GAO Audit Uncovers FDA's Struggles with Medical Device Safety Oversight

A recent audit by the U.S. Government Accountability Office (GAO) has shed light on significant challenges faced by the Food and Drug Administration (FDA) in keeping track of the safety of medical devices—issues that have real, and sometimes tragic, consequences for patients. The audit, which draws on data from the International Consortium of Investigative Journalists (ICIJ), reveals that the FDA is struggling to implement a critical surveillance program designed to protect people from faulty or dangerous medical devices. This program was supposed to be up and running years ago, but progress has been slow, leaving many patients at risk.

At the heart of this issue is the use of "unique device identifiers" (UDIs), which are like barcodes for medical devices. These identifiers are meant to help the FDA track which devices are being used by which patients and quickly identify any safety concerns. Despite nearly a decade of work to get UDIs on most devices, the system isn't working as it should. Many healthcare providers and insurance companies find it too burdensome to record these identifiers in patient records and billing information, meaning the FDA can't fully rely on them to monitor device safety.

The stakes are high. The GAO's report highlighted that the FDA's ability to oversee the safety of medical devices has been a "high-risk" issue for over a decade. According to Madris Kinard, a former FDA public health analyst and an expert in medical device surveillance, the lack of progress is alarming. She pointed out that when devices like implants go wrong, it can lead to multiple surgeries and a lot of pain and suffering for patients. “Even though these are relatively inexpensive devices, when something goes wrong, it can mean that the patient needs multiple follow-on surgeries, making them high-cost devices in the long term,” Kinard said.

This problem isn't just theoretical. The ICIJ’s investigation into medical device safety, known as the Implant Files, found that between 2008 and 2017, more than 1.7 million injuries and nearly 83,000 deaths in the U.S. were potentially linked to medical devices. And since the Implant Files was published in 2018, the number of reported injuries and deaths has only grown. Over the past few years, an additional 67,000 deaths and 4.6 million serious injuries have been reported to the FDA. These numbers are staggering, and they underscore the urgent need for a better system.

One of the main challenges the FDA faces is that it doesn't have the power to require hospitals and doctors to record UDIs in patient records or use them for billing purposes. Without this authority, the agency is limited in its ability to track devices and respond to safety concerns quickly. Adding to the problem is the difficulty in securing funding to support an effective surveillance program. The FDA has asked for more money to do this important work, but so far, those requests have gone unfulfilled.

Despite these challenges, there are some in the industry who believe that more can and should be done. Scott Whitaker, president of Advamed, a trade group for medical device manufacturers, said that while the industry supports the UDI program, decisions about funding more comprehensive surveillance efforts are up to Congress. Meanwhile, former sales representatives and other insiders have come forward with allegations that some companies may be underreporting problems with their devices to avoid taking responsibility.

As the GAO continues to monitor the FDA's efforts, the message is clear: patients deserve better protection. The flaws in the current system need to be addressed, and the sooner the better. For those who have been harmed by faulty devices, or who fear they might be, this issue is not just about numbers—it's about lives and well-being. The FDA’s mission to ensure the safety of medical devices is crucial, and the agency must overcome these obstacles to keep patients safe.