The FDA is Building an Active Postmarket Surveillance System for Medical Devices

A new GAO report details how the FDA has begun to build an active postmarket surveillance system for medical devices with plans to bring it live for two devices starting in December.

A new report from the Government Accountability Office (GAO) explains how the FDA has begun building an active postmarket surveillance system for medical devices in response to a 2012 congressional mandate.

This system aims to complement existing passive surveillance methods by using real-world evidence to detect potential safety issues more quickly and comprehensively.

The agency intends to begin active surveillance of two medical devices by December 2024 and plans to expand this system to successively more devices over the next four years.

Here are our key takeaways from the report.

Key steps taken by the FDA to date

Here’s what the FDA has been up to, at a glance:

• Partnering with the National Evaluation System for Health Technology Coordinating Center (NESTcc) in 2016 to build a real-world evidence network.

• Organizing a network of 19 collaborators (mostly health systems) to contribute data from electronic health records, claims, and other sources.

• Developing data governance principles and analytic methods for using real-world evidence.

• Building a federated data cloud to protect patient privacy while enabling analysis.

• Funding 21 pilot projects to evaluate the use of real-world evidence for device surveillance.

• Convening working groups of stakeholders to guide system development.

• Contracting a vendor in October 2023 to develop capabilities for active surveillance of two initial devices: duodenoscopes and devices used in gallbladder removal.

The FDA plans to begin active surveillance of these two devices by December 2024, using data from at least two partners covering at least 10 million patients. The agency then aims to expand surveillance to four additional devices per year in 2025 and 2026, with further growth planned over a 5-year period.

Inside the surveillance system

Based on the information provided in the GAO report, we can start to see the contours of the system the FDA is working on. It looks like it will complement existing passive surveillance methods by leveraging real-world evidence to detect potential safety issues more quickly and comprehensively.

Key features of the system include:

1. Data Sources: The system relies on a network of data contributors, primarily health systems and research organizations. These contributors provide various types of data, including:

   • Electronic health records

   • Billing claims

   • Pharmacy data

   • Patient-generated data (from mobile health applications and wearable devices)

   • Medical device and disease registries

2. Data Infrastructure: NESTcc has built a federated data cloud to safeguard data access and patient privacy. This cloud allows analyses within the original sources' data systems, with only aggregated results being shared to the cloud.

3. Data Governance: NESTcc has established a Data Quality Framework that includes principles for data access, use, and quality assurance to ensure accurate, traceable, and timely data.

4. Analytic Methods: A Methods Framework has been developed to guide study designs using real-world evidence, covering aspects such as objectives, target population, sample size, and device characterization.

5. Active Surveillance Process: While specific details are limited, the system is designed to conduct an ongoing review of real-world evidence to detect medical device safety issues that may otherwise go unreported. This involves analyzing the collected data to identify potential safety risks, such as higher-than-expected rates of adverse events.

The system will begin by monitoring two specific devices: duodenoscopes and devices used in gallbladder removal (such as robotically assisted surgical devices). The goal is to have access to data for at least 10 million patients from at least two data partners. The FDA then plans to expand the system over five years, adding four devices per year in 2025 and 2026 and onboarding more data partners to increase patient coverage.

While not explicitly detailed, the report suggests that this active surveillance system will complement existing passive surveillance methods, such as the Medical Device Reporting process.

A few other notable takeaways

Device professionals should pay attention to some key takeaways that jumped out at us.

• This system will focus on analyzing real-world evidence. As described, it relies heavily on real-world evidence from various data sources, including electronic health records, billing claims, pharmacy data, and patient-generated data. This shift towards real-world data analysis may impact how device safety and performance are evaluated post-market. If you're not already investing in capabilities to collect and analyze real-world data for your devices, such investments may be in your future.

• The system puts quite a bit of importance on UDIs. The report highlights the currently limited use of UDIs as a key challenge for the system. The FDA is actively promoting UDI adoption and inclusion in health records and claims data. Specifically, the FDA has:

  • Published a document with NESTcc describing the benefits of UDIs to health systems.

  • Advocated for UDI inclusion in HHS's national standard for electronic health care billing claims transactions.

  • Coordinated with HHS's Office of the National Coordinator for Health Information Technology to expand UDI capture in health IT systems.

  Device manufacturers should anticipate increased emphasis on UDI implementation and use. Now's the time to make sure all devices have proper UDI labeling and develop strategies to encourage UDI capture in clinical settings.