Ensuring Medical Device Safety: The Role of Standards Organizations and Regulatory Bodies. J Med Syst 2025 Jan 25;49(1):16
Date
01/26/2025Pubmed ID
39862365DOI
10.1007/s10916-025-02150-xScopus ID
2-s2.0-85216999282 (requires institutional sign-in at Scopus site) 4 CitationsAbstract
Medical devices significantly enhance healthcare by integrating advanced technology to improve patient outcomes. Ensuring their safety and reliability requires a delicate balance between innovation and rigorous oversight, managed through the collaborative efforts of standards development organizations, standards accrediting organizations, and regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This article explores the historical evolution of medical device regulation, the role of standards organizations, and the impact of regulatory practices on device safety. Highlighting the critical need for stringent regulations, informed by instances where medical devices caused patient harm, we discuss the processes and collaborations between various international standards and regulatory frameworks that ensure device safety and effectiveness. This comprehensive review addresses the complexities of regulatory compliance and standardization, aiming to bridge the knowledge gap among healthcare providers and enhance the implementation of safety standards in medical technology.
Author List
Daryanani AE, Maduekwe UN, Baird P, Ehrenfeld JMAuthors
Jesse Ehrenfeld MD, MPH Sr Assoc Dean, Exec Director, Professor in the Advancing a Healthier Wisconsin Endowment department at Medical College of WisconsinUgwuji N. Maduekwe MD Associate Dean, Associate Professor in the Surgery department at Medical College of Wisconsin
MESH terms used to index this publication - Major topics in bold
Device ApprovalEquipment Safety
Equipment and Supplies
Humans
Medical Device Legislation
Patient Safety
United States
United States Food and Drug Administration
