Pacemakers, like other medical devices, must go through an approval process at the FDA before they can be sold commercially. The FDA evaluates these medical devices (as they also do drugs) for both safety and efficacy. Efficacy in this case is a fancy medical term meaning: does the device do what the manufacturer says it will do?
When a new pacemaker is evaluated by the FDA, the manufacturer is asked to submit what is loosely called "data," but that makes it seem like it's no big deal. Data come from a variety of sources, including all kinds of clinical and bench testing. Manufacturers are expected to conduct and fund these tests which the FDA monitors. The results of all of these studies (the "data") are then reviewed by the FDA and play a major role in whether or not the device is approved so that it can be sold in the U.S.
The FDA approval process (technically called "clearance" since the FDA really does not "approve" or put a stamp of approval on anything; it clears for market release) is important. The U.S. Supreme Court has found that if the FDA approves a pacemaker or other medical device for sale, manufacturers are somewhat protected in the event that patients sue the manufacturer over the device.
Two studies were recently released (just this week) that indicate the FDA is likely going to be increasing scrutiny on medical devices like pacemakers and stents. One study was conducted by the FDA itself in conjunction with Beth Israel Deaconess Medical Center in Boston. That study found that in the clinical trials submitted to the FDA for use in product approvals from the time 2000 to 2007, about 40% of the studies used for cardiac devices lacked "high-quality data" about the treatment or safety goals of the study.
Nobody so far has made any connection that lack of high-quality data has led to substandard devices being approved. However, the first study by the FDA itself showed that data it accepted was not sufficient.
A second study was conducted by researched at the University of California San Francisco was just published in the prestigious Journal of the American Medical Assoociation. Dr. Rita Redberg was one of the investigators and she was quoted in the New York Times as saying that many cardiac device trial lacked sufficient "scientific rigor." This study was more critical of the FDA but has come under fire itself.
One of the problems with the California study, according to the New York Times article, was that authors tried to make standards in drug testing applicable to testing pacemakers and other devices and clinical trials for devices have be conducted differently for many reasons.
While experts continue to wrangle out the issues, this definitely means that the approval process for pacemakers and defibrillators will be scrutinized even more intensively in 2010 and beyond. Chances are very good that some of the procedures in place right now will be changed. In fact, the FDA already started to review its device approval procedures back in 2007 and that will continue in the wake of these two studies.
Fallout from these studies will go beyond pacemakers to include other "medical devices," like implantable hips and knees, spinal implants, and implantable pumps.
What does all this mean? For patients, it means that future pacemakers may be subject to more scientifically sound study. That's good news. For manufacturers, it may mean more expensive studies or some lost time as the confusion gets sorted out. The best possible outcome of this finding is that the medical community will join forces with the FDA to achieve practical, workable, but scientifically sound ways to evaluate new pacemakers and other medical devices.
