Materiovigilance and Hemovigilance (Theory)

Introduction to Vigilance Systems Overview of Materiovigilance, Hemovigilance and other vigilance system in Healthcare Importance of post-marketing surveillance in patient safety Scope and objectives of materiovigilance and hemovigilance programs Basic concepts of adverse event reporting and safety monitoring Historical evolution and global relevance of Materiovigilance, Hemovigilance practices

Materiovigilance Principles and Practices Introduction to Materiovigilance Programme of India (MvPI) Roles of NCC-MvPI and technical collaborators (e.g., Sree Chitra Tirunal Institute) Classification of medical devices (Class A to D) based on risk Identification and documentation of Medical Device Adverse Events (MDAEs) Medical device reporting forms, process flow, and responsibilities Causality assessment of Medical Device Adverse Events

Hemovigilance Principles and Practices Overview of Hemovigilance Programme of India (HvPI) Organizational structure: NIB, NBTC, hospital-based hemovigilance Adverse Transfusion Reactions (ATRs): Types and clinical manifestations Use of TRRF (Transfusion Reaction Reporting Form) and Haemo- Vigil software Responsibilities of blood banks, transfusion officers, and healthcare providers Case examples along with Causality assessment of Hemolytic reactions, TRALI, TACO, allergic responses.

Global Regulations, Risk Assessment & Root Cause Analysis International frameworks: US FDA (MAUDE), EU MDR, SHOT (UK), French Hemovigilance Comparison of Indian and global materiovigilance/hemovigilance practices Signal detection and evaluation of adverse events Root cause analysis (RCA) and implementation of corrective & preventive actions (CAPA) Risk communication and role of healthcare teams in mitigation

Reporting Systems, Quality Assurance, and Professional Role Demonstration: Reporting of MDAEs and ATRs using mock forms Practical exercises in form-filling and event documentation Integration of vigilance into hospital quality systems (e.g., NABH, ISO) Strategies to enhance adverse event reporting culture Ethical considerations and communication with patients/families Role of pharmacists, nurses, clinicians, biomedical engineers in vigilance programs