Advertisement

Long-awaited FDA regulation addresses a source of confusion in the medical/surgical supply chain to improve patient safety

For decades, the U.S. healthcare industry has struggled to overcome problems caused by bad or conflicting data in its supply chain, including multiple, differing or proprietary descriptions of medical/surgical products. The negative ripple effect of sharing unreliable or unverifiable product data has wreaked havoc up and down the supply chain, leading to challenges in the product recall process, shipping the wrong product and storing expired or outdated inventory, among other serious, and preventable, problems.

COMPONENTS OF THE FDA UDI SYSTEM

  • 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 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 ready by automatic identification and data capture (AIDC) technology, such as a linear or 2D data matrix 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. The consistent, global standards being used for GUDID data elements will also enable providers to leverage UDI data for longer-term goals, such as comparative effectiveness, outcomes research and population health management.

The era of confusion, added costs and safety concerns is now coming to an end, thanks in part to a long-awaited regulation recently finalized by the U.S. Food and Drug Administration (FDA). In September 2013, after years of industry input and advocacy, the FDA established a rule for 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. FDA UDI affects how manufacturers label their products and how they subsequently publish unique device identifiers to a centralized, publically accessible database.

Historically, manufacturers, distributors and hospitals have used thousands of different codes and numbering systems to name and track the shipment of devices through the U.S. healthcare supply chain. Information management systems have been bursting with inaccurate catalog numbers and company names, and self-created numbering systems that differ from user to user. Unreliable data has passed from hand to hand, and has created an environment for data exchange that is burdened with errors and inconsistencies, with a potential negative impact to patient safety.

Inconsistent device identification in healthcare has been the norm, and all of that is about to change. With UDI in place, the industry is at a turning point. Manufacturers, distributors and providers will now accelerate efforts to adopt consistent global identification standards and implement systems to provide accurate data throughout the healthcare supply chain.

This FDA UDI system is comprised of the UDI code, application of the UDI to the device’s label and packaging, and a related, central database that will serve as an authoritative source of information related to all the medical devices being developed and/or on the U.S. market. With patient safety as the highest priority, the system creates the foundation to enable many benefits, including:

  • Faster, more efficient product recalls
  • Improved product traceability
  • Better counterfeit detection and abatement
  • Greater accuracy in electronic transactions and information sharing
  • Lower costs in the supply chain
  • Access to product information for members of the public and the medical community

The FDA UDI will 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.

Click the image for a larger version

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 been committed to helping the healthcare industry apply these same standards in order to improve efficiency and quality, reduce costs, streamline care delivery, and enhance patient safety.

Global Location Number (GLN): Location Identification
This number is a standardized location identifier that replaces custom account and location numbers.

Global Trade Item Number (GTIN): Product Identification
This number is a standardized product identifier that replaces custom product numbers. 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 GDSN to store and share product information for faster standardization and better communication across the industry.

Because the U.S. healthcare supply chain does not start and stop at our borders, it’s gratifying to know that the UDI rule has implications beyond the U.S. The rule 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. All manufacturers that sell products in the U.S. are required to comply with the new rule.

The 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)

Although the UDI is fairly recent, it was initiated as a part of the FDA Amendments Act of 2007 and thus has been a long time in coming. Many major manufacturers have been working toward establishing standards-based identification processes internally and with partners, and have been using standardized identifiers (like the GS1 Global Trade Item Number (GTIN)) for their products. Other manufacturers may be newer to the concept. Companies that sell medical devices and have not yet started implementation to comply with UDI, must get started right away in meeting the regulation’s implementation timelines.

The FDA formally accredited GS1, a leading standards organization, as an issuing agency for UDIs. For over 40 years, GS1 has been helping companies to adopt and implement consistent data standards to identify, capture, and share their product information. Today, GS1 US is helping diverse industries drive efficiency, safety, and growth through the adoption and use of standards. In the healthcare industry, the largest manufacturers, distributors, leading providers and integrated delivery networks (IDNs), and group purchasing organizations (GPOs) have long been using GS1 Standards to improve patient safety and supply chain efficiency, and to prepare for regulatory requirements like FDA UDI (including regulations related to the pharmaceutical supply chain, state track and trace requirements, and the Drug Quality and Security Act). 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 support the FDA UDI regulation. GS1 US provides a multitude of educational resources for manufacturers and providers.

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. A UDI system accessed and leveraged by all trading partners in the supply chain will improve the speed and accuracy of product recalls as well as adverse event reporting and post-market surveillance, among other benefits.

The time has come for the industry to step up its efforts to implement UDI for the benefit of patients, healthcare providers and manufacturers here in the U.S. and around the world.

For more information, visit the GS1 Healthcare US UDI Resource Site.

Advertisement
Advertisement