SMART Medical Device Informatics

SMART Medical Device Informatics Think Tank Meeting
Improving device data capture in electronic health information
A Specific, Measurable, Achievable, Results-oriented Time-bound Collaboration

February 24-25, 2015
Agency for Healthcare Research and Quality Headquarters
Rockville, MD

Preliminary Summary

February 24
Improving structured device data capture: The current landscape

8:00-8:30 am – Continental Breakfast

8:30-8:45 am – Welcome & Introductions

8:45-10:00 am – Plenary: Building a SMART medical device data capture infrastructure
Purpose of this Session: To highlight key National initiatives that will inform prioritization of Think Tank projects and set a common vision and goals for expected outcomes over the two-day session

Sharing Knowledge to Improve Device Data Capture
Purpose of the Use Case Sessions: To review the use case areas and specific vignettes that provide the basis for the Think Tank Day 2 demonstration project discussions. Knowledge sharing sessions will be used to discuss and highlight reason for initiating project, impact on cost, quality and patient outcomes, best practices, common barriers, and elements of these projects to incorporate into day two demonstration projects and action plans.

10:00-11:00 am – Use Case One – Capturing device attributes
Session Leader: Mike Schiller
Description of Use Case: Capture and exchange of core device identification information within the healthcare provider environment for use as a master source to consistently identify the device in all downstream systems and processes.

11:00 am-12:15 pm – Use Case Two – Making the link between the patient and device
Session Leader: Natalia Wilson/Joseph Drozda
Description of Use Case: Link of structured device and patient data during a procedure into a patient-device data capture system including ability to exchange data with other systems that support linkage between procedure, device and patient.

12:15-12:45 pm – LUNCH (Demonstration Project Posters/Demos/Reviews)
Purpose of this Session: Use time to network and to view/discuss posters that outline National and International device ecosystem and demonstration efforts – comparison of different options.

12:45-1:30 pm – Use Case Three: Obtaining structured device data from implantable device output
Session Leader: Terrie Reed
Description of Use Case: Exchange of device information from device itself to/from patient-device data capture systems.

1:30-2:30 pm – Use Case Four: Extracting structured device data collected in previous uses cases for downstream system use
Session Leader: Marc Overhage
Description of Use Case: Input and exchange of patient and device information from source systems to a secondary source (e.g. Registry, AE Report or Clinical Trial). This may/may not include addition of supplemental data for purpose of populating secondary source.

2:30-2:45 pm – BREAK

2:45-3:45 pm – Environmental Review: Opportunities for device data engagement
Session Leader: Ed Hammond
Purpose of this Session: To provide overviews of related health data capture and downstream analysis initiatives and explore opportunities for engagement of device stakeholders and use cases in these efforts.

3:45-4:30 pm – Panel discussion of obstacles/lessons learned; Preparation for day 2
Session Leader: James Tcheng
Purpose of this Session: To summarize common themes heard in project summaries and help set priorities on the most important issues to address in Day 2 breakout sessions. Set expectations for Day 2 outcomes and ideas for path to success including envisioning the end to end environment.

4:30-5:00 pm – Preparation for Day 2

  • Review purpose of Day 2 breakout sessions and solicit comments
    • Distribute action plan ideas and common questions to be discussed
    • Define expected outcomes
    • Ensure that initial session assignments are known
    • Feedback to Session Leaders

February 25
Development of Action Plans for Pilot Projects
8:30 am – 3:30 pm

Facilitators for Overall Group Discussions – Mitchell Krucoff, Karen Conway

8:30-9:00 am Overview of Day’s Exercises
Summary of Day 1 – Review of Project/Issue Matrix: Participants will initially meet in a main room where there will be a recap of Day 1 Common Issues/Lessons learned and sharing of any last minute changes to the Breakout Session format.

9:00-10:30 am Use Case Discussions – Breakout Session Rooms by Use Case (see nametag for assignment)

Purpose of this Session: Provide time for interested parties in each Use Case area to discuss their projects in more detail and prepare Use Case Worksheets used as a reference for development of pilot project plans.

Breakout Session Leaders and scribes will be assigned to assist participants to meet the goals of the use case session. Leaders and scribes will receive session guides to assist in achieving objectives and preparing for development of action plans.

10:30-10:45 am – BREAK

10:45-11:30 am – Group Session: Discussion and Action Plan Area Assignment
Purpose of this Session: To review potential project areas and compile learnings from use case discussions to define collaborative grouping and begin work on pilot project plans. Participants will work with session leaders to select area of Interest. Potential areas for consideration:

Action Plan Area #1

PREREQUISITES: Define and resolve what is needed at the foundational level to facilitate generalizable medical device data capture and exchange across the healthcare ecosystem – from time of device manufacturer to time device is removed from patient or patient dies. Examples include:

  • Access to Master Device Identification Data
  • Infrastructure to support Device Data Capture and Exchange (bar code readers, codesets like SNOMED-GMDN, requirements for adding UDI/device identification fields in HIT systems)
  • Development of business value propositions for C-Suite support for demonstration projects
  • Funding source support for pilots
  • Vendor support for demonstrations – Consortium as means to provide common requirements

Action Plan Area #2

FLOW: Create a pilot plan to demonstrate that device information can be captured and exchanged from ‘barcode to bedside and beyond’ that can easily iterate, be generalizable and inform long term device analysis and evaluation of performance.

  • Include representatives from multiple stakeholder groups
  • Define business, clinical, and technology requirements – high level
  • Starting w/ existing projects, identify where current project work is happening or is already planned to happen
  • Identify opportunities to develop new projects that will advance current work and/or fill unmet needs

Action Plan Area #3

EVALUATION/ANALYSIS: Advance the capacity to leverage/exploit/analyze the data that’s available from medical devices for use in public health surveillance.

  • By device type, what data is available? What standards are available
  • What additional data must be leveraged such that analysis for public health surveillance can be performed
  • Where does that data come from (assuming it exists)
  • What tools and technologies are needed to create and use the resulting analysis datasets

11:30 am-12:30 pm – Form into Initial Action Plan Groups

  • Identify Potential Collaborators
  • Scope of Pilot to be defined
  • Begin planning discussions

12:30-1:15 pm Lunch

1:15-2:30 pm Commitment to Action Planning

  • Complete pilot project plans including proposed timelines and commitments to the work.

2:30-3:00 pm Report out of Action Plans by each Group

3:00-3:30 pm Final Summary of Proposed Action Plans and Next Steps


Our Vision

MDEpiNet Public Private Partnership provides global leadership in innovative data source development and analytic methodologies to enhance regulatory science applied to medical device research and surveillance.

Our Mission

To bridge evidentiary gaps, to develop datasets and innovative methodological approaches for conducting robust analytic studies to improve medical device safety and effectiveness understanding throughout the device life cycle.

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