FDA's Fast Track Approval Puts Consumers at Risk

If you want to know why medical devices that hurt and even kill patients keep finding their way into hospitals and other health care facilities, look no further for an example than Apple. The frequency with which the consumer-electronics giant releases gadgets — the iPhone4, the iPad2 — speaks volumes about America’s enthusiasm for what’s new. But does new always mean “new and improved”? In electronics, perhaps; in health care, definitely not.

Once upon a time, harmful medical devices had a harder time getting into health care facilities than they do today. The U.S. Food and Drug Administration required all devices to undergo clinical trials to prove their safety and efficacy before they could be sold — regardless of whether they resembled a device already on the market. After all, the thinking went, a medical device — a pacemaker clenching and unclenching a heart, a prosthetic hip helping put one foot before the other — is perhaps the most important and intimate product a consumer can use; the government has a responsibility to protect patients from those that may do them harm.