Designing and Developing a Multi-Center/Multi-Device National Registry for Implantable Medical Devices

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.