The U.S. Food and Drug Administration (FDA) has started creating an active post-market surveillance system for medical devices that can help the agency to identify faulty equipment and take necessary action such as recalls, according to a recent report by the Government Accountability Office (GAO).
The FDA started efforts to establish the surveillance system, which would collect “real-world evidence” of adverse events related to medical devices, including from sources such as electronic health records and billing claims, said the GAO report. So far in August, there have been three recalls ranging from faulty heart pumps to nerve monitoring systems. For instance, the FDA set up a cloud-based data infrastructure in 2021 to collect evidence of medical device performance.
The agency is planning to start active post-market surveillance of two medical devices by December this year. In 2024, the FDA’s surveillance will start collecting data for two devices from 10 million patients, which will expand to 10 devices and 30 million patients by 2026. From 2027 onwards, the number of patients will be raised as needed.
The number of surveilled devices will rise to 14 in 2027 and then to 18 or more a year later. FDA officials reported two key challenges in establishing the surveillance system. First is the limited use of unique device identifiers in electronic health records and billing claims.
This makes it difficult for the agency to identify devices used by patients. To tackle the .