CURRENT STATUS OF MATERIOVIGILANCE GLOBALLY-AN UTTER OVERVIEW WITH CLINICAL CASE PERUSAL
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2019, Vol 11, Issue 10
Abstract
Today’s medical devices are the lifesaving tool and these tools are very frequently used globally since long ago. With the increase in the number of medical devices and their uses, there is an increase in the number of adverse events related to such devices. That is why Materiovigilance is an important tool for the identification, collection, reporting, and analysis of any aversive catastrophe related to the use of medical devices and protection of a patient’s life by fending its reiteration. Post marketing surveillance of medical devices has been initiated in many countries, like the United States of America has started a program under the name Medical Device Reporting (MDR), France, Australia and the United Kingdom have also come up with their own programs. Apart from this India has also initiated the Materiovigilance program by Drug Controller General of India (DCGI) at the Indian Pharmacopoeia Commission (IPC) in Ghaziabad in 2015. In this article we have discussed about the risks associated with the use of different classes of medical devices and the need of Materiovigilance program. This article also discusses the adverse events associated with the medical devices, the reporting criteria of those adverse events and the different clinical events of the medical devices.
Authors and Affiliations
PRATIBHA CHAUHAN, AALIA ZARREEN, MOHAMMAD KASHIF IQUBAL
Keywords
Related Articles
- EP ID EP646236
- DOI 10.22159/ijpps.2019v11i10.34716
- Views 134
- Downloads 0
EVOLUTION OF NANOTECH ASSISTED PCR DIAGNOSIS OF MYCOBACTERIUM TUBERCULOSIS AND ITS ASSESSMENT WITH CONVENTIONAL METHODS
Objective: This study was focused on assessment and performance of conventional and nanotech assisted methods for detection of Mycobacterium tuberculosis. Tuberculosis (TB) still leftovers one of the top ten causes of de...
DESIGN AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS USING SINTERING TECHNIQUE
Objective: Itopride Hydrochloride (ITO) is a prokinetic agent commonly used for the treatment of gastroesophageal reflux disease. It activates GI propulsive motility due to its dopamine D2Â antagonizing activity and acet...
BIOPROCESS MODELING FOR THE PREDICTION OF THERAPEUTIC ENZYME L-ASPARAGINASE ACTIVITY IN SOLID STATE FERMENTATION USING MULTIPLE LINEAR REGRESSION AND ANN
Objective: L-asparaginase is an enzyme of industrial as well as therapeutic importance. The capabilities of bioprocess modeling of L-Asparaginase activity produced from Aspergillus niger by solid state fermentation (SSF)...
SOCIODEMOGRAPHIC PROFILE OF PATIENTS WITH ACUTE POISONING IN THE EMERGENCY WARDS OF A TERTIARY CARE HOSPITAL
Objective: To assess the socio-demographic profile and outcomes in the patients with poisoning admitted to the emergency wards of a tertiary care hospital.Methods: The prospective observational study was conducted for a...
OPTIMIZING NASAL FOROPTIMIZING NASAL FORMULATION FOR PREVENTION OF SERIOUS INFECTIONS CAUSED BY MRSAMULATION FOR PREVENTION OF SERIOUS INFECTIONS CAUSED BY MRSA
Objective: Lyophilized nasal insert formulations containing 2% mupirocin which is an antibiotic used to prevent serious infections caused by meticillin resistant Staphylococcus aureus (MRSA) pathogen were prepared.Method...