Building UDI into Longitudinal Data for Medical Device Evaluation
(The BUILD Initiative)
|Joseph Drozda, MD
||Brent Muhlestein, MD
|James Tcheng, MD
||Natalia Wilson, MD, MPH
|Jove Graham, PhD
||David Slotwiner, MD
The BUILD Initiative encompasses efforts to demonstrate, implement, and apply unique device identification (UDI) in health care. The initiative focuses on implantable devices, leveraging UDI to connect data sources, to access the global unique device identification database (GUDID), to move information on devices to clinicians for patient care, to allow researchers to assess device effectiveness and safety, and to support device innovation across the device product life cycle. BUILD is foundational work that advances UDI implementation in US health care and supports creation of the National Evaluation System for Health Technology (NEST).
BUILD has three complementary components:
- In Extension of the UDI Implementation Pilot the Mercy Health coronary stent UDI demonstration project will be extended to production status at two additional health systems, Geisinger and Intermountain Healthcare.
- In Medical Device Data Capture and Exchange: Leading Practices and Future Directions key informant interviews will be performed in hospital systems implementing UDI for implantable devices to rigorously assess leading practices and gaps; a multi-stakeholder consortium of hospital system and manufacturer leaders in UDI will be formed (BUILD Consortium) to facilitate coordination and collaboration of efforts for implementation and effective use of UDI; BUILD UDI webpages will be created and maintained for education and information sharing.
- In Electrophysiology structured reporting Providing UDI for Leads and devices using industry Standards to Electronic Health Records and CVIS systems (ePulse) the use and utility of UDI across multiple dimensions of health care (including patient engagement) will be demonstrated for cardiac implantable electronic devices (CIED) such as pacemakers, cardioverter defibrillators, and CIED leads.
- Extension of UDI Demonstration Pilot Distributed Data Network partners
- Mercy, Geisinger, Intermountain
- American College of Cardiology/National Cardiovascular Data Registry
- Industry: Abbott, Boston Scientific, Medtronic
- ePulse partners
- Weill Cornell/New York Presbyterian
- Industry: Biotronik, Boston Scientific, Medtronic, St. Jude, Sorin
What is UDI?
What is Unique Device Identification (UDI)?
- UDI is a unique identifier for a medical device that is required on the device label and packaging in both human and machine readable forms. This is also required on the actual medical device for devices that are intended for more than one use and intended to be reprocessed before each use.
- A unique device identification system was mandated by the U.S. Food and Drug Administration (FDA) in September 2013 (UDI Rule). Manufacturers are required to assign unique identifiers to their marketed devices and submit required device attributes to the FDA’s Global Unique Device Identification Database (GUDID)
- Examples of UDI
Timeline for Manufacturers
Detailed information on UDI is available through U.S. Food and Drug Administration: Unique Device Identification (UDI).
What is GUDID?
What is the Global Unique Device Identification Database (GUDID)?
- A database created by the U.S. FDA and administered by the National Library of Medicine that will serve as a reference catalog for every device with a UDI
- Information is publicly accessible through AccessGUDID
- Hospitals, clinicians, patients, researchers, and all interested parties can download information on specific medical devices
Detailed information on GUDID is available through U.S. Food and Drug Administration: Global UDI Database GUDID
Access is available through AccessGUDID
Benefits of UDI System
Benefits of UDI System
A realized UDI system has significant benefit for U.S. health care in clinical care, medical device evaluation, research, regulatory oversight, and health care operations. UDI capture and use is in step with our advancement as a nation towards electronic health records and health information exchange. It supports Triple Aim goals as well as quality of care, patient safety, and innovation.
Electronic capture and documentation of UDI is poised to serve as the standard system for device documentation and expected to dramatically change the landscape of medical device identification and postmarket evaluation.
When a device is used in a patient, UDI capture and documentation in the EHR electronically links that device in a standard way to the patient. This provides capabilities to support quality of care and safety for that patient immediately after their procedure and in the long term.
- Standardized documentation of devices in clinical care documentation
- Ease of device identification as needed in the course of care of a patient
- Single reference source of information for determining MRI compatibility and other parameters
- Facilitation of device recalls
- Facilitation of reporting of device-related adverse events
- Ease of identification of a failed device prior to a revision surgery or procedure so appropriate replacement devices and tools are available at the point of clinical care
- Easier aggregation of device data for evaluation and research to inform clinical decision making
- Standardized device documentation for FDA, clinical registries, and data networks to facilitate device surveillance, evaluation, research, and the National Evaluation System for Health Technology (NEST)
Medical Device Evaluation & Research
UDI is the key to connect data sources to provide better evidence on medical devices. Electronic health records, supplemental device data sets, claims, and other health IT systems contain valuable data that can be used to assess device safety and performance, effectiveness, comparative effectiveness, and differences in patient sub-populations.
- Strengthen post market surveillance for medical devices in the U.S.
- Provide a standard for device registries, coordinated registry networks (CRNs), NEST, FDA Sentinel System, and extended medical device data sets and sources
- Provide a standard for adverse event reporting, safety alerts, and recall reporting
- Support enhanced medical device research
More information on the Benefits of UDI is available through
- U.S. Food and Drug Administration Benefits
- National Evaluation System for Health Technology (NEST)
- U.S. Food and Drug Administration (FDA)
- UDI, GUDID
- Medical Device Epidemiology Network (MDEpiNet): A public- private partnership focused on innovative data source development and analytic methodologies to enhance regulatory science applied to medical device research and surveillance.
- National Medical Device Evaluation System (NEST): A proposed coordinated network of voluntary partnerships that include patient communities, government agencies, device manufacturers, institutional data partners, and methods partners, all working together to generate higher quality post-market device data and evidence at lower costs to inform and improve patient care.
- Office of National Coordinator for Health IT (ONC)
- 2015 edition ONC Health IT Certification Program: Standards and Certification Regulations
- This includes an Implantable Device List with UDI
- Interoperability Proving Ground
- Open community platform to share and learn about ongoing interoperability projects
- 2015 edition ONC Health IT Certification Program: Standards and Certification Regulations
- Centers for Medicare & Medicaid Services (CMS)
- Learning UDI Community (LUC): A multi-stakeholder group with the goal of creating a repeatable and generalizable framework for coordinating with expert workgroups to produce tools, resources, best practices, and implementation guidelines for community-identified UDI adoption issues. The Learning UDI Community is led by the Association of Healthcare Resource and Materials Management (AHRMM)
- LUC Work Groups
Peer-reviewed Journal Articles
Shuren J, Califf RM. Need for a National Evaluation System for Health Technology. JAMA. 2016; 316(11): 1153-1154. doi:10.1001/jama.2016.8708.
This viewpoint authored by Dr. Jeffery Shuren and Dr. Robert Califf of the U.S. FDA discusses dilemmas within the current regulatory framework for medical devices and the important role and value of the National Evaluation System for Health Technology (NEST). Highlighted is the importance of harnessing new technologies and methods – inclusive of UDI use, building on current efforts, and multi-stakeholder collaboration in NEST. The authors conclude that this should ultimately lead to a much more efficient national system supportive of patient safety, efficacy, and innovation.
Drozda JP, Dudley C, Helmering P, Roach J, Hutchison L. The mercy unique device identifier demonstration project: Implementing point of use product identification in the cardiac catheterization laboratories of a regional health system. Healthcare. 2016;4(2):116-119. http://www.sciencedirect.com/science/article/pii/S221307641500055X
This article examines results of the FDA-sponsored UDI demonstration where prototype UDIs of coronary stents were scanned and captured in Mercy’s electronic information system. The demonstration revealed improved inventory management and cardiac catheterization laboratory supply tracking. The resulting benefits of incorporating UDIs into the electronic information system included preventing procedure delays, lowering cost, and increasing revenue. Challenges with the demonstration ranged from technology integration to inventory management application and data limitations. The authors conclude the UDI system can be extended to all medical devices and implemented in most hospitals.
Wilson N, Broatch J, Jehn M, Davis CM. National projections of time, cost and failure in implantable device identification: Consideration of unique device identification use. Healthcare. 2015;3(4):196-201. http://www.sciencedirect.com/science/article/pii/S2213076415000408
The authors of this article developed national projections of time, cost, and failure in implant identification prior to revision total hip and knee arthroplasty (THA/TKA). Projections were significant, including projections for failure in implant identification prior to revision as greater than 50,000 preoperatively and 25,000 intraoperatively by 2030. Authors conclude that findings support the need for improved implant documentation and identification, highlighting the need for a UDI system that would set the standard for device documentation and identification.
Tcheng JE, Crowley J, Tomes M, et al. Unique device identifiers for coronary stent postmarket surveillance and research: A report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier Demonstration. Am Heart J. 2014;168(4):405-413. http://www.ncbi.nlm.nih.gov/pubmed/25262248
This article reports on the first phase of the UDI Demonstration Project funded through the Medical Device Epidemiology Network (MDEpiNet) initiative and conducted at Mercy. Discussed is system design for the implementation of coronary stent UDI-associated data in the information systems of Mercy, a multihospital health system, as well as description of proceedings of the expert panel and workgroup. These included identification of 18 use cases of UDI-associated data, a supplemental data set of clinically relevant attributes, and governance and administrative principles for data management. This multi-stakeholder partnership was felt to be a key aspect to the success of the demonstration. The article concludes with future steps moving towards development of a more robust UDI-based postmarket device surveillance system.
Wilson NA, Jehn M, York S, Davis CM. Revision Total Hip and Knee Arthroplasty Implant Identification: Implications for Use of Unique Device Identification 2012 AAHKS Member Survey Results. J Arthroplasty. 2014;29:251-255. http://www.ncbi.nlm.nih.gov/pubmed/23890830
The 2012 American Association of Hip and Knee Surgeons membership survey examined implant identification processes by orthopedic surgeons prior to revision total hip and knee arthroplasty. 87% of surgeons reported regularly using at least 3 methods to identify failed implants pre-operatively; 10% of failed implants could not be identified pre-operatively; and 2% of failed implants could not be determined intra-operatively. UDI in total joint arthroplasty registry and UDI in electronic medical records were indicated practices to best support implant identification and save time.
Rising J, Moscovitch B. The Food and Drug Administration’s Unique Device Identification System Better Postmarket Data on the Safety and Effectiveness of Medical Devices. JAMA Intern. Med. 2014; 174(11): 1719-20. http://www.ncbi.nlm.nih.gov/pubmed/25265502
This viewpoint article from the Pew Charitable Trust discusses the benefits of UDI use. Indicated is that inclusion of UDI in patient electronic health records, claims, and medical device registries is necessary to achieve benefit of the UDI system. A call to action is put forth for government agencies, specialty medical societies, and health care organizations to collaborate in order to achieve the potential of UDI use.
Campion TR, Johnson SB, Paxton EW, Mushlin AI, Sedrakyan A. Implementing Unique Device Identification in Electronic Health Record Systems. Organizational, Workflow, and Technologic Challenges. Med Care. 2014;52(1):26-31. http://www.ncbi.nlm.nih.gov/pubmed/24322986
Provided from the perspective of the MDEpiNet Science and Infrastructure Center at Weill Cornell Medical College, authors discuss the organizational, workflow, and technological challenges associated with UDI implementation. Recommendations to address UDI implementation challenges from regulatory, peer organization and specialty society perspectives are included. The authors propose that in order to achieve the benefits of the UDI system envisioned by the FDA, there must be integration among involved people, processes, and technology.
Wilson NA, Drozda J. Value of Unique Device Identification in the Digital Health Infrastructure. JAMA 2013;309(20):2107-2108. http://www.ncbi.nlm.nih.gov/pubmed/23695480
This viewpoint article by Natalia Wilson and Joseph Drozda, published prior to publication of the UDI Rule, highlights the role of UDI in supporting an effective medical device monitoring system and enhanced patient safety. The authors lay out the expected benefits of a UDI system to strengthen post market surveillance of medical devices, ensure ability to track a device across health care settings, support safe and accurate device use, standardize device documentation in health information technology systems, enhance recall management, and support health care cost savings.
Gross TP, Crowley J. Unique Device Identification in the Service of Public Health. N Engl J Med. 2012;367(17):1583-1585. http://www.nejm.org/doi/full/10.1056/NEJMp1113608
This perspective article discusses the need for development of a comprehensive strategy to collect, analyze and act on information regarding the post market performance of medical devices utilizing unique device identifiers (UDIs). According to the authors from the Centers for Devices and Radiological Health (CDRH), FDA, incorporation of UDIs into electronic health information is an integral element to the success of this strategy. UDI use could significantly support harnessing electronic health database information for better understanding of medical device safety.
NEST Planning Board. The National Evaluation System for health Technology (NEST): Priorities for Effective Implementation. Duke-Margolis Center for Health Policy. September 2016
This is the third Planning Board report in support of the FDA’s work in developing the National Evaluation System for health Technology (NEST). The report particularly focuses on organizational governance, priority areas and activities for development of the NEST Coordinating Center, building the shared resources of NEST, and high-value demonstration projects. Additionally put forth in the report is the Planning Board recommendation for Coordinating Center leadership in developing a national strategic plan for UDI implementation and use.
NMDES Planning Board. Better Evidence on Medical Devices: A Coordinating Center for a 21st Century National Medical Device Evaluation System. Duke-Margolis Center for Health Policy; April 2016. https://healthpolicy.duke.edu/files/2016/03/med-device-report-web.pdf
This report released from the Duke-Margolis Health Policy Center is the first of a series planned from the National Medical Device Evaluation System (NMDES) Planning Board to promote public discussion of how to address current issues and opportunities for better evidence on medical devices. The report provides preliminary recommendations from the Planning Board on the development, objectives, tasks, and capabilities of a new Coordinating Center that will be responsible for the creation of a NMDES. Included in the report are expected benefits of the system to patients and other stakeholders and essential uses of NMDES.
Daniel G, McClellan M, Colvin H, Aurora P, Khaterzai S. Strengthening Patient Care: Building an Effective National Medical Device Surveillance System. The Brookings Institution. Washington, D.C.; February 2015. http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm435112.pdf
As part of its Strengthening Our National System for Medical Device Postmarket Surveillance reports, FDA called for creation of a multi-stakeholder planning board to identify governance policies, priorities, and business models for a sustainable national medical device evaluation system. This report from the Brookings Institution presents the long-term vision and recommended implementation strategies from the Planning Board for a National Medical Device Postmarket Surveillance System. Included are recommendations for the national system’s mission, functions, governance principles, operational components, a strategic plan to develop and implement the system, and pilot concepts to initiate development of the national system.
Daniel G, McClellan M, Gardina S, Deak D, Bryan J, Streit C. Unique Device Identifiers (UDIs): A Roadmap for Effective Implementation. The Brookings Institution. Washington, D.C.; December 2014. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/BenefitsofaUDIsystem/UCM445330.pdf
This report from The Brookings Institution overviews the benefits of a UDI system and makes a series of recommendations for UDI integration into provider systems, administrative transactions, and patient-directed tools. Incorporated are examples of health care organizations that have already begun to operationalize steps for UDI implementation and adoption as well as two clinical scenarios about patients with medical devices that illustrate the impact of UDI use. The report serves as an important roadmap for organizations pursuing UDI implementation and adoption and for diverse stakeholders to understand the benefit and need for UDI use.
Drozda, JP, Helmering P, Moore V, Smith TR. UDI Demonstration Project Final Report. December 2013. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/BenefitsofaUDIsystem/UCM416128.pdf
This Final Report summarizes the 18-month UDI Demonstration Project performed at Mercy. The specific aims of the project are delineated. Outcomes including a medical device surveillance system for monitoring coronary stents created in the Mercy Health electronic systems; identification of key clinical attributes impacting the performance of cardiac stents with creation of a database that houses the attributes of almost all currently available coronary stents; and creation of a continually renewing database with clinical and device attributes are discussed. The Demonstration Project highlights the potential that a national medical device surveillance system has to optimize patient care and enhance patient safety.
Center for Devices and Radiological Health. U.S. Food and Drug Administration. Strengthening Our National System for Medical Device Postmarket Survillance. Update and Next Steps. April 2013. http://www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSurveillance/UCM348845.pdf
This report updates FDA’s Strengthening Our National System for Medical Device Postmarket Surveillance 2012 report. The 2013 report delineates FDA’s critical efforts towards creating a national medical device postmarket surveillance system through further implementation of its four specific actions from the 2012 report and establishment of a multi-stakeholder Medical Device Postmarket Surveillance System Planning Board.
Center for Devices and Radiological Health. U.S. Food and Drug Administration. Strengthening Our National System for Medical Device Postmarket Surveillance. September 2012. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM301924.pdf
This 2012 report from the Center for Device and Radiological Health (CDRH) provides an overview of FDA’s medical device postmarket authorities and evaluates the United States’ medical device postmarket surveillance system. From this evaluation, the CDRH proposes four specific actions to strengthen the medical device postmarket surveillance system in the United States: 1) establish a Unique Device Identification System and promote its incorporation into electronic health information; 2) promote the development of national and international device registries for selected products; 3) modernize adverse event reporting and analysis; and 4) develop and use new methods for evidence generation, synthesis and appraisal. These four proposed actions are outlined in depth in the report.
- CMS Meaningful Use Stage 3
- FDA Unique Device Identification (UDI)
- Global UDI Database (GUDID)
- Integrating the Healthcare Enterprise (IHE)
- International Medical Device Regulators Forum (IMDRF)
- Learning UDI Community (LUC)
- Medical Device Epidemiology Network Initiative (MDEpiNet)
- National Evalution System for Health Technology (NEST)
- ONC Health IT Certification Program: Standards and Certification Regulations
- ONC Implantable Device List Certification Criteria
- ONC Common Clinical Data Set (CCDS)
- ONC Interoperability Proving Ground
- UDI Issuing Agencies