Information about Unique Device Identification (UDI)
MedSun: Newsletter #37, June 2009
In 2007, legislation was passed that says the FDA must develop a standardized system to uniquely identify medical devices (Unique Device Identification - UDI). Manufacturers will have to place the UDI in human readable and/or AutoID formats on a device, its label (packaging) or both. The FDA will also have to create and maintain the UDI Database.
A recent FDA workshop focused on the standards that are being used to initiate UDI. The development and use of the UDI Database (UDID), adoption and implementation of UDI by other stakeholders and issues with the placement of UDI were also discussed. For more information about this workshop, see the April 2009 article titled, “Raising UDI’s Profile on the Flagpole.”
There are many benefits to adopting UDI. The article titled, “Change the Forecast from Perfect Storm to Perfect Order” discusses how bar-coded products and point-of-care scanning can assist hospitals with important patient safety initiatives by tracking products, recording serial numbers and managing expiration dates. Hospitals and some suppliers are now rallying behind a single set of GS1 standards that can be used to drive down hospital costs, create efficiencies, and ultimately improve patient safety.
Recalled products used on a patient can cause adverse outcomes. Sometimes, hospitals continue to use recalled products unknowingly because it is hard to keep track of every medical device and product. New legislation will require manufacturers to label their products with UDIs. The article titled, “UDI Goes Beyond UPN in Identifying Recalled Products, Preventing Surgical Dangers,” explains how UDI can help track recalled products and provide benefit to patients and health care facilities, alike. Once UDIs are put into place, every sector of the U.S. health system will be able to identify where the product was used and which product continues to be used.
See Additional Information below for access to these resources.
Raising UDI’s Profile on the Flagpole. Perrin, Richard. Healthcare Purchasing News. April 2009.
Change the Forecast from Perfect Storm to Perfect Order. Gundersen, Steve. Healthcare Purchasing News. January 2009.
UDI Goes Beyond UPN in Identifying Recalled Products, Preventing Surgical Dangers. Cooper, Mitch. Healthcare Purchasing News. March 2009.