MATERIOVIGILANCE PROGRAMME OF INDIA (MvPI)
MATERIOVIGILANCE PROGRAMME OF INDIA (MvPI)
Materiovigilance is the study and follow up of events occurred through medical devices. It enables to identify adverse events and adverse reactions associated with the use of medical devices. Every medical device has a certain degree of risk and may cause issues under certain circumstances. Monitoring the safety of these devices enables vicious devices to be withdrawn from market and to eliminate faults in the devices to provide the device with utmost safety to patients and consumers.
Medical device is defined as any instrument, equipment, material or other article used with any software to function accurately, which is intended by manufacturer to be used for humans for the following purposes:
• For diagnosis, prevention, control, treatment of disease.
• For mastering conception.
• To study, replace or modify any part of anatomy and physiological process.
In order to detect the safety of a medical device in the country, Ministry of Health & Family Welfare, Govt. of India has got approval and commenced materiovigilance programme of India. Drugs Controller general India (DCGI) launched MvPI On 6th July 2015 at Indian Pharmacopoeia Commission (IPC). IPC & MHFW functions as a National Coordination Centre for MvPI.
OBJECTIVES OF MvPI:
MvPI was introduced with the objective to protect the health and ensure safety of medical device users and also to reduce the recurrence of malfunctions and adverse events associated with the medical device.
• To determine risk-benefit ratio of a medical device usage.
• To generate evidence based data regarding safety of a medical device.
• To support CDSCO in decision – making process on use of medical devices.
• To communicate safety information on use of medical devices to various stakeholders for risk minimization.
Reporting of Medical Device associated Adverse Events (MDAEs)
What to Report?
All types of medical device associated adverse events can be reported irrespective of seriousness criteria, causality and expectedness assessment can be reported. Any adverse event related with medical device can be reported. Incident description, details of adverse events including description of medical device, hazardous risks associated with the device and associated risk of patient, user or person, any possible risk associated with previous use can be provided in MDAEs reporting form.
Where to Report MDAEs?
The HCPs and patients/consumers can report MDAEs to Sree Chitra Tirunal Institute of Medical Science and Technology (SCTIMST) or National Collaboration Centre (NCC). Duly filled form can directly send to the mail id mvpi@sctimst.ac.in.
How to Report MDAEs?
To report adverse events associated with medical devices one can download Medical Device Adverse Event Reporting Form from the website of IPC (www.ipc.gov.in). PvPI helpline number (1800 180 3024) is also available on weekdays from 9:00 am to 5:30 pm.
Whom to Report?
Duly filled MDAEs are directly submitted to NCC or SCTIMST. In certain circumstances, when reports are directly submitted to SCTIMST, those reports are confirmed and are validated by HCPs via following the case report entry into database and sent to NCC for further assessment. NCC review and assess the case and send the case to WHO – Uppsala Monitoring Centre (WHO-UMC). Confidentiality of patient details is strictly followed as per GDPR (EMA) and HIPPA (US FDA) guidelines.
CONCLUSION:
There is a proliferate growth in use of medical devices in recent years. There were no adequate safety measures to protect patients from adverse events associated with the medical devices. Materiovigilance program is meant to detect, analyze, and prevent the recurrence of hazardous reactions caused with medical devices. MvPI was a good initiative to ensure safety of medical devices among India. It is expected that effective implementation of MvPI will safe guard the safety of devices by preventing the recurrence of adverse effects.
REFERENCES:
1) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6176688/
3) https://cdsco.gov.in/opencms/opencms/en/PvPI/
Chintam Srinivasulu,
B.Pharmacy
Reference id: 069/0421.
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