MINNEAPOLIS /PRNewswire/ -- On July 10, 2012, the Food and Drug Administration released its proposed rule for Unique Device Identification (UDI) of medical devices in the United States. The system focuses on creating standardized device identifiers that are applied to packaging and devices, corresponding to entries in an FDA-managed Global Unique Device Identification Database (GUDID). The rule contains guidelines for UDIs being applied to devices in both human-readable form and encoded in some type of Auto ID technology (e.g., barcode, RFID). Within the GUDID, additional device details will be stored, such as manufacturer details, device name, description and characteristics. The proposed system is expected to provide numerous benefits including: reduction in medical errors, simplified integration of device identification with data systems, and facilitation of faster response to adverse events and recalls.
The proposed UDI rule is significantly important because it lays the foundation for standardized medical device serialization and tracking in the U.S. As stated in the proposed rule, potential additional benefits of UDI are increased detection of counterfeit devices and improvement in supply chain visibility. Through deep experience with serialization and traceability, Verify Brand can help medical device manufacturers understand the end-to-end impacts of UDI and serialization - from packaging/labeling and distribution to meeting regulatory requirements and enhancing product authentication.
Verify Brand's VB Enterprise software supports all stated standards in the proposed UDI rule, including:
- GS1 GTIN and HIBCC HIBC for device identification
- HL7 SPL data transmission to the GUDID via the VB Enterprise Message Management Service
- Production Identifier elements: lot/batch, serial number, expiration date, manufacture date
Verify Brand is a recognized leader in developing, deploying and supporting supply chain security and management solutions for manufacturers, high tech and life science companies. Verify Brand's Software-as-a-Service (SaaS) offering provides optimized supply chain visibility through unique product identification (UID) and its related object data to securely manage products, provide valuable information, and analytics throughout the UID life cycle to improve business and government operations.
About Verify Brand, LLC
Verify Brand started in 2004 and is exclusively focused on enabling serialization and traceability systems for unique identification life-cycle management. The company's first customer was a medical device division of a Fortune 50 Life Sciences company. Our Software-as-a-Service cloud-based solutions help brand owners address numerous supply chain security and management challenges as well as rapidly emerging regulatory or procurement requirements for serialization and traceability around the world. Verify Brand services are helping to secure 100s of millions of products with customers across industries, languages, and in over 80 countries around the world.
On July 10, 2012, the Food and Drug Administration released its proposed rule for Unique Device Identification (UDI) of medical devices in the United States. The system focuses on creating standardized device identifiers that are applied to packaging and devices...