Medical Device Safety: The Rise of Active Postmarket Surveillance

By
Irina Smith
September 6, 2024
10
min read
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The Urgent Need for Active Post-market Surveillance of Medical Devices

Medical devices are intended to improve our health and well-being. However, even with rigorous pre-market testing, potential safety issues may emerge only after devices are used in real-world settings. A 2018 study of FDA data revealed a startling statistic: more than 1.7 million injuries and 83,000 deaths in the United States over a 10-year period were potentially linked to medical devices. This underscores the critical need for robust post-market surveillance to ensure the safety of these devices and protect patients.

The FDA's current system relies heavily on passive surveillance, which depends on manufacturers, healthcare providers, and patients voluntarily reporting adverse events. This approach, however, has significant limitations. Underreporting, incomplete information, and time delays are common, hindering the FDA's ability to quickly identify and address potential safety risks.

Active post-market surveillance offers a vital solution. Unlike passive surveillance, it proactively seeks evidence of device performance in real-world settings. By leveraging data sources like electronic health records, billing claims, and patient registries, active surveillance can provide a more comprehensive and timely picture of device safety. This allows the FDA to detect potential safety issues that might otherwise go unnoticed, enabling quicker intervention and potentially preventing further harm to patients.

The high number of injuries and deaths potentially linked to medical devices highlights the urgency of transitioning to a more active approach. Investing in active post-market surveillance is an investment in patient safety and public health. It's about ensuring that the medical devices intended to heal us don't inadvertently cause harm.

Applications of Real-World Evidence for Medical Devices

FDA Takes Action: Building a Safer Future with Active Medical Device Surveillance

The FDA recognizes the limitations of passive surveillance and is actively working to establish a robust active post-market surveillance system for medical devices. This commitment to patient safety is evident in the significant steps the agency has already taken:

  • Establishing a Coordinating Center: In 2016, the FDA partnered with the Medical Device Innovation Consortium to create the National Evaluation System for health Technology Coordinating Center (NESTcc). NESTcc is responsible for organizing a network of data sources, including health systems and other collaborators, to generate real-world evidence for medical device evaluation.
  • Building a Secure Data Infrastructure: Recognizing the importance of patient privacy, the FDA completed a cloud-based data infrastructure in 2021. This infrastructure allows for the secure collection and analysis of real-world evidence while protecting sensitive patient information.
  • Initiating Active Surveillance: The FDA is set to begin active post-market surveillance of two medical devices by December 2024. The duodenoscope, known for potential infection risks, and robotically-assisted surgical devices for gallbladder removal, which have strong data capture potential, will be the first devices under active surveillance. This initial step demonstrates the FDA's commitment to putting the system into practice.

The FDA's plan doesn't stop there. The agency has outlined an ambitious expansion strategy over the next five years.

  • Expanding Device Coverage: Starting in 2025, the FDA plans to add four new devices to the active surveillance program annually. This will broaden the scope of the system, enhancing patient safety across a wider range of medical devices.
  • Growing the Data Network: The FDA aims to onboard additional data partners each year, with a goal of adding data representing 10 million new patients annually in the first two years. This expansion will provide a larger pool of real-world data, improving the system's ability to detect safety signals.

The FDA's proactive approach to building an active surveillance system signifies a major step forward in medical device safety. By leveraging real-world evidence and embracing advanced data analytics, the FDA is paving the way for a future where medical devices are not only effective but also demonstrably safe for all patients.

Planned Expansion of FDA’s Active Post-market Surveillance System

Real-World Impact: How Active Surveillance Makes Medical Devices Safer

Active surveillance isn't just a theoretical concept – it's a powerful tool already being used to improve patient safety. By analyzing real-world data, healthcare organizations are identifying potential device-related issues and taking action to prevent harm. Here's a real-world example of active surveillance in action:

Kaiser Permanente, a leading healthcare provider, has successfully used active surveillance to improve patient care. Leveraging data from device registries and electronic health records, they've identified medical devices with higher-than-expected revision rates. These revisions, often stemming from complications or device-associated problems, can signal potential safety concerns. By proactively identifying these trends through active surveillance, Kaiser Permanente can inform clinical decision-making, guiding physicians in selecting the safest and most effective devices for their patients.

This example illustrates how active surveillance translates into tangible benefits for patients. By shifting from a reactive to a proactive approach, we can:

  • Identify potential safety issues earlier: Detecting trends before they escalate into widespread problems allows for timely interventions, potentially preventing adverse events and improving patient outcomes.
  • Make more informed clinical decisions: Data-driven insights from active surveillance empower healthcare providers to choose devices based on real-world performance, ensuring patients receive the safest and most appropriate care.
  • Drive device improvement: Information gathered through active surveillance can be used to improve device design, manufacturing processes, and clinical guidelines, leading to safer and more effective medical devices for all.

Active surveillance is a critical step towards a healthcare system where medical devices consistently deliver on their promise of improving health and well-being. By embracing data-driven insights and proactive monitoring, we can create a safer and more effective healthcare landscape for all.

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Irina Smith

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