Digital tags for medical devices

Johnson & Johnson's MedTech business has completed a nearly decade-long effort to incorporate Unique Device Identifiers (UDIs) into the barcodes of its approximately 70,000 different medical devices sold in the United States. UDIs are digital tags embedded in each barcode, providing machine-readable information about the medical device. This move makes Johnson & Johnson one of the first healthcare companies globally to adopt this standard.

The push for UDIs was prompted by U.S. government calls to reduce medical errors and expedite the identification of product safety issues. The legislation, passed in 2013, mandated the inclusion of information-carrying barcode labels on medical devices, with a focus on UDIs. Johnson & Johnson had already started adopting barcode standards developed by GS1, requiring a globally unique 14-digit number (GTIN) and additional product identifiers in the barcode.

Implementing UDIs involved significant efforts from Johnson & Johnson, including designing new labels, managing printing, gathering and organizing vast amounts of data, creating internal systems, and uploading information to a government database. Standardizing and harmonizing diverse existing device data was one of the most challenging aspects.

UDIs offer several benefits, particularly in enhancing patient safety. Swift identification and recalls of devices become possible, reducing the potential for adverse outcomes. Healthcare providers can make more informed treatment decisions by accessing device performance data, and cost-effectiveness is achieved through digitizing product identification data and streamlining the supply chain.

Johnson & Johnson is now expanding its UDI efforts globally, tackling projects in countries like China, Europe, Saudi Arabia, and Taiwan. The challenge lies in navigating diverse UDI regulations across countries, but the company aims to promote standardization. The overarching goal is to improve efficiency, accuracy, and, ultimately, patient safety worldwide.