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<p>This study aimed to examine the nature and frequency of adverse events reported for four commonly used medical devices, namely IV sets, IV cannulas, syringes, and blood administration sets between 2018 and 2024, and to identify gaps in India’s current post-marketing surveillance system. A retrospective observational analysis was conducted using data from the Materiovigilance Programme of India (MvPI). Reports were collected from Medical Device Adverse Event Monitoring Centres (MDMCs), Adverse Drug Reaction Monitoring Centres (AMCs), Marketing Authorisation Holders (MAHs), and Pharmacovigilance Programme of India helpline number. Events were categorized by device type, seriousness, source, and year of reporting. Out of 35,391 total device-related reports between 2018 and 2024, 3,107 were associated with the four selected devices. A notable rise in reporting was observed in 2023 and 2024. Most events were non-serious and primarily reported through MDMCs. However, the reporting rate remains disproportionately low given the population size and widespread use of these devices. The findings underscore a critical gap in India’s regulatory approach, which currently excludes non-serious adverse events. To improve patient safety and device reliability, India must enhance its materiovigilance system through policy reform, capacity building, and digital reporting infrastructure.</p>

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The Silent Signals of Device Defects: A Retrospective Study of Adverse Events in Common Medical Devices in India

  • 期刊论文

  • 发表日期：

    2026年3月10日

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  • Jaishree Suresh,
  • V. Naveen,
  • Shubham Choubey,
  • Kalaiselvan Vivekanandan,
  • Rajeev Singh Raghuvanshi

摘要

This study aimed to examine the nature and frequency of adverse events reported for four commonly used medical devices, namely IV sets, IV cannulas, syringes, and blood administration sets between 2018 and 2024, and to identify gaps in India’s current post-marketing surveillance system. A retrospective observational analysis was conducted using data from the Materiovigilance Programme of India (MvPI). Reports were collected from Medical Device Adverse Event Monitoring Centres (MDMCs), Adverse Drug Reaction Monitoring Centres (AMCs), Marketing Authorisation Holders (MAHs), and Pharmacovigilance Programme of India helpline number. Events were categorized by device type, seriousness, source, and year of reporting. Out of 35,391 total device-related reports between 2018 and 2024, 3,107 were associated with the four selected devices. A notable rise in reporting was observed in 2023 and 2024. Most events were non-serious and primarily reported through MDMCs. However, the reporting rate remains disproportionately low given the population size and widespread use of these devices. The findings underscore a critical gap in India’s regulatory approach, which currently excludes non-serious adverse events. To improve patient safety and device reliability, India must enhance its materiovigilance system through policy reform, capacity building, and digital reporting infrastructure.