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UDI – Unique Device Identification


Unique Device Identification, or UDI, is a new identifying system to be used to identify and mark medical devices within the healthcare supply chain. The system will work by assigning a unique identifier to most medical devices distributed within the United States.

The FDA released the final rule in September, 24, 2013. The rule requires the label of most medical devices to include a unique device identifier (UDI), except for defined exceptions. A UDI is made up from two components.  The first is an identifier of the specific model and labeler (usually but not always the manufacturer) of a device. The second is a production identifier which may include batch/lot, serial number, expiration date, and/or manufacture date. The required production identifier is based on the class of the device and the labelers internal traceability processes.

In addition to identifying medical devices with a UDI, the labeler must submit product information involving the medical devices to the FDA’s Global Unique Device Information Database (GUDID).

The U.S. Food and Drug Administration (FDA) stipulates that UDI implementation requires:

  • A unique identifier to be placed on the label of a device, unless another location is stipulated by the FDA.
  • The identification of a device by the unique identifier through the device’s distribution and use
  • The device manufacturer to include the unique identifier on every model and/or version of their devices
  • An FDA-specified lot or serial number be mentioned on the unique identifier
  • The unique identifier to be readable, machine readable and available in AutoID format.
To put it a plainly, medical devices will be identified with direct product marking and labels providing pertinent product information to healthcare users. Behind this physically simple change however, is a world of better things for everyone linked to healthcare.

Better Patient Safety

One of the biggest positive impacts of UDI will be on patient safety. This will be in part due to the UDI system enabling healthcare professionals to identify counterfeit products and distinguish between similar devices with different functions. Efficiencies will be enhanced for medical systems across the country.

Better Healthcare Management

Not only will patients enjoy better healthcare, hospitals will benefit from the more efficient healthcare supply chain. UDI removes ambiguity from the equation, something that makes countless lives associated with healthcare a lot easier.

More accurate reporting, efficient recall management, less medical errors, these are some of the ways that the UDI system will be touching lives in healthcare, extending quite a few of these in the process. This is a very promising development for all stakeholders from healthcare facilities to healthcare givers to patients.

What UDI Implementation Can Mean

Once implemented, the UDI system can:

  • Let users quickly identify and resolve issues with problem devices
  • Decrease medical errors by way of swift device identification
  • Create a standard method for analyzing devices in the market, accelerating pre-market approval and clearance
  • Enable device manufacturers, distributors and healthcare facilities to manage recalls more efficiently
  • Lay the foundation for a worldwide distribution chain

In the wake of the UDI implementation, a globally recognized medical device identification system will soon shape up. Better, functioning and error-free medical devices will quickly arrive in the market where healthcare givers will make the most of them.