Should devices get the same scrutiny as drugs?

Should medical devices get the same regulatory scrutiny as drugs?

According to a controversial article in the Journal of General Internal Medicine, they should.

Lead researcher Mitchell Feldman (right) of the University of California at San Francisco said this is just about getting good information to doctors.

“Sometimes, the only information out there is what the manufacturer provides," his press release says, so doctors don't know how to deal with new devices, or whether to trust them.

He's also worried that fewer than 100 devices a year undergo the same scrutiny as a new drug. If a new device does what an old one did, approval is generally automatic.

What he seems to be calling for here is a new bureaucracy, an independent review of all devices which will inform the public, physicians, and those who pay for devices.

For instance, just because a device is new, is it that much better than what it replaces, and is that worth the difference in price? Right now there's no way to know.

You can argue that the study does not come to us with clean hands. UCSF sub-contracts with the California Technology Assessment Forum, which does this kind of work on a state level. You can argue Feldman is advertising for himself.

You should also know the study was funded by the Blue Shield of California Foundation, and it seems many of the implied benefits of this work would go to insurers, in the form of lower costs.

But what about the general issue? Do we need independent assessments of devices, resulting in simple summaries patients can understand?

Or should that be left to the industry?

It's going to be an interesting HIMSS forum. The industry's annual conference is scheduled for the end of February in Orlando, and ZDNet is planning on being there.

We'll see if they answer Feldman's question or just call him names.