Unique Device Identification
The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States. It was signed into law on September 27, 2007, as part of the Food and Drug Administration Amendments Act of 2007. This act includes language related to the establishment of a Unique Device Identification System. When implemented, the new system will require:
- The label of a device to bear a unique identifier, unless an alternative location is specified by the U.S. Food and Drug Administration (FDA) or unless an exception is made for a particular device or group of devices.
- The unique identifier to be able to identify the device through distribution and use
- The unique identifier to include the lot or serial number if specified by FDA
A national UDI system will create a common vocabulary for reporting and enhance electronic tracking abilities. Currently, analysis of adverse event reports is limited by the fact that the specific devices involved in an incident are often not known with the required degree of specificity. Without a common vocabulary for medical devices, meaningful analysis based on data from existing voluntary systems is problematic. Reliable and consistent identification of medical devices would enable safety surveillance so that the FDA and manufacturers could better identify potential problems or device defects, and improve patient care.
The UDI is expected to improve patient safety (in part by helping to identify counterfeit products and by improving the ability of staff to distinguish between devices that are similar in appearance but serve different functions), facilitate and improve the recall process, and create efficiences within the medical system.
In the most basic format, the UDI would be a coded number registered with standards organizations, and would incorporate a variety of information, including (but not limited to) the manufacturer of the device, expiry dates, the make and model of the device, and any special attributes that the device may possess. In a medical sense, "device" refers to any product that is not pharmaceutical in nature, and while the FDA have been given approval to exempt some devices, Jay Crowely (who was responsible for implementing the UDI requirements in the Act), has expressed an intent to apply the UDI to "everything until somebody gives us good reason not to", (excluding devices which won't need identification).
Since the passing of the Act, there have been calls for the FDA to publish a timeline for the implementation of the UDI.
- Ament, Lucy (November 13, 2006). "AHA calls for medical device identification system". AHA News 42 (23): p. 2.
- DiConsiglio, John (September 2007). "Solve a unique challenge". Materials Management in Health Care 16 (9): pp. 24–26.
- DiConsiglio, John (September 2007). "Solve a unique challenge". Materials Management in Health Care 16 (9): p. 26.
- Joch, Alan (October 2008). "A device by any other name". Materials Management in Health Care 17 (10): 16.
- "Hospitals calling for device ID". Materials Management in Health Care 17 (6): p. 4. June 2008.
- UDI Case Study
- FDA's web site about UDI and the Global UDI Database (GUDID)
- Johnson & Johnson gateway page announcing their global move to GS1 standards for UDI with links to assigned GTIN identifiers cross referenced to their legacy part numbers.
- FDA testimony before US Senate Committee including statements on intent, timeline, benefits and reach of UDI in the United States (April 13, 2011)
- Online Webinar Series addressing adoption of UDI data standards in healthcare (2013)
- Presentations at the UDI Conference in Orlando, FL including updates from FDA, GS1, HIBCC and industry participants (October 21, 2009)
- Press release from GS1 announcing newly elected global healthcare leadership team and outlining global effort toward a harmonized UDI system (July 2, 2009)
- UDI status update presentation by Jay Crowley (FDA) at GS1 Global Healthcare conference (June 16, 2009)
- GS1 Healthcare Global meeting presentations including adoption status updates for item and location identification standards in healthcare. Video links are promised but not yet added. (June 16–18, 2009)
- presentation by Jeff Secunda, Vice President, Technology & Regulatory Affairs , AdvaMed (AdvaMed's member companies produce medical devices, diagnostic products and health information systems) (June 16, 2009)
- UDI status update presentation by Rodolphe MUÑOZ (European Commission DG Enterprise Unit F3 - Medical Devices and Cosmetics) discussing Global Harmonization Task Force initiatives toward UDI at GS1 Global Healthcare conference (June 16, 2009)
- Comments submitted by healthcare industry organizations to FDA Request for Comments regarding UDI (February 2009)
- Information about the October 25, 2006 public meeting on Unique Device Identification
- Public Notice that requested comments on Unique Device Identification (August 9, 2006)
- Comments Received from the August 9, 2006 Public Notice on Unique Device Identification Presentations ERG Final Report: Unique Identification for Medical Devices (March 22, 2006)
- The Food and Drug Law Institute / CDRH Report on Meeting to Discuss Unique Device Identification (April 14–15, 2005)
- ECRI / FDA White Paper: Automatic Identification of Medical Devices (August 17, 2005)
- The Food and Drug Law Institute / CDRH Report on Meeting to Discuss Unique Device Identification (October 27, 2005)