Skip to main content
[email protected]
Menu
Language
Appearance

GS1 Identifiers and FDA UDI: One Barcode, Two Jobs

ASAzHeC Standards Desk
February 4, 2025
2min read
WhatsAppEmail

One of the most useful convergences in modern healthcare logistics is also one of the least discussed: the same barcode that a hospital’s supply chain uses to order and receive a product can also serve as the device-safety identifier that regulators and registries depend on. That convergence runs through GS1 standards and the FDA’s UDI system.

The shared identifier

GS1’s Global Trade Item Number (GTIN) is one of the identifier systems the FDA accepts as the device-identifier portion of a UDI. In practice that means a single GS1 DataMatrix barcode, encoding a GTIN plus production data such as lot and expiration, can simultaneously satisfy supply-chain identification and UDI labeling. One scan, two jobs.

Locations and shipments, too

GTIN identifies the product, but GS1’s family of identifiers goes further. The Global Location Number (GLN) uniquely identifies a physical or functional location — a specific receiving dock, a particular nursing unit — and the Serial Shipping Container Code (SSCC) identifies a shipment unit. When manufacturers, distributors, and hospitals all use the same identifiers, ordering, receiving, and traceability data can flow without translation between each party’s private codes.

Why the overlap is valuable

Historically, supply-chain identity and clinical/regulatory device identity lived in separate worlds, each with its own codes. The UDI rule’s acceptance of GTIN as a device identifier collapsed that gap for products labeled accordingly. A nurse scanning an implant at the point of use can capture an identifier that feeds the patient record, the recall system, and the inventory ledger at once.

The capture challenge

The remaining work is point-of-use data capture — ensuring the scan actually happens and the captured identifier lands in the right systems. That requires scanning workflows, fields in clinical documentation that can hold UDI data, and exchange standards that carry it forward. AzHeC’s Standards work area covers GS1 and UDI in plain language, and our Connected Devices coverage addresses how device data reaches the EHR. The barcode is ready; the workflows are where the value is won or lost.

Reading Time

2 min read

Published

February 4, 2025

Views

1.2k

Shares

234

Article Topics

AS

Written by

AzHeC Standards Desk

Join Our Community

Connect with like-minded readers, share your thoughts, and engage in meaningful discussions.

Explore More Articles

Discover our extensive library of health research and evidence-based insights.

Explore Related Topics

Comments

0

Sign in to join the discussion

Share your thoughts and engage with the community

No comments yet

Sign in to be the first to comment!