A global comparison of implementation and effectiveness of materiovigilance program: overview of regulations
| العنوان: | A global comparison of implementation and effectiveness of materiovigilance program: overview of regulations |
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| المؤلفون: | Niraj Kumar Jha, Kamal Dua, Bimlesh Kumar, Monica Gulati, Gaurav Gupta, Saurabh Gupta, Ishita Sharma, Sachin Kumar Singh, Thakur Gurjeet Singh, Deeksha Joshi, Dinesh Kumar Chellappan, Abhimanyu Prashar, Piyush Kumar Gupta, Sonia Dhiman, Poonam Negi, Sukriti Vishwas |
| المصدر: | Environmental Science and Pollution Research International |
| بيانات النشر: | Springer Berlin Heidelberg, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Canada, China, Health, Toxicology and Mutagenesis, Medical equipment, India, Harmonization, Review Article, 03 Chemical Sciences, 05 Environmental Sciences, 06 Biological Sciences, Medical device regulations, Patient safety, Japan, Environmental Chemistry, Humans, Adverse effects, Australia, General Medicine, Pollution, United States, Europe, Risk analysis (engineering), Government Regulation, Medical devices, Business, Materiovigilance, Delivery of Health Care, Environmental Sciences, Healthcare system |
| الوصف: | 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. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1614-7499 0944-1344 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4170401f2a4c03110894131834605b51Test http://europepmc.org/articles/PMC8436859Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....4170401f2a4c03110894131834605b51 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 16147499 09441344 |
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