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.