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/
General Hospital of Eastern Theater Command, PLA, Nanjing Jiangsu 210002, China;
2. Department of Equipment, Nantong First People’s Hospital, Nantong Jiangsu 226001, China
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.
吴敏1a，黄亚萍1a，黄丹1b，李婷婷2，汪长岭1a. 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.
WU Min1a, HUANG Yaping1a, HUANG Dan1b, LI Tingting2, WANG Changling1a. Clinical Evaluation and the Establishment of Quality Control Standards for Dural Repair Materials. China Medical Devices, 2019, 34(3): 117-121.
