A New York Time editorial
How Safe Are Medical Devices? Published: August 4, 2011
"A prestigious medical group is concerned that most medical devices are cleared for sale without evidence that they are safe and effective. That should give everyone pause. A panel of experts assembled by the Institute of Medicine found the current regulatory approach so flawed that it called for it to be scrapped and replaced with a system better designed to protect the public’s health.
The committee found no reason to believe that any devices on the market are unsafe or ineffective; it said their use in clinical practice provides at least some level of confidence. But it threw up its hands and said it had no way to determine which, if any, devices might be risky because there is virtually no data to rely on.
That’s because only the highest-risk devices, such as implantable defibrillators and replacement heart valves, undergo clinical trials in patients to show that they are safe and effective. Devices deemed only a “moderate risk” are cleared if the manufacturer can show that they are “substantially equivalent” to devices previously cleared. Those devices in turn may have been cleared because they were “substantially equivalent” to earlier devices that may no longer be in use."
READ THE ENTIRE EDITORIAL HEREhttp://www.nytimes.com/2011/08/05/opinion/how-safe-are-medical-devices.html?nl=todaysheadlines&emc=tha211