A global comparison of implementation and effectiveness of materiovigilance program: overview of regulations.

Autor: Joshi D; Chitkara College of Pharmacy, Chitkara University, Punjab, India., Sharma I; Chitkara College of Pharmacy, Chitkara University, Punjab, India., Gupta S; Chitkara College of Pharmacy, Chitkara University, Punjab, India. saurabhgupta80@gmail.com., Singh TG; Chitkara College of Pharmacy, Chitkara University, Punjab, India., Dhiman S; Chitkara College of Pharmacy, Chitkara University, Punjab, India., Prashar A; Chitkara College of Pharmacy, Chitkara University, Punjab, India., Gulati M; School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab, 144411, India., Kumar B; School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab, 144411, India., Vishwas S; School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab, 144411, India., Chellappan DK; School of Pharmacy, International Medical University, Bukit Jalil, Kuala Lumpur, Malaysia., Gupta G; School of Pharmacy, Suresh Gyan Vihar University, Jagatpura Mahal Road, Jaipur, India., Jha NK; Department of Biotechnology, School of Engineering and Technology (SET), Sharda University, Noida, Uttar Pradesh, India., Gupta PK; Department of Life Science, School of Basic Sciences and Research, Sharda University, Greater Noida, Uttar Pradesh, 201310, India., Negi P; School of Pharmaceutical Sciences, Shoolini University of Biotechnology and Management Sciences, Solan, 173229, India., Dua K; Discipline of Pharmacy, Graduate School of Health, University of Technology Sydney, Sydney, NSW, 2007, Australia.; Faculty of Health, Australian Research Centre in Complementary and Integrative Medicine, University of Technology Sydney, Ultimo, NSW, 2007, Australia., Singh SK; School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab, 144411, India. singhsachin23@gmail.com.
Jazyk: angličtina
Zdroj: Environmental science and pollution research international [Environ Sci Pollut Res Int] 2021 Nov; Vol. 28 (42), pp. 59608-59629. Date of Electronic Publication: 2021 Sep 13.
DOI: 10.1007/s11356-021-16345-5
Abstrakt: Medical devices, being life-saving tools, are considered to be a boon for healthcare system. However, in addition to their therapeutic effects, there are several ill consequences that are caused by these devices. An effective cohort vigilant system was needed to manage such adverse effects. This had led to the introduction of materiovigilance. Materiovigilance is the study and follow-up of occurrences that arise as a result from the usage of the medical equipment. It not only manages adverse events (AE) but also creates harmonization among countries. Keeping these objectives in focus, the principles, perspectives, and practices with regard to materiovigilance that are followed in the USA, Europe, China, Japan, Australia, Canada, and India are being compared. Such a comparison is essential, which will help us to understand the gaps in the current regulatory systems in the above-mentioned countries and furthermore will provide a comprehensive picture to the regulatory authorities to amend any existing laws if required. These amendments may ensure optimal patient safety by providing them a benign experience from the use of medical devices.
(© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
Databáze: MEDLINE
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