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 Where paper-based methods and outdated labeling systems are being used—still commonplace in many medical device manufacturing organizations—it will be a struggle to manage the increased amount of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.