UDI FDA Compliance
Unique Device Identification (UDI) - It's Official
But there's no need to panic...
Healthcare industries know they need a better way to track products to gain better inventory and tracking elements for their businesses. And beginning in 2013, they have another impetus: the U.S. Congress, together with the FDA, has passed their ruling on UDI that will effect the entire medical industry (including manufacturers, distributors and healthcare providers), with a 5-year, incremental roll-out by product class.
What do you do now?
Whether you decide to mark with linear or 2D bar codes, an RFID (Radio Frequency Identification) tag or both, The Danby Group has the solutions for marking just about anything.
We know marking...utilizing traditional thermal transfer label printing, C02 laser printing, or marking directly on the item itself, we can deliver the right solution that will offer your company more than just compliance - a way to better track assets, inventory, warranties and recalls, and much more.
We know data collection...partnering with Innovatum, Inc., Danby provides a complete labeling management system specifically designed for healthcare compliance. Easily track and manage UDI, serialization, track and trace, regulatory images, multi-lingual translations, inspection and reporting aspects of your company's labeling applications.
The Compliance Trend: The FDA has its' UDI Rule, and the International Medical Device Regulators Forum unveiled its long-awaited plan for device identification, pushing for a “highly interoperable” and harmonized system to globally track medical devices. The release dovetailed with the European Commission’s recommendation for an EU-wide UDI system. Both plans are closely aligned with the FDA’s rule on UDI - but no matter which compliance mandates your company must adhere to, there is one place to call: 800-262-2629.
The International Medical Device Regulators Forum is charged with the responsibility of issuing opinions/guidance to those regulatory authorities (local, state and national) seeking to develop a globally harmonized system for Unique Device Identification. This report gives high level guidance on those items having a global impact for entities to use as they develop their individual requirements. UDI must be an internationally adopted, harmonized system for all four impacted groups to benefit - manufacturers, healthcare providers, patients and regulatory authorities. This recently released document is considered the international framework for such a system. Click here for a link to this important and timely document: International Medical Device Regulations Forum, Proposed Draft
Additionally, the U.S. Congress, FDA, pharmaceutical manufacturers, distributors, retailers and healthcare providers are plunging into SNI (Standardized Numeric Identifier). And the International Council for Commonality in Blood Banking Automation (ICCBBA) has implemented a worldwide serialization system for blood transfusions, organ transplants, tissue and tissue-engineered products, eye bank, cellular therapy, and human breast milk banking contained in the standard ISBT 128 standard.
So, like it or not, marking products with a unique identifying code is here to stay, and growing. The Danby Group can help your company make sense of the rules, and implement a 100% compliant solution across your product line with little disruption to your day-to-day operations.
The Danby Group, through its founding membership in the UDI Committee, a sub-committee of AIM, works diligently with policy makers, Congress, the FDA, and the medical device community to assist in the implementation and clarification of these programs. Our clients consult with us regularly and count on us to have the most up-to-date information on these topics.
Danby brings this active work together with our 30+ years in the successful design and installation of automated identification systems, as well as detailed knowledge of hardware and supply components make us uniquely qualified to assist our customers with both UID and UDI compliance requirements. Providing complete turnkey systems, consulting, hardware (scanners, printers, verifiers and supplies) the Danby Group is your one stop source for automatic data collection assistance. Danby partners with industry leaders such as Zebra, Innovatum, Webscan, Honeywell, Motorola and others, to build the best solution available to meet your company’s individual needs.
Please see our Resources box to the right for more related information. Our blog page contains several helpful articles on UDI and unique ID technology components. Blog