A Blockchain-Based Post-Marketing Surveillance System for Medical Devices

Abstract

Nowadays, medical devices are widely used around the world. In every country, the safety of these devices is inextricably related to public health and security. Despite all these sensitivities and legal oversight, issues such as lack of transparency in the medical device supply chain, lack of real feedback from incidents and clinical reports related to these devices, and consequently the failure to update risk management systems and improve the quality of these devices, resulting in increased safety risks for users/patients. Therefore, the development and implementation of an effective post-market surveillance and management system for medical devices is essential.In this article, in addition to a review of some applications of blockchain technology in the health sector, the requirements and structural framework for an information and management system for post-market surveillance of medical devices based on this technology were also presented. This system was developed with the approach of tracking medical devices to enhance transparency, provide rapid information dissemination, and reduce the rate of adverse incidents, and clinical reports related to these devices throughout their supply chain. A blockchain-based post-market surveillance system for medical devices could provide all stakeholders with valuable and real recommendations and information in the form of smart contracts by ensuring complete informational transparency throughout the supply chain. Blockchain technology could be used by regulatory and oversight organizations to effectively monitor and manage the performance of medical devices, ensuring greater transparency, and thereby guaranteeing enhanced safety and quality for stakeholders.

Keywords

• postmarketing product surveillance
• equipment and supplies
• safety
• blockchain
• technology