Drug-Device Combinations And Materiovigilance In The Cardiology Department Of A Tertiary Care Private Corporate Hospital

Plan:

To categorize the drug-device combination products used in the Cardiology department and identify and report any adverse reactions related to these products.

Preface: The Materiovigilance Program plays a vital role in ensuring medical device safety in India by monitoring, identifying and reporting, and reacting to undesirable occurrences.

Methodology:

Various diagnostic, monitoring and therapeutic medical devices routinely used in the Cardiology department were systematically classified according to their associated risk. These devices were meticulously monitored and any suspected adverse reactions linked to medical devices were promptly reported to the NCC-MvPI via the materiovigilance centre of the study site.

Outcome:

A total of 1029 medical devices were enlisted and monitored, with the majority being used for therapeutic applications. Among them, 6.1% comprised of drug-device combinations, specifically, drug-eluting stents, pace makers and others. The study identified, documented and reported eighteen suspected adverse reactions associated with cardiology medical devices.  Significantly, the study effectively implemented a materiovigilance program within the Cardiology department of a multispecialty hospital.