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Medical devices have revolutionized healthcare, but they also come with inherent risks. Post-marketing surveillance (PMS) is a critical component of ensuring patient safety once these devices are in clinical use. India, through the Materiovigilance Programme (MvPI), is at the forefront of strengthening PMS efforts.
What is Post-Market Surveillance? Post-market surveillance (PMS) involves the continuous monitoring of a medical device’s safety and efficacy after it has entered the market and is in clinical use. The primary goal is to promptly identify any issues or problems with the device, enabling corrective actions to be taken.
The Need for Post-Marketing Surveillance Clinical trials conducted during device approval have inherent limitations related to sample size and duration. Therefore, it is crucial to monitor devices post-launch as they are introduced into diverse patient populations and settings.
Key Benefits of Post-Marketing Surveillance : Identifying New Problems: Clinical trials may not foresee issues that emerge during long-term device use in diverse populations.
Understanding Underlying Causes: Investigating adverse events reveals the root causes and whether they are device-related or due to user errors. Informing Procurement Decisions: PMS provides systematically generated evidence on device safety performance, enabling informed procurement choices. Preventing Issue Recurrence: By analyzing event data, recurrent problems can be identified, and necessary actions taken to prevent similar adverse events. Improving Device Standards: Real-world data contributes to the revision of safety standards to address problematic device features or technology risks discovered post-marketing. Enabling Design Improvements: Manufacturers can use PMS insights to redesign products, enhance materials, update software, or strengthen cybersecurity.
Post-Market Surveillance: Requirements and Reporting In India, the Medical Device Rules (MDR) 2017 outline PMS requirements. These include the establishment of a robust complaint handling system, adverse event (AE) and serious adverse event (SAE) reporting, and field safety corrective actions (FSCA).
Data Sources for PMS PMS relies on various data sources, including adverse event reports, device registries, user complaints, new clinical studies, research publications, and faulty device analysis. These sources help identify risks, failure modes, and areas requiring corrective action.
The Collaborative Effort for Effective PMS The success of PMS relies on a coordinated effort from all stakeholders, such as healthcare professionals, hospitals, clinical/biomedical engineers, manufacturers, and regulators. Collaboration is essential to improve healthcare outcomes.
The Materiovigilance Programme of India (MvPI) Launched in 2015, MvPI aims to monitor device safety, guide policies and regulations, and promote safe device use. The program has established vigilance monitoring centers across India and introduced an adverse event reporting form for data collection. Active participation from all stakeholders is crucial to realize its potential.
Conclusion: In conclusion, post-marketing surveillance is indispensable for ensuring patient safety and optimizing the use of medical devices. MvPI in India strengthens these surveillance efforts, but its full potential can be realized with the active participation of all stakeholders. With a coordinated effort, post-marketing surveillance empowers proactive and preventive vigilance over the entire device life cycle.
Contact Us for Your Regulatory Needs Regulatory Solutions India stands ready to assist with your regulatory requirements, including post-market surveillance, to ensure that medical devices are both safe and effective. Your success in the field of healthcare remains our top priority.
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