Tracking Risks, Saving Lives: How India and the U.S. Protect Patients through Materiovigilance

Materiovigilance refers to the system of safety monitoring and performance of medical devices after being placed on the market and involves collecting, analyzing, and responding to reports of malfunctions, adverse events, or other issues related to medical devices used in healthcare settings. Materiovigilance goal is to ensure that medical devices continue to meet safety and effective standards throughout their lifecycle and to take corrective actions when necessary. Key Elements of Materiovigilance are Adverse Event Reporting, Data Collection and Analysis, Regulatory Oversight, Post-Market Surveillance and Risk Management. Materiovigilance helps in Patient Safety, Device Improvement and Regulatory Compliance. Examples of Materiovigilance Activities include adverse reaction Reporting of a cardiac stent, ventilator failure tracking. This review examines how India and the United States monitor medical device safety to protect patient health. In the U.S., the FDA has a strong system that includes the Medical Device Reporting (MDR) and MedWatch programs, which enable quick reporting of safety issues by manufacturers, healthcare providers, and patients. This organized approach allows for fast responses to potential risks, enhancing patient safety. India’s system, managed by the “Materiovigilance Programme of India” (MvPI) under the “Central Drugs Standard Control Organization (CDSCO),” is newer and faces challenges such as low awareness and varying compliance among healthcare providers. However, recent initiatives to improve reporting and engage providers show promise.