Hospitals across India have been asked to strengthen systems for detecting, documenting and reporting suspected medical device-related adverse events under the updated Materiovigilance Programme of India (MvPI) guidelines.
The guidance document, developed by the Indian Pharmacopoeia Commission (IPC) in collaboration with WHO India and other stakeholders, covers medical device malfunctions, performance failures, near-miss incidents, use errors and other events that could affect patient or user safety.
Prompt reporting encouraged
The framework states that suspected medical device adverse events should be reported even when a definite causal link between the device and the incident has not yet been established. Early reporting is intended to support investigation, safety-signal detection and corrective or preventive action.
Serious events involving death or serious deterioration in health are to be reported to MvPI within 15 days. Non-serious events that could potentially result in serious harm should be reported within 30 days, while suspected unexpected serious adverse events are to be reported to the concerned licensing authority within 15 days.
The guidance also recommends reporting when there is uncertainty about whether an incident meets the reporting criteria.
Focus on records and root-cause analysis
Hospitals are expected to maintain records of device-related incidents along with preventive maintenance and calibration records. Significant or recurring adverse events should undergo structured root-cause analysis, followed by corrective and preventive actions and monitoring of their effectiveness.
Healthcare facilities have also been advised to designate a nodal officer or establish a Medical Device Adverse Event Monitoring Centre, where applicable. Regular training for clinical, nursing and biomedical engineering staff is recommended to improve identification of device failures and abnormal performance.
Active surveillance for high-risk devices
The framework calls for active surveillance of critical and life-saving devices used in areas such as intensive care, cardiology, neurosurgery, oncology and emergency medicine.
Depending on the device’s risk profile and usage, hospitals are expected to conduct monitoring on a weekly or monthly basis. Departments including ICUs, operation theatres, catheterisation laboratories and specialty wards should prominently display their monitored-device lists and designate personnel to oversee reporting.
Devices covered by IPC safety alerts are also to be included in active surveillance programmes.
Framework covers all levels of healthcare
The guidance applies to primary, secondary and tertiary healthcare facilities, recognising that device-related incidents can first emerge at frontline healthcare facilities.
The MvPI, launched in 2015, has established 775 Medical Device Adverse Event Monitoring Centres across India as of September 2026, according to the document. The IPC serves as the National Coordination Centre and uses reported information to identify emerging safety signals and support recommendations to regulatory authorities.
Reports can be submitted through the IPC’s Adverse Drug Reactions Monitoring System (ADRMS), reporting forms and other available mechanisms. Consumers can also report suspected events directly.
The updated framework comes as healthcare facilities increasingly use connected and implantable devices, in-vitro diagnostics, artificial intelligence-enabled technologies and software as medical devices, creating new categories of safety risks requiring continuous monitoring.
