We saw this coming. More than 1 million procedures every year to implant artificial body parts. Two million patients with heart-regulation implants. And the big question :
You can fix a squeaky bike, but what about a squeaky hip? You can take a bum cell phone back to the store, but what about a heart implant? What do you do when the product you want to return is part of your body?
Latest example: an emerging fight over the interface between your heart implant and your heart. The FDA is on one side; Dr. Robert Hauser an Dr. Adrian Almquist of the Minneapolis Heart Institute, writing in the New England Journal of Medicine , are on the other. Their commentary is behind a subscription wall, so here’s a summary of the debate from Barry Meier in the New York Times :
Federal regulators are about to approve use of a critical new electrical component for implantable heart devices without adequately testing for its potential risks, a prominent cardiologist warned Wednesday. The potential problem involves a new way of connecting defibrillators to the wires, or leads, that carry high-voltage electrical jolts between such units and the heart …
Dr. Hauser argued that manufacturers should perform at least some clinical trials on patients to ensure that the new technology is not prone to short-circuiting, a problem that can prevent a defibrillator from delivering the life-saving electrical jolt … The Food and Drug Administration, on the rationale that the new wiring connectors are simply a design modification and not a new technology, is not requiring human tests. Instead, it is requiring producers to carry out mechanical stress tests of the new connectors and study their performance in animals.
In other words, the FDA is treating the new technology as a detachable gizmo: You can test it in the lab, or in an animal, or whatever. Then you put in people and assume that since the last version worked, the upgrade will work, too. Hauser is treating it as a human body part: You have to test it in people, since that’s where it’s going to live, as it were.
Who’s right? I don’t know. Hauser has a better track record than the FDA does in assessing the safety of heart implants. But the key question, from what I can tell, is which standard of testing to apply. Should we let implant makers upgrade their devices just like other technology companies, or not? Think carefully. Because if you don’t have an artificial body part today, there’s a good chance you’ll have one tomorrow.
