RAPID – Registry Assessment of Peripheral Interventional Devices (RAPID)

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Join us on January 14, 2020 for the RAPID Pathways WG Meeting at the US FDA

Quick Links:

March 20, 2019 Rapid Working Group Meeting
NIH Collaboratory Grand Rounds (October 20, 2018)
Meeting Agenda

Phase I and Phase II Materials: For information about the Phase I and Phase II working groups, click the Phase I and Phase II tabs below.

RAPID Initiative

Principal Investigators

Phase I and II 

Pablo Morales, MD, U.S. FDA

Robert Thatcher, 4C Medical Technologies

Jack Cronenwett, MD, Society for Vascular Surgery (SVS), Vascular Quality Initiative (VQI)

Phase III

Misti Malone, PhD, U.S. FDA

Melanie Raska, Boston Scientific

Daniel Bertges, MD, Society for Vascular Surgery (SVS), Vascular Quality Initiative (VQI)

MDEpiNet Key Advisors

Mitchell Krucoff, MD, Duke Clinical Research Institute (DCRI)

Danica Marinac-Dabic, MD, PhD, MMSc, FDA


Project Management and Informatics Support

Mina Baqai, DCRI,

Sarah Palmer, DCRI

Rebecca Wilgus, DCRI

RAPID focuses on a pre-competitive, stakeholder ecosystem approach to enhanced TPLC evaluation of devices for peripheral vascular intervention. This system was developed by the Predictable And Sustainable Implementation Of National (PASSION) Registries for Cardiovascular Devices program of MDEpiNet. RAPID is currently a formally designated NESTcc Demonstration Program coordinated by the Duke Clinical Research Institute.

RAPID Phase I originated the construct of the “minimum core data structure” for PAD device evaluation, as a re-usable model across NEST-based CRNs supporting efficient systems interoperability. For the Phase I use case in PAD, data elements from pivotal trial and professional society case report forms were leveraged as a starting point to develop and publish in the public domain the core minimum set of data elements to support evaluation of devices used to treat PAD. In parallel, efforts to promote the adoption of GUDID were initiated in the peripheral vascular community. RAPID Phase I was not only completed ahead of schedule, but through this inclusive, productive collaborative effort, good faith and trusting relationships were built between stakeholders throughout the peripheral device ecosystem.

RAPID Phase II developed the most contemporary OPG for devices used in the SFA and femoral-popliteal anatomy available in the PAD literature. The timeline for completion of this OPG was dramatically accelerated and facilitated by the “rapid” implementation of the Phase I minimum core data elements by the VQI registry. This achievement by our professional society partners thus provided the real-world data utilized to update OPC for PAD devices. Results of the Superficial Femoral Artery-Popliteal EvidencE Development OPG were shared in the RAPID stakeholder meeting at the FDA on March 20, 2019 26. These results have currently been submitted for peer review.

RAPID Phase III Pathways was launched in June of 2019 following the FDA’s Special Advisory Panel on the mortality/safety signal concerns following PAD intervention with devices delivering paclitaxel. Pathways is intended to leverage the immediate challenges of questions surrounding the paclitaxel mortality signal discernment as a use case promoting improvements to the evaluation of all PAD devices throughout their lifecycle. RAPID Pathways will provide a neutral ground to foster frank dialogue among stakeholders already engaged in these issues, and to promote pragmatic, collaborative, pre-competitive approaches with well-defined deliverables and timelines serving these objectives.

Pathways is structured to combine leadership from regulatory, industry, clinical and professional society stakeholders in multiple areas of key expertise, including clinical data content, clinical data structure, biostatistics, patient preference science, as well as to host currently active studies examining data from industry, professional societies, claims, third party payers, the VA Medical Centers, and international sources.

Pathways will develop a ‘lean’ case report form and explore other opportunities to support future device trials using lessons learned from the PTX experience. RAPID Pathways will focus on the goal of “better, faster, cheaper” PAD device evaluation.

Phase I

Phase I WG Chairs

Schuyler Jones, MD, DCRI (Clinical)

James Tcheng, MD, DCRI (Informatics)

Terrie Reed, FDA (GUDID)

Phase I WG Informaticists

Anne Heath, DCRI

Mary Williams, DCRI


Work Products

Click on the plus sign (+) to view additional information.

RAPID Leadership Team

‘The RAPID Leadership Team sets direction, provides oversight and guidance, and facilitates stakeholder engagement & support for the RAPID project. Representatives from the Leadership team actively participate in the RAPID Working Groups, author publications, and raise awareness for RAPID at professional meetings and conferences.’ Members include the RAPID Principle Investigators, advisors from the MDEpiNet Public Private Partnership, Phase I Work Group Chairs, international representatives, and other key thought leaders.

18 People from 7 Organizations

  • 4C Medical Technologies
  • Centers for Medicare and Medicaid Services (CMS)
  • Duke University & Duke Clinical Research Institute
  • Mercy Health System
  • Pharmaceuticals and Medical Devices Agency (PMDA)
  • Society for Vascular Surgery
  • US Food and Drug Administration (US FDA)
RAPID Clinical Expert Working Group

Members of the RAPID Clinical Expert Working Group, analyzed a pool of data elements that are currently collected by stakeholders and prioritized those that were applicable across use cases & PAD devices for the RAPID core data set.  Members also collaborated with the RAPID Informatics Working Group and GUDID Working Group as needed.

51 People from 29 Organizations

  • Abbott Vascular
  • American College of Cardiology
  • Australian Vascular Audit, ICVR countries
  • BARD
  • Baylor College of Medicine (BCM)
  • Boston Scientific
  • Boston-Biomedical
  • Cardiovascular Systems, Inc (CSI)
  • Centers for Medicare and Medicaid Services (CMS)
  • Cleveland Clinic/SCAI
  • Cook Medical
  • CR Bard (Bard Peripheral Vascular, Inc.)
  • Duke University/Duke Clinical Research Institute
  • Epic
  • German Vascular Registry
  • Mass General Vascular Center, VasCore
  • Medical University of South Carolina (MUSC)
  • Medstreaming
  • Medtronic Aortic and Peripheral Vascular
  • Mercy Health System
  • Office of the National Coordinator (ONC)
  • Pharmaceuticals and Medical Devices Agency (PMDA)
  • Saint Joseph Mercy Hospital
  • Society for Vascular Surgery
  • Society of Interventional Radiology
  • University of Virginia Health System
  • US Food and Drug Administration (US FDA)
  • Veteran’s Administration Eastern Colorado Healthcare System
  • Volcano Corp/Philips Health Technology
RAPID Informatics Working Group

Members of the RAPID Informatics Working Group developed a core set of metadata and related technical specifications needed to support implementation and adoption of the core data elements across registries and beyond.   Additionally, the Informatics Working Group collaborated with the Clinical Expert Working Group and the GUDID Working Group as needed.

36 People from 18 Organizations

  • American College of Cardiology – NCDR
  • Aorta Medical Inc.
  • Boston Biomedical Associates
  • Centers for Medicare and Medicaid Services (CMS)
  • Cook Medical
  • Duke University/Duke Clinical Research Institute (DCRI)
  • Epic
  • Geisinger Health System
  • HealthJump, Inc.
  • M2S
  • Medstreaming
  • Office of the National Coordinator (ONC)
  • Pharmaceuticals and Medical Devices Agency (PMDA)
  • Society for Vascular Surgery
  • Society of Interventional Radiology
  • US Food and Drug Administration (US FDA)
  • Vanderbilt
  • Volcano Corp/Philips Health Technology
RAPID Global Unique Identifiers (GUDID) Integration Working Group

Members of the RAPID GUDID Integration Working Group explored operational opportunities to adopt and demonstrate the usefulness the GUDID as a means for standardizing device data and improving the ability to link across peripheral device registries. The primary responsibilities of this Work Group were to:

1.Define a best practice for accessing and downloading data attributes from the GUDID into existing registry data sources.

2.Review and provide feedback on the clinical relevance of the Global Medical Device Nomenclature/SNOMED CT for PVI devices (e.g., plain balloon, specialized balloon, self- expanding bare metal stent, balloon expandable bare metal stent, drug coated stent, covered stent, atherectomy device, total occlusion device, embolic protection device).

3.Agree on a key set of core data attributes available in GUDID that each registry could download and then extract the information needed for their registry.

4.Provide feedback on the ability to link/expand existing registries to accommodate the use of the device identifier, the key in the GUDID, to ensure the ability to download from clinical data sources that are expected to capture UDI information when such systems become more widely available.

Additionally, members collaborated with the RAPID Informatics Working Group and the RAPID Clinical Expert Working Group to determine device identification data elements that should be included in the RAPID core data element set.

39 People from 23 Organizations

  • 4C Medical Technologies
  • American College of Cardiology
  • BARD
  • Boston Scientific
  • Cardiovascular Systems, Inc (CSI)
  • Centers for Medicare and Medicaid Services (CMS)
  • Cook Medical
  • Department of Defense (DoD)/ AHRMM
  • Duke University/Duke Clinical Research Institute (DCRI)
  • Epic
  • GMDN Agency
  • M2S
  • Medtronic
  • Mercy Health System
  • National Library of Medicine (NLM)
  • Society for Interventional Radiology
  • Society for Vascular Surgery
  • Society of Interventional Radiology
  • University of Washington Health Sciences Center
  • University of Michigan
  • US Food and Drug Administration (US FDA)
  • Volcano Corp/Philips Health Technology
  • Weill Cornell Medical College and New York Presbyterian
Additional RAPID Stakeholders

The following organizations have participated in one or more RAPID in-person meetings but are not currently participating in a Working Group:

  • Agency for Healthcare Research Quality (AHRQ)
  • Avinger
  • Cordis
  • Duke Margolis Center for Health Policy
  • Harvard
  • Kaiser Permanente
  • Novella Clinical, A Quintiles Company
  • Quintiles
  • Spectranetics Corporation
  • Terumo
  • W.L. Gore

Phase II

Work Product

RAPID Phase II Goals & Aims:

  • Implement the RAPID core data set (clinical and GUDID data elements) in a variety of healthcare information systems to advance the collection and exchange of interoperable electronic health data;
  • Represent the RAPID core data elements (CDEs) in interoperable, standards-based models (LOINC, SNOMED, HL7);
  • Describe a minimal set of common domain variables (general patient identifiers & common clinical data elements) needed to aggregate data sets from multiple sources;
  • Develop a core set of unique device attributes (AUDI) to complement the RAPID core data set and common domain variables to support PAD studies;
  • Assess & evaluate quality of data in the AccessGUDID database for devices used to treat peripheral vascular disease;
  • Develop projects to demonstrate extraction & use of patient-level data for the RAPID core data elements to support regulatory applications;
  • Assess and evaluate data governance, sharing, access and publication guidelines of RAPID data partners

Click here for a summary of SPEED.

RAPID Phase II Working Groups

Informatics, Interoperability & GUDID Working Group


Joe Drozda, MD, Sisters of Mercy Health System

Ted Heise, PhD, MedInstitute

Behnaz Minaei & Terrie Reed, US Food and Drug Administration

James Tcheng, MD, Duke Clinical Research Institute

Members of the RAPID Informatics and GUDID Integration Working Group are advancing the interoperable collection and exchange of health information, promoting adoption of GUDID in health information systems, and demonstrating the utility of the GUDID as a means of standardizing device data and improving the ability to link records across registries and other data sources.

Key Responsibilities:

  • Describe the core set of common domain variables (general patient identifiers & common clinical data elements) needed to aggregate data sets from multiple sources
  • Provide subject matter expertise needed to support the representation of RAPID core data elements (CDEs) in interoperable, standards-based models (i.e., LOINC, SNOMED CT).
  • Develop sets of supplemental clinically relevant device attributes for PAD devices (by device category).
  • Provide input to FDA regarding enhancements for GUDID tools and functionality available to industry partners who need to revise their GUDID entries when quality concerns are identified.
  • Review and update core GUDID data elements & value sets from Phase I to ensure the quality of data in GUIDID is acceptable to health systems, registries and supports the statistical analysis plan for the SPEED OPC, and is aligned with Learning UDI Community recommendations and initiatives.
  • Use existing device data in VQI to identify and review the GMDN and SNOMED Hierarchies to develop a device categorization approach to be evaluated in Phase III for aggregation and reporting.
  • Develop mechanisms for hospitals to incorporate UDI into EHI systems (supply chain, procedure documentation, EHR, billing) via bar code scanning.
  • Interface with the AHRMM Learning UDI Community.
Governance, Access & Data Sharing


Ralph Brindis, MD American College of Cardiology/National Cardiovascular Data Registry

Jens Jorgenson, MD, Society of Vascular Surgery

Pablo Morales, MD, US Food and Drug Administration

Josh Smale, Beckton-Dickinson Peripheral Intervention

Members of the RAPID Governance, Access & Data Sharing Working Group are exploring the principles & guidelines for the governance, provisioning, sharing and uses of aggregate, multi-sourced datasets. This includes data sharing with industry, data protection requirements and cost, value, & use by each RAPID data partner.

Key Responsibilities:

  • Evaluate data governance and provisioning guidelines & recommendations of RAPID data partners
  • Develop principles/guidelines for publications based on analysis of aggregate RAPID data set
Protocol Development & Registry-based Trial Framework


Daniel Bertges, MD & Jack Cronenwett, MD University of Vermont & Society of Vascular Surgery, Vascular Quality Initiative

Mitchell Krucoff, MD Duke University

Aaron Lottes, PhD Cook Medical

Misti Malone, PhD, US Food and Drug Administration

Melanie Raska, Boston Scientific

Members of the Protocol Development working group are developing research proposals to demonstrate use of patient-level data for the RAPID core data elements extracted from RAPID data partners and used to support regulatory applications.

Key responsibilities:

  • Develop statistical analysis plan (SAP) for the SPEED Objective Performance Goal
  • Define covariates and endpoints for SPEED
  • Identify variables from RAPID data partner to support the SPEED SAP
  • Provide leadership and support for the data transfer and analysis for the SPEED OPC
Educational Outreach


Brian Fortier, Aorta Medical

Robert Thatcher, 4C Medical Technologies

Pablo Morales, MD US Food and Drug Administration

Mitchell Krucoff, MD Duke University

Members of the Educational Outreach working group are developing a value plan, raise awareness, and increase visibility across the medical device ecosystem.

Key activities:

3 Major U.S. Societies / Registries

American College of Cardiology (ACC)

  • National Cardiovascular Disease Registry (NCDR)

Society of Interventional Radiology (SIR)

  • National Interventional Radiology Quality Registry (NIRQR)

Society for Vascular Surgery (SVS)

  • Vascular Quality Initiative (VQI)

7 U.S. Federal Agencies

  • FDA (CDRH pre- and post-market, and CEDR)
  • Agency for Healthcare Research and Quality (AHRQ)
  • Centers for Medicare and Medicaid Services (CMS)
  • Department of Defense (DOD) Healthcare Resources
  • Office of the National Coordinator (ONC)
  • National Heart, Lung and Blood Institute (NHLBI)
  • National Library of Medicine (NLM)

12 Peripheral Vascular Device Manufacturers

  • Abbott
  • Aortic Medical Inc.
  • Bard Peripheral Vascular
  • Boston Scientific
  • Cardiovascular Systems Inc.
  • Cook Medical

16 Related Companies / Organizations

  • Association for Healthcare Resource & Materials Management (AHRMM)
  • Boston Biomedical Assoc.
  • Cerner
  • Cognitive Medical Systems
  • Deloite Healthcare
  • Device Events
  • Epic
  • First Database, Inc.
  • Global Healthcare Exchange
  • Healthjump Inc.
  • M2S
  • MedStreaming
  • NEST
  • Novella Clinical, Quintiles
  • PCPI
  • Pharm3r
  • UltaMed Corp. INC Research

Phase III

RAPID Phase III- Pathways Mission:
• Provide a pre-competitive, neutral ground in which to convene and facilitate collaboration among multiple independent stakeholders that have interest in peripheral arterial disease (PAD) device evaluation
• Support the safe, efficient and informed prospective use and evaluation of PAD devices in clinical practice and clinical trials throughout their lifecycle
• Promote and utilize coordinated PAD registry networks in the assessment of PAD devices
• Facilitate the alignment of strategies, analytics and reporting in order to achieve a more expeditious and informative signal discernment of PAD devices including drug eluting technologies
• Promote principles of leaner and more efficient prospective and retrospective device safety/benefit PAD device evaluation and potentially generalizable beyond PAD devices in alignment with RAPID’s designation as a NESTcc Demonstration Programs

RAPID Phase III Working Groups

LEAN CRF for Peripheral Studies Working Group

Leadership Team:
Dr. James Black, Vascular & Endovascular Surgery Society (Chair)
Dr. Antonio Gutierrez, Duke University Health System & Durham Veterans Administration (Co-Chair)
Dr. Donna Buckley, U.S. Food and Drug Administration (Co-Chair)
Nina Deno, Cook Medical (Co-Chair)
Caroline Morgan, RN Society for Vascular Surgery Vascular Quality Initiative (Project Leader)

Work Product:
Develop a consensus, harmonized case report form (CRF) for randomized controlled trials or coordinated registry network studies of peripheral arterial disease devices (PAD) using the RAPID PAD specific core data elements as a foundation updated with reference to more recently reported studies.

SMART CRF for Peripheral Studies Working Group
Leadership Team:
Dr. James Tcheng, Duke University (Chair)
Dr. Alan Matsumoto, America College of Radiology (Co-Chair)
Dr. Asiyah Yu-Lin, U. S. Food and Drug Administration (Co-Chair)
Dr. Ted Heise, MedInstitute (Co-Chair)
Rebecca Wilgus, MSN Duke Clinical Research Institute (Project Leader)
Work Product: Through consensus across patient, clinician, informatics, industry and regulatory sectors, we will develop a set of tools and artifacts that will enable the capture, aggregation and analysis of high quality, real world data for the evaluation of peripheral vascular interventional devices. This will be accomplished by leveraging informatics and data science to specify clinical concepts as interoperable discrete data elements, augmenting the predicate work of the RAPID core common peripheral arterial disease (PAD) terminology set with information provided by patients and with healthcare administrative data, and ultimately enabling analytics via the specification of a RAPID Common Data Model built upon existing data models such as Sentinel and PCORNet.
Patient Science (Patient Preference & Patient Reporting Outcomes) Working Group
Leadership Team:
Dr. Danny Bertges, Society for Vascular Surgery, Vascular Quality Initiative (Chair)
Renee Mitchell, Boston Scientific (Co-chair)
Dr. Jessica Simons, Society for Vascular Surgery, Vascular Quality Initiative (Co-chair)
Dr. Shelby Reed, Duke Clinical Research Institute (Co-chair)
Dr. Michelle Tarver, U.S. Food and Drug Administration (Co-chair)
Dr. Dan Stephens, Boston Scientific (Project Leader)

Work Product:
The Patient Science Work Group will:
1) Develop and present content for a “Patient Science 101” interactive webinar to the RAPID community with a timeline of one to three months.
2) Develop recommendations for peripheral arterial disease (PAD) for patient reported outcomes and incorporate into coordinated registry/research networks that meet the needs for clinical and regulatory usage within a timeline of three to six months.
3) Complete a retrospective review of prior and existing industry sponsored device trials that have included patient reported outcomes (PROs) to analyze responsiveness of instruments such as the VQ-6 with a timeline for this of six to eighteen months.
4) Plan a prospective study of PRO data elements within a clinical registry with a timeline of one to two years.
5) Execute a patient preference study to examine the tradeoff between the predicted longer durability versus the potential for late mortality after treatment with a device with a timeline of one to two years.

Signal Discernment Analytics & Biostatistics Working Group (SANEST)
Leadership Team
Dr. Danica Marinac-Dabic, U.S. Food and Drug Administration (Chair)
Dr. Christina Mack, IQVIA (Co-Chair)
Mary Beth Ritchey, MedTechEpi (Co-Chair)
Roseann White, Syntactx (Co-Chair)
Marta Steliac, U.S. Food and Drug Administration (Project Leader)

Goals: The Safety Signal Discernment and Biostatistics (SANEST) Working Group (WG) will develop multi-stakeholder consensus on best methodologies to evaluate peripheral arterial disease (PAD) devices through incorporating lessons learned from the paclitaxel (PTX) signal. This work will be informed by application of robust epidemiologic approaches to PTX signal refinement and signal evaluation.
Deliverables: Specifically, the WG deliverables will include consensus-driven Statistical Analysis Plans (SAPs) to help guide future PTX analyses, PTX-relevant decision trees, practical summaries and reference libraries. In addition, a portfolio of the PTX signal driven epidemiologic and statistical approaches will be submitted for publication in a special methodological supplement of a major international peer-review journal. It is anticipated that these foundational principles will be applicable to the specific PTX signal, other signals and other clinical areas.
Portfolio of efforts: The overall work informing the development of SAPs has been focusing on the best approaches to evaluate magnitude and clinical significance of signal and describe similarities and differences in statistical methods and best practices to refine and understand identified signal in real-world and Randomized Control Trials data. In the PTX context, the WG will offer best methods to (1) assess data quality, construct cohorts, and leverage data driven methodologies including Artificial Intelligence/Machine Learning/Block Chain capabilities for signal refinement; (2) assess and understand impact of missing data and how/when to apply instrumental variable analyses, sensitivity analyses and imputation (3) assess and manage misclassifications (4) apply statistical considerations to develop, assess and inform predictive models; and (5) to use this signal refinement and evaluation to inform benefit/risk assessments.

Collaborative Paclitaxel (PTX) Projects Working Group
Leadership Team:
Dr. Kenneth Rosenfield, Multi-Specialty Coalition on Paclitaxel (Chair)
Dr. Sara Royce, U. S. Food and Drug Administration (Co-Chair)
Dr. Andrew Farb, U. S. Food and Drug Administration (Co-Chair)
Dr. Aaron Lottes, Cook Medical (Co-Chair)
Rebecca Wilgus, MSN Duke Clinical Research Institute (Project Leader)

Work Product: This workgroup will share collective knowledge regarding industry-sponsored and independently conducted studies of peripheral paclitaxel (PTX) devices, will examine the landscape of ongoing studies and determine when new meaningful data will become available. This information will be used to inform the reevaluation of global PTX data by the US FDA and other stakeholders. Lessons learned and gaps in data will be identified, and recommendations for future trials, including design, conduct, and data analysis, will be shared. The workgroup will publish a comprehensive white paper focused on a lessons learned from paclitaxel research.

Participating Organizations

National Initiatives

NESTcc identifies and selects key demonstration projects to provide proof of concept for scalable approaches to evidence generation across device types and across the total product life cycle. Early NESTcc Demonstration Projects are studies that contribute to the field of Real-World Evidence (RWE) within the medical device ecosystem. These projects range in size and scope but will:

  • Develop, verify, and operationalize methods of evidence generation and data use in the pre- and post-market space
  • Demonstrate scalability across healthcare systems, device types, and manufacturers
  • Demonstrate impact on patients by stimulating innovation in medical device innovation and decreasing the timeline for development and market launch
  • Inform NEST’s strategy as it builds out critical functions and processes for a future sustainable organization

Demonstration Projects

Demo Projects Press Release



Malone, M. (2018). SPEED: A New Initiative in Real-World PAD Evidence Evaluation. An overview of the FDA’s new multistakeholder project to support real-world evidence evaluation for devices aimed at treating peripheral artery disease. Endovascular Today 17.9 (2018): 57-60.

Registry Assessment of Peripheral Interventional Devices (RAPID) Phase II Global Unique Device Identification (GUDID)/Informatics Work Group Summary

Shuren, J., & Califf, R. M. (2016). Need for a National Evaluation System for Health Technology. Jama. doi:10.1001/jama.2016.8708

Morales, J.P.,  Cronenwett, J, Thatcher, R. (2016). Registry Assessment of Peripheral Interventional Devices (RAPID). Endovascular Today 15.8 (2016): 85-94.

Jones W.S., Krucoff M.W., Morales P., Wilgus R.W., Heath A.H., Williams M.F., Tcheng J.E., Marinac-Dabic J.D., Malone M.L., Reed T.L., Fukaya R.Lookstein R.A., Handa N., Aronow H.D., Bertges D.J., Jaff M.R., Tsai T.T., Smale J.A., Zaugg M.J., Thatcher R.J., Cronenwett J.L. Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements. (2018). NCBI PMID:29389426

W. Jones-Mitchell Krucoff-Pablo Morales Registry Assessment of Peripheral Interventional Devices (RAPID)― Registry Assessment of Peripheral Interventional Devices Core Data Elements. (2018). Journal of Vascular Surgery,82(2), 316-322.


Learning UDI Community

The following Learning UDI Community work groups are active:

  • Catalog Number Fields: This work group will focus on the importance of catalog numbers in GUDID information.
  • Clinically Relevant Size: This work group will discuss how to make the GUDID more useful and what device size types and Units of measure to capture.
  • Search Criteria for High Risk Implants: This work group is being charged with developing a more user-based set of search criteria that would be run against AccessGUDID and return a search result to document implants in health IT— including those working with the automated billing process—and to be shared publicly.
  • Device Categorization: GMDN/SNOMED Terminologies: This work group should review the pros and cons of GMDN and SNOMED terminologies and review findings of preliminary pilot exercises (RAPID), while also recognizing that additional vocabularies for medical devices, such as UMDNS, UNSPSC, or others, may provide value to GUDID device data and NEST priorities.
  • Medical Devices Containing Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P): The work group will focus on the tracking of medical devices containing HCT/P through the entire supply chain and will engage participants from all parts of that chain to develop educational material and guidance to address the issues described in the summary.
  • UDI Benefits to Healthcare Supply Chain Processes: This work group will develop five important workflow processes as they currently work without UDI and then contrast these to future workflows where UDI is incorporated in hospital information systems and operations.
  • UDI Capture: The ultimate goal of this work group is to identify opportunities for case studies, initiate them, and bring answers to the greater Learning UDI Community to foster learning and hopefully, shorten the adoption curve for capturing UDI’s within healthcare.
  • UDI Single Use Device (SUD) Packaging Exception and Distributor Low Unit of Measure Programs: The work group will explore cost effective and sustainable solutions around labeling at the lowest unit of measure/unit of use—where technically feasible—devices that meet the UDI final rule’s SUD packaging exception.
  • *Unit of Use: This is an “unmarked” or “virtual” Device Identifier (DI); assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. This is usually applicable to situations when the Device Count in the base package is >1. This work group is working to identify legitimate UoU cases where a UoU UDI is applicable (i.e., products/situations where you would absolutely need a DI for each widget within the lowest package level). These examples will help assist in a potential solution rather than requiring a UoU UDI for all products with multiple widgets/eaches.
    *denotes the group is full, and no longer accepting new participants.

MDEpiNet AUDI (SUDID) Working Group

The mission of the Augmented UDI (AUDI) workgroup is to provide the framework for expanding the FDA GUDID system to manage additional data about medical devices.

ONC Interoperability Proving Ground

The Interoperability Proving Ground (IPG) is an open, community platform where you can share, learn, and be inspired by interoperability projects occurring in the United States (and around the world).

NIH Collaboratory Knowledge Repository & Living Textbook

Supported by the Common Fund at the National Institutes of Health (NIH), the NIH Health Care Systems Research Collaboratory aims to improve the way clinical trials are conducted by creating a new infrastructure for collaborative research with healthcare systems. The ultimate goal is to ensure that healthcare providers and patients can make decisions based on the best available clinical evidence.


PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct comparative clinical effectiveness research efficiently by creating a large, highly representative network for conducting clinical outcomes research that directly involves patients in the development and execution of the research.


Sentinel is the FDA’s national electronic system which has transformed the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices.


The MDEpiNet 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.

Healthcare Services Platform Consortium

The Healthcare Services Platform Consortium (HSPC) is a provider-driven organization of leading healthcare organizations, IT vendors, systems integrators, and venture firms dedicated to unlocking the power of entrepreneurial innovation to improve healthcare outcomes. The mission of HSPC is to improve health by creating a vibrant, open ecosystem of interoperable applications, knowledge, content, and services.

2016 Planning Board Report

Better Evidence on Medical Devices: A Coordinating Center for a 21st Century National Medical Device Evaluation System.

Duke-Margolis Center

The Duke-Margolis Center brings together capabilities that generate and analyze evidence across the spectrum of policy to practice, supporting the triple aim of health care – improving the experience of care, the health of populations and reducing the per capita cost.


The Clinical Information Modeling Initiative (CIMI) is an international collaboration dedicated to providing a common format for detailed specifications for the representation of health information content. In this way semantically interoperable information may be created and shared in health records, messages, and documents. The mission of the CIMI is to improve the interoperability of healthcare systems through shared implementable clinical information models.

The PEW Charitable Trusts Medical Device Initiative

Pew’s medical device initiative seeks to enhance medical device safety and foster device innovation that benefits patients. Pew’s initiative has three main areas of focus, including:

  • Improving the current state of medical device registries—databases containing information on patients who use or are treated with a specific device;
  • Supporting the adoption of a unique device identification (UDI) system to better track medical devices; and
  • Fostering medical device innovation with these and other new approaches without compromising patient safety.


The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI).

ACC/AHA 2012 PVD data standards

The data standards covered in this document are divided into 6 distinct tables. The first table covers general data elements common to all PAVDs, including demographic information, atherosclerotic risk factors, concurrent atherosclerotic diseases, comorbid conditions, medications, the cardiovascular examination, and relevant blood chemistries and hematology. The remaining tables cover data standards specific for lower extremity PAD, AAA, renal artery disease, mesenteric artery disease, and extracranial carotid and vertebral artery disease, respectively. Each of the disease-specific tables includes the following data elements: medical history, physical examination, laboratory testing, diagnostic procedures, invasive therapeutic procedures (both endovascular and open surgical), pharmacological therapy, follow-up, and outcomes.

PARC PVD data standards 2015

Evaluation and Treatment of Patients With Lower Extremity Peripheral Artery Disease. Consensus Definitions From Peripheral Academic Research Consortium (PARC). The PARC, together with the U.S. Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, has developed a series of pragmatic consensus definitions for patients being treated for peripheral artery disease affecting the lower extremities. These consensus definitions include the clinical presentation, anatomic depiction, interventional outcomes, surrogate imaging and physiological follow-up, and clinical outcomes of patients with lower-extremity peripheral artery disease. Consistent application of these definitions in clinical trials evaluating novel revascularization technologies should result in more efficient regulatory evaluation and best practice guidelines to inform clinical decisions in patients with lower extremity peripheral artery disease.


The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization. It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.


The Society for Vascular Surgery® (SVS) is a not-for-profit professional medical society, composed primarily of vascular surgeons, that seeks to advance excellence and innovation in vascular health through education, advocacy, research and public awareness.

VQI registry

The Vascular Quality Initiative (VQI) is a collaborative of regional quality groups collecting and analyzing data in an effort to improve patient care. The VQI collects perioperative and one-year follow-up data to generate real-time benchmarked reports to assess quality of care and determine best practices in vascular surgery.


The Society of Interventional Radiology is a national organization of physicians, scientists, and allied health professionals dedicated to improving public health through disease management and minimally invasive, image-guided therapeutic interventions.

RAPID Meetings