By: Amanda Dolan for Heart1
A few days ago the Associated Press reported on two recent studies that found the Food and Drug Administration (FDA ) regulation of medical heart devices to be insufficient. These heart devices, like pacemakers and stents , were often approved without proper scientific testing. The studies on such devices were often small and performed out side the US and lacked a clear goal and randomization—two important components to study standards. In fact, devices were often approved based on a single study. This insufficient testing led to many recalled devices and put patients at risk. The FDA responded to these studies by promising to look into their device program and make adjustments and changes to the way they regulate them.
The FDA, an arguably overworked sect of the US government (responsible for everything from food production to vaccines), is in charge of approving every type of heath products “ranging from wrinkle fillers to artificial knees.” And, according to the AP, “heart devices fall into a category of high-risk devices that require the toughest review before they can be marketed, including implantable defibrillators, valves, and stents.” These high-risk devices were not put through enough of a rigorous approval process, causing many such devices to be recalled.
For patients, this poses many potential problems including injury. But, as the AP notes, the US Supreme Court found that it is against federal law for patients to sue manufacturers if the device was FDA-approved. This is especially interesting because patients are allowed to drug companies over FDA-approved drugs. This is because the drugs makers put their products through such rigorous tests and submit large, randomized studies to the FDA for approval. If the FDA were to require the same from device-makers, patients would win on both fronts. There would be fewer recalls and injuries and, in turn, the opportunity perhaps to sue a manufacturer for harming the patient. The difference between drug and device approval lies in the fact that devices cannot be tested up against placebos or put through randomized trials. This creates a more difficult situation for testing devices, especially because they are more difficult to implant and monitor compared to drugs which are easily taken and manufactured for large trials. According to the LA Times , the FDA started testing devices in 1976 and, in recent years, “the numbers of devices have soared.” In fact, last year about 350,000 people received pacemakers, 140,000 received implanted cardioverter defibrillator, and upwards of 1 million received stents. Since the number of patients will only continue to rise as diagnoses and health care, itself, improves, it is important to start improving devices and device-approval as soon as possible.
What do you think of FDA device-approval system? Learn more at FDA.gov and add your thoughts to the discussion in the Hearts1 Forum.
