RLG Encouraged by FDA’s Proposed Rule Establishing a Unique Device Identification System

The Rottenstein Law Group has learned that the FDA has proposed a rule that would require most medical devices distributed in the United States to carry a unique device identifier, or UDI.

The FDA has proposed implementing an identification system that would assign to each medical device a unique code that will be the “key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information… such as its expiration date and batch or lot number,” according to a July 3, 2012, FDA press release.

The FDA expects the UDI system to, among other things, “allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly” and “provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.”

Rochelle Rottenstein is the devoted advocate of claimants allegedly injured by recalled medical devices—including Boston Scientific’s Protegen Sling vaginal mesh product, which was recalled in 1999, according to a May 4, 2009, New York Times article, and the DePuy ASR Hip Resurfacing System, which DePuy voluntarily recalled in August 2010, according to the manufacturer’s own web site. This experience has made Rottenstein aware of the importance of keeping track of adverse event reports filed in connection with injuries sustained from medical devices. Accordingly, Rottenstein has long been a proponent of the FDA’s adoption of a UDI system, which she believes can go a long way toward minimizing the injuries caused by potentially dangerous medical devices.

Just last week Rottenstein told a reporter at Medical Device and Device Industry (MD+DI) online that, to better protect consumers, the FDA should act immediately to “require the use of unique device identifiers that would enable the FDA to better track medical device malfunctions.”