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FDA's Medical Device ID System Still Inactive

Scott Mace, for HealthLeaders Media, April 3, 2012

If the U.S. can't get this unique identification done, it will probably be done by another country. "There's benefit in the U.S. leading here and creating a standard that others abide by," Childs says. Recent controversy in Europe about recalled breast implants have catalyzed efforts there.

Ultimately, though, it will be up to those of you reading this—hospital executives and your peers in medical practices, as well as payers—to insist upon well-labeled medical devices in your purchasing decisions. Premier represents hospitals but does not have the power to require hospitals to buy uniquely-identified devices.

So I'll put it in a way that may really provoke a few of you.

A few years from now, if hospitals are competing with Wal-Mart and the pharmacies for a slice of the ACO pie, would you want them to be miles ahead in insisting on such a simple patient safety strategy, while hospitals dither? Will patient safety groups end up recommending purchase of medical devices through Wal-Mart?

Fortunately, medical devices are regulated, and this law is, in fact, law. So it shouldn't come to that. Should it?

By the way, AdvaMed, the Washington-based association for the medical device industry, put out a generally supportive statement on S.1995. If you buy truckloads of devices from AdvaMed's members, now would be a good time to let them know they should be putting more actions behind their words.


Scott Mace is senior technology editor at HealthLeaders Media.
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