Safety monitoring of orthopaedic implants under the Materiovigilance programme of India – A current perspective

Introduction: The safety of medical devices, used in orthopaedics is monitored under the Materiovgilance Programme of India (MvPI). Methods: This article aims to convey the process of Orthopaedic implants (OIs) associated adverse events (AE) reporting to MvPI. Results: This article provides the curr...

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Main Authors: Kalaiselvan V, Shubhang Arora, Rajeev Singh Raghuvanshi
Format: Article
Language:English
Published: Elsevier 2023-06-01
Series:Journal of Orthopaedic Reports
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2773157X23000176
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author Kalaiselvan V
Shubhang Arora
Rajeev Singh Raghuvanshi
author_facet Kalaiselvan V
Shubhang Arora
Rajeev Singh Raghuvanshi
author_sort Kalaiselvan V
collection DOAJ
description Introduction: The safety of medical devices, used in orthopaedics is monitored under the Materiovgilance Programme of India (MvPI). Methods: This article aims to convey the process of Orthopaedic implants (OIs) associated adverse events (AE) reporting to MvPI. Results: This article provides the current practices of adverse events with the use of OIs reporting system evolved at MvPI. Though a system has been put in to focus the safety of OIs, quantity of reports available as negligible. Conclusion: Therefore, there is a need to continuously sensitize the healthcare providers and orthopaedicians about OIs adverse events reporting procedure. This article also urges for collaborative approach among the stakeholders.
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spelling doaj.art-9662c29de03c4940a58678129f231c892023-04-22T06:24:39ZengElsevierJournal of Orthopaedic Reports2773-157X2023-06-0122100145Safety monitoring of orthopaedic implants under the Materiovigilance programme of India – A current perspectiveKalaiselvan V0Shubhang Arora1Rajeev Singh Raghuvanshi2Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India, Sector 23, Raj Nagar, Ghaziabad, Uttar Pradesh, 201002, India; Corresponding author.Yashoda Super Specialty Hospitals, Ghaziabad, Uttar Pradesh, IndiaIndian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India, Ghaziabad, IndiaIntroduction: The safety of medical devices, used in orthopaedics is monitored under the Materiovgilance Programme of India (MvPI). Methods: This article aims to convey the process of Orthopaedic implants (OIs) associated adverse events (AE) reporting to MvPI. Results: This article provides the current practices of adverse events with the use of OIs reporting system evolved at MvPI. Though a system has been put in to focus the safety of OIs, quantity of reports available as negligible. Conclusion: Therefore, there is a need to continuously sensitize the healthcare providers and orthopaedicians about OIs adverse events reporting procedure. This article also urges for collaborative approach among the stakeholders.http://www.sciencedirect.com/science/article/pii/S2773157X23000176Adverse eventsMateriovigilanceOrthopaedics implantsMedical devices
spellingShingle Kalaiselvan V
Shubhang Arora
Rajeev Singh Raghuvanshi
Safety monitoring of orthopaedic implants under the Materiovigilance programme of India – A current perspective
Journal of Orthopaedic Reports
Adverse events
Materiovigilance
Orthopaedics implants
Medical devices
title Safety monitoring of orthopaedic implants under the Materiovigilance programme of India – A current perspective
title_full Safety monitoring of orthopaedic implants under the Materiovigilance programme of India – A current perspective
title_fullStr Safety monitoring of orthopaedic implants under the Materiovigilance programme of India – A current perspective
title_full_unstemmed Safety monitoring of orthopaedic implants under the Materiovigilance programme of India – A current perspective
title_short Safety monitoring of orthopaedic implants under the Materiovigilance programme of India – A current perspective
title_sort safety monitoring of orthopaedic implants under the materiovigilance programme of india a current perspective
topic Adverse events
Materiovigilance
Orthopaedics implants
Medical devices
url http://www.sciencedirect.com/science/article/pii/S2773157X23000176
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AT rajeevsinghraghuvanshi safetymonitoringoforthopaedicimplantsunderthemateriovigilanceprogrammeofindiaacurrentperspective