FDA on Monday issued draft guidance to clarify how unique device identifiers (UDIs) used to track medical devices should be formatted, as well as what information UDIs should contain.
UDIs aim to improve the safety of medical devices by:
- Enabling quick and efficient recall of medical devices;
- Improving the accuracy and specificity of adverse event reports;
- Providing a secure, global distribution chain to address counterfeiting and diversion; and
- Offering a clear path for documenting device use in electronic health record (EHR) systems and clinical information systems.
FDA in September 2013 issued a final rule establishing its UDI system. The final rule calls for manufacturers to assign UDIs to medical devices to make it easier to track the devices' expiration dates, lot or batch numbers, and manufacturing dates.
In addition, the final rule called for the creation of a public, searchable dataset administered by FDA, called the Global Unique Device Identification Database, to serve as a reference catalogue for all devices that have a UDI.
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FDA is phasing in the UDI system over seven years. Manufacturers were required to include UDIs on class III medical devices starting in 2014 and on implantable, life-supporting, and life-sustaining devices in 2015. Manufacturers will be required to include UDIs on class II medical devices later this year and on class I and non-classified devices by 2018.
Draft guidance clarifies UDI requirements
The draft guidance proposed that UDIs be formatted on a device's label in two ways:
- In "easily readable plain-text form"; and
- In a form that uses automatic identification and data capture technology, such as a barcode, that can be automatically entered into an individual's EHR or other computer systems.
In addition, the guidance detailed how UDI information should be ordered. For example, it suggested that automated UDIs be formatted in a way that can be recognized by a barcode scanner or similar technology. FDA said the automated version could be divided into multiple segments if space on the device is limited.
Further, the draft guidance stated that plain text UDIs should be located near or below their automated versions. UDIs' plain-text versions could be displayed in a single line of text or divided into multiple lines.
FDA said UDIs should precede any non-UDI information. The agency stated that manufacturers would be able to choose the best way to disclose automated UDIs' locations if the UDIs are not immediately visible.
In addition, FDA in the draft guidance clarified that UDIs only are required to contain information about a devices' unique identifier. The agency wrote, "While some of the FDA-accredited issuing agencies may allow for non-UDI elements, such as quantity, in the UDI carrier, we do not recognize any such additional non-UDI elements as being part of the UDI." It added that the final rule "does not include any additional requirement to place" device production information on the UDI label. FDA wrote, "There are some situations where a UDI may comprise a [device identifier] only."
Still, FDA noted that some UDIs might contain device production information. The agency wrote, "The UDI of a class I device, for instance, is not required to include a [product identifier]," but devices in other classes must include a product identifier if it is included on the product label.
FDA also said UDIs should include any necessary data delimiters to make it easier for users to identify and verify device and product identifiers.
FDA is accepting public comments on the draft guidance for 60 days (Chacko, The Hill, 7/25; American Health Line, 9/23/13 [subscription required]; Brennan, Regulatory Focus, 7/25; FDA draft guidance, 7/25).
Learn more about internet-enabled health care devices
As more and more devices in the world become increasingly electronic, software-enabled, intelligent, wireless, and connected, it is worth exploring how the Internet of Things—the connectivity and interoperability of increasingly smart objects, such as appliances, sensors, controllers, wearables, and medical devices—can be leveraged in health care and health IT.
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