Hospitals Asked to Strengthen Monitoring, Reporting of Medical Device Adverse Events

The guidance covers incidents such as device malfunction or deterioration, incorrect or out-of-specification test results, design flaws, labelling inaccuracies, use errors and serious public health threats.

Hospitals across India have been asked to strengthen systems for monitoring and reporting medical device adverse events, including malfunctions, near misses, and performance failures, under updated Materiovigilance Programme of India (MvPI) guidance.

Hospitals have been directed to establish structured processes to identify, document, assess, and report suspected adverse events associated with medical devices.

The updated guidance also calls for greater vigilance around critical devices and stronger documentation of incidents to support patient safety.

Updated Guidance for Hospitals

The guidance document, Guidance Document for Hospitals in India for Safety Monitoring and Reporting of Medical Device-Related Incidents/Adverse Events, Version 1.3, has been developed by the Indian Pharmacopoeia Commission (IPC) in collaboration with WHO India and other national stakeholders. The framework applies across primary, secondary, and tertiary healthcare facilities.

Under the reporting framework, hospitals are expected to report suspected Medical Device Adverse Events (MDAEs) even when a definitive causal link with the device has not been established.

"Early reporting of suspected events facilitates timely assessment, investigation, signal detection, and implementation of appropriate corrective or preventive measures to enhance patient and user safety," the document states.

Reporting Timelines & Incident Monitoring

Serious adverse events involving death or serious deterioration in health must be reported to MvPI within 15 days, while non-serious events that could potentially result in serious harm should be reported within 30 days.

Suspected unexpected serious adverse events are required to be reported to the concerned licensing authority within 15 days.

The guidance covers incidents such as device malfunction or deterioration, incorrect or out-of-specification test results, design flaws, labelling inaccuracies, use errors and serious public health threats.

Where there is uncertainty about whether an incident qualifies for reporting, hospitals have been advised to report it.

Hospitals have also been asked to maintain records of device-related incidents, preventive maintenance and calibration, along with root-cause analyses.

"All significant or recurrent adverse events must undergo structured root cause analysis (RCA)," the document states.

Corrective and preventive actions should subsequently be implemented and monitored for effectiveness.

Active Surveillance of Critical Devices

The guidance recommends appointing a nodal officer or establishing a Medical Device Adverse Event Monitoring Centre (MDMC), where applicable. Regular training for clinical, nursing, and biomedical teams is also encouraged.

For critical and life-saving devices used in intensive care, cardiology, neurosurgery, oncology, and emergency settings, the guidance calls for active surveillance based on device risk and usage.

Monitored device lists should be displayed in relevant clinical departments, with designated personnel overseeing monitoring and reporting.

MvPI Network & Digital Reporting

The MvPI, launched in 2015, has established 775 Medical Device Adverse Event Monitoring Centres nationwide as of September 2026, according to the document. IPC serves as the National Coordination Centre, using reported data to identify safety signals and support recommendations to regulators.

Reports can be submitted through IPC's Adverse Drug Reactions Monitoring System (ADRMS), reporting forms, and other channels.

The guidance also allows consumers to report suspected adverse events directly.

The expanded monitoring framework comes as hospitals increasingly use connected devices, implants, in-vitro diagnostics, AI-enabled technologies, and software as a medical device, creating new categories of risk requiring continuous safety monitoring.

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