Semester VI · PCI syllabus 2026

Materiovigilance and Hemovigilance

BP607T-E2 1 credit Elective Coming soon

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) 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)

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