Last Updated on January 23, 2021 by The Health Master
To effectively report serious adverse events (SAEs) due to faulty medical devices, the Indian Pharmacopoeia Commission (IPC) on behalf of the Materiovigilance Programme of India (MvPI) has rolled out sensitization programmes for manufacturers on causality assessment and post market recall to ensure safety of medical devices.
The latest in the series of such programmes conducted pan-India benefited manufacturers associated with Association of Indian Medical Device Industry (AiMeD).
The participants were given a low down on capacity building in terms of compliance to reporting adverse events due to a medical device with reference to new Medical Device Rules (MDR) – 2017 for effective regulatory regime.
As of today, there are 50 medical device adverse event (MDAE) reporting centres in the country which are working on causality assessment, baseline methodology and post market recall to ensure safety of medical devices.
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To report adverse events effectively and systematically, IPC launched MDAE reporting form to generate independent and evidence-based recommendations on the safety of medical devices and to communicate the findings to all key stakeholders.
The reporting form includes adverse event details, severity of the event, date, location, device category, model of the device available with the organisation, its use after the event, name of medical device, manufacturer, brand name, model number, serial number and batch number among others.
Union health ministry has also recommended that all non-serious, known or unknown, frequent or rare SAEs need to be reported on war footing.
Duly filled in Medical Device Adverse Event Reporting (MDAER) Form can be sent to the nearest Medical Device Adverse Event Monitoring Centre (MDMC) or directly to NCC for MvPI through helpline number or mail.
Sensitization programmes are also being conducted to do capacity building of MDMCs in the country for effective medical device adverse event reporting.
The IPC had earlier sent circulars to MDAE reporting centres in the country to keep a check on SAEs due to faulty ventilators or personal protective equipment (PPE) used by the healthcare staff and patients to tackle C-19.
It also sent circulars across all the Indian Council of Medical Research (ICMR) labs conducting IVD tests to report SAEs to tackle C-19 effectively.
In order to help IPC facilitate baseline study of products available with medical devices companies in India and assure patient safety, the union health ministry has also directed medical device manufacturers to register at medical devices information sharing portal through hyperlink –www.mvpi.co.in.
This portal which would serve the purpose as an India specific tool has been developed in consultation with Central Drugs Standard Control Organisation (CDSCO) to ensure that safe medical devices are available in the country.
Union health ministry is also planning to create a Registry of High Risk Medical Devices to effectively study and follow MDAE.
The registry would track usage of high risk medical devices in India mandatorily.
The same would be worked out taking reference of international scenarios so that SAEs can be prevented soon before it arises from the manufacturer’s end.
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