FDA Builds Surveillance System to Identify Faulty Medical Devices: GAO

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 identify faulty equipment and take necessary action such as recalls, according to a recent report by the Government Accountability Office (GAO).
The FDA reviews the safety and effectiveness of medical devices.
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, according to 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 onward, 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 issue, the “FDA has taken actions to encourage use of unique device identifiers, such as coordinating with federal entities and publishing a document advertising the benefits of use to health systems,” the report noted.
The second issue concerns the funding required to support the active surveillance program, which is estimated to cost $8 million annually.
“Recalls must be conducted in an efficient manner in order to mitigate harm. However, this does not happen all of the time,” the letter said, pointing to the 2021 recall issued by Philips Respironics. The recall pulled out millions of machines used by patients with sleep apnea, COPD, and other respiratory conditions to help them breathe.
The company received “thousands of additional adverse event reports for more than a decade” but failed to report them to the FDA or initiate a recall, the letter stated.
The report “suggests that FDA knew Philips Respironics had a history of withholding adverse event reports from the agency, but still allowed it—and other medical device manufacturers—to submit late adverse event reports without appropriate enforcement for such violations,” the senators wrote.
The FDA reportedly received at least 30 adverse event reports of Phillips’s machines before the recall, they said.
The lawmakers pointed out that an earlier GAO report from 2011 found FDA’s oversight of medical device recalls “often failed to conduct recall-related inspections.” These insights were crucial when Congress passed the Food and Drug Administration Safety and Innovation Act in 2012.
“Given recent reporting and the dramatic increase in recalls since then, it is clear that GAO and Congress must examine FDA’s oversight of medical device recalls once again,” the lawmakers wrote.