Daijiworld Media Network - New Delhi
New Delhi, Sep 22: Hospitals across India have been asked to establish structured systems to monitor and promptly report suspected adverse events linked to medical devices, including malfunctions, near-miss incidents and performance failures, under updated guidelines of the Materiovigilance Programme of India (MvPI).
The Guidance Document for Hospitals in India for Safety Monitoring and Reporting of Medical Devices Related Incidents/Adverse Events, Version 1.3, has been developed by the Indian Pharmacopoeia Commission (IPC) in collaboration with the World Health Organization (WHO) India and other national stakeholders.
The document aims to strengthen the systematic identification, documentation, assessment and reporting of medical device-related adverse events.
According to the guidelines, all suspected Medical Device Adverse Events (MDAEs) should be reported promptly, irrespective of whether a definite causal relationship between the device and the incident has been established.
The document states that early reporting of suspected incidents enables timely assessment and investigation, helps detect emerging safety signals and facilitates appropriate corrective or preventive measures to protect patients and healthcare workers.
Serious adverse events involving death or serious deterioration in health are required to be reported to the MvPI within 15 days. Suspected unexpected serious adverse events are also to be reported to the concerned licensing authority within 15 days. Non-serious incidents that could potentially result in serious harm are also covered under the reporting framework.
The guidance advises healthcare institutions to report an incident whenever there is uncertainty over whether it qualifies for reporting. Device malfunction or deterioration, incorrect or out-of-specification test results, design flaws, inaccurate labelling, serious public health threats and use errors are among the incidents that may warrant reporting.
Hospitals have been directed to maintain complete records of device-related incidents, preventive maintenance, calibration and root-cause analyses. Significant or recurrent adverse events should undergo structured Root Cause Analysis (RCA), followed by corrective and preventive actions and monitoring of their effectiveness.
The guidelines call for hospitals to designate a nodal officer or establish a Medical Device Adverse Event Monitoring Centre (MDMC), wherever applicable. Regular training should also be provided to clinical, nursing and biomedical staff so they can identify device malfunctions, failures and abnormal performance.
Healthcare professionals have been advised to remain vigilant for any malfunction, failure, abnormal performance or unexpected patient outcome associated with a medical device and ensure prompt reporting of suspected incidents.
The framework covers primary, secondary and tertiary healthcare facilities. The document notes that adverse events can first be identified at primary healthcare centres and that equipping frontline healthcare personnel to recognise, document and report such incidents can support early detection of safety concerns.
For critical and life-saving devices used in high-risk settings such as intensive care, cardiology, neurosurgery, oncology and emergency care, the guidelines call for active surveillance. Hospitals are required to monitor identified critical devices weekly or monthly, depending on their usage and risk profile.
The list of devices under active surveillance should be prominently displayed in clinical areas such as intensive care units, operation theatres, catheterisation laboratories and specialty wards. A designated nodal person in each department will oversee monitoring, sensitise staff about potential risks and ensure timely reporting.
Any adverse event, incident, near-miss or malfunction associated with monitored devices is to be promptly reported to the National Coordination Centre of MvPI at the IPC in accordance with the prescribed timelines.
The guidelines also place particular emphasis on devices covered by safety alerts issued by the IPC. Hospitals have been advised to include such devices in their active surveillance lists and maintain heightened vigilance and documentation.
Launched in 2015, the MvPI had established a nationwide network of 775 Medical Device Adverse Event Monitoring Centres across India as of September 2026, according to the guidance document. The IPC functions as the National Coordination Centre and uses reports to identify emerging safety signals and support evidence-based recommendations to regulatory authorities.
Reporting can be carried out through the IPC's Adverse Drug Reactions Monitoring System (ADRMS), prescribed reporting forms and other available mechanisms. Consumers can also directly report suspected adverse events. The IPC has established a toll-free helpline, 1800-180-3024, to facilitate reporting.
The ADRMS provides a centralised digital platform for reporting, monitoring, evaluation and analysis of adverse events involving medical products, including medical devices and in-vitro diagnostic devices. The system supports electronic reporting, case tracking and follow-up, as well as safety-signal detection.
The updated guidance comes amid the increasing use of sophisticated medical technologies, including connected and implantable devices, in-vitro diagnostics, artificial intelligence-enabled technologies and software as a medical device.
The document notes that these technological developments have introduced new and evolving categories of risk, making robust and continuous safety monitoring essential to ensure patient and user safety.