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

Abstract

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.

Keywords

• Adverse events
• Materiovigilance
• Orthopaedics implants
• Medical devices