Medical Device Vigilance - A Critical Process for Patient Safety
As medical devices play an increasingly important role in healthcare, ensuring their safety once they reach the market is paramount. However, unexpected issues can arise even after thorough testing and clinical evaluation. This is where medical device vigilance comes in. By continuously monitoring devices post-market and acting on collected information, vigilance helps protect patients and supports device improvements. Let's take a deeper look at this vital process.
What is Medical Device Vigilance?
Medical Device Vigilance refers to the systematic oversight and lessons learned from all adverse events associated with medical devices after they become commercially available or enter clinical practice. The goal is early identification, evaluation, and prevention of issues related to device use or malfunction. Vigilance activities involve collecting, investigating, trending, and reporting adverse incidents to competent authorities. They also aim to determine any necessary corrective or preventive actions.
Importance of Adverse Event Reporting
Prompt reporting of adverse events provides the foundation for vigilance. Healthcare professionals, facilities, patients, and manufacturers all play a role in notifying the appropriate parties when issues arise. Reports provide real-world insights that can't be gained from pre-market testing alone. They reveal potential problems in product design, labeling, manufacturing, or use that need addressing. Timely sharing of this post-market surveillance data allows lessons to be learned across geographic regions and patient populations.
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