Unique Device Identification: From Compliance to Value

It took five years, but the U.S. FDA has finally issued the proposed Unique Device Identification(UDI) rule that will require manufacturers of medical devices to uniquely identify their products and populate FDA’s global UDI database (GUDID). Orthopaedic manufacturers will be among the first impacted, as early as 2014. 

What is the Purpose of UDI?

Creation of a UDI system was mandated as part of the FDA Amendment Acts (FDAAA) of 2007, but the concept dates back to the 1999 To Err is Human report, which found that as many as 98,000 people die in hospitals each year as a result of preventable medical errors. In an effort to minimize medication errors, the FDA issued the medication barcode rule in 2004 to make it possible for clinicians to scan barcodes to verify that the right drug in the right dose and right route of administration is being given to the right patient at the right time. The rule, which went into effect in 2006, requires certain human drug and biological product labels to contain a linear bar code consisting of the National Drug Code (NDC). At the time, the FDA Center for Devices and Radiological Health (CDRH) wanted to create a similar rule for medical devices, only to find that there was not a comparable standard identifier, like the NDC, for devices. That set the wheels in motion for inclusion of language mandating UDI in the FDAAA.

Orthopaedic device manufacturers will need to comply with UDI by September 24. Learn best practices for implementation and how to maximize your value from the mandated investment at OMTEC 2014. Karen Conway and executives from Medtronic and Johnson & Johnson will share compliance strategies during the UDI Knowledge Center.

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What is UDI? What will you need to do to comply? And by when?

The proposed UDI rule was published in the Federal Register on July 10, 2012, which kicked off a 120-day comment period that ends on November 7, 2012. Also in July, President Obama signed the FDA Safety and Innovation Act (FDASIA); it requires the final UDI rule to be issued within six months after the close of the comment period, which would be May 2013. If the timelines included in the proposed rule stand, manufacturers of Class III devices, which include orthopedic implants, will need to carry the unique identifiers on their labels within 12 months after the final rule is published, or likely May 2014. The next batch of covered products is what FDASIA describes as “devices that are implantable, life-saving, and life-sustaining.” They must bear the unique identifiers within 24 months after issuance of the final rule or May 2014; Class II products follow a year later and non-exempt Class I devices three years later.


What’s a Manufacturer to Do? 

Compliance with the UDI regulation will be a three- part process for manufacturers:

  1. Assigning UDI-compliant codes to covered products, including production data (lot, serial number and expiration date) for many products
  2. Labeling those products with unique identifiers that are both human and machine readable
  3. Publishing specified data on those products to the GUDID

While it seems fairly straightforward, each of these steps includes its own level of complexity. Below is a check list for things for suppliers to consider.

Assigning UDI-Compliant Codes to Products

  • Become a member of one of the authorized issuing agencies, e.g., GS1, HIBCC
    • FDA has indicated that it will accept identifiers that are part of the ISO 15459 series of standards, which includes both the GS1 Global Trade Item Number (GTIN) and the HIBCC Labeler Identification Code (LIC).
  • Determine which products require a code and at which packaging levels, e.g., case, box, each, etc.
    • The UDI rule will require that covered products bear unique identifiers at each unit of measure.
  • Determine which products will require direct part marking (DPM)
    • FDA plans to require DPM for products that remain in use for extended periods of time and are likely to be separated from their labels, such as implantable devices
  • Develop processes and policies for assigning and maintaining the codes, e.g. determine who is responsible, when new codes are required, etc.
  • Determine whether your ERP system(s) can hold the codes and make changes as necessary

Labeling Products with Unique Identifiers

  • Determine if existing labels have the required space for UDI codes in both human and machine readable formats and change artwork as necessary
  • Determine which auto identification and capture (AIDC) carrier you will use
    • Unlike the medication barcode rule, the UDI rule will be technology neutral, allowing use of a variety of carriers, e.g., linear barcodes, 2-dimensional barcodes, RFID, etc.
  • Involve all of the departments that will participate in the label change process, e.g., quality, regulatory, marketing, production, etc.
  • Address critical questions, such as:
    • Is your print technology suitable, e.g., can it handle AIDC, what will be the impact on line speed, etc.?
    • Is the label material and ink suitable for AIDC, e.g., does the combination provide the right amount of contrast, is the paper too translucent, etc.?
    • Can your printing system accept dynamic (production) data?
    • What process will you use to validate that the labels can be accurately scanned?
    • What impact could DPM have on product performance, e.g., could it compromise orthopedic device coatings?

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Populate the GUDID

  • Determine which attributes will be required .
    • Examples include:
      • Manufacturer’s name, address and contact information
      • Global Medical Device Nomenclature (GMDN) preferred code and term
      • Whether the product is labeled as single use, packaged sterile and/or needs to be sterilized before use, if it contains latex (Yes or No)
      • Clinical size and/or special storage conditions (if applicable)
  • Determine where the data resides within your organization, e.g., what department/system and who owns the data.
  • Develop processes and install technology as needed to collect the data internally and submit it to the GUDID.

FDA is conducting User Acceptance Testing (UAT) with suppliers to determine whether it has identified the right attributes and created the right processes for populating the database. A 2009 FDA pilot study found that one of the biggest challenges for manufacturers is aggregating all of the required attributes, which are often housed in multiple and discreet systems.

 

UDI: A Global Perspective

Regulatory agencies around the world are watching what the U.S .FDA does, and many are planning to issue their own regulations in the near future. The European Commission could issue its draft directive, which will also include provisions to track medical products, as early as this fall. (Editor's note: The EC issued its draft directive in September, after press date.)

Recognizing the challenges multiple regulations could pose for global manufacturers, the U.S. FDA has worked closely with its regulatory counterparts as part of the Global Harmonization Task Force (GHTF) to create some consistency in the regulations. Last fall, the GHTF issued a guidance document that includes many of the components that are included in the U.S. proposed rule. As more countries adopt UDI regulations, there will likely be multiple databases with potentially different requirements.

Now that the GHTF has concluded its work, a new organization, the International Medical Device Regulators Forum, has begun working on an implementation plan for UDI. Its members include the founding members of GHTF: Australia, Brazil, Canada, Europe, Japan and the U.S., plus regulatory observers from China and the Russian Federation.


Delivering on its Promise

FDA has also worked hard to craft a regulation that avoids many of the pitfalls of the medication barcode rule, which after six years has not led to widespread barcode scanning of pharmaceuticals at many U.S. hospitals. By helping increase adoption and use of UDIs, FDA hopes the regulation delivers on its promise of improved patient safety, as opposed to just being a regulation that adds costs to healthcare. While the UDI rule only mandates action by manufacturers, how providers use UDIs could impact their bottom line. For example, documentation of unique device identifiers in electronic health records (EHRs) could be required as part of stage 3 of meaningful use, while the National Quality Forum is looking at the role UDI can play in quality measures that The Joint Commission and the Centers for Medicare and Medicaid (CMS) could use for measuring accountability performance and determining reimbursement, respectively.

Using UDIs to standardize how device use is documented and linking that information with EHRs, claims data and product registries are key elements in FDA’s preliminary report on, "Strengthening Our National System for Medical Device Postmarket Surveillance,” published in September. As part of FDA’s Medical Device Epidemiological Network (MDEpiNet) initiative, Weill Cornell Medical College and Kaiser Permanente are working to leverage UDIs to better understand the clinical risks and benefits of orthopedic devices. Kaiser is capturing UDI-like data today and incorporating it into EHRs and its total joints registry. Working with the International Consortium of Orthopedic Registries (ICOR), the goal is to create a large set of globally harmonized data within a network of registries that can help researchers better understand the various attributes of orthopedic devices and their associated impact on performance. ICOR, which FDA helped create in 2010, will contain data on more than 3.5 million orthopedic surgical procures and all of the implantable devices on the market. Some orthopedic manufacturers are already involved, and the principal researchers welcome more, to help ensure that they are establishing the right attributes and capturing data on products correctly.

Linkages between UDIs, EHRs and registries can also play a role in clinical practice, Natalia Wilson, MD, MPH, co-director of the Arizona State University Health Sector Supply Chain Research Consortium, has been conducting research to understand how UDIs can help orthopedic surgeons identify implants in patients prior to revision surgery. Her research will be presented at the annual meeting of the American Association of Hip and Knee Surgeons in early November.


A Strategy, Not a Project

UDI has a wide range of applications and therefore impacts on the healthcare industry. As such, manufacturers should treat UDI as a strategy, not simply an exercise in regulatory compliance, by looking at the benefits as well as requirements. For example, can the use of standard identifiers improve your internal processes, or could adoption of standard identifiers before the required date increase customer satisfaction? Healthcare systems participating in the Healthcare Transformation Group (Mayo, Geisinger, Intermountain Healthcare, Mercy and Kaiser Permanente) and many group purchasing organizations have called on suppliers to use standard identifiers in business transactions by the end of 2012. Increasingly, U.S. hospitals and healthcare providers will be looking for data on which products deliver the best value, in terms of quality and cost, over time and across patient populations. Access to post market data can help manufacturers more effectively market their high performing products. By recognizing the broad value of UDI to your organization, to your customers and to the patients that depend on your products, you can help realize a much greater return on what is a required investment.

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As Executive Director of industry relations for GHX, Karen Conway works with industry associations, standards bodies, government agencies, analyst firms, academic institutions and the media to identify opportunities for hospitals and suppliers to improve business and clinical performance. Conway serves on the board of directors of AHRMM, the supply chain organization for the American Hospital Association; the leadership council of the ASU Health Sector Supply Chain Research Consortium and as co-chair of the HIMSS Supply Chain Special Interest Group. Please reach Ms. Conway at This email address is being protected from spambots. You need JavaScript enabled to view it..

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