Health Sector Supply Chain Research Consortium - Unique Device Identification (UDI)

Unique Device Identification (UDI)

The U.S. Food and Drug Administration's Unique Device Identification (UDI) System Final Rule was published in the Federal Register on September 24, 2013. The rule requires the label and package of marketed devices to include UDI. For devices intended to be used more than once and reprocessed before each use, UDI must be directly marked on the device. UDI consists of a device identifier that identifies manufacturer and model and a production identifier that identifies lot number, serial number, expiration date, and/or date of manufacture. UDI establishes a standard format for medical device identification and the ability to track a device through distribution and use.

Compliance dates for adherence to the rule depend on class of device with highest risk devices being impacted first. UDI on labels and packages of Class III devices are required one year after the final rule and two years after the final rule for other implantable devices. UDI for other devices and direct marking will be required in a step-wise fashion 2-7 years after the final rule. The expected value of UDI use across health care is extensive and is inclusive of clinical, post-market surveillance and supply chain benefits.

There is not parallel regulation or meaningful incentive requiring UDI use at  this time although there are ongoing national-level efforts to address this.  Some hospitals are readying their systems for UDI use.  Many hospitals are seeking information.  Achieving full value of UDI across health care will require implementation and adoption of UDI in multiple areas as well as IT integration. Necessary is multi-stakeholder education and collaboration, research efforts focused on implementation and adoption, and leadership through knowledge and involvement.

From a supply chain perspective, expected value includes

  • A standard for device documentation in supply chain IT systems
  • Greater accuracy and efficiency in procurement
  • Improved inventory and recall management
  • Better charge capture
  • Enhanced availability of device data

From a clinical perspective, expected value includes

  • Greater patient safety and accuracy surrounding device use in clinical care
  • A standard for device documentation in HIT systems
  • Greater comprehensiveness and efficiency in device recalls
  • Availability of enhanced data for internal assessment or post-market surveillance activities on devices
  • Standard device-identifying information for health care providers and patients

From a post-market surveillance perspective, expected value includes

  • Enhanced use of device data from EHR
  • Standard device-identifying information in adverse event reports
  • A standard for device-identifying data in clinical registries and research databases
  • A standard identifier for devices across FDA data systems
  • A standard identifier for device recalls
Natalia Wilson

HSRC-ASU Research:

Impact of Barcode Scanning in Orthopedic Surgery (2012-present)

Peri-operative Total Hip and Knee Arthroplasty Implant Documentation and Identification Practices: Implications for Use of Unique Device Identification in Orthopedic Surgery (2011-12)

  • Project conducted in collaboration with the Research Committee of the American Association of Hip and Knee Surgeons (AAHKS).  Presented at the AAHKS 22nd Annual Meeting, November 2012 and Academy Health's Annual Research Meeting June 2013.

Journal Publications

Wilson NA, Jehn M, York S, Davis CM.  Revision Total Hip and Knee Arthroplasty Implant Identification: Implications for Use of Unique Device Identification 2012 AAHKS Member Survey ResultsJ Arthroplasty 2014; 29(2): 251-55.

Wilson, NA, Drozda, J.  The Value of Unique Device Identification in the Digital Health InfrastructureJAMA 2013; 309(20): 2107-8

Education & Other Publications:

The Final UDI Rule- The Clock is Now Ticking (vhatv), December 11, 2013

The FDA’s Unique Device Identification System Rule, (Bloomberg BNA), December 9, 2013

What Pacemaker is this? The Value of Unique Device Identification (KnowWPC).  June 27, 2013

The Impacts of the FDA Unique Device Identification System (vhatv), December 12, 2012

The value of unique device identification across healthcare (white paper), December 2012

Unique Device Identification Across Health Care (HSRC-ASU Webinar), September 13, 2012

National-level Efforts:

  1. Brookings Institution Unique Device Identification Workshops & Webinars

    Accessing and Communicating Device Information: UDI as a Tool for Improved Patient and Provider Connectivity, March 18, 2013

    Improved Access to Device Information: What a UDI System Can Do for Patients and Consumers (webinar), Feb 26, 2013

    Unique Device Identification Expert Workshop 2: Identifying Steps for Implementation and Integration of UDI within Electronic Data Infrastructure of Care Delivery Sites, December 13, 2012

    The Value of Unique Device Identification for Health Care Systems and Providers (webinar), November 5, 2012

    Unique Device Identification Expert Workshop 1: Exploring the Opportunities and Challenges Associated with Capturing UDIs in Claims, October 15, 2012

    Unique Device Identification (UDI) Implementation Work Group Kick-Off, July 16, 2012

  2. U.S. Food and Drug Administration

    FDA Unique Device Identification (UDI) for Postmarket Surveillance and Compliance Public Workshop, Integrating UDI Throughout Hospital Systems: The Clinical Value. September 13, 2011

Important Links: