The Journal of the American Medical Association (JAMA) and the American Journal of Therapeutics (AJT) have both published papers criticizing the way in which the Food and Drug Administration (FDA) approves medical devices. Citing a lack of legitimate safety and effectiveness studies, the papers allege that the FDA is approving medical devices without proper scientific evidence proving that they work and will not harm patients.
Researchers from the University of California, San Francisco, pored over seven years worth of FDA public summaries concerning approved medical devices. Researchers from Beth Israel Deaconess Medical Center in Boston wrote the AJT piece, concluding that the FDA’s safety and effectiveness data for medical devices is inconsistent and unreliable. William Maisel, one of the researchers, indicated that the FDA needs to improve its clinical trial standards for medical devices.
When drugs are approved, they typically go through a series of studies prior to even being evaluated by the FDA. A medical device, however, can be approved based on the results of a single study which may or may not contain important specifics such as who participated in the study. Critics note that, since a medical device is usually a permanent addition to someone’s body, it deserves even more intense scrutiny than prescription drugs which can be discontinued if found to be harmful. This is especially true with heart devices that are necessary in order to keep a person alive.
Dr. Jeffrey Shuren, acting director of the FDA’s device division and co-author of one of the studies, conceded that the FDA’s process for evaluating medical devices is inadequate. He explained that the FDA is working on creating stronger standards for evaluation and approval but that device manufacturers need to work more closely with them to establish study goals.
Janet Trunzo, an executive vice president of AdvaMed, an advocacy group for the medical device industry, defended the FDA’s current approach to approving medical devices. She expressed that device manufacturers submit extensive data to the FDA who spends 1,200 hours reviewing it all prior to approving a device.
Many approved medical devices have been recalled over the years for safety reasons. The FDA maintains a list of the most serious medical device recalls for which the products in question may cause “serious health problems or death.” There are over 30 devices on the list from 2009 alone. Since 2004, there have been 137 medical devices recalled by the FDA.