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).
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)
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.).
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.
ASTP 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.
The American Clinical Laboratory Association (ACLA) appreciates the opportunity to comment on the applicable vocabulary standard, FDA Unique Device Identification (UDI) System.
We would like to express our support and specific feedback for the overall changes made to the United States Core Data for Interoperability (USCDI) version 6, specifically the establishment of the LOINC lab standard for laboratory orders and broadening the use of the Unique Device Identifier (UDI). ACLA believes improvements to interoperability should focus on the high-quality treatment of patients and we believe that the USCDI will help drive interoperability forward. Efforts ensuring that laboratory orders contain the necessary information for timely and high-quality treatment of a patient is critical to our national interoperability infrastructure.
The change to broaden the use of the UDI data element is needed to ensure that the devices used during patient care can be identified and tracked. ACLA supports improvements to interoperability infrastructure that will increase patient safety. However, there will be some major challenges with ensuring high quality UDI data is broadly available. The first is the limited use of UDI data in most clinical encounters and settings. Providers do not currently factor UDI information into the clinical decision-making process as it is not a critical piece of information for treatment decisions. The required inclusion of non-pertinent information to a test result can slow down the decision process and adds costs to interoperability support and implementations. Furthermore, existing LIS platforms may not broadly support the inclusion of UDI information with a test result. Updating these LIS systems can be expensive and time consuming while having limited impact on patient treatment decisions. ACLA is concerned that the inclusion of UDI in USCDI version 6 will not lead to broad adoption with high-quality data.
This is not currently supported by most laboratories and would have an impact on the technology and operational aspects. We suggest that ASTP work with FDA, CMS/CLIA, public health agencies, laboratories, and instrument manufacturers to establish a practical roadmap.
Recommendation: CMS CCSQ supports the inclusion of the Unique Device Identifier (UDI) element, that is more broadly applicable beyond implantable devices, in the final USCDI v6. In response to ASTP's request for feedback on the optimal approach to distinguishing between implantable and non-implantable devices within this data element, CMS CCSQ recommends USCDI include the ability to distinguish between implantable and non-implantable devices. CMS CCSQ defers on making a recommendation on the appropriate strategy for handling this distinction until a future commenting cycle pending further research.
Rationale: The FDA established the UDI system to adequately identify medical devices sold in the United States. While the FDA has defined compliance policy related to certain implantable, life-supporting or life-sustaining devices, the FDA expects a UDI for most medical devices. Medical devices include both implantable and non-implantable devices that range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems. In line with the FDA’s intent, CMS CCSQ supports the proposal for this UDI element to be more broadly applicable.
As mentioned with the proposed update, UDI is now expanded to include many types of medical devices including high-risk implantables, disposable medical devices, and durable medical devices. There are significant advantages to the ability to readily distinguish whether a medical device is or is not implantable when tracking it using the current UDI system: i. Enhanced Care Coordination: Identifying implantable devices enables healthcare providers, caregivers, and first responders to quickly filter and access critical information specific to these devices. This includes details about compatibility, safety, and long-term performance, which are essential for developing effective treatment plans and ensuring patient safety during care or diagnostic evaluation (e.g. MRI scans need information about implantable devices). ii. Improved Patient Communication: Patients often need clear and accurate information about the medical devices used in their care, particularly those implanted in their bodies. UDIs that distinguish implantable devices ensure caregivers are aware of these devices during patient visits, facilitating informed discussions and personalized care.
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.
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.
The "Optional Background Text / Cover Letter" field provides space for additional context or introductory information related to your comment.
If you wish to provide context, explanation, or an introduction to your comment, enter this information in the field labeled "Optional Background Text / Cover Letter." This is entirely optional and is most useful when submitting multiple related comments or when additional background would help reviewers understand your feedback.
If you are only commenting on a single data class or element, you may leave this field blank.
2. Select the Data Class
To specify which data class your comment addresses:
In the "Data Class" drop-down menu, select the appropriate data class you want to comment on.
If you are providing a general comment that is not specific to a data element, select "General" from the options. Comments with this designation will be displayed on the USCDI landing page.
Note that the Data Class field will automatically populate based on your current location in the platform:
If you are on a data class page, the field will be set to that specific data class
If you are on a data element page, the corresponding data class will be pre-selected
3. Select the Data Element
To specify which data element your comment addresses:
In the "Data Element" drop-down menu, select the specific data element you want to comment on.
The drop-down menu will display only the elements available under the data class you selected in the previous step.
You can use the search function within the drop-down to quickly locate a specific data element.
If you are commenting on the data class itself rather than a specific element, you may leave this field blank.
Note: Comments on a specific data element will appear on the respective data element page, while comments on a data class (without a specific element selected) will appear on the landing page for that data class.
Fig 1 The "Data Class" and "Data Element" dropdown menus allow users to specify the exact content they wish to comment on.
4. Optional: Propose New Data Class or Element
If you cannot find the appropriate data class or element for your comment:
Instead of clicking the "Comment On An Existing Data Class Or Element" button, click the adjacent button labeled "Propose a New Data Class or Data Element."
This will redirect you to the ONDEC (ONC New Data Element and Class) Submission System.
In the ONDEC system, follow the provided instructions to submit your proposal for a new data class or element.
Once your proposal is submitted through ONDEC, it will be reviewed separately from the commenting process.
Fig 2 The "Propose a New Data Class or Data Element" button redirects users to the ONDEC Submission System for proposing new data elements not currently available in the system.
5. Complete the Comment Form
Fill out the required fields in the comment form:
Subject: Enter a brief, descriptive title that summarizes your comment. This helps reviewers quickly understand the nature of your feedback.
Comment: In this field, provide the full details of your comment or feedback. Be as clear and specific as possible about your suggestions, concerns, or observations. Include any relevant details that support your position.
6. Optional: Add Additional Comments
If you need to comment on multiple data classes or elements:
After completing your first comment, click the link labeled "Comment on another data element" at the bottom of the form.
A new comment section will appear, allowing you to enter details for your additional comment.
For each additional comment, you must select the appropriate data class and data element from the drop-down menus.
Complete the Subject and Comment fields for your additional comment.
Repeat this process for each additional comment you wish to submit.
Fig 3 The "Comment on another data element" link enables users to create multiple comments addressing different elements within a single submission.
7. Optional: Upload Supporting Files
The platform allows you to upload supporting documentation to enhance your comment:
Locate the "File Upload" section at the bottom of the comment form.
Click to upload any files (such as PDFs or documents) that provide additional context, evidence, or clarification for your comment.
Important: If you have already entered your comments using the form fields, there is no need to upload duplicate content in PDF format. The file upload feature is intended for supplementary materials only. Please avoid uploading files that contain the same information already provided in your comment text.
Fig 4 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.
8. Optional: Save and Exit
If you need to pause your work and return to complete your comment later:
Click the "Save and Exit" button at the bottom of the form.
Your comment will be saved as a draft that you can access and complete later.
When you return to the platform, you will see a red triangle with an exclamation mark next to the “Return to saved Comment” button, indicating that you have saved comments in draft status.
Click this button to continue working on your draft.
You will be taken to a review page where you can:
Select "Submit Comment" to officially submit your feedback.
Click "Edit" to return to the comment form and make changes
Select "Discard Draft" to delete the saved draft and start fresh
Fig 5 A red triangle with exclamation mark indicator appears next to the “Return to saved Comment” button when draft comments are saved in the system.
9. Review and Submit
Once you have completed your comment:
Click the "Review and Submit" button at the bottom of the form.
This will take you to a review screen displaying your comment(s) in full.
Review all information for accuracy and completeness.
On this review screen, you have three options:
Click "Submit Comment" to officially submit your feedback
Click "Edit" to return to the comment form and make changes
Click "Discard Draft" to delete the comment and start fresh
The review screen also includes a "Print" button that allows you to create a printed copy of your comments for your records.
If you choose to submit, your comment will be recorded in the system and made available for review by the appropriate stakeholders.
Fig 6 The review screen allows users to verify comment content and make any necessary modifications before final submission.
Submitted by jkegerize on
ACLA Comment: Unique Device Identifier for Draft USCDI Version 6
The American Clinical Laboratory Association (ACLA) appreciates the opportunity to comment on the applicable vocabulary standard, FDA Unique Device Identification (UDI) System.
We would like to express our support and specific feedback for the overall changes made to the United States Core Data for Interoperability (USCDI) version 6, specifically the establishment of the LOINC lab standard for laboratory orders and broadening the use of the Unique Device Identifier (UDI). ACLA believes improvements to interoperability should focus on the high-quality treatment of patients and we believe that the USCDI will help drive interoperability forward. Efforts ensuring that laboratory orders contain the necessary information for timely and high-quality treatment of a patient is critical to our national interoperability infrastructure.
The change to broaden the use of the UDI data element is needed to ensure that the devices used during patient care can be identified and tracked. ACLA supports improvements to interoperability infrastructure that will increase patient safety. However, there will be some major challenges with ensuring high quality UDI data is broadly available. The first is the limited use of UDI data in most clinical encounters and settings. Providers do not currently factor UDI information into the clinical decision-making process as it is not a critical piece of information for treatment decisions. The required inclusion of non-pertinent information to a test result can slow down the decision process and adds costs to interoperability support and implementations. Furthermore, existing LIS platforms may not broadly support the inclusion of UDI information with a test result. Updating these LIS systems can be expensive and time consuming while having limited impact on patient treatment decisions. ACLA is concerned that the inclusion of UDI in USCDI version 6 will not lead to broad adoption with high-quality data.
This is not currently supported by most laboratories and would have an impact on the technology and operational aspects. We suggest that ASTP work with FDA, CMS/CLIA, public health agencies, laboratories, and instrument manufacturers to establish a practical roadmap.