Baig Mansoor Ali, Househ Mowafa, Shagathrh Fahad Al, Zahrani Somayah Al, Alanazi Abdulrahman, Saab Yassir Al, Afzal Jawad
King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia.
College of Public Health and Health Informatics, King Saud Bin Abdulaziz University for Health Sciences (KSAU-HS), Ministry of National Guard, Health Affairs, Riyadh, Kingdom of Saudi Arabia.
Stud Health Technol Inform. 2018;251:219-222.
Designing, developing, and establishing the multi-device/multi-center Comprehensive Implantable Medical Device Registry (CIMDR) for Saudi Arabia is a strategic objective of the Saudi Food and Drug Administration (SFDA). The goal of the CIMDR is to capture all related clinical data along with device related information for implantable medical devices and study population-related outcomes. There is an immediate need in Saudi Arabia to establish the CIMDR to carryout device surveillance, gauge the efficiency and efficacy of various implantable medical devices, and track and recall implantable medical devices.In this work, we report on the development of the SFDA's CIMDR. We specifically focus on the project organization, five primary modules of the CIMDR, and development of the CIMDR through dynamic forms. We anticipate that the collected information in the CIMDR will be used by hospitals and the SFDA to improve patient safety relating to implantable medical devices in Saudi Arabia. Future development of the CIMDR will include a wide range of reporting and embedded analytical tools that will help researchers improve clinical standards and contribute to the research and development of implantable medical device technology.
为沙特阿拉伯设计、开发并建立多设备/多中心综合植入式医疗器械注册系统（CIMDR）是沙特食品药品管理局（SFDA）的一项战略目标。CIMDR的目标是收集与植入式医疗器械相关的所有临床数据以及设备相关信息，并研究与人群相关的结果。沙特阿拉伯迫切需要建立CIMDR，以开展设备监测、评估各种植入式医疗器械的效率和效果，以及追踪和召回植入式医疗器械。在这项工作中，我们报告了SFDA的CIMDR的开发情况。我们特别关注项目组织、CIMDR的五个主要模块以及通过动态表单开发CIMDR。我们预计，CIMDR中收集到的信息将被医院和SFDA用于提高沙特阿拉伯与植入式医疗器械相关的患者安全。CIMDR的未来发展将包括广泛的报告和嵌入式分析工具，这将有助于研究人员提高临床标准，并为植入式医疗器械技术的研发做出贡献。
