GAO: UDI, funding shortfalls weaken FDA’s active surveillance program for devices
Limited use of unique device identifiers (UDIs) in electronic health records and funding shortfalls are key challenges affecting the US Food and Drug Administration’s (FDA) active postmarket surveillance program for medical devices, according to a recent report by the Government Accountability Office (GAO).Despite these challenges, the report noted that the agency has made progress in establishing an active postmarket surveillance system for medical devices.
The report was prompted by a request from Reps. Anna Eshoo (D-CA), ranking member of the Energy and Commerce Committee’s health subcommittee, and Debbie Dingell (D-MI), to review the status of FDA’s active postmarket surveillance system.
Congress mandated that FDA establish an active postmarket surveillance system for medical devices in 2012. Active surveillance involves the use of real-world evidence to detect medical device safety issues, and relies on such sources as electronic health records, insurance claims data, pharmacy data, as well as medical device and disease registries.
The report follows several high-profile device safety issues in recent years, including one that led to a court ordering Philips and its Respironics subsidiary to stop making its sleep apnea machines in the US until they resolve manufacturing issues earlier this year. (RELATED: Court orders Philips to stop CPAP, BiPAP, ventilator production, Regulatory Focus 11 April 2024)
The GAO report asserted that more than 1.7 million injuries and 83,000 deaths that occur in the United States over a 10-year period are potentially linked to medical devices.
GAO said one challenge in implementing a robust active surveillance program is the limited use of UDIs among health care providers and payers, which makes identifying devices that patients use more difficult.
The report states that “unique device identifiers are important for linking patients to the medical devices they use; yet health care providers and payers generally do not capture these identifiers in electronic health and claims records … This can make identification of devices used by patients, and therefore active surveillance related to those devices, challenging.”
While most medical devices require UDIs, the agency does not have the authority to mandate that providers capture such identifiers in electronic health records at the point of care or use identifiers for billing purposes.
Lack of funding is another challenge noted by GAO. While FDA estimates that it costs $8 million per year to establish and maintain an active postmarket surveillance system, it only received $5 million of its request in the n FY 2024 budget.
Despite these challenges, GAO said that FDA has made progress in its active surveillance programs, including establishing a coordinating center in 2016 to partner with a network of data sources in its surveillance efforts; completing a cloud-based data infrastructure to collect evidence of medical device performance in 2021; and will start its active postmarket surveillance of two medical devices by December 2024, with plans to expand surveillance to other devices over five years.
These two devices are the duodenoscope, which is a lighted tube used for viewing the small intestine, and robotically assisted surgical devices used in gallbladder removal.
GAO
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