医疗器械安全管理信息平台的研究和开发

目的探讨面向医疗器械安全的信息管理平台构建。方法自主研究和开发了医学工程信息管理平台,包括医疗设备的购置准入、资产管理、质量管理（风险评估、预防性维护、维修、检测、计量、培训）和分析评估功能,以及医用耗材的购置准入、库房管理、临床使用监测功能,并且分别探讨了基于风险评估的预防性维护流程、基于质量控制的医用耗材业务流程和基于条形码的植入性医疗器械管理流程。结果该平台的应用突出了医疗设备和医用耗材的安全使用和质量控制要素,优化了日常业务流程。结论该平台可为构建医疗器械安全管理体系提供数字化支持。

Research and Development of Medical Device Safety Management Information Platform

Objective To investigate the IT management platform for medical device based on safety issue.Methods A clinical engineering information platform was researched and developed independently.It includes the following function modules,such as purchase,assets management,quality management（risk assessment,preventive maintenance,repair,test and training）,analysis and system assessment of medical device,and purchase,store management,monitoring of clinical use of medical consumable materials.The preventive maintenance procedures based on risk assessment,medical consumable materials process based on quality control and barcode-based implantable medical device management process were discussed respectively.Results The application of this platform focused on the safe use and quality control of medical device and consumable materials and optimized the daily services process.Conclusion This platform can provide digital information support for constructing quality system of medical device.