UDI Implementation: What are Your Next Steps?

Unique Device Identification (UDI) implementation will impact nearly every area of your company. Successful implementation will take careful planning and coordination throughout the organization and in some cases, outside of your company.

The UDI regulation is a maze. It is said that it is often easier to start at the end when trying to solve a maze. This same philosophy should be used to implement UDI in your company. Start your implementation process with the outcome in mind. Implementation is more than simply meeting a timeline. It should be viewed as a way to improve your business and the processes you use every day. It should help you standardize these processes, especially as they relate to data gathering, label design and communication with your trading partners. Implementation will ultimately yield useful marketing information, which is one of the greatest values of a UDI system.

The First Step
The first step is to make the decision to begin. FDA regulation has now mandated UDI implementation for most medical device labelers. Compliance dates have been established, with class III devices the first required to comply starting September 24. Future dates include compliance of class II devices in 2016 and class I devices in 2018. (See Exhibit 1.) Miss the date or dates relevant to your devices, and you no longer can legally sell your medical devices.

Exhibit 1: UDI Timelines

Manufacturers adhering to later deadlines shouldn’t wait to implement UDI. UDI systems have been used in healthcare for many years. Early adopters understood the benefits of developing UDI capabilities in advance of any regulatory requirements. These companies’ customers also played a role in their early implementation of UDI. Customers were telling them to employ standardized methods, such as UDI; otherwise they would discontinue buying their products. This is a very powerful incentive. These companies also understood the many benefits of being early UDI adopters, which include:

• Ability to control pace of implementation without concern with mandated timelines
• Becoming “easy to do business with”
• Reduction in transaction errors
• Decreased order-to-cash process time
• Ability to help customers ensure that patients receive right products
• Reduction in product recall costs and other business processes
• Increased patient safety and satisfaction
• Improved inventory management throughout the supply chain—reduced waste
• Increased revenue through increased product line exposure to customer base
• Increased speed-to-market of new devices

Now what? The next step…
Since this is a significant undertaking for any company, a UDI champion and implementation team should be created with members from key impacted departments before the planning process begins. It is also important to involve top management; obtaining their support is critical to having a successful implementation. Department managers from key departments—IT, regulatory, manufacturing/packaging, purchasing/supply chain and sales/marketing—should be involved in the initial planning for UDI Implementation.

The planning begins…
One of the first steps in the implementation process is selection of the issuing agency that best meets yours and your customers’ needs. FDA has accredited three organizations that assign labeler IDs: GS1, Health Industry Business Communication Council (HIBCC) and International Council for Commonality in Blood Bank Automation (ICCBBA). GS1 and HIBCC assign labeler IDs to “labelers” of medical devices, while ICCBBA is for medical devices of human origin (blood, cell, tissue and organ products), also known as HCT/P. GS1 assigns Global Location Numbers (GLN); HIBCC uses Health Industry Numbers (HIN) and ICCBBA issues Facility Identification Numbers (FIN).

Companies that have yet to partner with one of the issuing agencies should survey their key customers to see if they have or are implementing UDI systems. You may find that customers have implemented all three versions of UDI (GTIN from GS1, HIBC from HIBCC and ISBT-128 from ICCBBA). If you don’t label HCT/P devices, then you can rule this system out. Conversely, if you only sell HCT/P devices, you can rule out GS1 and HIBCC. Ultimately, the decision is your company’s to make—and remember, you are allowed to enter two device identifiers (DIs) for each medical device in to GUDID.

Analyze, Strategize and Prepare Your Plan
Analyzing, strategizing and planning are essential to a successful UDI implementation and the related GUDID submission. A full understanding of your devices, labeling/manufacturing locations and packaging requirements is needed. Study the UDI Regulation to comprehend which aspects you need to comply with as you develop your plan. Specifically, these undertakings should be completed as part of the planning process:

• Start with the end in mind. Understand the UDI Maze. What outcomes do you want?
• Create a Playbook: focus on solving business problems, seek to standardize as much as possible, tailor your solutions to your organization and its needs.
• Group your products by device class, manufacturing location, packaging requirements (sterile, kit, etc.) and any other criteria as needed.
• Perform gap analysis to determine needed data and equipment (labeling, computer systems, etc.).
• Determine if your data management system(s) have the ability to maintain the GUDID information (See Exhibit 2.) and can communicate UDI or DI information as required (sales orders, purchase orders, labeling, etc.)
• Identify changes that need to be made to your existing Quality System standard operating procedures.
• Decide changes to 21 CFR Part 11—will electronic records revalidation be required? (Note: companies or third-parties using HL7 SPL for data submission to GUDID and labeling software will need to validate the software used for this purpose.)
• Determine early on what additional resources are needed (FTE or consultants).

This information gathering should be used to create your strategic plan and budget. The plan should include timelines, assignments and identify strategic partners (outside vendors and customers). The plan should address changes required in your PLM/ERP and supply chain systems, labeling and packaging equipment and procedures. It should define the gateway to GUDID submission, and create validation and compliance plans of action.

Create an Implementation Playbook
Creating a playbook or strategic plan is an absolutely necessary step. Without one, your hope of ever successfully implementing UDI requirements will be severely reduced. Your playbook should focus on solving real business problems within your organization. Problems such as, how will you collect missing data? Creating “label brand” through standardization? Are you able to develop a cross-functional team for implementation and beyond? Can you streamline your labeling and packing functions? What other processes can be improved? The playbook you develop needs to be tailored to solving your organization’s specific issues.

Now the specifics
Implementing your strategic plan requires coordination of UDI-related activities from all impacted areas identified in your plan. In addition to having an overall UDI champion, each area should have an identified person responsible for making sure the tasks assigned to their area are completed. The major components of each plan should include:

• Acquire missing data attributes and create a data management process
  • Develop protocol for obtaining missing attributes
  • Determine who is responsible for amassing the information
  • Determine who is responsible for managing the collected information
    • Enter information, e.g. in an Excel spreadsheet
  • Establish validation process
  • Determine who is responsible for validating the information
    • Review source documents against gathered information
• Amend label/packaging composition and components; order by device compliance date
  • Develop label template for entire organization
  • Develop label sign-off process to include all impacted areas
  • Ask: Will AIDC technology work for you? Should it be concatenated, stacked, 2-D matrix? What are the technology capabilities of your trading partners?
  • Decide what packaging changes are required to accommodate new labels?
  • Determine the global considerations for label changes. Do other regulatory agencies need to approve label changes? Will amended or new device submissions be required?
• Compose, create, administer and validate software system changes and integrations
  • Does 21 CFR Part 11 apply to these changes?
• Acquire new or upgrade existing labeling and packaging equipment and validate
• Rehearse connectivity with GUDID and validate all systems are functioning correctly
  • Does 21 CFR Part 11 apply?
• If required, plan for direct marking requirements
  • Obtain etching equipment appropriate for your devices
• Create/revise Quality System SOPs as needed and conduct process validation
• Determine if, as part of your strategic plan, your company should invest in building inventory levels—using the 3-year extension period for inventory labeled prior to compliance date—to create a buffer in case implementation is delayed.
• Develop training programs to train staff on new responsibilities to maintaining UDI system

Whether the outcome of your implementation is successful or not, is directly tied to how well your team plans and executes. Validation of the changes becomes a significant aspect of the implementation process and cannot be taken lightly. Remember the old adage “Garbage in, Garbage out”? In this case, there are serious ramifications for “Garbage in.”

UDI: The forever project
UDI is not a one-and-done project. The entire system will need continual maintenance. Computer systems will need constant updating as changes to devices or new ones are developed. You will need to appoint someone with clear responsibility for maintaining your information in GUDID. Postmarket surveillance activities also feed into the post implementation process as device changes are made as a result of tracking and reporting activities. And you will find that you will continually need to train your staff on UDI requirements, especially with staff turnover.

The true value is not in the barcode, it is the DATA that will be generated as a result of using barcodes. And finally, identify the appropriate value proposition for your organization and remember that in healthcare, there is no single answer for all situations.

Jonathan Bretz, President of RSQM Associates LLC, has worked in the medical device field—private and provider sectors—for nearly 40 years. He held various senior executive positions in marketing/sales, operations, and then coordinating, managing and staffing a regulatory department. Mr. Bretz has been responsible for regulatory submission to FDA, EU and Health Canada and managing Quality systems. He earned his Executive MBA from Anna Maria College and a BS in Occupational Therapy from Tufts-University. He can be reached at jbretz@rsqmassociates.com.

RSQM Associates LLC
http://rsqmassociates.com/

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