News Excerpt:
The Drugs Controller General of India (DCGI) has directed all medical device licence holders and manufacturers to promptly report any adverse events associated with life-saving medical equipment on the government-administered Materiovigilance Programme of India (MvPI) platform.
More about the news:
- The DGCI asked for early identification of risks associated with medical equipment, so that appropriate measures can be taken to mitigate those risks and safeguard public health.
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About DCGI:
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About MvPI:
Objectives of MvPI:
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Key highlights of the decision:
- Establishment of Robust Systems: All medical device licence holders must establish robust systems and processes to promptly identify, document, and report adverse events.
- Utilisation of MvPI Platform: MvPI is highlighted as a crucial platform for reporting adverse events and coordinating analysis, etc. for medical devices,
- Medical devices consist of electronic equipment, implants, consumables and disposables, surgical instruments and in-vitro diagnostic reagents, etc.
- Licence holders are urged to use the MvPI platform for reporting any adverse or serious events associated with the devices to enhance risk identification procedures.
- Post Market Surveillance (PMS): DCGI emphasises the importance of PMS for ensuring the safety and performance of medical devices, and it enables regulatory authorities to mitigate risks and safeguard public health.
- Training for Adverse Event Reporting: Licence holders and manufacturers are instructed to seek training to understand and proficiently report adverse events.
The impacts of increased Postmarket Surveillance due to MvPI:
- Postmarketing surveillance conducted by MvPI is gaining momentum, aligning with global regulatory standards.
- The total number of reported adverse events has been increasing annually, rising from 40 events in 2015 to 897 in 2019. However, these figures remain lower compared to other countries, both in total numbers and other safety metrics like recalls.
- The emphasis is on MvPI's significant progress in collecting and processing adverse event data, as well as generating signals for recall actions.
Areas of improvement:
- Data collection is still limited to recognized medical colleges and hospitals, autonomous institutes, and importers. Larger involvement of private hospitals, nursing homes, and laboratories has to be promoted.
- The data generated by MvPI are not available in the public domains which edge the manufacturers and stakeholders from real-time awareness of adverse events and delay corrective action.
Way Forward:
- Update academic curricula for healthcare and paramedical courses to include MvPI and instil the practice of reporting medical device-related adverse events MDAEs during internship and postgraduate programs.
- Make MvPI a compulsory learning requirement for all doctors to renew their licence, as recommended by the Medical Council of India, and foster collaboration with medical institutions and corporate hospitals to enhance MDAE reporting culture.
- Implement implant registries at the hospital level and include information about implanted devices in patient outpatient department cards as routine practice, while enhancing clinicians' capability to correlate adverse events with medical devices used.
- Suggest incorporating MvPI into NABH (National Accreditation Board for Hospitals & Healthcare Providers) fulfilment criteria, similar to pharmacovigilance.
- Escalate grassroots participation for the flourishing of MvPI and amplify awareness among healthcare professionals and the public about MvPI.
