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

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...

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Autores principales: Joshi, Deeksha, Sharma, Ishita, Gupta, Saurabh, Singh, Thakur Gurjeet, Dhiman, Sonia, Prashar, Abhimanyu, Gulati, Monica, Kumar, Bimlesh, Vishwas, Sukriti, Chellappan, Dinesh Kumar, Gupta, Gaurav, Jha, Niraj Kumar, Gupta, Piyush Kumar, Negi, Poonam, Dua, Kamal, Singh, Sachin Kumar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8436859/
https://www.ncbi.nlm.nih.gov/pubmed/34515931
http://dx.doi.org/10.1007/s11356-021-16345-5
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author Joshi, Deeksha
Sharma, Ishita
Gupta, Saurabh
Singh, Thakur Gurjeet
Dhiman, Sonia
Prashar, Abhimanyu
Gulati, Monica
Kumar, Bimlesh
Vishwas, Sukriti
Chellappan, Dinesh Kumar
Gupta, Gaurav
Jha, Niraj Kumar
Gupta, Piyush Kumar
Negi, Poonam
Dua, Kamal
Singh, Sachin Kumar
author_facet Joshi, Deeksha
Sharma, Ishita
Gupta, Saurabh
Singh, Thakur Gurjeet
Dhiman, Sonia
Prashar, Abhimanyu
Gulati, Monica
Kumar, Bimlesh
Vishwas, Sukriti
Chellappan, Dinesh Kumar
Gupta, Gaurav
Jha, Niraj Kumar
Gupta, Piyush Kumar
Negi, Poonam
Dua, Kamal
Singh, Sachin Kumar
author_sort Joshi, Deeksha
collection PubMed
description 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.
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spelling pubmed-84368592021-09-14 A global comparison of implementation and effectiveness of materiovigilance program: overview of regulations Joshi, Deeksha Sharma, Ishita Gupta, Saurabh Singh, Thakur Gurjeet Dhiman, Sonia Prashar, Abhimanyu Gulati, Monica Kumar, Bimlesh Vishwas, Sukriti Chellappan, Dinesh Kumar Gupta, Gaurav Jha, Niraj Kumar Gupta, Piyush Kumar Negi, Poonam Dua, Kamal Singh, Sachin Kumar Environ Sci Pollut Res Int Review Article 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. Springer Berlin Heidelberg 2021-09-13 2021 /pmc/articles/PMC8436859/ /pubmed/34515931 http://dx.doi.org/10.1007/s11356-021-16345-5 Text en © The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2021 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Review Article
Joshi, Deeksha
Sharma, Ishita
Gupta, Saurabh
Singh, Thakur Gurjeet
Dhiman, Sonia
Prashar, Abhimanyu
Gulati, Monica
Kumar, Bimlesh
Vishwas, Sukriti
Chellappan, Dinesh Kumar
Gupta, Gaurav
Jha, Niraj Kumar
Gupta, Piyush Kumar
Negi, Poonam
Dua, Kamal
Singh, Sachin Kumar
A global comparison of implementation and effectiveness of materiovigilance program: overview of regulations
title A global comparison of implementation and effectiveness of materiovigilance program: overview of regulations
title_full A global comparison of implementation and effectiveness of materiovigilance program: overview of regulations
title_fullStr A global comparison of implementation and effectiveness of materiovigilance program: overview of regulations
title_full_unstemmed A global comparison of implementation and effectiveness of materiovigilance program: overview of regulations
title_short A global comparison of implementation and effectiveness of materiovigilance program: overview of regulations
title_sort global comparison of implementation and effectiveness of materiovigilance program: overview of regulations
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8436859/
https://www.ncbi.nlm.nih.gov/pubmed/34515931
http://dx.doi.org/10.1007/s11356-021-16345-5
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