An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.

Data Element
Unique Device Identifier (UDI)
Description
Standardized numeric or alphanumeric code for medical devices that enables adequate identification and traceability of medical devices used in healthcare settings (including inpatient, outpatient, and home health care) or implanted in patients. This code generally consists of the Device Identifier (DI) and one or more Production Identifiers (PI). Examples (optional) UDI Basics | FDA (https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics) Usage notes (optional) Availability of UDI in human readable and machine readable/Automatic Identification and Data Capture (AIDC) technologies (e.g., barcodes, 2D Matrix, RFID, etc.) on device labels and packages facilitates multiple ways to capture UDI information in electronic health record at the point of care. UDI can be scanned and data can be parsed via APIs available on AccessGUDID and OpenFDA, the two GUDID public portals. Applicable standard (if applicable) FDA's Unique Device Identification System final rule (https://www.federalregister.gov/documents/2013/09/24/2013-23059/unique-device-identification-system)
Submitted By: Marti Velezis / FDA/CDRH/Indira Konduri (FDA/CDRH/OPEQ/ORP/DRPIII)
Data Element Information
Rationale for Separate Consideration We propose that the current “Unique Device Identifier – Implantable” be replaced by a broader “Unique Device Identifier” element that incorporates all medical devices subject to the FDA UDI Rule. This will also remove the need to include the data elements proposed in Level 2, Test Kit Unique Identifier, and Level 1, Instrument Unique Identifier from the Laboratory Data Class. Both of these would fall under the “Unique Device Identifier” data element in the Medical Device Class.
Use Case Description(s)
Use Case Description The main use case is for patient safety and the ability to reliably identify medical devices that have been used by patients, used for patient care, or implanted in the patient during a healthcare encounter regardless of the setting.
Availability of the device identifier in the electronic medical record enables the following improvements in healthcare:

Effective reporting and evaluation of adverse events involving medical devices: electronic recording of UDI at the point of care enables providers to specifically identify the device(s) involved in adverse events, to allow for device specific post market surveillance, such as ability to identify potential safety signals and performance issues. Availability of the UDI in the EHR enables unambiguous linkage of a specific device to patient outcomes for longitudinal evaluation and real-world evidence.

Implementation of device-related recalls: specific device information enables healthcare organizations and manufacturers to efficiently and comprehensively identify relevant patients affected by device recalls and take corrective measures as necessary.

Coordination of care: UDI information can ensure that caregivers in distributed care systems have the device-related information they need to make correct decisions about patient care.

Electronic Source Data: With the increasing use of real-world data (which may originate in health information systems – specifically electronic health records, and associated health records and transactions) it is imperative that the data collected about devices is standardized across the healthcare ecosystem so that it may be used for interoperability. Secondarily, it may be used for real-world world evidence for regulatory decision making.

Interoperable device communication and accurate data interpretation: precise device information in the EHR can enable system developers to implement device-specific communications and allow increasingly prevalent software algorithms and AI/ML models to interpret device-dependent data more effectively when the device source of measurement data is specified.

Accurate and efficient inventory management: availability of the UDI in the EHR enables healthcare organizations to efficiently maintain device inventory
Estimate the breadth of applicability of the use case(s) for this data element All medical devices to which the UDI rule applies could be applicable to this use case.
The unique device identifier is intended to be the key identification data for all devices used by patients or providers, or implanted in patients in a healthcare or medical context to include but not limited to: identification of reusable devices when they are causing infection in patients (e.g., endoscopes-associated pathogen transmission); identification of recalled devices in healthcare inventory to limit the use of recalled devices during procedures; identification of medical devices implanted in a patient when components need to be replaced (e.g., pacemaker leads, infusion pumps catheters); identification of diagnostic devices used during a procedure or test; and identification of devices when there may be a software defect or interface issue (e.g., point of care devices – infusion pumps, vital signs monitors, ventilators, imaging devices, etc.).
Link to use case project page https://www.hl7.org/documentcenter/private/standards/HL7_DAM_UDI%20_R1_INFORM_2021OCT.pdf
ONC Priority
  • Mitigate health and health care inequities and disparities
  • Address the needs of underserved communities
  • Address public health interoperability needs of reporting, investigation, and emergency response
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) FDA Unique Device Identification System (UDI System)
https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-rule-guidances-training-and-other-resources#rule
Additional Specifications HL7® Cross-Paradigm Implementation Guide: UDI Pattern, Release 2 (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=487)

HL7 CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes STU Companion Guide Release 4.1 (US Realm) Standard for Trial Use June 2023; UDI Organizer: https://www.hl7.org/ccdasearch/templates/2.16.840.1.113883.10.20.22.4.311.html

HL7® FHIR® US Core Implementation Guide (all) includes the Implantable Device Profile that can be used for all medical devices subject to the UDI Rule (https://www.hl7.org/fhir/us/core/StructureDefinition-us-core-implantable-device.html)

HL7® v3 Structured Product Labeling in the FDA GUDID Implementation Specification Several guidance documents, training, and technical documents (https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-rule-guidances-training-and-other-resources) provide the necessary guidance and technical specifications for using this data element.

NCPDP SCRIPT Standard, Implementation Guide, Version 2023011 (https://standards.ncpdp.org/Access-to-Standards.aspx)
Note - Previous: NCPDP SCRIPT Standard, Implementation Guide, Version 2022011 and NCPDP® SCRIPT Standard, Implementation Guide, Version 2017071
Current Use (Level 2) Captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer
Extent of exchange (Level 2) Between more than two production EHRs or other HIT modules using available interoperability standards
Supporting Artifacts UDI is implemented in Cardiac Catheterization and EP Lab EHR system at Duke and MERCY Hospital
375 CHPs have been certified for the Implant List
737 CHPs have been certified for UDI – Implantable data element (since USCDI v1).
As this is already required for implantable devices the certified EHR or other HIT systems, expanding it to all medical devices subject to the UDI Rule should already be supported.
Additional Cases Studies and demonstration projects are being gathered at the time of this submission to further exemplify use of UDI in the healthcare ecosystem to include capture, access and exchange of UDI across healthcare organizations. (https://dukemed.webex.com/recordingservice/sites/dukemed/recording/6cffd5142c96103bbf7f00505681490b/playback)
https://www.dovepress.com/the-medical-device-unique-device-identifier-as-the-single-source-of-tr-peer-reviewed-fulltext-article-MDER; https://pubmed.ncbi.nlm.nih.gov/27343161/
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) Not applicable. Standardized unique device identifier information is available for use on device labels and packages and in two public portals of the GUDID, AccessGUDID and OpenFDA.
Restrictions on Use (e.g. licensing, user fees) Not applicable. No restrictions. There is no licensing requirement or user fees associated with the UDI.
Privacy and Security Concerns Not applicable.
Estimate of Overall Burden Given that the UDI for implantable devices is already in USCDI, there is limited additional burden for EHR vendors or SDO to broaden the scope to all devices subject to the UDI rule.
As most medical devices will be accounted for in the patient’s record for billing purposes, it should be straight forward as to the value of capturing the UDI at point of care. This requirement has been in place for the past decade. Efficient capture of the device identifier requires barcode scanning capability to minimize impact on normal clinical workflow. Effective implementation of UDI capture requires coordination between the hospital unit management, technical staff, and device inventory and supply chain management (e.g., Transition was estimated by Duke to require capital cost of less than $20,000 and 500 person-hours for their records).
Other Implementation Challenges The identification of a medical device could help to improve the reliability of the data being generated in the healthcare setting and used as real-world data.
ONC Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 2 - Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
Criterion #3
Maturity - Current Exchange		 Level 2 - Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 2 - Use cases apply to most care settings or specialties.

Comment

Submitted by TMJAssociation on

Support for the expansion of UDI to all medical devices

The TMJ Association strongly supports the proposal to replace the current “Unique Device Identifier – Implantable” with a broader “Unique Device Identifier” (UDI) element that encompasses all medical devices subject to the FDA UDI Rule. This change is critical for enhancing patient safety, improving medical device tracking, and ensuring comprehensive healthcare data interoperability.

For individuals with temporomandibular disorders (TMD) and other conditions requiring medical devices, the ability to reliably identify all devices—whether used in patient care, implanted, or otherwise involved in treatment—is essential. The inclusion of UDI data in electronic health records (EHRs) will offer transformative improvements in multiple areas of healthcare, including:

  • Adverse Event Reporting & Post-Market Surveillance: Capturing UDI information at the point of care allows for precise identification of devices linked to adverse events, facilitating robust post-market surveillance and safety monitoring.
  • Device Recalls & Patient Safety: A standardized UDI system enables healthcare organizations and manufacturers to efficiently identify affected patients during recalls and take necessary corrective actions.
  • Care Coordination: Ensuring that all caregivers have access to device-specific data in distributed healthcare settings supports informed decision-making and improves patient outcomes.
  • Real-World Data & Regulatory Decision-Making: Standardizing device data across health systems strengthens real-world evidence collection, supporting regulatory evaluations and future medical device improvements.
  • Interoperable Device Communication & AI Integration: Including precise device information in EHRs enhances the accuracy of software-driven analytics, AI algorithms, and machine learning models that rely on device-specific data.
  • Efficient Inventory Management: A unified UDI system streamlines inventory tracking, helping healthcare facilities optimize supply chain management and reduce inefficiencies.
  • Mitigating Health Disparities & Advancing Health Equity: Standardized UDI data ensures that underserved communities receive equitable care by providing accurate device tracking and safety monitoring across all patient populations.
  • Public Health Interoperability & Emergency Response: Integrating UDI data into public health reporting and investigation systems will enhance emergency preparedness, improve response efforts during health crises, and strengthen national safety measures.

The adoption of a comprehensive UDI data element will close critical gaps in patient safety, healthcare equity, and public health infrastructure. We strongly urge the implementation of this proposal to ensure all medical devices are effectively tracked, monitored, and integrated into patient care.

Submitted by james.tcheng@d… on

Support for “Unique Device Identifier” data element

Thank you for providing the opportunity to provide perspectives regarding the proposal to update the ONC draft USCDI v5 Level 2 data element Unique Device Identifier – Implantable with a broader term Unique Device Identifier. I fully support removing the “implantable” qualifier. This will encourage a holistic approach for identifying and managing all medical supplies, products, and devices that will maximize the benefits of UDI across healthcare.

The implementation of UDI in the Duke University Health System Cardiac Catheterization and Electrophysiology Laboratories (referenced in the application) purposefully chose to include the universe of supplies, products, and devices used during our procedures – not just implantable devices. Numerous products that are NOT implanted (e.g., catheters, guidewires, balloons) are critical to the safe, effective, and efficient performance of cardiac procedures. Documentation of their use is a standard component of the procedure log and operative procedure note. By using the UDI as the single source of truth identifying all supplies, products, and devices (rather than just implantable devices), we created an end-to-end solution, a clinically integrated supply chain. In our environment, UDI is captured (by scanning) at the point of care and shared in real time with multiple information systems, including inventory management, procedure (clinical) documentation, billing and coding, electronic health record, supply chain, and enterprise data warehouse systems. Using the UDI assures 100% accuracy about product usage, prevents the usage of expired or recalled products, optimizes coordination of immediate, short-term, and longitudinal patient care, triggers just-in-time resupply of inventory, and captures product usage data for medical product surveillance and adverse event reporting. Staff burden is reduced (and staff satisfaction increased) by scanning with a return on investment of less than 6 months.  Specific to the EHR implant table, the UDI data stream is parsed to identify items to include in the table.

While the concept of digital product marking is well understood in retail, there remains a large gap between the promise of UDI and the enabling implementation across healthcare enterprises. Replacing the current “Unique Device Identifier – Implantable” with the broader “Unique Device Identifier” reflects the need to exchange product, supply, and device data – not just implantable device usage – among health information systems to optimize patient safety, clinical care, and healthcare operations. 

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