News Feature | October 15, 2015

Federal Ruling Requires UDI Inclusion Into EHR/EMR

By Jof Enriquez,
Follow me on Twitter @jofenriq


The Office of the National Coordinator for Health IT (ONC) of the U.S. Department of Health & Human Services (HHS) issued recently a final rule that requires the integration of unique device identifiers (UDIs) into electronic health records (EHR) so that care providers can better track the safety and performance of devices used by their patients, regardless of the point of care.

In the 2015 Edition Health IT Certification Criteria, ONC said incorporating UDIs in the Common Clinical Data Set (CCDS) – a standardized set of data codes and elements generated from care records – will promote patient safety and healthcare quality.

"Crucially, recording and exchanging UDIs in patients' electronic health records would enable this information to travel with patients as they move among providers and throughout the health care system. With access to this information at the point of care, clinicians can accurately identify a patient's implantable devices and prevent adverse events resulting from misidentification or non-identification of the device and its associated safety characteristics (such as MRI compatibility and latex content)," states the notice published in the Federal Register.

Even if subsequent care providers were not the ones who performed surgical implantation, or are unfamiliar with the implanted device, they can still diagnose, coordinate follow-up care, and prevent potential device-related problems, just by pulling up the UDI information in the patient's EHR, via the FDA AccessGUDID (Global Unique Device Identification Database).

FDA started implementing GUDID early in 2015 and initially required UDIs for all implantable devices by September 2015. However, the program will be done in phases and full implementation is not expected until 2020. Given the timeframe, ONC believes now is the perfect time for health IT engineers to enable UDI exchange functionality of their EHR/EMR systems.

According to RAPS, 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."

For UDI integration with EHRs to be successful, the ruling says health IT modules need technically to be able to "record, change, and access a list of unique device identifiers (UDIs) corresponding to a patient's implantable devices (‘implantable device list’), parse certain data from a UDI, retrieve the ‘Device Description’ attribute associated with a UDI in the Global Unique Device Identification Database (GUDID), and make accessible to a user both the parsed and retrieved data."

Concurrent with the ONC ruling, the Centers for Medicare and Medicaid Services (CMS) likewise published a final rule detailing the requirements that eligible providers and hospitals must meet to qualify for Stage 3 Electronic Health Record (EHR) incentive payments for meaningful use (MU). Some of the incentives are linked to UDI integration and are meant to motivate providers in adopting UDIs with their EHR systems.

"Incorporation of UDIs into electronic health information is a critical cornerstone of the FDA’s plan to strengthen our National Medical Device Postmarket Surveillance system. Although full implementation of the unique device identification system will take several years, the inclusion of UDIs for implantable devices as part of EHR certification criteria and the CCDS are pivotal to developing the infrastructure needed to incorporate standard, structured device information into Health IT," reads a statement from the FDA UDI team.