Beyond Compliance and the FDA Unique Device Identification Rule – How to Achieve Global Standardization

Healthcare Nurse

As companies are faced with the challenges of managing Health Care information and are being required to comply with regulations in regional markets, many are asking: “Do we focus on regulatory compliance alone or is there a greater focus?”  If regulatory requirements can be met at the same time as business initiatives to reduce costs, increase patient safety and improve business processes throughout the supply chain, can we take that approach?  Can we have it all?

With the adoption of GS1 standards as an option to comply with the US Food and Drug Administration (FDA) Unique Device Identification (UDI) Rule, medical device suppliers can achieve compliance and begin on a global journey towards labeling, identifying and exchanging item information with their trading partners, distribution networks and ultimately to end consumers and patients.  Adopting a global healthcare standard that meets regional needs is the ultimate goal.

Unique Device Identification – The Impact on Medical Device Suppliers

Unique Device Identification is a system that is used to identify medical devices in the healthcare supply chain, enabling greatly improved tracking and tracing for these products.  The International Medical Device Regulator Forum (IMDRF), the United States Food and Drug Administration (FDA) and the European Commission are working together to create a global standard for the purposes of device identification, using GS1 Standards.

What is the FDA UDI Rule?

The FDA UDI rule was established to fulfill a requirement of the Federal Food, Drug and Cosmetic Act that directs the FDA to issue regulations establishing unique identification for medical devices.

Each UDI will consist of two portions:

  • A device identifier for the specific version or model of the device.
  • A production identifier that more precisely identifies the device with additional information such as the lot, batch, serial number and dates.

The FDA’s UDI Rule is supported by the Global Unique Device Identification Database (GUDID).  This database is searchable by the public and will provide key product information for medical devices and track and trace capabilities.  To support this database, all medical devices unless exempt, are required to have a unique device identifier.  For you – the labeler, a manufacturer or third party of a medical device – you are now responsible for submitting the device information to the GUDID.

Why was the FDA UDI ruling created?

The FDA’s UDI Rule was put in place to enable adequate identification of medical devices used in the U.S. and to be able to quickly identify the device’s attributes in order to ensure safety and effective use for the public.  As stated by the FDA, the key public health objectives are:

  • Reduce medical errors
  • Simplify the integration of device use information into data systems
  • Provide for more rapid identification of medical devices with adverse events
  • Provide for more rapid development of solutions to reported problems
  • Provide for more rapid, more efficient resolution of device recalls
  • Better focused and more effective FDA safety communications
  • Additional Benefits: Use in educational and informational materials, supply chain management, Electronic Health Records (EHRs) and Personal Health Records (PHRs)
  • Standard format for dates provided on a device Label

How can you comply with the rule?

Device information can be submitted manually on the FDA’s GUDID User Interface / Website or by an electronic submission using Health Level 7 Structured Product Labeling (SPL) XML or via a third party such as 1WorldSync.

The key question for you to determine is how will your company will gather, submit and maintain that information moving forward as part of a standard business process centered on your Product Information Management (PIM) business processes?

Unique Device Identification Goes Global

As countries are recognizing the value in Unique Device Identification; the use of labeling and identifying medical products is expanding globally.  Below are some examples of activities around the world:

  • European Union: The European Commission’s proposed UDI framework is similar to what the U.S. FDA has ruled — manufacturers must label their products at each packaging level with a human and machine readable code and populate a UDI database with additional information about those products.  The European regulations include provisions for device traceability as well.
  • China: Has a national system for unique identification of pharmaceutical products. There is current discussion around whether China will require medical devices to be identified using its own national system of standards, or if it will utilize the GS1 standard for product identification, the Global Trade Item Number (GTIN).
  • Japan: The vast majority (90-95%) of medical devices sold in that country already bear GS1 product identifiers.  Japan has also established a database that contains information on these devices and plans to use this as its UDI database.
  • Korea: Is moving forward with requirements for pharmaceutical serialization and is considering UDI regulations.
  • Several other countries, including Canada, Australia and Brazil, have stated that they were waiting on the FDA UDI final ruling and will be establishing guidelines in the near future.

What Role Does GS1 Healthcare Standards Play In Helping You Achieve UDI Compliance?

GS1 is a neutral, non-profit organization dedicated to the design and implementation of GS1 Standards.

GS1 Standards are a system that supports the identification and labeling of products, locations, patients, assets and services.  GS1 Global Data Synchronization Network (GDSN) supports the synchronization of productGS1 Logo data across the supply chain using Global Trade Item Numbers (GTIN) and Global Location Numbers (GLN).   The standards enable secure, accurate synchronization of data.

GS1 Standards have been in place for over 30 years and are used globally across many sectors.  These standards are a great fit to support the UDI initiatives since they are global, proven over the years and supported by key players in the Healthcare industry.  The FDA certified GS1 as a submitting agency late in 2013.

How are GS1 Standards being used today by other Healthcare companies?

The Healthcare industry shows adoption and focus on GS1 standards and is active in driving the use of GS1 standards to comply with the UDI Rule. GS1 Healthcare members see the value in using one standard to not only drive the quality of the data in their supply chain but to leverage this same data for global compliance requirements.

GS1 Standards adoption and use based on the GS1 US Healthcare 2013 annual report:

  • 477,000 healthcare GLNs are currently registered in the GLN Registry – a 20% growth in 2013.
  • Over 224,000 healthcare GTINs are currently registered in the Global Data Synchronization Network (GDSN) for the U.S. target market – a 19% growth since the new U.S.-specific benchmark was established in May 2013.
  • Over 4,400 healthcare products were scanned in warehouse receiving, storerooms and surgical areas during barcode assessments in 2013. Results showed that 61% of the products were marked with GS1 Barcodes.

In addition, companies such as Abbott Laboratories and Amerinet have adopted GS1 standards.

In 2010, Geisinger Health System, Intermountain Healthcare, Kaiser Permanente, Mayo Clinic and Mercy collaborated to form the Healthcare Transformation Group (HTG) to share best practices and drive positive change across the healthcare supply chain.

How can GS1 Standards be used to comply with the FDA UDI Rule?

The GS1 GDSN is currently available and used by the Healthcare industry to share standardized healthcare product information across the supply chain and can also be used to populate the FDA GUDID.  The same method you would use to publish product data to one of your trading partners would be used to publish product data to the GUDID.

A Global Solution

In summary, there are some key components of a global solution to support Healthcare companies’ need for a standardization solution for device identification, supply chain tracking and trading partner collaboration.

  • A single point of truth for your item information that can be disseminated throughout your company, supply chain and to the end customer and patient.
  • One global standard for device identification.
  • A fully integrated, end to end system where the integrity of the data from the source to the target is consistent.
  • A business process that supports data quality and ownership of the item information.
  • A standard process to gather, transmit and publish your item data to trading partners and regulatory databases.
  • A standards process that changes and grows as your business changes, as regulatory changes occur and as trading partner requirements change.
  • A flexible process that allows regional differences.

Complying with the FDA UDI mandate can be turned into an opportunity to adopt and embrace global standards to move your company; and ultimately, enable you to be more agile and positioned for future growth in the area of product management across your supply chain.

Diane Walker

Author: Diane Walker

Diane is the Data Synchronization Services Manager for LANSA in the Americas. With over 25 years Application Design, Development and IT Management experience, Diane is responsible for the LANSA Data Sync Direct product, the product's development team and Data Synchronization services. Diane has extensive experience with Global Data Synchronization standards, has been active on many GDSN teams and has been a speaker at GS1 events.The value she brings to an organization is to provide a complete GDSN solution that enables businesses to integrate GDSN processes with their business processes, allowing streamlined item management.

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