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, every day ailments. Medical devices come in all shapes and sizes, from imaging systems and implants to laboratory and blood products, dentistry, over-the-counter remedies, and everything in between. The industry is diverse, and produces millions of products that vary dramatically in size, complexity, packaging, and use. Some devices come in boxes, some are packaged individually, and others are not packaged at all. Some are used once and thrown away, while others are used and reprocessed, or are implanted into patients. Information about medical devices, particularly those 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.
Today, manufacturers, distributors, and hospitals use thousands of different numbers to track the shipment of devices across the U.S. healthcare supply chain. Information management systems are exploding with inaccurate and manually created catalog numbers and company names, and self-created numbering systems that differ from user to user. These challenges have led to decades of unreliable data passing hands and being stored in the supply chain. Healthcare has created an environment for data exchange that is burdened with errors and inconsistencies, with a potential negative impact to patient safety. 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 (FDA) 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. 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 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 for information related to all the medical devices being developed and 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. 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.
Components of the ruling
The FDA UDI is designed to provide a standardized way to identify devices across all information sources and systems, including electronic health records and devices registries, from the time of the product’s conception and prototyping all the way though patient use. The rule has obvious implications for manufacturers, who will be under regulated timelines for compliance, but it also affects device design engineers, who must now factor in labeling requirements at the earliest stages in the design of their products. The components of the FDA UDI system are:
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
Global Trade Item Number (GTIN): product identification
Global Data Synchronization Network (GDSN)
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, if applicable, the expiration date (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. 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. 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 the final rule, which occurred on Sept. 24, 2013:
Class III – One year (by September 2014)
Class II implants and life-supporting/life-sustaining devices – Two years (by September 2015)
The rest of Class II – Three years (by September 2016)
Class I – Five years (by September 2018)
The FDA will grant some exceptions to the timeline for grandfathered devices. A device that is in commercial distribution prior to the applicable compliance date does not have to comply with the final rule, and devices that are manufactured and labeled before their compliance date (i.e., inventories) have an exception from the rule (this expires three years after the compliance date for that device).
Though the UDI is a new regulation, it was initiated as a part of the FDA Amendments Act of 2007. Many manufacturers have been working toward establishing UDI processes internally and have been using UDIs for their products, and as a result, some are ready for UDI compliance. Still, others may be newer to the concept. If your company sells medical devices and has not yet started implementation to comply with UDI, you may already be late in meeting the regulation’s implementation timelines. Luckily, there are organizations standing by, ready to help manufacturers in their compliance efforts.
In the healthcare industry, the largest 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. The Global Trade Item Number (GTIN), a GS1 standard, is recognized across the healthcare industry as a unique identifier of medical/surgical products for every level of packaging and supports UDI regulation.
To support UDI implementation at an organization using GS1 Standards, manufacturers should 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 in your organization for assignment of:
- UDI / GTINs – usually those responsible for packaging
- GUDID – data aggregation, submission, and maintaining the data in the FDA’s database UDI and GUDID updates – work with your regulatory affairs to manage updates to both
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 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 expiration date and serial number.
8. Load GTIN and GTIN data attributes, if applicable, into the Global Data Synchronization Network (GDSN) to submit to the U.S. FDA GUDID. The GDSN is currently used by the industry to share standardized healthcare product information across supply chain partners and may be used to populate the FDA GUDID. Create and use a cross-reference file between the old identification numbers and GTINs.
9. Communicate with about any new packaging, labeling, and usage in procurement and contracting efforts.
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. 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 and adverse event reporting, among other benefits. The industry is ready, willing, and able to implement UDI to the benefit of patients, healthcare providers, and manufacturers in the U.S. and around the world.
UDI resource site: Tools, resources, and education for implementing GS1 Standards to support UDI: www.gs1us.org/hcudi
About the author: M.J. Wylie is the senior director of healthcare for GS1 US, and is a certified Global Regulatory Affairs Compliance Professional (GRACP). She may be reached at 609.620.0200.