Unique Device Identification: The New Technology That Could Save Lives
Unique Device Identification: The New Technology That Could Save Lives

Most people today are familiar with barcodes. They can be found on almost any item you purchase from a retail store: gum, fruit, ice cream, shoes, clothing—the list is endless.

Barcodes are valuable because they provide a way to identify a product electronically. We can thank barcodes for getting us through the grocery checkout line faster, since they provide key information on store inventory, pricing and other details with just a swipe of a scanner.

When it comes to medical devices, using unique barcodes for identification is fairly new. Several years ago, the U.S. Food and Drug Administration (FDA) recognized the potential risks of not being able to accurately identify each medical device out in the world because there are tens of thousands of versions and different models on the market today.

Let’s say you or someone you know has a knee or hip replacement. You want to be assured that the device the hospital ordered is the exact one prescribed for your procedure and captured in your medical records.

With the recent implementation of Unique Device Identification (UDI), you can be even more confident that the product you are receiving is the right one.

How UDIs Help Make Hospitals Safer

The FDA established UDI in 2013 to accurately identify medical devices sold in the United States. Similar to the UPC barcodes you see on products at the supermarket, a UDI number will now be placed on every medical device package in the U.S., and in some cases, the device itself. This way, the FDA can keep a record of each one sold, making it easier to track in the event that a problem should arise that necessitates a product recall.

Here are just a few ways that UDI benefits you as a patient:

  • It provides your doctor with important clinical information about the product (like what it is and who made it), which can reduce medical errors
  • It helps to identify counterfeit products in the market, and improves medical device manufacturers’ ability to identify and recall defective products
  • UDI barcodes are easy to scan, making hospitals more efficient at tracking inventory, lessening manual input errors and better protecting patients from the inadvertent use of expired devices
  • UDI will help researchers better analyze the device’s effectiveness over time, facilitating medical device innovation

How We Are Leading the UDI Way

At Johnson & Johnson, we are at the forefront of making sure our medical devices comply with UDI regulations. While the FDA is requiring compliance with their UDI standards over the next few years, we created enterprise supply chain programs focused on product identification and traceability several years ago—and UDI is one of our major programs.

Our medical device franchises work in partnership to meet FDA requirements. The magnitude of this effort is substantial and may grow when other countries implement their own UDI-type regulations.

Tom Werthwine, Director of Industry Standards, says he sees “UDI going global” in the coming months and years. I think Mike Rose, Vice President, Supply Chain Visibility, said it best: “We are just scratching the surface” in terms of UDI’s potential to deliver value to our patients, our partners and our business.

I agree—and look forward continuing to be part of this exciting effort.

To learn more about UDI, check out our video, “Welcome to the World of UDI.”

Tom Jones is the Director End-to-End of Traceability and Unique Device Identification (UDI) Program Director for Johnson & Johnson Supply Chain. He’s worked in IT, business intelligence, and supply chain at the company, and has held multiple program leadership roles at Ethicon Endo, DePuy and within the supply chain organization.

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