Medical devices are being used in healthcare facilities for diagnosis, monitoring, prevention and treatment of an array of diseases. To ensure user/patient safety associated with the medical devices being used in healthcare industry, it is of utmost importance to closely monitor the adverse events associated with the medical devices through a robust, sustainable and scaled surveillance. Materiovigilance Programme of India (MvPI) provides a reliable system to report adverse events associated with medical devices. Under MvPI, various modalities to report adverse events associated with medical devices have been developed. These modalities include an editable medical device adverse event reporting form, a toll-free helpline number and a field safety corrective action form (FSCA). FSCA form is used to notify the regulatory authority and healthcare professionals on corrective actions or recall by the manufacturer. Due to the emergence of the Coronavirus disease 2019 (COVID-19) pandemic, one-page editable form has been developed to boost the adverse event reporting of Personal Protective Equipments (PPEs). MvPI also coordinates with healthcare facilities and medical device industries across the country for reporting the medical device-related adverse events. The collected scientific data is utilized to develop regulatory policies and enhance measures to ensure the quality of medical devices. All the healthcare workers are, therefore, encouraged to report adverse events to MvPI. This chapter aims to describe the systems, procedures and modalities available for the reporting of Medical Device Adverse Events (MDAEs) in India, in order to intensify the nature of reporting and creating an environment that encourages the public to perform MDAE reporting.
Part of the book: New Insights into the Future of Pharmacoepidemiology and Drug Safety
The pharmacovigilance has been evolved as a professional and ethical practice in ensuring the safety of medicines. The Adverse Drug Reactions (ADRs) associated with the use of medicines including Anti-Tuberculous Therapy (ATT) through a robust system of pharmacovigilance helps in promoting the safety of patients at large. The occurrence of ADRs associated with the use of ATT is expected, a large number of medicines are combined and used for prolonged duration. The suspected ADRs associated with first line ATT are well documented. However, the drugs used in second line or multidrug resistant to tuberculosis (TB), namely bedaquiline, reported to cause QT prolongation in electrocardiogram reading as one of the most common ADRs. Therefore, early identification and prevention of ADRs during ATT is essential for promoting the rational use and reduce the burden of anti-microbial resistance, besides achieving better treatment outcomes.
Part of the book: New Insights into the Future of Pharmacoepidemiology and Drug Safety