FDA Struggles To Create A User-Friendly Device Identification System

Full article reprinted from "The Gray Sheet" - June 22, 2009

The hardest part about establishing a mandatory unique identification system for devices is crafting one that all users - from manufacturers to distributors to hospitals - will be able to implement, FDA says. Read more...

FDA Struggles To Create A User-Friendly Device Identification System

Full article reprinted from "The Gray Sheet" - June 22, 2009 

The hardest part about establishing a mandatory unique identification system for devices is crafting one that all users - from manufacturers to distributors to hospitals - will be able to implement, FDA says.

"At 50,000 feet, unique device identification is very simple. We could get it done tomorrow, we could get it out there, we could get UDI on medical devices," says Jay Crowley, CDRH senior advisor for patient safety and head of FDA's unique device identification (UDI) initiatives.

"But if it's not implemented, if it doesn't work its way through the supply chain, through distributors, into hospitals, to that point of patient encounter - we haven't done anything."

Crowley and other experts discussed the challenges of developing universal UDI at the Global GS1 Healthcare Conference in Washington, D.C., June 16.

In a nutshell, UDI will require some type of scannable barcode system to track devices from manufacture to patient use. The system could deliver big benefits, including more efficient adverse event reporting; smaller, more targeted recalls; and supply chain efficiencies, proponents say (The Gray Sheet' Feb. 16, 2009).

Are Hospitals Ready?

But FDA and industry reps at the conference questioned whether hospitals, in particular, are prepared to carry out their role in the UDI chain.

"Hospitals are not ready for this," Crowley said. "They do not have the technology in place to be able to take advantage of UDI right now."

Jeffrey Secunda, of the device trade group AdvaMed, agreed.

"Hospitals and all health care providers have to assess what their current hardware capabilities are," Secunda, associate VP for technology and regulatory affairs for the association, said at the meeting. "That's not just scanners - that's also their infrastructure, their IT systems."

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