In the last blog, I started the discussion on UDI implementation and how it will impact nearly every area of your company. Successful implementation will take careful planning and coordination throughout the organization, and in some cases, outside your company. As with every other FDA regulation, you will need to have resources available to maintain and update your systems; plus you will need resources to update and maintain the Global UDI Database (GUDID).
What Comes Next?
The UDI regulation is a maze. In trying to solve a maze, it is often easier to start at the end. This same philosophy should be used to implement UDI in your company. Start your implementation process with the outcome in mind. It is more than simply meeting a timeline. UDI implementation should be viewed as a way to improve your business with the processes you use every day. It should help you standardize your daily processes, especially as it relates to data gathering, label design and communication with your trading partners. This process will yield useful marketing information, which is one of the greatest values resulting from implementing a UDI system.
Create an Implementation Playbook
Creating a playbook or strategic plan is a 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? Create “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 the strategic plan for your organization requires coordination of UDI-related activities from all impacted areas identified in your plan. In addition to having an overall UDI leader, each area should have an identified person responsible for ensuring the tasks assigned to their area are completed. The major steps of each plan should include:
1. Acquire missing data attributes and create a data management process
o Develop a protocol for obtaining missing attributes
o Determine who is responsible for compiling the information
o Determine who is responsible for managing the collected information
- Enter into Excel spreadsheet
o Establish verification and validation process
o Determine who is responsible for validating the information
- Review source documents against gathered information
2. Amend label/packaging composition and components; order by device compliance date
o Develop label template for entire organization
o Develop label sign-off process to include all impacted areas
o ADIC Technology will work for you? Concatenated, Stacked, 2-D Matrix? What are the technology capabilities of your trading partners.
o What packaging changes are required to accommodate new labels?
o Determine what the global considerations for label changes are. Do other regulatory agencies need to approve label changes? Will amended or new device submissions be required?
3. Compose, create, administer and verify/validate software system changes and integrations
o Does 21 CFR Part 11 apply to these changes?
4. Acquire new or upgrade existing labeling and packaging equipment and verify/validate
o Does 21 CFR Part 11 apply?
5. Rehearse connectivity with GUDID and verify all systems are functioning correctly
o Does 21 CFR Part 11 apply?
6. If required, plan for Direct Marking requirements
o Obtain etching equipment appropriate for your devices
7. Create/revise Quality System SOPs as needed and conduct process validation
8. Determine if, as part of your strategic plan, your company should invest in building inventory levels – using the three (3)-year extension period for inventory labeled prior to compliance date – to create a buffer in case implementation is delayed.
9. Develop training programs to train staff on new responsibilities in maintaining the UDI system. Whether the outcome of your implementation is successful or not, it 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.” But 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 in healthcare there is no single answer for all situations.