According to a report from the U.S. Government Accountability Office (GAO), more than 1.7 million injuries and 83,000 deaths over a recent 10-year period (according to a 2018 study of FDA data) in the nation have been potentially linked to faulty medical devices. The products range from surgical masks to implantable pacemakers.
An article on the report says that “FDA has begun building a surveillance system to look for potential safety issues in such devices. It plans to start with a few devices and expand over time. However, it has had problems getting funding and identifying patients who are using the devices. FDA is taking steps to overcome these challenges.”
The article adds that “Active postmarket surveillance involves the ongoing review of evidence—derived from the analysis of data sources such as electronic health records, billing claims, pharmacy and other data—to detect medical device safety issues that may otherwise go unreported.”
Additionally, the FDA, according to the article, has taken steps to establish postmarket surveillance including establishing a coordinating center to partner with FDA to organize a network of data sources (like health systems and other collaborators), completing a could-based data infrastructure, and planning to begin active postmarket surveillance of two medical devices by December of 2024 with plants to expand over the next 5 years.
The article adds that “FDA has faced two key challenges establishing its system, according to agency officials: (1) limited use of unique device identifiers in electronic health records and billing claims, which makes identifying devices used by patients more difficult; and (2) funding considerations to support active surveillance. 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. In addition, FDA has estimated current and future active surveillance costs and is considering options for how to fund the work by advocating for alternative funding sources.”
GAO says it will continue to monitor FDA's progress in establishing an active postmarket surveillance system.
