In a Notification dated 26th November 2019 the Central Drugs Standard Control Organisation (“CDSCO”) has stated that all healthcare professionals and clinicians must inform and duly report about medical devices adverse event to Materiovigilance Programme of India (“MvpPI”) MvPI-IPC to all states Drugs Controller/Authorities in order to strengthen public health.
“MvpPI” aims to improve patient safety and welfare of the Indian population by monitoring medical devices’ safety and thereby reducing the risks associated with the use of medical devices.
A system of continuous monitoring of the medical devices is essential as it helps in assessing, monitoring and detecting adverse effects of medical devices, their malfunctions etc. that can result in higher morbidity and mortality.
The measure will help to maximize benefits and minimize risks associated with medical devices.
Healthcare professionals need to be well informed about the adverse effects of medical devices by developing educational and promotional interventions like continuous medical education, awareness program, workshops, conferences on materiovigilance etc