의료기기 데이터베이스 구축과 활용: 스코핑 리뷰를 통한 의료기기 생애주기 분석
Medical Device Database: Scoping Lifecycle Review
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Objectives: This study examines the utilization and lifecycle management of medical device databases in multiple regions including the United States, Europe, Japan, and Canada, and evaluates their public health impact. The objective is to identify best practices, gaps, and challenges in the current sys- tems to inform future improvements and standardization efforts on a global scale. Methods: A comprehensive comparative analysis was conducted on databases in these regions. The analysis focused on the structure, operation, and application of these databases in lifecycle management. Key factors include data collection, integration, utilization throughout the product lifecycle, data accessibility, user interfaces, integration with other healthcare data, regulatory compliance, and public health impacts. Data were collected through literature reviews, policy documents, and expert interviews to provide a robust understanding of each system. Results: Results show reveal significant variations in how regions utilize medical device databases to enhance device safety and efficacy. While all regions aim to improve device safety and public health outcomes, there are notable differences in data accessibility, usage, and management practices. Comprehensive coverage of the medical device lifecycle from pre-market approval to post-market surveillance varies significantly. Integration with regulatory processes and support for public health interventions through detailed tracking and reporting mechanisms also differ widely. Data accessibility and integration with national databases remain challenging. Inconsistent data formats, varying levels of data granularity, and differences in regulatory requirements hinder effective global monitoring and comparison. Despite these challenges, the study highlights the potential for medical device databases to significantly enhance healthcare quality and patient safety. Conclusions: National medical device databases are crucial for improving healthcare quality and safety. They serve as vital tools for identifying issues and informing policy-making. Korea should consider developing a comprehensive database focused on user health protection and safety enhancement, aligned with global standards.
Abstract
Objectives: This study examines the utilization and lifecycle management of medical device databases in multiple regions including the United States, Europe, Japan, and Canada, and evaluates their public health impact. The objective is to identify best practices, gaps, and challenges in the current sys- tems to inform future improvements and standardization efforts on a global scale. Methods: A comprehensive comparative analysis was conducted on databases in these regions. The analysis focused on the structure, operation, and application of these databases in lifecycle management. Key factors include data collection, integration, utilization throughout the product lifecycle, data accessibility, user interfaces, integration with other healthcare data, regulatory compliance, and public health impacts. Data were collected through literature reviews, policy documents, and expert interviews to provide a robust understanding of each system. Results: Results show reveal significant variations in how regions utilize medical device databases to enhance device safety and efficacy. While all regions aim to improve device safety and public health outcomes, there are notable differences in data accessibility, usage, and management practices. Comprehensive coverage of the medical device lifecycle from pre-market approval to post-market surveillance varies significantly. Integration with regulatory processes and support for public health interventions through detailed tracking and reporting mechanisms also differ widely. Data accessibility and integration with national databases remain challenging. Inconsistent data formats, varying levels of data granularity, and differences in regulatory requirements hinder effective global monitoring and comparison. Despite these challenges, the study highlights the potential for medical device databases to significantly enhance healthcare quality and patient safety. Conclusions: National medical device databases are crucial for improving healthcare quality and safety. They serve as vital tools for identifying issues and informing policy-making. Korea should consider developing a comprehensive database focused on user health protection and safety enhancement, aligned with global standards.
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