M-CERSI Workshop – Envisioning the Future of Mobile Informatics
Isaac Chang, Ph.D.
Director
Division of Postmarket Surveillance
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Overview
I.
What DPS does…
II.
The Brick Model…
III. Where Social Media Fits…
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Division of Postmarket Surveillance
M-CERSI Workshop – Envisioning the Future of Mobile Informatics
What does DPS do?
Purpose:
•
To conduct global post-market surveillance of medical devices and related emerging technologies
through the regulation, collection, integration, and dissemination of adverse event data to identify and
communicate actual and/or potential public health risks to FDA and public stakeholders.
How we achieve our goal:
•
•
•
Establish, interpret, and enforce requirements for medical device reporting (21 CFR Part 803Medical Device Reporting); and provide outreach and education to FDA and public stakeholders to
help them understand the requirements of the medical device reporting regulation.
Monitor, analyze and synthesize adverse event data to identify signals (of new device issues) and
trends (of known device issues); and to ensure that CDRH effectively uses adverse event report data
in premarket review, postmarket evaluation studies, compliance and enforcement matters, and timely
public health communications in support of the CDRH mission.
Lead the continuous refinement and maintenance of the IT postmarket infrastructure to efficiently
receive, process, retrieve , and analyze adverse event data in support of CDRH and FDA offices.
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Division of Postmarket Surveillance
M-CERSI Workshop – Envisioning the Future of Mobile Informatics
Medical Device Landscape
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Division of Postmarket Surveillance
M-CERSI Workshop – Envisioning the Future of Mobile Informatics
Medical Device Landscape
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Division of Postmarket Surveillance
M-CERSI Workshop – Envisioning the Future of Mobile Informatics
Best Use of MDRs
• Qualitative profile of adverse events for a device or device type
– Device use in real world
– Types of malfunctions/clinical events.
– Vulnerable populations (i.e. Pediatrics, etc.)
• Monitor device performance
– Time to event and failure modes
– New types of issues with approved devices
– Monitoring long term device use
• Signal detection
– Rare, serious, or unexpected events
– Change in severity of expected events
– Use error/human factors issues
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Division of Postmarket Surveillance
M-CERSI Workshop – Envisioning the Future of Mobile Informatics
Context is Important…
Dow Jones Industrial Average
US Govt
unveiled
rescue of
AIG
Successive
Interest Rate
Drops
Stimulus
plan
Hurricane
Katrina
Tensions
Between
N. andS.
Korea
US loses
AAA Credit
Rating
TARP
9/11
War concerns
and bad
corporate outlook
Data Source: Timelines of History Database
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Division of Postmarket Surveillance
M-CERSI Workshop – Envisioning the Future of Mobile Informatics
The Brick Model
Social
Media
PERCEPTIONS
Orientation
Incentives
BEHAVIORS
Models
Patterns/
Mechanism
TRENDS
Forecasts
EVENT
Resource
Allocation
Interpretations
Signals
OUTPUT
OUTCOME
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Division of Postmarket Surveillance
M-CERSI Workshop – Envisioning the Future of Mobile Informatics
New approaches for Social Media
• Focus on the right target…
– What is happening ----> Why is it happening
– Confirmation of signals ----> Trend drivers
– What are we seeing ----> What should we be seeing
• Weather analogy
– College Park 86
– Dallas 94
– Chicago 67
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Division of Postmarket Surveillance
M-CERSI Workshop – Envisioning the Future of Mobile Informatics
Summary
• Big Data Analytics is always built around what you are trying
to find.
• The goal of analyzing Big Data is to re-focus efforts on the
right problems.
• Play to the strengths of social media – explaining behavior and
understanding how people think about issues.
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Division of Postmarket Surveillance