The FDA's clearance process for medical devices is under increased scrutiny due to concerns that many devices, including those implanted in the human body, do not undergo the same rigorous testing as prescription drugs. This has led to avoidable harm for some patients, with critics arguing for more stringent scientific evaluation before devices are approved for use.
A recent study in the Annals of Internal Medicine examined recalls of heart devices, such as pacemakers, stents, and defibrillators, from 2013 to 2022. The study found that of the 157 heart devices with Class I recalls (the most urgent type), only a fifth had been subjected to clinical testing. A majority (71%) were approved via the FDA's 501(k) pathway, which allows devices to be marketed if they are shown to be similar to already-approved devices.
Concerns Over Clinical Evidence
According to the study, the remaining 29% of devices, considered high-risk, followed a pathway requiring clinical trials. However, these trials often fell short of the standards required for new drugs. Trials for 30 of the recalled devices were not randomized, and 18 did not include a control group. Surrogate measures, such as lab results or radiology images, were frequently used as endpoints instead of direct patient outcomes. The follow-up period for these clinical trials averaged only six months, potentially insufficient to capture medium- and longer-term safety risks.
"Medical devices later recalled due to safety issues often had little clinical evidence supporting their original authorization," the study authors concluded.
Historical Context and Current Challenges
Public pressure on the FDA to expedite approvals, particularly since the HIV/AIDS epidemic of the 1980s, may contribute to the lack of clinical evidence in many Class I recalls. More than a million patients have received high-risk heart devices subject to Class I recalls, including 600,000 coronary stents, 200,000 implantable pacemakers, and 200,000 heart valves.
In 2011, the Institute of Medicine (IOM) reviewed the FDA’s 510(k) clearance process and recommended it be scrapped due to its lack of relevance for patient safety. While the FDA has since updated some policies and procedures, concerns persist. The FDA has expanded the 510(k) pathway to include a "de novo" method for new devices without an existing predicate. These devices can be approved with minimal or no clinical data if deemed low risk.
The Role of Predicate Devices and Postmarket Surveillance
Notably, a recalled device can serve as the predicate for a new device, increasing the risk of recall for the new product sixfold. In 2023, the FDA updated its guidance on selecting predicate devices, urging manufacturers to consider reported safety issues or recalls.
Some recalled devices remain in use if alternative treatments are limited and the issue can be addressed with a correction to the device or its labeling. For instance, Abbott’s MitraClip cardiac device was recalled in 2016 but continued to be implanted after revised instructions and mandatory training for doctors. Getinge intra-aortic balloon pumps, subject to eight Class I recalls from December 2022 to July 2023, were initially allowed for continued use due to limited alternatives but were eventually removed after 15 patient deaths.
Calls for More Rigorous Testing
Experts advocate for more rigorous clinical studies before device approval. They also point out that device manufacturers are protected against lawsuits if the FDA approved their devices after premarket testing. Furthermore, the FDA’s adverse event reporting and postmarket surveillance are underfunded.
According to Rita Redberg, MD, a cardiologist and member of the 2011 IOM task force, device companies influence the FDA’s processes through the Medical Device User Fee and Modernization Act (MDUFA), which allows them to dictate how MDUFA funds are spent, often prioritizing faster market access over stringent evidence standards.
Patient Considerations
Before receiving an implanted medical device, patients should understand the potential risks. Richard Kovacs, MD, of the American College of Cardiology, advises patients that "machines break, wires break, and so the chance that a medical device will fail is real. It’s a small chance, but it’s real and should be discussed."
