Dingell, Eshoo Release Report on FDA Postmarket Surveillance of Medical Device Safety

Representatives Debbie Dingell (MI-06) and Anna Eshoo (CA-16) today released the findings of a Government Accountability Office (GAO) report they requested to review the Food and Drug Administration's (FDA) efforts related to postmarket surveillance of medical devices.

The FDA is responsible for ensuring the safety and effectiveness of medical devices marketed in the United States. A 2018 study found that more than 1.7 million injuries and 83,000 deaths in the US were potentially linked to medical devices. Dingell and Eshoo requested this report to better understand existing systems for medical device surveillance and oversight and address shortcomings.

"Medical devices from wheelchairs to pacemakers exist to help patients and improve quality of life. I'm concerned by increasing number of adverse effects associated with medical devices, and we must have stronger systems in place for oversight," Dingell said. "This GAO report supports our understanding of FDA's post-market surveillance of these devices and identifies areas for improvement. Strengthening these systems is critical to addressing adverse events and protecting patient health and safety."

"Medical devices are designed to improve and save patients' lives, but unfortunately there are too many cases where these devices injure or kill people. It's the responsibility of Congress to provide the FDA with the resources it needs to ensure patients have access to high-quality, safe medical devices to improve their lives," Eshoo said. "I'm pleased that the GAO in a report released today acknowledged that fact. The report was requested by me and Rep. Dingell and it highlights that the FDA needs to reform the way it tracks its medical devices once they are on the market. Congress must do its part to hold up its end of the bargain by providing more funding."

The report states that FDA has taken steps to establish an active postmarket surveillance system for medical devices, including:

• Establishing a coordinating center in 2016 to partner with FDA to organize a network of data sources (health systems and other collaborators);
• Completing in 2021 the cloud-based data infrastructure necessary to collect evidence of medical device performance while protecting patient privacy; and
• Planning to begin active postmarket surveillance of two medical devices by December 2024, with plans to expand over 5 years.

Dingell wrote to GAO in 2022 to request the report.

"The Food and Drug Administration (FDA) in the Department of Health and Human Services (HHS) is primarily responsible for protecting and promoting public health through the control and supervision of a variety of products, including medical devices. Within the FDA, the Center for Devices and Radiological Health (CDRH) is responsible for the premarket approval of medical devices, as well as oversight of manufacturing, performance and safety of these devices," Dingell said in her 2022 letter. "However, the number of adverse events associated with medical devices in the United States has continued to increase in recent years. According to an investigation by the International Consortium of Investigative Journalists, almost 2 million injuries and over 80,000 deaths were associated with medical devices between 2008 and 2017. Improved post-market surveillance of these devices is critical to the agency's stated mission to protect public health and safety."

View the full report here.