RAPID- Registry Assessment of Peripheral Interventional Devices (RAPID)

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Registry Assessment of Peripheral Interventional Devices (RAPID) Working Group Meeting-
May 2, 2018

Event Agenda

Phase I Work Products: Click on Phase I tab below.

RAPID Initiative

Principal Investigators

Pablo Morales, MD, FDA

Robert Thatcher, 4C Medical Technologies

Jack Cronenwett, 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,

Katy Knowlin, DCRI

Sarah Palmer, DCRI

Rebecca Wilgus, DCRI

Contact

mdepinet@dm.duke.edu

 

 

 

 


RAPID emerged from the Predictable And SuStainable Implementation Of National (PASSION) Registries for Cardiovascular Devices program of the Medical Device Epidemiology Network (MDEpiNet), a public-private partnership supported by U.S. FDA funding to advance the nation’s approaches to the evaluation of medical devices.  It is one project in a series initiated to advance and support an interoperable flow of data and information across electronic health information systems with the intent to create a total product lifecycle (TPLC) approach to evaluate the medical device ecosystem.

RAPID is focused on devices for peripheral vascular intervention as an archetype of the envisioned TPLC ecosystem. A core minimum set of data elements related to the care and treatment of patients with peripheral arterial disease are being developed for use with data elements from the Global Unique Device Identification Database (GUDID) database to create a structured dataset that supports pre- and post-market assessment, quality improvement, and safety surveillance of peripheral interventional devices (Phase I). Subsequent phases will validate the data elements’ potential for implementation in various healthcare information systems such that structured, interoperable data is collected at the point of care and is available for use by patient registries, clinical research and medical device evaluation initiatives. Additionally, the RAPID data elements will inform the development of a global case report form and data collection instruments needed in the interim. As such, this work facilitates peripheral arterial device development, addresses regulatory needs, and creates efficiencies that will reduce overall time and costs and support quality improvement efforts across the medical device lifecycle.

Participants in RAPID include representatives of specialty societies, device manufacturers, electronic health information systems vendors, US FDA and other federal partners as well as international device registries and regulators.

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
  • NHLBI, NIH
  • Novella Clinical, A Quintiles Company
  • Quintiles
  • Spectranetics Corporation
  • Terumo
  • W.L. Gore

Phase II

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. Results will be shared at the May 2nd F2F WG meeting.

Register here for the RAPID WG Meeting

RAPID Phase II Working Groups

Informatics, Interoperability & GUDID Working Group

Co-Chairs:

Joe Drozda, MD Sisters of Mercy Health System

Ted Heise, PhD, MedInstitute

Behnaz Minaei & Terrie Reed, US Food and Drug Administration;

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

Co-Chairs: 

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

Co-chairs:

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

Co-chairs: 

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:

  • Educational Webinars
  • Press releases
  • Social media campaign

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

Under Construction

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

Publications

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.

Links

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

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

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.


BUILD

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.


OpenCIMI.org

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.

AccessGUDID

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.


IMDRF

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.


SVS

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.


SIR

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