What are Unique Device Identifiers (UDI)?

The Unique Device Identifier (UDI) system is a numbering system devised by the FDA in 2013 in order to better mark and identify medical devices within the healthcare supply chain. The UDI code is comprised of two components: the device identifier, and the production identifier. The device identifier is a mandatory portion of the UDI that identifies who labeled the product, as well as the specific model or version of the device. On the other hand, the production identifier is conditional and variable. It identifies when the following variables are included in the labeling of a device: the batch or lot number, the serial number, the expiration date, the manufacturing date, or the identification code required for human cell, tissue, or cellular and tissue based products (FDA).

What are the current UDI requirements?

  1. September 2013: FDA announces a slow roll out of regulations and UDI requirements
  2. September 2018: All class II and class III devices that can be reused must have the DI permanently on the body of the device. Similarly, all class II and II devices and implantable, life-supporting, and life-sustaining devices must bear a UDI, and all device data must be included in the GUDID database.
  3. September 2022: all class I, II, and III devices that fall into the category of requiring a UDI must bear one on the device body (FDA).

Who Issues UDIs?

UDIs are not issued by the FDA, instead they are issued by an FDA accredited agency. Prospective issuing agencies must go through a rigorous application process to ensure that they are equipped to properly issue UDIs. There are currently three FDA accredited UDI issuing agencies (FDA).

How are UDIs used?

According to the FDA, the purpose of UDIs is, “To reduce medical errors that result from misidentification of a device or confusion concerning its appropriate use, and to improve the quality of information in medical device adverse event reports” (Lieberman, 2016). UDIs ensure that all available information on a device is accessible, and that the correct versions of devices are used.

How does the UDI system impact Hospital Supply Chain?

UDIs contain huge potential impacts on hospital supply chain management. According to research done by Inspirage, “Adopting standards can also help improve and streamline inventory management” (Lieberman, 2016). This occurs because hospital supply chains are better enabled to pinpoint the location of devices within supply chain, and analyze how they are being used within the hospital (Lieberman, 2016). As UDIs are further embedded into the device labeling process, the ability to obtain data will be enhanced; making decisions with better data, in conjunction with supply chain management software, should lead to efficiencies and cost-effective processes when executed properly.

Sources:

Lieberman, M. (2016, October 10). UDI mandate: Is your supply chain ready? Retrieved March 30, 2018, from http://www.inspirage.com/2015/11/udi-mandate-supply-chain-ready/

Center for Devices and Radiological Health. (n.d.). Unique Device Identification — UDI. Retrieved March 30, 2018, from https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

Center for Devices and Radiological Health. (n.d.). Compliance Dates for UDI Requirements. Retrieved March 30, 2018, from https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/CompliancedatesforUDIRequirements/default.htm