It’s difficult to recall a time when product packaging wasn’t stamped with barcodes, the blocks of black lines and digits that appear on almost every item you buy.
The food industry introduced these Universal Product Codes, or UPCs, in the 1970s to speed up supermarket checkout lines and streamline inventory-taking. Millions of UPCs are scanned across the United States every day to accurately identify a product’s price.
Most healthcare products have carried barcodes for decades as well. But within the past decade, the industry has been working to overhaul and improve them on behalf of patients. It’s been a huge undertaking, especially when it comes to medical devices. That’s because of all the different items falling into the medical device category—that is, any tool, diagnostic or technology intended to be used for medical purposes. In Johnson & Johnson’s MedTech business, this includes products like sutures and artificial knees and hips.
The overhaul means that medical device packaging (and in some cases, like with reusable surgical instruments, the device itself) will now feature digital tags known as Unique Device Identifiers, or UDIs, embedded into each barcode. These machine-readable UDIs allow a healthcare professional or manufacturer to obtain crucial details about the device with a simple scan of the barcode.
Last fall, Johnson & Johnson reached a major milestone, completing a nearly decade-long effort to embed UDIs into the barcodes on the approximately 70,000 different medical devices it sells in the United States—becoming one of the first healthcare companies in the world to do so.
“Continuing to ensure and increase the safety of our products for our patients is really what UDI is all about,” says Tom Jones, Project Director for UDI at Johnson & Johnson. For example, when doctors and other healthcare providers are in surgery, “they can scan the label to easily make sure they have the right medical device for the right patient at the right time,” he explains.
Read on to learn more about UDIs: what they are, who they benefit and what Johnson & Johnson’s ongoing effort to implement them on all the company’s medical device products around the world means for product safety and patient protection.
What Exactly Is a UDI?
Prompted by calls within the U.S. government to create a system that would reduce medical errors and hasten the identification of product safety issues, Congress passed legislation mandating that manufacturers assign information-carrying barcode labels to medical devices. The information required to be embedded in the barcode includes a UDI.
Yet even before the regulations were passed in 2013, Johnson & Johnson had already begun adopting the barcode standards developed by GS1, a nonprofit international supply chain standards organization. GS1 requires a globally unique 14-digit number called the Global Trade Item Number (GTIN) to be embedded in the device’s barcode. The organization also mandates that one or more product identifiers, which include the item’s lot or batch number, the manufacturing date, the expiration date and/or its serial number be embedded in the barcode as well.
Putting updated labels on devices may sound simple enough. But for companies with vast, diverse inventories, it’s an enormous job. At Johnson & Johnson, teams designed the new labels, handled the printing, gathered and streamlined huge amounts of data, created a detailed internal system to store all of the new UDIs and associated product information and uploaded this information to a government-run database.
Before starting, however, they had to invent and implement new processes to get it all done.
The formidable task of complying with the UDI regulation is worth the effort because it benefits everyone who has contact with a device, such as hospital administrators, providers and researchers. But patients are the ones who have the potential to gain the most.
One of the biggest challenges of the project was wrangling existing device data, which could vary widely. “Our mission was to standardize and harmonize all of that data,” says Lee-Ann Norman, Senior Director, UDI Programs, at Johnson & Johnson MedTech.
A Detailed Look at the Benefits of UDIs
The formidable task of complying with the UDI regulation is worth the effort because these identifiers benefit everyone who has contact with a device, such as hospital administrators and healthcare providers. But patients are the ones who have the potential to gain the most. Here’s how:
1. UDIs enhance patient safety by helping manufacturers and the U.S. Food and Drug Administration conduct swifter product recalls. The faster healthcare professionals can act on a recall and stop using a specific device or group of similar devices, the greater the likelihood of reduction in potential adverse outcomes.
2. They can help healthcare providers make more informed treatment decisions for patients. Say a patient needs a hip replacement revision and their surgeon is formulating a treatment plan. Identifying the UDI associated with the patient’s existing hip implant and looking up how that model performed in patients with similar disease profiles allows the provider to chart a more informed treatment course.
3. Cost-effectiveness is a benefit, too. First, digitizing product identification data eliminates the need to purchase physical paper. Plus, UDIs assist in tracking a device through the supply chain and can aid in ensuring that the right devices will be delivered to the right places at the right time, potentially streamlining shipping expenses and making the process more efficient.
4. The fight against illicit trade is also a factor. In the world of medical devices, counterfeiting can be a serious concern. UDIs can help protect patients from illicit and potentially dangerous items by enabling verification along the supply chain. If a device doesn’t have a UDI, or the information in the UDI isn’t recognized, that may indicate that the product is counterfeit.
The Next Step for UDIs
Johnson & Johnson is now focusing on expanding its UDI efforts in other countries.
Introducing the new labels globally has been a balancing act, says Desiree Koehler, Director, Supply Chain Programs, Johnson & Johnson Vision. “Each country has specific UDI requirements, and sometimes that includes specific asks for product labeling. As an organization with global packaging, that can be a challenge. So a lot of work goes into promoting standardization across different UDI regulations.”
Adds Jones: “Because all of these countries’ regulations are not the same, we’ve tried to play a role to help harmonize them so that we don’t create labels that are dramatically different in one country versus another.”
This year, the company is working on UDI implementation projects in China, Europe, Saudi Arabia and Taiwan, among other places.
“I’m proud,” Norman adds. “By implementing UDIs, we can make things more efficient and accurate.”
All in the name of making patients safer—here and everywhere.
