UDI and Labeling Standards

UDI and Labeling Standards

The healthcare industry has unique safety requirements for the labeling of medical products, such as devices, that are not typically found in commercial retail settings. HIBCC was provided our initial mandate in 1983: Develop a uniform bar code labeling standard for products shipped to hospitals.

Bar Codes, Automatic Data Capture (AI/Universal Product Number (UPN)) System

This idea represented a big change for the industry. By agreeing to place a consistent pattern of computer-readable bar codes on their products, manufacturers would provide a control mechanism that would yield enormous benefits to both their hospital customers and distributors.

The alphanumeric Health Industry Bar Code (HIBC) Standards that we created were specifically designed to address the more stringent safety and security considerations of the healthcare setting. As such, HIBC data formats are consistent, flexible, globally compatible and industry supported.

Our standards are designed with health care in mind. The first part of the standard, the HIBC Supplier Labeling Standard (SLS), covers the formats used by suppliers of products. The second part, the HIBC Provider Standard, covers the formats used for internal labeling by health care providers themselves.

UDI – Leveraging Existing Standards

The Food and Drug Administration (FDA), in their recent proposed rule for Unique Device Identifiers (UDI) (a system to mark and identify medical devices within the healthcare supply chain), addressed the importance of leveraging existing standards. You can learn more about the proposed FDA UDI rule here.

Need a Bar Code? First Apply for an LIC

HIBCC was formed to administer the HIBC standard and issue Labeler Identification Codes (LIC); an LIC identifies individual manufacturers and is included within each bar code that manufacturer creates.

If you need to create a bar code, first apply for an LIC assignment by submitting an application online or offline. If your organization already has an LIC, you can create a bar code here.

Contact HIBCC Today

If you have any questions about our HIBC Standards, please contact us by calling 1-855-HIBC-UDI or by using our contact form.