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AuthorSapkota, Binaya
AuthorPalaian, Subish
AuthorShrestha, Sunil
AuthorIbrahim, Mohamed Izham Mohamed
Available date2023-06-20T05:28:34Z
Publication Date2023-04-27
Publication NameTherapeutic Innovation and Regulatory Science
Identifierhttp://dx.doi.org/10.1007/s43441-023-00514-4
CitationSapkota, B., Palaian, S., Shrestha, S., & Ibrahim, M. I. M. (2023). Materiovigilance in Perspective: Understanding Its Concept and Practice in the Global Healthcare System. Therapeutic Innovation & Regulatory Science, 1-13.
ISSN2168-4790
URIhttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85153739807&origin=inward
URIhttp://hdl.handle.net/10576/44586
AbstractMateriovigilance (Mv) has the same purpose and approach in ensuring patient safety as pharmacovigilance but deals with medical devices associated with adverse events (MDAEs) and their monitoring. Mv has been instrumental in recalling many defective or malfunctioning devices based on their safety data. All MDAEs, such as critical or non-critical, known, or unknown, those with inadequate or incomplete specifications, and frequent or rare events should be reported and evaluated. Mv helps to improve medical devices’ design and efficiency profile and avoid device-related complications and associated failures. It alerts consumers and health professionals regarding counterfeit or substandard devices. Common events reported through Mv are device breakage and malfunction, entry- and exit-site infections, organ perforations or injuries, need for surgery and even death, and life cycle assessment of devices. Health authorities globally have developed reporting frameworks with timeframes for MDAEs, such as MedWatch in the USA, MedSafe in New Zealand, and others. Health professionals and consumers need to be made aware of the significance of Mv in ensuring the safe use of medical devices and getting familiar with the reporting procedures and action plans in case of a device-induced adverse event.
Languageen
PublisherSpringer
SubjectDevice recall
Materiovigilance
Medical devices
Medical devices associated adverse events (MDAEs)
Pharmacovigilance
Regulation
Reporting guidelines
TitleMateriovigilance in Perspective: Understanding Its Concept and Practice in the Global Healthcare System
TypeArticle
Pagination1-13
ESSN2168-4804
dc.accessType Open Access


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