Medical device manufacturers have been in the process of rolling out Unique Device Identifiers (UDIs) on their products for the past several years in order to comply with the FDA’s UDI labeling requirements. On September 24 of this year, the UDI rule will reach its fourth milestone, when additional devices will be required to bear a permanent mark or label.
The UDI program was initiated in order to help improve traceability and recalls for medical devices, but there are other benefits as well. With better device tracking, hospitals can improve internal efficiencies, reduce medical errors, and better optimize the use of their devices.
From 2014 to 2016, a variety of device manufacturers were required to either implement UDI labeling or submit device data in order to populate the device database (Global UDI Database, or GUDID), which serves as the central repository for the data.
How UDI Labeling Benefit Healthcare Providers
With those devices now in use in hospitals and other facilities, providers and other healthcare stakeholders can potentially leverage the UDI to enable a number of benefits:
- Reduced Medical Errors: By tying device data to patient identification and other data collection processes, providers can ensure that the right medical device has been issued for the correct patient. In the operating room, the UDI can help automate inventory counts before and after procedures to ensure that the equipment is on hand.
- Enhanced Device Analysis: The UDI can provide a standard way to document device use in electronic health records and clinical information systems. UDI labeling can also help create a more robust post-market tracking system that could be leveraged to support approval or clearance of new devices or new uses of current devices.
- More Accurate Device Reporting: Adverse events can be more accurately reported and linked to specific devices, which can more quickly uncover potential problems.
- Reduced Counterfeiting/Diversion: Medical devices are highly valuable, and the supply chain is rife with fraud. UDI labeling can ensure that the device that arrives is not a counterfeit item and can also help identify stolen devices that are then re-sold in the aftermarket.
- Improved Recalls: Having a standard identifier will also help manufacturers, distributors, and healthcare facilities more effectively manage medical device recalls. Specific devices can be tracked to the point of use, allowing recalls to be more targeted and effective.
UDI Milestones
As the final deadlines loom, even more medical devices will be required to bear a UDI mark or label. The upcoming September 24 deadline will include:
- Class II devices required to be labeled with a UDI must bear a permanent UDI mark on the device itself, if it is to be used more than once.
- Labels and packages of Class I devices and unclassified devices must bear a UDI.
- Dates on labels of all devices (including those exempted from UDI) must be formatted per FDA requirements
- Data for Class I and unclassified devices that fall under the UDI requirements must be submitted to GUDID; Class I standalone software must provide a UDI as well.
The next major milestone for UDI comes in September 2020 when all Class I devices or unclassified devices that fall under the requirements must bear the UDI as a permanent mark if the device will be used more than once.
Barcode labeling software can help ensure your labels are UDI compliant. Seagull Scientific’s BarTender software is already being used by medical device manufacturers. With the right labeling software in place, you can easily automate and manage UDI labeling requirements.
Companies that need assistance implementing UDI labeling requirements, or providers that want to better leverage the use of UDI-marked devices, can contact Imprint Enterprises for help with their labeling and direct marking needs.
