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U.S. Food and Drug Administration Proposes New System for Medical Device Safety

Published August 20, 2012 on

On July 3, 2012 the U.S. Food and Drug Administration proposed that medical devices distributed in the United States include a unique device identifier. The suggestion comes in response to requirements from legislation passed in Congress. The unique identifier system or UDI is designed to improve the quality of information available about medical devices which in turn will help improve safety. FDA Commissioner Margret Hamburg, M.D. notes the following in a recent press release: “The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety.”

Under the suggested system, a UDI would include a device identifier (numeric or alphanumeric code) and a production identifier. The FDA suggests that high risk medical devices be included first in the proposed system and that it be phased-in for lower risk devices over time. Over-the-counter devices would not be included in the new system as they typically have UPC codes.

The UDI system is expected to lead to several benefits including more accurate reporting, reduction in medical errors, data consistency, ease of managing medical devices, and improved security in the distribution chain. Learn more about the proposed rule from the FDA.

At Carey Danis & Lowe we welcome the change to the FDA system as a means of improving the safety of medical devices. Through previous medical device litigation, Carey Danis & Lowe has witnessed countless examples of avoidable medical issues arising from defects in medical devices and failure to communicate potential dangers and side effects. The new system is intended to mitigate known issues within the medical device distribution system and improve safety for consumers.