MedPage Today: Groups Call on FDA for Final Device ID Rule

Publication: MedPage Today

Author: David Pittman

07/26/2013 - "WASHINGTON -- Medical groups and patient advocates are clamoring for the FDA to release a final rule requiring most medical devices distributed in the U.S. to carry a unique alphanumeric code allowing for better information tracking.

The unique device identifier (UDI) system -- which Congress first authorized in 2007 -- would improve the quality of information in adverse event reports, reduce medical errors, and provide a consistent way to enter information about a device, the FDA and industry experts said.

However, the agency is months behind on releasing final rules on the program, even 6 years after Congress first called for the system. Last year, lawmakers further mandated that the FDA finalize the rules by the June 19, a deadline that has obviously come and gone.

"This unique device identifier system will serve as the cornerstone to improving medical device safety and quality," Douglas Wood, MD, president of the Society of Thoracic Surgeons (STS), said last week in a letter to the Office of Management and Budget. "Further delay will impair the FDA's ability to conduct important safety surveillance of medical devices to improve patient safety and the quality of care."


"Consumer watchdogs like the Pew Charitable Trusts have sent letters to the White House's Office of Management and Budget (OMB) urging them to finalize and release the rule. STS sent a similar letter to OMB last week.

A UDI will allow physicians and manufacturers to analyze data on devices used in practice if patient demographic information is collected. For example, researchers can link patient outcomes to devices to determine if specific characteristics make it more likely they will perform better with a specific device, Wood wrote.

"STS believes that this approach to medical research will foster innovation in targeted healthcare rather than stifle the development of new products," Wood wrote."

Read the full article at MedPage Today. 


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