Medical device manufacturers should welcome the proposed ruling for Unique Device Identification (UDI); however, being compliant by the effective date (based on classification) for some organizations may be a concern.
UDI aims to identify errors involving medical devices and provide more rapid resolution of device problems. The standardization of a common UDI mandate will increase visibility and improve the quality of information in medical device adverse event reports, improve traceability and security within the supply chain, and reduce potential medical errors through consistent, unambiguous, harmonized data. Furthermore, UDI will facilitate the storage, exchange, and integration of data and systems between suppliers and providers.
While all of this is good for anyone who may need to use a medical device to improve health outcomes, on the “manufacturing and labeling side,” this can be a daunting task.
Organizations should already be seeking best practices in managing labeling lifecycle processes. Where paper-based methods and outdated labeling systems are being used—still commonplace in many medical device manufacturing organizations—it will be a struggle to manage the increased amount of data and information that will be generated. Organizations should be carefully planning their future labeling operations strategy now and consider implementing a validated, secure label lifecycle management solution. These systems will manage the design, approval, print, inspection, re-print, reconciliation, and audit log of these labels, making it much simpler to become UDI compliant.
To properly identify products in accordance to the upcoming regulation, UDI is also going to be dependent upon the integrity of the specific data used, as well as the management, version control, and integration of that data. Information required is in two parts: first, the device identifier specific to version or model, the labeler of that device, and product description; and second, the production identifier comprising of lot/batch manufactured, serial number, expiration date, and date of manufacture in a specified format.
UDI will require that the information on the label be displayed in both plain-text format and a code format—such as a liner bar code, 2D bar code, or RFID tag—that can be read by AIDC (automatic identification and data capture) technology. Although not yet resolved, these will more than likely be a GS1 code format. This information will need to then be “fed up” to the UDI database from the ERP system and the labeling management system.
Because UDI only succeeds if the integrity of the label data is assured to be correct, protected, and ultimately published to the Global UDI Database, it is recommended that these data elements are to be managed by those persons who have the permission and credentials to enter, approve, and version control these label data elements in a secure database.
So for the device identifier, again, this is the data that identifies the specific version or model of a device and the labeler of that device; it is recommended to manage these data elements in a secure, closed, validated labeling solution that offers a mechanism to enter, review, approve, and systematically version control each data element.
In the industry, it is common knowledge that labels and label data live in a state of change for multiple reasons, and it’s how we manage these changes that impacts our ability to achieve success. Further, it is also how we manage these changes that will impact the ability to ensure UDI compliance.
Likewise, for the production identifier, the lot or batch number should be generated and controlled in an ERP system, and preferably data-driven at print time, as the integrity of these elements is critical to the ability to uniquely identify each product in the marketplace for proper traceability and post market surveillance.
Other production identifiers, such as serial numbers, the date of manufacture, and the expiry date, should be generated and controlled either in an ERP system or a secure labeling lifecycle management solution and converted into a barcode format at the time of print.
When the labeling lifecycle is properly managed, resulting in a UDI for each and every applicable medical device product, there will be a number of significant and enormously valuable benefits for the healthcare provider and the patient.
For the device manufacturer, benefits will include improved supply chain management, including:
- Enhanced device traceability, improving post-market surveillance with the ability to rapidly and definitively identify a device and key attributes that affect its safe and effective use
- Elimination of unnecessary and costly product scrapping where devices that are not implicated by the problem would be less likely to be “swept up” in an over-broad attempt to remove potentially hazardous devices
- Better security of devices through more effective detection and removal of counterfeit devices
For the healthcare provider and patient, benefits will include:
- Helping to ensure that the intended device will be used in the treatment of a patient, rather than a similar device that may not fully meet the requirements of the healthcare professional who ordered its usage
- Reducing medical errors that result from misidentification of a device or confusion concerning its appropriate use
The real questions for medical device manufacturers are, based on your current system capabilities:
- Are you able to properly control the elements and execution of your print jobs and then capture the data elements of every label printed?
- Will you be positioned to efficiently capture and submit the necessary UDI data to the Global UDI Database?
If you can’t give a definitive yes, then you need to think about how you will manage this in the future. By planning and implementing a label lifecycle management strategy with the right processes and right solution, you will guarantee UDI readiness for your organization without derailing your production.