Regulatory Focus™ > News Articles > UDIs for Implantable Devices Now Included in Common Clinical Data Set

UDIs for Implantable Devices Now Included in Common Clinical Data Set

Posted 13 October 2015 | By Zachary Brennan 

UDIs for Implantable Devices Now Included in Common Clinical Data Set

For the first time ever, unique device identifiers (UDIs) will have to be included as part of a set of common clinical data intended to help physicians better track patients' implanted devices.


Back in 2013, a final rule from the US Food and Drug Administration (FDA) mandated that most devices marketed in the US will eventually be required to be marked with a UDI to distinguish devices from one another and make them easier to track, particularly for adverse events.

Composed of two parts, a UDI includes a device identifier that corresponds with the type of device and its manufacturer, and a production identifier that states its lot, batch, serial number, expiration date, date of manufacture and other relevant information. FDA says the UDI system will be phased in over several years.


Last week, the Office of the National Coordinator for Health IT (ONC) jumped on board the push to increase the utility of UDIs by publishing a final rule for the 2015 Edition Health IT Certification Criteria, which is intended to help the flow of secure electronic health information and improve transparency and competition in the health IT marketplace.

In that rule, ONC says that it has revised the definition of the Common Clinical Data Set (CCDS) "to support patient safety and improve care" through clearly referenced data elements and the inclusion of new patient data, such as through UDIs.  Previously, the CCDS was known as the Common Meaningful Use Data Set, which, like the CCDS, facilitates the reporting of all summary of care records, care transitions, discharges and patient access information for more advanced clinical processes.

"The inclusion of the UDI in the CCDS reflects the understanding that UDIs are an important part of patient information that should be exchanged and available to health providers of patients with implanted medical devices," ONC says in the final rule. "The documentation of UDIs in a patient medical record and the inclusion of that data field within the CCDS requirements for the summary of care documents is a key step toward improving the quality of care and ensuring patient safety."

Further, to facilitate the exchange of UDIs and increase their availability and reliability in certified health IT, ONC proposed including the 2015 Edition implantable device list certification criterion in the 2015 Edition Base electronic health record (EHR) definition and including a patient’s UDI as data within the CCDS definition for certification to the 2015 Edition.

"Health IT certified to the proposed criterion would be able to 'parse' a UDI into its constituent components (or 'identifiers') and make those accessible to the user," ONC adds.

Separately, ONC says that health IT moving forward would be able to retrieve and provide a user with access to, if available, the optional "Device Description" associated with a UDI in FDA’s Global Unique Device Identification Database (GUDID).


Helene Clayton-Jeter, OD, of the Office of Health and Constituent Affairs at FDA, wrote in the FDA Diabetes Monitor: "These regulations are expected to go into effect during the spring of 2016 and will create a new source of information to improve patient and clinician decision-making because it will give providers access to information about their patients’ implantable devices."

And although full implementation of FDA's UDI system isn't expected until 2020, the inclusion of UDIs for implantable devices "are pivotal to developing the infrastructure needed to incorporate standard, structured device information into health IT," Clayton-Jeter wrote.

ONC Final Rule


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.