Medical Devices

ACLA Comment for USCDI v6: Unique Device Identifier (UDI)

The American Clinical Laboratory Association (ACLA) appreciates the opportunity to comment on the applicable vocabulary standard, FDA Unique Device Identification (UDI) System.

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 7 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.

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.

CMS-CCSQ Supports UDIs inclusion in USCDI v6

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.

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.

STS Comments on USCDI v6 UDI

Please see the following comments from The Society of Thoracic Surgeons in regard to the USCDI v6 Unique Device Identifier data element: https://drive.google.com/file/d/1My_4009NMZq2ULmZKXSkA_7sxvzqWJZm/view?usp=sharing 

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.