Comparative analysis of medical device adverse event reporting forms for patients and industries across various countries, and the introduction of a unified generic form for harmonization

Abstract

Introduction: This comparative study examines the complexities of adverse event reporting forms for medical devices across various nations. Despite rigorous clinical trials and surveillance techniques, variations persist in processes and data elements used to report adverse events. The study highlights the importance of standardizing adverse event reporting for medical devices and suggests a comprehensive 'Generic Adverse Event Reporting Form' to accurately determine causality. The advice encourages widespread use of this generic form to create a standardized and effective system for reporting adverse events related to medical devices.

Areas covered: The present investigation provides comprehensive comparison of medical devices adverse event reporting form for users and industries across various nations, challenges, and rationale for a unified generic form.

Expert opinion: The introduction of a unified generic adverse event reporting form has the potential to enhance the effectiveness and efficiency of medical device vigilance systems worldwide. However, addressing challenges related to regulatory harmonization, data standardization, usability, and data privacy is essential for successful implementation and adoption of the generic form. Collaborative efforts among stakeholders, including regulators, manufacturers, healthcare professionals, and users are necessary to overcome these challenges and establish a robust global framework for medical device adverse event reporting.

Keywords: Adverse event; Comparative analysis; Generic Reporting form; Pharmacovigilance; Reporting Form; medical devices.