The Food and Drug Administration (FDA) is in the process of establishing an active postmarket surveillance system to enhance the safety monitoring of medical devices. This initiative follows a federal mandate from 2012 that requires improved tracking and oversight of medical devices after they are introduced to the market. The move aims to utilize real-world evidence from various sources such as electronic health records, billing claims, and pharmacy data to identify potential safety issues more swiftly and effectively.
The Government Accountability Office (GAO) conducted an investigation and released a report on August 15 detailing the FDA’s progress and the challenges it faces in setting up this surveillance system. The report was prompted by concerns raised by members of Congress, including Representatives Anna Eshoo and Debbie Dingell, following a series of serious safety issues with medical devices from major manufacturers like Philips, Medtronic, and Allergan. These high-profile cases highlighted deficiencies in the product safety and recall processes, sparking calls for a more robust system to protect consumers.
According to the GAO report, the FDA has partnered with the National Evaluation System for health Technology Coordinating Center (NESTcc) to lay the groundwork for this new surveillance initiative. Their efforts have focused on three main areas: organizing collaborators to provide data, developing the necessary data infrastructure, and drawing on expertise from stakeholders to plan the system’s operation. The immediate goal is to begin active surveillance of certain high-risk devices such as duodenoscopes and robotically-assisted surgical devices used in gallbladder removals, with plans to progressively include more devices over time.
By December, the FDA aims to initiate active surveillance for the first two types of devices, expanding to include additional devices each year to cover at least 18 different products by 2028. This scaling-up strategy also involves increasing the number of data partners to extend coverage to an additional 10 million patients in the next few years.
However, the FDA’s ambitious plan faces significant hurdles. One major challenge is the limited use of unique device identifiers (UDIs) in electronic health records and billing claims. UDIs are critical for accurately tracing devices to specific patients, especially during recalls and safety alerts, yet many healthcare providers and payers have not fully adopted their use. Although device manufacturers are now required to include UDIs on their products, the FDA does not currently have the authority to mandate healthcare providers to record these identifiers in patient records or use them in billing processes.
Another pressing issue is funding. Implementing and maintaining an active surveillance system is estimated to cost $8 million. The FDA has allocated $5 million from its existing budget and requested an additional $3 million from Congress, which has not been granted. The consequence of inadequate funding means that resources may need to be diverted from other critical postmarket activities, which could undermine the overall effectiveness of medical device safety oversight.
The FDA has proposed that medical device user fees could be a potential solution to fund the surveillance system; however, this would require changes to current laws and cooperation with both the industry and legislative bodies.
Despite these challenges, the FDA continues to push forward with developing the active surveillance system, navigating the complexities of legislative, financial, and operational constraints to enhance the safety and oversight of medical devices. Such enhancements are crucial for protecting public health by ensuring medical devices are not only effective but also safe for users throughout their lifecycle.
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