This blog explains the first 4 steps of UDI system implementation.
UDI implementation will impact nearly every area of your company. Successful implementation will require careful planning and coordination throughout the organization and, in some cases, outside your company. You will need to assign resources to update and maintain your systems and the Global UDI Database (GUDID).
The Commitment to Begin is Step 1
The first implementation step is making the commitment to begin. Unique Device Identification (UDI) systems have been used in healthcare for many years, especially for over-the-counter products (commonly known as “UPCs”). Many companies have already implemented UDI systems, using one or more of the Issuing Agencies protocols. They understood the benefits of moving forward with developing UDI capabilities in advance of any regulatory requirements. Customers also played a role in influencing early adopters of UDI. Customers told companies to employ standardized methods, such as UDI, otherwise they would stop buying their products. The fear of losing a customer is a powerful incentive, but early adopters also understood the additional benefits of being an early adopter of UDI–including:
- Ability to control the pace of implementation without having to be concerned with mandated timelines
- Becoming “easy to do business with”
- Reduction in transaction errors
- Decreased order-to-cash process time
- Help customers ensure patients receive correct products
- Reduce costs associated with product recalls and other business processes
- Increase patient safety and satisfaction
- Reduce waste through better inventory management throughout the supply chain
- Increase revenue through greater product line exposure to customer base
- Increase speed-to-market of new devices
FDA regulation has now mandated UDI implementation for most medical device labelers. Compliance dates are established. If you miss the date(s) relevant to your devices, you no longer can legally sell your medical devices. Why wait? Start the implementation process now.
Now what? The second step…
Since UDI implementation is a significant undertaking for any company, a UDI champion and implementation team should be created with members from all impacted departments before beginning the planning process. It is also important to involve top management, because obtaining management support is critical to a successful implementation.
Step 3: Selecting an Issuing Agency
The next step of the UDI implementation process is to select an Issuing Agency that best meets your needs and the needs of your customers. The FDA accredited three organizations that assign Labeler IDs you can choose from: GS1, Health Industry Business Communications Council (HIBCC) and International Council for Commonality in Blood Banking 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).
If your company is not already partnered with one of the Issuing Agencies, or still needs to select an Issuing Agency, you should survey your key customers to determine if they are implementing UDI systems, or already have UDI systems. You may find customers using all three versions of UDI labeling (GTIN from GS1, HIBC from HIBCC and ISBT-128 from ICCBBA). If you don’t label blood, cell, tissue and organ (HCT/P) devices, then you can rule out ICCBBA. Conversely, if you only sell HCT/P devices, you can rule out GS1 and HIBCC. Ultimately, the selection of an Issuing Agency is your company’s to make–and remember that you are allowed to enter two different Issuing Agencies for each medical device in the GUDID.
Step 4: Unique Device Identification Implementation Planning
Analyzing, strategizing and planning are essential to determining if you will successfully implement UDI and the related GUDID submission. You need to have a full understanding of your devices, labeling/manufacturing locations and packaging requirements. Study the UDI Regulation to comprehend which aspects you will 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 to focus on solving business problems. Standardize procedures as much as possible, and tailor solutions to your company and its needs.
- Group your products by Device Class, Manufacturing Location, Packaging Requirements (sterile, kit, etc.) and any other criteria you need.
- Perform gap analysis between the device information you have and what you need for submission to GUDID.
- Determine if your data management system(s) have the ability to maintain GUDID information, and communicate UDI or DI information as required (sales orders, purchase orders, labeling, etc.).
- Determine what changes need to be made to your existing quality system procedures.
- Will revalidation of electronic records be required in order to comply with 21 CFR Part 11? (Note: Companies or third-parties using HL7 SPL for data submission to GUDID 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 Product Lifecycle Management (PLM), Enterprise Resource Planning (ERP) and supply chain systems, labeling/packaging equipment and procedures. It should define the gateway to GUDID submission, and create plans of action for validation and compliance.
In my next blog post, I will discuss implementation and ongoing maintenance.