Last Updated on April 18, 2021 by The Health Master
The Materiovigilance Programme of India (MvPI) has in total received and evaluated 1,257 Medical Devices Adverse Events (MDAE) reports till date through its reporting tools which were launched on February 8, 2019, at Indian Pharmacopoeia Commission (IPC), Ghaziabad.
Out of the total 1,257 reports evaluated, 69% of reports were marked as serious and 31% reports were reported as non-serious as per the Medical Devices Rules (MDR) – 2017.
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All reporting tools and documents are available on the website of IPC-www.ipc.gov.in. IPC is currently working on the development of resource material and reporting tools as the National Coordination Centre (NCC) for MvPI which was launched in 2015.
IPC functions as the NCC for MvPI and Sree Chitra Tirunal Institute of Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram acts as its collaborating center. Technical support is being provided by the National Health System Resource Centre (NHSRC) in New Delhi.
The Union health ministry had in 2019 also directed medical device manufacturers to register at the medical devices information sharing portal through hyperlink -www.mvpi.co.in. This portal serves as an India-specific tool to help IPC facilitate baseline study of products available with medical device companies in India and assure patient safety.
IPC in consultation with Central Drugs Standard Control Organisation (CDSCO) has developed the portal to ensure that safe medical devices are available in the country.
The MDAE reports are processed at IPC NCC- MvPI to get as much information and also determine reporters’ authenticity. Thus, complete reports are carried forward to clinical assessment and root cause analysis expert committee.
Based on the evaluation, it was found that around 76% of serious adverse events reports led to further medical intervention. These adverse events included mainly dissection, stent thrombosis, stenosis, migration of the implanted device, stent elongation among others. Around 7% of the serious adverse events led to the patient death and 10% of the serious adverse events led to the hospitalization of patients (prolongation of existing hospitalization or re-hospitalization).
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Around 7% of the serious adverse events were associated with other causes like the malfunctioning of the device, device break, device expulsion, pain, infection, manufacturing defects, quality issues, device explosion among others.
Out of total 1,257 MDAE reports, 77% reports were reported by Marketing Authorization Holders (MAH), 21% reports were reported by Medical Device Adverse Event Monitoring Centres (MDMCs) and 2% reports were received from Adverse Drugs Reaction Monitoring Centres (AMCs) inclusive of 5 reports from consumers.
Around 51% of total 1,257 reports were associated with cardiac stents including drug-eluting stents, covered stents etc, 5% of reports were associated with catheter including, all peripheral stents, guide wires etc, 3% of cases were associated with heart valves, 11% reports were associated with intrauterine contraceptive devices, 4% reports were related to orthopedic implants and 2% reports were associated with IV cannula.
All the other medical devices contributed to a total of 24% of adverse event reports. As the adverse events associated with devices are reported on a voluntary basis, most of the cases were reported for follow-up information.
Other reporting tools and reference documents for manufacturers available on the IPC website are an updated medical devices adverse event reporting (MDAER) Form (version 1.1), a field safety corrective action (FSCA) form, a reference manual for medical devices, and a handbook for MvPI.