Unique Medical Device Identification Tracking System Finalized by FDA

Federal health regulators have issued the final version of new regulations that will require the creation of a medical device tracking system in the United States, which is designed to identify potentially dangerous and defective medical devices, such as hip replacements and knee replacements.  

On September 20, the FDA announced the final rule for a Unique Device Identification (UDI) system, which is designed to allow the agency to track medical devices and help raise warning flags about problems that may exist with a particular model.

The UDI has two parts. One part is a unique identification number that will be assigned to each medical device, which will enable quick identification of the lot number, expiration date and manufacturing date for each medical device.

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The second part will be a database that is searchable by the public, called the Global Unique Device Identification Database (GUDID). While the database will have no identifying patient information, it will become a reference catalogue for every medical device with a unique device identifier number, allowing patients and the medical community to see for themselves whether a specific medical devices appears to be linked to failures and other problems.

“UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the FDA press release. “A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovate, and less costly device development.”

The FDA intends to phase in the UDI system, starting with high-risk devices. However, some low-risk medical devices will be partially or fully exempt. The agency first proposed the rule in July 2012.

New Rule Gets Praise, Criticism

The consumer watchdog group Public Citizen responded with reserved enthusiasm for the new law, saying it was too long in coming and that the FDA is taking too long to fully implement it. However, the group called it a key step forward in improving medical device safety.

“Congress first passed a law requiring the FDA to develop regulations for a UDI system when it renewed the agency’s medical device user fee program in 2007. However, because that law failed to provide a deadline for action, the agency was able to drag its feet without being held accountable,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group, in a statement the day the final rule was announced. “More prompt action by the FDA likely would have prevented numerous deaths and injuries related to unsafe medical devices.”

In the past, the U.S. public had to often wait for problems to be noticed since adverse event reports were not consistently tracked and the manufacturer was largely responsible for identifying issues after medical devices were introduced. Often with the first warnings about problems with medical devices came from oversees, since Australia and the U.K. have extensive databases for medical devices hip replacement systems and knee implants.


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