Getting Ready for UDI: What Suppliers and Providers Need to Know (1)
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Karen Conway, Vice President, Healthcare Value
Earlier this week, the U.S. Food and Drug Administration (FDA) at long last issued its proposed Unique Device Identification (UDI) rule, which requires creation of a system that can uniquely identify medical devices through distribution and use. In order to comply with the regulation, manufacturers will need to place unique identifiers on the labels of their devices and provide additional data on those products for a UDI database (UDID). In the second post in this series, we will focus on what suppliers need to know and do to get ready for UDI.
The healthcare industry and other interested parties will have an opportunity to comment on the proposed rule for 120 days, after which the FDA, under language in the recently passed FDA user fee act, will have six months to issue the final regulation. If the timeline in the proposed rule stands, Class III products, which include implantable devices, will need to bear the identifiers within a year after the final rule is published. Class II devices would need to comply two years later, and Class I devices four years later.
UDI compliance will be most challenging for global suppliers who will need to meet the requirements of different and potentially conflicting regulations in the various countries in which they market their products. While the regulation will likely be issued first in the U.S., regulators in many other countries are closely watching what the U.S. FDA does and plan to follow suit. To try to create some uniformity in UDI regulations around the globe, the US FDA and its counterparts in the European Union, Canada, Australia, Japan, and China worked together as part of the Global Harmonization Task Force (GHTF). Last year, the GHTF published a UDI guidance document to serve as a framework for regulators around the world. This is a great place for suppliers to start to better understand what UDI regulations are likely to require. Moving forward, a new organization - the International Medical Device Regulatory Forum (IMDRF) - will focus on building a roadmap for implementation of UDI regulations, likely based on the GHTF framework. The IMDRF includes regulators from Australia, Brazil, Canada, Europe, Japan and the U.S., regulatory observers from China and the Russian Federation, and the World Health Organization.
In the US, compliance for manufacturers will be a three-part process:
- Assigning UDI-compliant codes to covered products
- Labeling those products with unique identifiers that are both human and machine readable
- Publishing specified data on those products to the FDA’s UDID
While it seems fairly straightforward, each of these steps includes its own level of complexity. Below is a check list of some of the things suppliers can and should consider as part of the process.
Assigning UDI Codes to Products
- Become a member of an ISO 15459 standards organization, e.g., GS1 or HIBCC
- The US 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 specific units of measure.
- Develop processes and policies for assigning and maintaining the codes, e.g. determine who is responsible, when is a new code required, etc.
- Determine whether your ERP system can hold the code and make changes as necessary
Label Products
- 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
- The UDI rule will be technology neutral, allowing use of a variety of carriers, e.g., linear barcodes, 2-dimensional barcodes and RFID
- Involve the various 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 the impact be on line speed, etc.?
- Is the label material and ink suitable for AIDC, e.g., the right amount of contrast, not translucent, etc.?
- Can your printing system accept dynamic production data (if required)?
- What process will you use to validate that the labels are compliant and can be accurately read
- Do you have products that will require direct part marking?
- Direct part marketing will be required for products that need to be positively identified after they have been removed from their package.
Populate the UDID
- Determine which attributes will be required
- Remember, as more UDI regulations are issued around the world, there will be multiple UDIDs with different requirements
- Example of attributes include:
- Quantity per package
- 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 (Yes or No)
- Clinical size and/or storage conditions (if applicable)
- Determine where the data resides within your organization, e.g., what department/system and who owns the data
- Determine the formats for the various data, e.g., electronic or paper
- Develop processes and install technology as needed to collect the data internally
The FDA is still finalizing details around the UDID, including whether they have defined the right core attributes and the process by which the UDID will be populated and the data accessed. User Acceptance Testing (UAT) of a beta version of the FDA UDID will begin soon. The first phase will include testing how data is submitted, either via an online web application or Excel files in an HL7 structured product labeling format. The http://www.ahrmm.org/submission process being tested incorporates some of the findings from a 2009 pilot study conducted to identify challenges manufacturers would face gathering the required data elements from multiple systems and maintaining the database. GHX participated in the 2009 pilot and is now working with suppliers and the Global Data Synchronization Network (GDSN) to test how they can use the GHX Health ConneXion® datapool to load data into the UDID via the GDSN. A future UAT phase will be designed to determine how hospitals and other data consumers can download and export authorized information from the UDID. AHRMM, the supply chain organization of the American Hospital Association, will likely participate in that phase.
For suppliers, UDI is an exercise in master data management that requires knowing the objectives, benefits and impacts on their organizations. Often these objectives and the associated benefits extend beyond just regulatory compliance. In a case study, Siemens Healthcare Diagnostics provides a great example of how to prepare for regulatory requirements around product standardization in a manner that also helps improve patient safety, supply chain efficiencies and customer service. With a clear understanding of the various objectives and benefits, companies can determine who needs to be involved, who or what will be impacted, and how and where data should be maintained. Most importantly, as the case study points out, approaching UDI and product standardization as a strategy, and not a project, can yield a much greater return on what will be for many a required investment.
Another critical step to realizing the full potential of UDI is provider adoption. Hospitals and healthcare delivery organizations can use the identifiers for a variety of purposes, ranging from more accurate supply chain processes to better recall and inventory management. The pending UDI regulation will be aimed at device manufacturers, but there are efforts underway that could require providers to capture and use the identifiers. After all, if they don’t use them, much of the intended value of UDI will be lost. In the next blog post in this series, we will look at some of these potential requirements, as well as the value that the UDI can deliver, with or without government mandates, to providers.
In the meantime, if you are a supplier and need assistance with UDI or product standardization, contact Mike Gillespie with GHX Business Solutions at mgillespie@ghx.com.