FDA's Medical Device ID System Still Inactive

You would think that a 2007 federal law related to patient safety would be implemented five years later.

You'd be wrong.

The law in question will give hospitals unique identifiers for every medical device that's in their inventory or in use with patients. It's the kind of identifier you can find today on just about any appliance you buy at Wal-Mart.

Such IDs are commonplace at the retailing behemoth, in everything from bread makers to rice cookers, because of the enormous clout the retail giant wields. The Wal-Mart effect also ensures that much other retail merchandise is similarly labeled.

The fractured healthcare and hospital industry thought it had summoned a similar amount of clout in 2007 with passage of the Medical Device User Fee and Modernization Act (MDUFMA). Yes, it's the same act that gave us the "medical device tax" so reviled by the medical device industry.

Well, here's a memo to the medical device industry: If the medical device tax is so onerous, you need more allies to fight it. And you won't make those allies the way you're fighting implementation of the unique identifier provisions of MDUFMA.

That's the view of Blair Childs, senior vice president of Premier, a performance improvement alliance of more than 2,500 U.S. hospitals and 81,000-plus other healthcare sites.

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."

The new bipartisan legislation, the Medical Device Patient Safety Act, or S.1995, was introduced last December by Sen. Charles Grassley (R-Iowa), with co-sponsors Sen. Richard Blumenthal (D-Conn.), Sen. Jeff Merkley (D-Ore.), and Sen. Herbert Kohl (D-Wis.).

With the proposed law now referred to a Senate committee, Childs doubts there will be a specific hearing on the bill. "This is bipartisan legislation, it passed overwhelmingly, and now it's just a question of getting it done," he says.

So more than ever, Premier needs to fire up public opinion, which in no small part prompts this column today. Having covered tech in Washington D.C. for nearly a decade, I fully appreciate the slowness of federal bureaucracies. So, everybody get ready to get out pen and paper and write your Congress people.

When you do, remind them of the following salient benefits of unique medical device identification:

• It can allow hospitals and the FDA to spot trends in the numbers and types of device recalls, including the types of devices recalled and causes of recalls.
• It can identify the length of time needed for a person subject to a device recall to complete the recall.
• It can identify which persons have been subject to the most device recalls.
• The system can be set up in such a way to protect patient confidentiality.

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.