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Published 11/1/2013
Elizabeth Fassbender

FDA Issues Final Rule on UDI

On Sept. 20, 2013, the U.S. Food and Drug Administration (FDA) released the much-anticipated final rule on a Unique Device Identifier (UDI) system. The FDA has worked for 10 years to develop the system and database to track medical devices, and the final rule was well-received by patient groups, providers, and industry as an important step to enhance patient safety.

One of the biggest changes in the final rule was the removal of the requirement for all implantable devices to have the UDI marked directly on the device. The original proposal required manufacturers to directly mark a UDI on three device types: those implanted in the body for more than 30 days, those intended to be used more than once, and stand-alone software.

The final rule requires that the UDI be marked directly on devices intended to be used more than once and reprocessed before next use and on stand-alone software. Implantable devices will not be required to have the UDI marked directly on the device.

The final rule also extends the UDI exemption for class 1 individual single-use devices to all individual single-use devices regardless of class, except for any implantable devices, as long as the device package bears a UDI. FDA officials say they are still concerned that UDIs stay linked to each implant after it has been inserted in a patient, but they believe this can be accomplished by having UDIs entered into each patient’s electronic health record (EHR).

Several groups have urged the U.S. Department of Health and Human Services (HHS) to include UDIs in Stage 3 Meaningful Use health information technology incentives. The FDA will be working with the HHS Office of the National Coordinator for Health Integration Technology to help integrate UDIs into EHRs and other databases.

Another contentious issue addressed in the final rule involved changing the date format for product labeling. The FDA had originally proposed an American-centric date format, which device firms had uniformly opposed. The final rule adopts instead the date format that follows the International Organization for Standardization format in which the date is represented as a four digit year, two-digit month, and two-digit day. For example, Oct. 1, 2014, would be represented as 20141001.

Compliance dates have not changed from the proposed rule: UDI on labeling and data entry into the global UDI database will be required within 1 year for all Class III, high-risk devices; within 2 years for Class II/I implantable and life-sustaining or life-supporting devices; within 3 years for the remaining Class II devices; and within 5 years for Class I and nonclassified devices. The FDA may also grant a 1-year extension for Class III devices when it is in the best interest of the public health.

In the final rule, the FDA clarified that the devices already in inventory, and any finished devices that are manufactured and labeled prior to the compliance date that applies to that device, are exempt from the UDI requirement. The exemption expires 3 years after the compliance date that applies to the particular device, which will allow an additional 3 years for inventories of medical devices to be depleted.

The FDA also simplified the requirements for combination products and kits. The final rule exempts the device constituent parts packaged within a combination product or a convenience kit from a UDI if the combination product or convenience kit as a whole bears a UDI.

However, devices that may be reprocessed for use in multiple patients still present a substantial challenge to patient safety. Materials on the FDA website point to barriers to appropriately reprocessing devices to prevent the retention of debris that may lead to infection. Frequently, these problems are related to the difficulty of removing debris from crevices and other textured surfaces. Direct marking of these devices may increase the areas that could potentially retain debris and inhibit reprocessing, and therefore diminish the safety the UDI is intended to enhance.

Elizabeth Fassbender is the communications specialist in the AAOS office of government relations. She can be reached at fassbender@aaos.org

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