The United States Food and Drug Administration has developed legislation for Unique Device Identification (UDI) in order to make patient safety a priority in the medical field by more accurately tracking medical devices. UDI, which will also help improve healthcare business processes, must be efficiently implemented worldwide in order to be completely effective.

Medical device manufacturers are already utilizing UDIs on some classes of equipment. As of September 2014, Class III medical devices and devices licensed under the Public Health Service Act (PHS) were required to bear a UDI. Over the next five years, UDI will be expanded to other classes of medical devices, and it is vital that professionals in the healthcare industry are educated and prepared for the coming medical device management regulations.

What is UDI?

The FDA UDI rule requires that most medical devices distributed in the U.S. carry a unique device identifier. By doing so, the FDA hopes to identify product problems faster and perform more thorough recalls. Once fully implemented, this system will greatly improve the ability to track medical devices.

The UDI includes a device identifier (DI) that identifies the labeler and the specific version or model of a device, and a production identifier (PI) that identifies lot/batch numbers, serial numbers, expiration dates, date of manufacture, and other information. The codes are applied to the devices via labels or direct marking, and a Global Unique Device Identification Database (GUDID) will be used to manage the information. The UDI data is presented in both human-readable form and using automatic identification methods such as barcoding.

What is the FDA's UDI Implementation Schedule?

Implementation is already well under way. Class III devices (unless granted an extension) had to be labeled by Sept. 24, 2014. Over the next several years, the number of devices requiring a UDI will expand.

As of Sept. 24, 2015, the labels and packages of implantable, life-supporting and life-sustaining devices also must bear a UDI. In September 2016, Class III devices must bear a UDI as a permanent mark on the device itself (if the device will be used more than once and reprocessed). Labels and packages for Class II devices also must bear a UDI. The permanent direct marking requirement extends to Class II devices in 2018; also in 2018, the label/packaging requirements will be extended to Class I medical devices and devices that have not been otherwise classified. Class I devices must bear a permanent mark after September 2020. You can see a complete list of compliance dates here.

What are the Benefits of UDI?

While UDI was principally targeted at improving medical device safety and making it easier to manage recalls, there are other benefits as well.

Improved Inventory Management: Precise equipment identification will not only help enable more efficient and targeted recalls, but will also provide granular data that can help improve supply chain and distribution operations. Medical devices will also be more secure with a unique identifier, because it will be more difficult for counterfeit items to enter the global distribution chain.
Improved Device Performance: A more robust post-market safety surveillance mechanism can support better pre-market clearance and approval for devices. By having device-level performance data, manufacturers can more quickly remedy defects and incorporate those improvements into future devices.

Better Patient Treatment: Reliable and consistent medical device identification will make it easier for the FDA to track equipment safety and for manufacturers to quickly identify potential defects or other problems. All of this will improve patient care and can potentially reduce medical errors by ensuring patients receive treatment using the correct devices and implants.

By integrating the UDI with the patient electronic health records and insurance claims, hospitals and insurers can better monitor device performance and reduce costs.

Although medical device manufacturers are the stakeholders most directly affected by UDI requirements, hospitals, physicians, distributors, insurers, and even patients stand to gain by leveraging the improved product information that UDI can provide. That's why it is critical that professionals throughout the healthcare industry are prepared for this new approach to medical device management.