The Central Drugs Standard Control Organisation(CDSCO) has issued an alert to healthcare providers, heart patients and medical device distributors on measures they have to take to prevent safety issues with three models of Medtronic’s pacemakers.
This alert was issued after US Food and Drug Administration(FDA) in its safety communication had alerted healthcare providers and patients about the batteries in certain Medtronic implantable pacemakers.
US FDA had said that the pacemakers or cardiac resynchronization therapy pacemakers(CRT-Ps) which can drain faster than expected without any warning could lead to devices losing power quickly and triggering a medical emergency.
Pacemakers are battery-powered devices that provide pacing for slow heart rhythms and heart failure.If a capacitor which is one of the electronic components of these devices is cracked it may lose functionality and create an electrical short which can cause rapid battery depletion.
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical device It functions under the Drugs and Cosmetics Act.CDSCO comes under Directorate General of Health Services,Ministry of Health & Family Welfare.
CDSCO is responsible for (a)approval of New Drugs (b)Conduct of Clinical Trials, (c)laying down the standards for Drugs (d)control over the quality of imported Drugs in the country and (e)coordination of the activities of State Drug Control Organizations by providing expert advice with a view to bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
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