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.
