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Health ministry to create Registry of High Risk Medical Devices to study medical device associated adverse events
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Shardul Nautiyal, Mumbai
September 25 , 2018
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Three years after the introduction of Materiovigilance Programme of India (MvPI) in the country to ensure safety of medical devices, the Union health ministry is now planning to create a Registry of High Risk Medical Devices to effectively study and follow medical device associated adverse events (MDAE) and enable dangerous ones to be withdrawn from the market.
The registry would track usage of high risk medical devices in India mandatorily. The same would be worked out taking reference of international scenario so that serious adverse events (SAE) can be prevented soon before it arises from the manufacturer’s end. Provisions may be introduced under the law to have a legal backing for issuing alerts and warnings to the manufacturer.
This is significant with reference to Johnson & Johnson faulty hip implants case in India which was withdrawn first from Australia promptly as they have in place a registry - Australian Orthopaedics Association National Joint Replacement Registry.
Government is also planning to introduce a legal provision under the new Medical Device (MD) Rules, 2017 which will mandate companies to offer compensation to patients in case of a SAE due to malfunctioning of a medical device. Due to the lack of a legal provision, the companies until now are not liable to pay compensation to the affected patients.
A health ministry expert committee headed by Arun Agarwal formed to study Johnson & Johnson faulty hip implant case which had proposed to introduce the legal provision for compensation has also recommended to create an independent registry of high risk medical devices to effectively report adverse events. This will be taken up with the subsequent Drug Technical Advisory Board (DTAB) meet for further action.
As many as 4,700 patients in India had received articular surface replacement (ASR) hip implants manufactured by J&J subsidiary DePuy Orthopaedics Inc between June 2004 and August 2010, until a global recall over concerns that the metallic implants could leak toxic cobalt and chromium into patents' bodies and pose a risk to their health.
The MvPI launched in 2015 to ensure safety of medical devices is currently being coordinated by the Indian Pharmacopoeia Commission (IPC) at Ghaziabad. The Commission functions as the national coordination centre and Sree Chitra Tirunal Institute of Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram acts as the collaborating centre. Technical support is being provided by the National Health System Resource Centre in New Delhi.
Uptill now, MvPI has put 10 exclusive centres under it to collect and disseminate reporting of adverse events due to medical devices at the point of care besides the 250 adverse drug reaction monitoring centres (AMCs) across the country.
IPC has also launched a reporting form for MvPI. The reporting form called as MDAE reporting form will help generate independent, 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, batch number, catalogue number for instruments, date of installation/implantation/explanation and list of accessories among other relevant details like actions taken immediately after the incident/event.
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