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FDA's Medical Device ID System Still Inactive

Scott Mace, for HealthLeaders Media, April 3, 2012

Childs says the delay is "probably incompetence" at the overworked and underfunded FDA, aggravated by inertia at the White House's Office of Management and Budget.

"How can it take five years to get a proposed rule out on something that has been used in commerce in this country for 40 years?" Childs asks. "It can't be that difficult."

The answer is probably rooted in the fact that there are no demonstrable hospital fatalities from medical devices lacking serial numbers today. It could be front-page news tomorrow, however. We live in the age of product recalls. The medical device market, valued at $106 billion in 2011 by market intelligence firm Espicom, isn't immune from those recalls. And given the rapid growth of the industry, more are likely.

Just as Wal-Mart had to dictate bar code identifiers to its suppliers, so it would appear that a government-mandated unique ID for devices was economically necessary to move an industry. It would have been nice if the device industry had managed to "get 'er done" without federal legislation. But that ship has sailed.

Now, to force the issue, Premier and its allies have introduced new legislation to do something that should have done in the original bill: legislation governing the law's implementation.

"We tried to get a deadline on it that says it needs to be done in two years or something like that, but we weren't able to because of objections by the device industry, so we are now waiting," Childs says. "It's literally been five years. It boggles the brain."

 

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