Health ministry to set up a panel to review medical device-related adverse events

New Delhi: The health ministry is establishing an expert committee to monitor medical devices for adverse effects and to take measures to improve patient safety.

The goal is to improve patient safety by monitoring, recording, and analysing the root cause of adverse events or risks associated with the use of medical devices, including in-vitro-diagnostics.

The health ministry is looking for experts in cardiology, gastroenterology, gynaecology, neurology, radiology etc for the committee which will suggest appropriate action.

Medical devices comprise electronic equipment, implants, consumables and disposables, surgical instruments and in-vitro diagnostic reagents, among others. Such equipment form a critical part in medical diagnosis, patient safety and support as life saving system.

Medical devises such as X ray machine are thought to be more prone to causing adverse effects.

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“India Pharmacopiea Commission (IPC) implements the materiovigilance programme. Initial examination of the received cases is being done by the Materiovigilance Programme of India (MvPI) team. It is again discussed in a meeting which comprises of the experts from National Health Systems Resource Centre (NHSRC), Sree Chitra Tirunal Institute of Medical Sciences (SCTIMST), and Central Drugs Standard Control Organization (CDSCO), to arrive at a meaningful conclusion on adverse events,” the official said.

“Based on the discussion in the MvPI Partners meeting, MvPI issues recommendations to CDSCO for their necessary action at their end and safety alerts to Medical Device Adverse Event Monitoring Centres (MDMCs) and Adverse Drug Reactions Monitoring Centres (AMCs) pan India,” the official added.

India, is largely dependent on 80% imported medical devices. Of the ₹44,000 crore spent on importing medical electronics equipment, the medical device industry estimates that over 60% were pre-owned imports.

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Experts say that cases of adverse events are commonly seen in pre-owned medical devices.

“Lack of calibration facilities, and lack of regulatory oversight over validation of accuracy and results can lead to adverse diagnostic consequences or exposure,” said Rajiv Nath, from Association of Indian Manufacturers of Medical Devices (AIMeD).

According to AIMeD, the domestic medtech market was valued at approximately $12 billion in 2023-24, and is expected to more than quadruple to $50 billion by 2030.

“Recently, the government of India halted the imports of refurbished medical devices, which is good. However, India’s regulatory focus on patient safety and quality assurance for refurbished medical devices is insufficient, with no comprehensive system for adverse event reporting. There’s a need to align with international standards and enhance safety and quality, improve certification and inspection processes and promote better environmental practices, and prioritize patient safety,” said Dr Sudhir Srivastava, founder & CEO-Chairman at SS Innovations.

Queries sent to the health ministry remained unanswered. 

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