The U.S. medical device industry continues to innovate, producing sophisticated, life-saving products for the nation’s most at-risk patients, developing cutting-edge treatments to improve the quality of life for those with chronic conditions, and offering tried-and-true approaches for common, everyday ailments. Information about medical devices, particularly those that are needed to save lives, should be clear, accurate and easy to find. This is especially critical to foster recalls or to identify contaminated products; yet sharing information about medical devices throughout the supply chain, and directly with the patient, is needlessly complex.
Lack of consistent device identifiers in healthcare has been a long-standing problem, yet is one that is solved with the adoption of consistent global identification standards across the industry and the implementation of systems to provide accurate data throughout the healthcare system.
In late September 2013, the U.S. Food and Drug Administration issued its highly anticipated final rule establishing a unique device identification (UDI) system that provides a platform for communicating accurate, reliable information about medical devices to all recipients who need information about the device. The new regulation will affect how manufacturers label their products and publish device identifiers to a centralized database (see www.gs1us.org/hcudi for more information). It comes after many years of industry collaboration and input, and marks a turning point in healthcare. Its impact will be felt across all of healthcare, from the different points in the healthcare supply chain to clinicians, payors and members of the public – all of whom will be able to rely on consistent, publicly accessible standardized information regarding medical devices, thus increasing patient safety and improving supply chain efficiency and security.
This UDI system is comprised of the UDI code, application of the UDI to device labeling and packaging, and a related, centralized database that will serve as a one-stop shop of sorts for information related to all the medical devices being developed and/or on the market. The system will enable many benefits that will ultimately improve patient safety, including:
- Faster and easier product recalls
- Improved traceability
- More effective counterfeit detection and abatement
- Increased accuracy in electronic transactions and information sharing
- Reduced supply chain costs
- Increased access to product information for members of the public and the medical community
Perhaps more importantly, the UDI rule has implications beyond the U.S. healthcare supply chain, as it supports global alignment efforts to use data standards that provide global product visibility and can identify recalled products that need to be removed from a supply chain that crosses international borders. Any manufacturer located anywhere in the world that sells products in the U.S. is required to comply with the new rule.
The components of the FDA UDI system are:
- The UDI – a unique numeric or alphanumeric code that includes a device identifier (DI), which is specific to a device model, and a production identifier (PI), which includes the current production information for that device, such as the lot or batch number, the serial number and/or the expiration date (including year, month and day).
- The label – the UDI must appear on the label in human readable format as well as in a manner that can be read by automatic identification and data capture (AIDC) technology, such as a linear or 2D DataMatrix barcode, for example. A UDI must be applied to the base package and higher levels of packaging.
- The database – Manufacturers must submit the UDI to the FDA Global UDI Database (GUDID), and include a standard set of basic identifying attributes for each UDI. The GUDID will store information about all medical devices, and providers, patients, and members of the public will be able to access the information when needed, leading to better decisions concerning patient care. Using consistent, global standards will also enable providers to harness data for longer-term goals, such as comparative effectiveness, outcomes research and population health management.
The proposed effective dates for UDI requirements are based on risk class after publication of final rule, which occurred on September 24, 2013:
- Class III – 1 year (by September 2014)
- Class II implants and life-supporting/life-sustaining devices – 2 years (by September 2015)
- The rest of Class II – 3 years (by September 2016)
- Class I – 5 years (by September 2018)
GS1, a leading standards organization, was named by the FDA as an accredited issuing agency for UDIs. Healthcare’s 11ptst manufacturers, distributors, leading IDNs, and GPOs are already using GS1 Standards to improve patient safety, supply chain efficiency, and prepare for regulatory requirements such as FDA UDI. GS1 Standards, specifically the Global Trade Item Number® (GTIN®), are recognized across the healthcare industry as a unique identifier of medical/surgical products for every level of packaging and supports UDI regulation.
While the FDA UDI regulation is now a reality, it is important to remember that organizations representing all aspects of the supply chain have been working together for many years to support UDI capabilities, not only in anticipation of the law, but because it is the right thing to do for patient safety. In addition, clean, consistent and global data has immeasurable value for any organization that decides to implement standards. A UDI system accessed and leveraged by all constituents in the U.S. supply chain will improve the speed and accuracy for product recalls as well as adverse event reporting, among other benefits. The time is now – the industry is able to implement UDI to the benefit of patients, healthcare providers and manufacturers here in the U.S. and around the world.
MJ Wylie is the Sr. Director of Healthcare for GS1 US, leading US healthcare trading partners to actively engage, adopt, and use the GS1 standards to improve their business and supply chain operations, with a clear passion to support the FDA’s Unique Device Identification (UDI) regulation to enhance patient safety. Ms. Wylie is a certified Global Regulatory Affairs Compliance Professional (GRACP).
Additional Resources
UDI Implementation for Manufacturers
To support UDI implementation using GS1 Standards, I recommend that manufacturers take the following approach:
1. Assess how your company currently identifies and marks its products in terms of the UDI requirements (e.g., identification numbers, labeling, barcodes). Does your company know where the FDA-requested data attributes reside? Do you know how your products are classified?
This step could take several weeks, even months, and perhaps is the most time and research-intensive of all the steps, so get started right away.
2. Determine the responsible party within your organization for assignment of:
· UDI / GTINs (usually those responsible for packaging)
· GUDID: data aggregation, submission, and maintaining the data to the FDA’s database
· Work with your regulatory affairs to manage updates to both the UDI and GUDID
3. Join GS1 US to obtain a GS1 Company Prefix, which is the foundation for creating GS1 identification numbers (i.e. GTINs) for UDI requirements. You may also need to identify your locations with Global Location Numbers (GLNs) to meet customer requirements.
4. Assign GTINs and design your approach to production information for your products.
5. For smaller to mid-sized manufacturers, select a solution provider partner and/or use the online GS1 US Data Driver® tool to generate your GTINs.
6. Prepare notification of adoption of standards for product and location identification. There are a host of useful tools to help manufacturers get started on UDI, including visuals, a GTIN Quick Start Guide and a UDI “Frequently Asked Questions” at www.gs1us.org/hcudi
7. Begin marking products with barcodes containing GTIN plus, if applicable, the secondary information, such as expiry date, serial number and such.
8. Load GTIN and GTIN data attributes, if applicable, into the Global Data Synchronization Network (GDSN) to submit to the US FDA GUDID. The GDSN is currently used by the industry to share standardized healthcare product information across supply chain partners, and may also be used to populate the FDA GUDID.Create and use a cross-reference file between the old identification numbers and GTINs.
9. Communicate with your customers about any new packaging, labeling and usage in procurement and contracting efforts.
About GS1 Standards
The GS1 System of global supply chain data standards has revolutionized efficiency, accuracy and cost-effectiveness in a broad range of industries. Recognizing the impact that industry-wide adoption of a common language can have, GS1 Healthcare US has set out to apply these same standards to helping the healthcare industry improve efficiency and quality for lower costs, more streamlined care delivery and better patient safety.
Global Location Number (GLN): Location Identification
This number is an industry-wide, standardized location identifier that replaces custom account and location numbers.
Global Trade Item Number (GTIN): Product Identification
Manufacturers are moving toward adopting a standardized product identifier to ensure accuracy of product information at every level of packaging, throughout the supply chain.
Global Data Synchronization Network (GDSN)
The GDSN is an authoritative source of standardized healthcare product information. With this network, all supply chain partners will be able to access identical, up-to-date, reliable product data efficiently. The GDSN plays an integral role in the adoption of GTINs. Healthcare organizations can use the network to create and store product information for faster standardization and better communication across the industry.
Source: November 2013 Healthcare Implementation Workshop: AHRMM, HSCA, SMI, GS1 Healthcare US