性的解决医用耗材功能、免疫性、服役寿命等不能很好地满足临床应用要求的问题。结论 基于医疗器械国家标准、行业标 准、地方标准、企业标准的各级法规标准的学习融汇,进行医用耗材的使用评价和安全性监测也是医院临床工程技术人员 的重要的研究和工作方向。

Abstract

Objective The use of medical consumables plays an indispensable role in the diagnosis and treatment of modern hospitals. In order to ensure and improve the quality of medical care, attention should be paid to the follow-up management and quality control of the purchase of medical consumables. This article discussed common problems through the study of consumables. Methods A standard for testing items that could be implemented was established by comparing the clinical use of implantable dural repair materials in the top three hospitals. Results Through in-depth understanding and discussion of the clinical use and quality control standards for medical consumables, it was possible to solve the problem that the medical consumables’ functions, immunity, and service life could not meet the requirements of clinical applications. Conclusion Based on the integration of various national standards, industry standards, local standards, and corporate standards, the use of medical consumables for evaluation and safety monitoring is an important research and work direction for hospital clinical engineering technicians.

关键词

硬脑膜修复材料 / 医用耗材 / 使用评价 / 质量控制 / 医疗器械国家标准

Key words

dural repair materials / medical supplies / use evaluation / quality control / national standards for medical devices

引用本文

导出引用
吴敏, 黄亚萍, 黄丹, . 硬脑膜修复材料的临床使用评价和质控标准建立的研究[J]. 中国医疗设备, 2019, 34(3): 117-121 https://doi.org/10.3969/j.issn.1674-1633.2019.03.032
WU Mina, HUANG Yapinga, HUANG Danb, et al. Clinical Evaluation and the Establishment of Quality Control Standards for Dural Repair Materials[J]. China Medical Devices, 2019, 34(3): 117-121 https://doi.org/10.3969/j.issn.1674-1633.2019.03.032
中图分类号: R628   

参考文献

[1] 王亮,田建军,申月波,等.医院医用耗材质控管理信息化研究 [J].河北省科学院学报,2017,34(4):32-36.

基金

江苏省第五期333工程科研资助项目(BRA2017594)。

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