硬脑膜修复材料的临床使用评价和质控标准建立的研究

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
Clinical Evaluation and the Establishment of Quality Control Standards for Dural Repair Materials
WU Min1a, HUANG Yaping1a, HUANG Dan1b, LI Tingting2, WANG Changling1a 1. a. Department of Medical Engineering; b. Department of Neurosurgery, Jinling Hospital, Nanjing University School of Medicine/
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
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
[中图分类号] R628
[文献标识码] A
doi：10.3969/j.issn.1674-1633.2019.03.032
[文章编号] 1674-1633(2019)03-0117-05
引言 伴随生物医学材料的应用取得极大成功，医用耗材的
使用在现代医院诊疗中发挥的作用不可或缺，占医疗器械
市场份额已超 40%。临床医学工程技术人员通过对医用耗 材流通各个环节的深入分析研究，实现对医用耗材的透明
monitoring is an important research and work direction for hospital clinical engineering technicians.
Key words: dural repair materials; medical supplies; use evaluation; quality control; national standards for medical devices
RESEARCH WORK
研究论著
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
1. 东部战区总医院 a. 医学工程科；b. 神经外科，江苏 南京 210002；2. 南通市第一人民医院 设备处，江苏 南通 226001
[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。 [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
管理、溯源管理、全过程管理，确保临床诊疗工作和应急 救援的器材供应 [1]。重视医用ห้องสมุดไป่ตู้材采购后的跟踪管理和质 量控制，包括采购人员和库管人员定期到临床科室的巡访， 临床和管理科室对植入性材料（如心脏起搏器、人工脑膜
收稿日期：2018-04-11
修回日期：2018-06-21
General Hospital of Eastern Theater Command, PLA, Nanjing Jiangsu 210002, China; 2. Department of Equipment, Nantong First People’s Hospital, Nantong Jiangsu 226001, China
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