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
UDIs are unique identifiers for a medical device that are required on the device label and packaging of both human and machine-readable forms. These are required on the medical devices that are intended for more than one use and intended to be reprocessed before each use. The U.S. FDA mandated the UDI system in September 2013.
The BUILD Initiative supports MDEpiNet by developing the infrastructure and methodology for robust post-market surveillance, research, and innovation through a system of automated capture of clinical data from EHRs and UDI associated device data, all of which are linked to national registries. The focus of the BUILD initiative is to:
• Implement an UDI system at the point of clinical care and leverage UDI to connect data sources
• Access the global unique device identification database)
• Move information on devices to clinicians for patient care,
• Allow researchers to assess device effectiveness and safety
• Support device innovation across the device product life cycle
The BUILD Initiative has three complementary components:
• Extension of the UDI Implementation Pilot: The Mercy Health coronary stent UDI demonstration project was extended to production status at two additional health systems, Geisinger and Intermountain Healthcare.
• Medical Device Data Capture and Exchange: Leading Practices and Future Directions: Leadership interviews were performed in hospital systems that have implemented UDI for implantable devices to rigorously assess leading practices and gaps; a multi-stakeholder consortium of hospital system and manufacturer leaders in UDI was formed (BUILD Consortium); a BUILD website was created and maintained for education and information sharing.
• Electrophysiology structured reporting Providing UDI for Leads and devices using industry Standards to EHRs and CVIS systems: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.
Building UDI into Longitudinal Data for Medical
Device Evaluation (BUILD) – Point of Care Capture of UDI for Implantable Devices Final Summary Report & Roadmap (June 28, 2019). Author: Natalia Wilson, M.D. MPH.
- 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
- MDEpiNet, AHRMM LUC, and Cross-cutting Projects Related to BUILD
Unique Device Identifier (UDI) Implementation in the Electronic Information of a Single Health System: An MDEpiNet Demonstration
Principal Investigator: Joseph P. Drozda, Jr., M.D.
The U.S. Food and Drug Administration (FDA) envisions strengthening the system of medical device postmarket surveillance through the use of electronic health information gathered in the course of care and sees unique device identifiers (UDIs) as keys enabling linking of disparate systems. To this end, the FDA supported a demonstration performed by Mercy Health (a 4-state regional health system headquartered in St. Louis, Missouri) that had 3 aims:
- to implement a coronary stent surveillance system in its electronic health record (EHR),
- to identify the obstacles for creating such a system along with potential solutions, and
- to assess the usefulness of the EHR data in device safety surveillance.
Mercy designed and implemented a system for capturing prototype coronary stent UDIs by means of barcode scanning in its cardiac catheterization laboratories (cath labs) and incorporating them in its supply chain management, inventory management, billing, and cath lab clinical systems. The UDI was used to link the specific coronary stent with the patient in whom it was implanted. This resulted in creation of a database that included pertinent UDI-related device information and clinical data obtained from the EHR thus enabling assessment of coronary stent safety and effectiveness over time.
This “proof of concept” pilot demonstrated that EHR data can be useful in evaluating implanted medical devices in the postmarket setting. The next step would be to work with a national device registry to obtain this same information in de-identified format from multiple health systems in order to assess large numbers of devices nationally and create a clearer picture of device performance and safety in the real world.
Read the report (ppt): MDEpi UDI Demo FDA Epi Conf Final
Mercy is a member of the Healthcare Transformation Group (HTG)—an alliance of 5 large health systems that includes Geisinger, Intermountain Healthcare, Kaiser Permanente, and Mayo Clinic. HTG is advocating for supply chain standardization aimed at reducing costs while improving healthcare quality and safety and actively supported the Mercy UDI demonstration. In conjunction with its HTG partners, Mercy assembled an expert panel of interventional cardiologists to help in refining the project design and to select meaningful coronary stent attributes for inclusion in the surveillance database. The expert panel accomplished this task by working with a broader group of stakeholders that included representatives of HTG health systems, professional societies (American College of Cardiology and Society for Cardiovascular Angiography and Interventions), and industry (Abbott, Boston Scientific, and Medtronic) as well as FDA.
The Mercy team was multidisciplinary; it was led by a senior health services researcher, and was a combined effort of a number of departments: Cath Lab, research, information technology, supply chain, and operational optimization.
Sources of Funding
The UDI implementation pilot was a part of the MDEpiNet Methodology Center of Harvard Medical School. This work was supported by contract DHHS/FDA-22320172C from the Center for Devices and Radiological Health, USA Food and Drug Administration.
The major product of this initiative was a dynamic database (the UDI Research database or UDIR) that is a dataset generated from Mercy’s data warehouse, that contains UDI-associated coronary stent attribute data and clinical data, and that receives clinical data extracted from the EHR on a weekly basis to enable long term patient follow up. The UDIR, then, provides information that can be used in assessment of device safety and effectiveness.
Open Source Information
Detailed information on the project including UDIR data structure is available at Advancement of Innovative Methodologies and Medical Device Specific Infrastructure for Evidence-Based Regulatory Science and Public Health Surveillance.
Tcheng JE, Crowley J, Tomes M, Reed TL, Dudas JM, Thompson KP, Garratt KN, Drozda Jr. JP. Unique device identifiers (udis) for coronary stent post-market surveillance and research: A report from the FDA’s Medical Device Epidemiology Network (MDEpiNet) udi demonstration, American Heart Journal, 2014;168(4);405-13,e2., doi: 10.1016/j.ahj.2014.07.001.
Drozda JP, Smith TR. Medical device research at a regional health system: the Mercy experience. Asian Hospital & Healthcare Management, 2014:30, http://www.asianhhm.com/equipment_devices/medical-device-research.html. Accessed November 20, 2014.
Drozda JP, Dudley C, Helmering P, Roach J, Hutchison J. The Mercy unique device identifier demonstration project: Implementing point of use product identification in the cardiac catheterization laboratories of a regional health system, Healthcare (2015), http://dx.doi.org/10.1016/j.hjdsi.2015.07.002i.
Slayton R, Roach J, Smith P, Helmering P, Reed T, Resnic F, Normand S-L, Drozda JP Jr. Leveraging health information technology in a large health system: barriers to designing and implementing a unique device identifier research database. Academy Health Health Information Technology Interest Group Meeting, June 7, 2014.
Unique Device Identifiers in Electronic Health Records. U.S. Food and Drug Administration Unique Device Identification (UDI) for Postmarket Surveillance and Compliance Public Workshop, Bethesda, MD, September 12, 2011.
Results of the FDA Unique Device Identifier Demonstration. GS1 Connect 2013 Conference, San Antonio, TX, June 13, 2013.
Food and Drug Administration UDI Demonstration. Global GS1 Healthcare Conference, San Francisco, CA, October 3, 2013.
Implementation of Unique Device Identification Demonstration Project – A Report from MDEpiNet. Food and Drug Administration Center for Device and Radiologic Health Epidemiology Grand Rounds, Silver Spring, MD, February 20, 2014.
Food and Drug Administration UDI Demonstration. HIMSS 2014, Intelligent Hospital Pavilion, Orlando FL, February 25, 2014
Update on Mercy’s UDI Demonstration: What’s Next? GS1 Connect Conference, San Diego, CA, June 11, 2014.
Device Specific Surveillance: The UDI Demonstration and Beyond. MDEpiNet Annual Meeting. Bethesda, MD, October 14, 2014.
FDA UDI Demonstration. HIMSS webinar: UDI at the Heart of the Triple Aim. November 19, 2014.
Evaluate how UDI capture in patients’ medical records and other data systems used by providers and clinicians can improve care and affect workflow, and identify standards revisions that are needed to obtain benefits. Part of a panel. Realizing the Benefits of the Unique Device Identifier in Health Care. An event co-hosted by the U.S. Food and Drug Administration, the Office of the National Coordinator for Health Information Technology, and The Pew Charitable Trusts, Washington, DC, December 9, 2014.
Mercy’s UDI Journey. GS1 Canada Carenet Healthcare Sector Board Meeting Conference Call and Webinar. March 4, 2015.
Mercy’s Unique Device Identification Journey. GS1 Canada Healthcare Advisory Council Meeting, Conference Call, and Webinar, April 9, 2015.
Medical Devices and the Triple Aim. GHX Supply Chain Summit, Scottsdale, AZ, May 6, 2015.
|Involvements in Cross-cutting Projects and Initiatives|
|PROJECT||LEAD ORGANIZATION(S)||BUILD INVESTIGATOR(S)||ROLE||DESCRIPTION||DELIVERABLES|
|Augmented UDI Data (AUDI) Workgroup||MDEpiNet||J. Drozda
|Co-chairs||Extension of Mercy SUDID to other device types||Report of the MDEpiNet AUDI Workgroup|
|Business Case for UDI Workgroup
UDI to Registries Subgroup
|AHRMM LUC||J. Drozda||Co-chair||Demonstration of value for health care systems of UDI implementation
Subgroup: Evaluation of process of reporting to registries & implication of adding UDI
|Business Case for the UDI Work Group Report
|Clinically Relevant Size Workgroup||MDEpiNet
|J. Tcheng||Co-Chair||Structured representation of meaningful device dimensions in GUDID||Report of the GUDID Clinically Relevant Size (CRS) Work Group|
|Data Quality Subcommittee||NESTcc||J. Tcheng||Member||Development of data quality standards, processes to conform, & recommendations for implementation|
|Device Categorization Workgroup||MDEpiNet
|Workgroup members||Evaluation of classification schema for clinically meaningful groups of medical devices|
|Informatics Working Group Chair and Leadership Team member
Leadership Team member
|Development of infrastructure & methodology for using registry data for evaluating peripheral arterial devices||Registry Assessment of Peripheral Interventional Devices (RAPID Initiative)
|Sentinel-MDEpiNet Common Data Model Collaboration||MDEpiNet
|Co-leads||BUILD & RAPID collaboration with Sentinel to develop medical device aspects of Common Data Model|
|Supply Chain Advancement Network in Health (SCAN Health) initiative||University of Windsor Odette School of Business
PI Anne Snowdon
|J. Drozda||Member, Expert Advisory Council and Member, Metrics and Impact Working Group||Networks of Centres of Excellence funded Knowledge Translation Platform to address key problems for Canadian health systems.||SCAN Health|
|UDI to Claims||Brigham & Women’s Hospital
PI Joel Weissman
|Studying feasibility of transmission of claim with UDI between hospital & insurer||White Paper|
|Use of EHR-Based Data Network to Support Evidence Generation Across the Total Product Life Cycle (TPLC)||NESTcc||J Drozda||PI||Validate use of an EHR-based data network for evidence generation on medical devices|
|Unique Device Identifier (UDI): An MdEpiNet Demonstration||Mercy||J. Drozda||Chair||strengthening the system of medical device postmarket surveillance through the use of electronic health information gathered in the course of care, and linking disparate systems.||Unique Device Identifier (UDI) Implementation in the Electronic Information of a Single Health System: An MdEpiNet Demonstration
|VANGUARD||MDEpiNet||J. Drozda||Advisor||Developing clinical data infrastructure & methodology for evaluating central venous access devices|
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 medical device documentation and identification standard for patients, clinicians and other health care system personnel
- 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)
National Initiatives & Policy
National Initiatives & Policy
- 2013: Publication of the U.S. Food and Drug Administration’s (FDA) Unique Device Identification System Rule which mandates manufacturers to label their marketed devices with UDIs. U.S. Department of Health and Human 21 CFR § 16, 801, 803, 806, 810, 814, 820, 821, 822, 830 2013.
- 2015: The Office of the National Coordinator for Health Information Technology (ONC) includes UDI in the Common Clinical Data Set (CCDS) as well as the requirement for an implantable device list for Electronic Health Record (EHR) Certification. U.S. Department of Health and Human Services. 45 C.F.R. 170
- 2017: The Accredited Standards Committee X12 formally recommends inclusion of the DI for high risk implantable devices in the insurance claim form
- 2019: The Accredited Standards Committee X12 releases draft versions of updated insurance claim forms including for the DI of high risk implanted or explanted devices
- Medical Device Epidemiology Network (MDEpiNet): A public-private partnership including FDA, other government agencies, academic organizations, health care organizations, medical device manufacturers, and specialty societies that is focused on developing methodologies and conducting studies to optimize development, regulation, and use of medical devices.
- National Medical Device Evaluation System (NEST): A proposed national coordinated network of voluntary partnerships including health care organizations, payers, device manufacturers, patient communities, government agencies, and registries, all working together to generate high quality, real world, lower cost post-market device data and evidence to inform and improve patient care.
- MDIC NEST Coordinating Center is operationalizing this network in support of NEST goals. The primary priority areas include establishment of Governance, a Data Network, Sustainability, and Stakeholder Engagement.
- LUC Work Groups
|AHRMM LUC Work Groups|
|Work Group Name||Charter||Deliverable(s)|
|Catalog Number Fields||Catalog Number Charter||Catalog Number Report|
|Clinically Relevant Size||Clinically Relevant Size Charter||Clinically Relevant Size Report|
|Medical Devices Containing Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P)||HCTP Charter||HCTP Report|
|Multiple Device Identifier||Multiple DI Charter||Multiple DI Report|
|UDI Benefits to Healthcare Supply Chain Processes||UDI Benefits Charter||UDI Benefits Report|
|UDI Capture||UDI Capture Charter||Baptist Health Case Study
FMOL Case Study 2018
FMOL Case Study 2017
|UDI Single Use Devices (SUD) Packaging Exception & Distributor Low Unit of Measure Programs||SUD LUM Charter||SUD LUM Report|
|Unit of Use||UOU Charter||UOU Part 1 – Webcast|
|Bar Code at the Point of Care||BC@POC Charter|
|Device Categorization: GMDN/SNOMED Terminologies||GMDN/SNOMED Charter|
|High Risk Implants||High Risk Implants Charter|
Peer-reviewed Journal Articles
Zerhouni YA, Krupka DC, Graham J, Landman A, Li A, Bhatt DL, Nguyen LL, Capatch K, Concheri K, Reich AJ, Wilson N, Weissman JS. UDI2Claims: Planning a Pilot Project to Transmit Identifiers for Implanted Devices to the Insurance Claim. J Patient Saf. 2018 Nov 21. doi: 10.1097/PTS.0000000000000543. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/30480650
This article reports on the UDI2Claims pilot project. The first objective was to compare EHR-only versus insurance claims data for post-market device surveillance. The second objective was to analyze the feasibility of transmitting device information from the point of care (POC) to the payer by inputting the device identifier (DI) information into the insurance claims. Evidence was found to support use of insurance claims data over EHR-only in tracking for device effectiveness and adverse events. Five challenge areas for transmission of the UDI from the POC to the payer were identified from this pilot project. Solutions were recommended for each challenge with payer and provider organization responsibilities in mind. The findings from this pilot project favor implementing DI information into insurance claims.
Aston JW, Howarth AL, Wilson N, Mahabir RC. The Value of Unique Device Identification in Plastic Surgery. Aesthet Surg J 2018; 38(11): 1264-1266. https://doi.org/10.1093/asj/sjy210
This article discusses the current UDI landscape under the U.S. Federal and Drug Administration (FDA) rule and highlights the benefit of UDI documentation and use in plastic surgery. Indicated is the lack of requirement for health care systems or private providers to use UDI. Summarized are ongoing efforts through research and industry workgroups to address barriers to widespread implementation and use of UDI. The National Breast Implant Registry is used as an example to indicate how inclusion of UDIs would augment available data for safety surveillance in plastic surgery.
Dhruva SS, Ross JS, Schulz WL, Krumholz HM. Fulfilling the Promise of Unique Device Identifiers. Ann Intern Med. 2018;169(3):183-185. https://annals.org/aim/article-abstract/2683615/fulfilling-promise-unique-device-identifiers? doi=10.7326%2fM18-0526
The authors of this opinion article discuss the unrealized potential of a UDI system due to the lack of broad integration of UDIs into EHRs and administration claims. Emphasized was the benefit that would accrue for patients, hospital systems, payers, and researchers from clinical care, patient safety, and cost perspectives. The authors highlight the need to surmount resistance within hospital systems for development of systems to capture UDIs in EHRs in order to effectively move towards a learning health care system for medical devices.
Drozda JP, Roach J, Forsyth T, Helmering P, Dummitt B, Tcheng JE. Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration. JAMIA 2018; 25(2): 111-120. doi: 10.1093/jamia/ocx041 https://www.ncbi.nlm.nih.gov/pubmed/28472359
This article describes the “system of systems” created in the Unique Device Identifier Demonstration Project conducted at Mercy Health. The informatics architecture, UDI-associated data flow from manufacturer through point of use, and the role and deliverables of the various stakeholders are detailed in useful figures and tables. Also included is a depiction of the UDI Research Database created to link device and clinical data for purposes of safety surveillance and research. Challenges and gaps delineated in the article lay the groundwork for needed next steps to support a robust medical device evaluation system and the importance of ongoing projects such as BUILD. The demonstration provided proof of concept that UDIs can be captured in supply chain and provider information systems and that UDI-associated device data can be linked with clinical data at the point of care for use in longitudinal tracking and analysis.
Reed TL, Drozda JP, Baskin KM, Tcheng J, Conway K, Wilson N, et al. Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank. Healthcare. 2017 Dec; 5(4): 158-164. doi:10.1016/j.hjdsi.2016.10.004. https://www.sciencedirect.com/science/article/pii/S2213076416300252?via%3Dihub
This article discusses the Medical Device Epidemiology Network (MDEpiNet) SMART Think Tank held in February of 2015 which brought together stakeholders to collaboratively identify and address gaps in electronic capture and exchange of device data. Two multi-stakeholder initiatives that resulted from this Think Tank are delineated – Building UDI into Longitudinal Data for Surveillance and Research (BUILD) which is extending a UDI system established at one health care system to three; creating a device-output project ePULSE and assessing leading practices for device date capture and exchange using UDI, and Venous Access: National Guideline and Registry Development (VANGUARD) which is creating a national/international central venous access registry. These two pilots are working towards goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology (NEST).
Morales JP, Cronenwett J, Thatcher R. Registry Assessment of Peripheral Interventional Devices (RAPID). Endovascular Today. 2016;15(8):85-94. http://evtoday.com/2016/08/registry-assessment-of-peripheral-interventional-devices-rapid/
This article discusses the RAPID project that is focused on development of a minimum core dataset for registry assessment of peripheral arterial intervention devices. The authors indicate the challenge faced in evaluation of these devices due to the variety of device types available, heterogeneity of disease process, number of medical specialties that use the devices, and lack of standardized core data elements. Detailed was Phase 1 of this three-phase project which involved identification of the core data elements, development of the technical specifications for exchange, and consensus surrounding GUDID data elements for download. Indicated is the significant multi-stakeholder collaboration and foundation built in Phase 1 of RAPID, supporting potential of this work to improve device effectiveness, improve quality, and reduce variation in device use by different specialties in different countries.
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.
Food and Drug Administration. Office of Medical Products and Tobacco. Center for Devices and Radiological Health: Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. A CDHR Report.
This report presents CDRH’s vision to enhance programs and processes for medical device safety to protect patients and spur innovation of new products that are safer, more effective, and address unmet medical needs. Outlined are key actions by FDA:
- Establish a robust medical device patient safety net in the United States
- Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations
- Spur innovation towards safer medical devices
- Advance medical device cybersecurity
- Integrate the Center for Devices and Radiological Health’s (CDRH’s) premarket and postmarket offices and activities to advance the use of a Total Product Life Cycle (TPLC) approach to device safety
Levinson DR. Shortcomings of Device Claims Data Complicate and Potentially Increase Medicare Costs for Recalled and Prematurely Failed Devices. Office of Public Affairs, Dept. HHS. 2017 September; Report No. A-01-15-00504. https://oig.hhs.gov/oas/reports/region1/11500504.asp This OIG study was undertaken to determine if Medicare costs for replacement of recalled or prematurely failed medical devices could be identified using claim data and to identify the costs to Medicare for replacement of seven specific recalled and prematurely failed devices over a nine-year period. The outcome of the study was that these costs could not be identified from claims data. Rather, the $1.5 billion cost to Medicare of replacement of the seven recalled and prematurely failed devices was determined via a labor-intensive auditing process. Estimates were also made of $140 million in beneficiary payments. As a result of this report, OIG recommended CMS’ continued work with ASC X12 for DI in claims.
Harvard Medical School/Brigham and Women’s Hospital/Geisinger Health System. Pilot Study. Transmitting the UDI from the Point of Use to Insurance Claims: Changes in Workflows and Information Systems. May 2017.
This white paper reports on the planning phase of one institution’s effort to capture the UDI at the clinical point of care, record it in the EHR, and transmit the DI to an insurance company on the insurance claim. In a step-wise manner, the proposed processes are described: UDI Capture and Documentation at the Point of Use, How the UDI will be transmitted to and stored in the hospital billing/revenue cycle, and How the UDI is transmitted in the claim form to the payer. Included is a data flow map.
NEST Planning Board. The National Evaluation System for health Technology (NEST): Priorities for Effective Early 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. https://www.fda.gov/media/84409/download
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.
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)
- MDIC NEST Coordinating Center
- 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 Sets (CCDS)
- ONC Interoperability Proving Ground
- ONC Proposed Rulemaking to Improve Interoperability of Health Information
- UDI Issuing Agencies