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The Dynamic AED Registry aims to provide postmarket surveillance of AEDs, offer valuable data, enable embedded studies on AED effectiveness, and surveil mobile MDs. Methods include linking to existing registries, crowdsourcing AED locations, utilizing unique codes, and more. Current status includes FDA approval for surveillance, ongoing scavenger hunts, and 5000+ AEDs reported.
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Dynamic AED RegistryJo Ann Broeckel Elrod PhDResearch Scientist, University of Washington-Harborview Center for Prehospital Emergency CareProject Director, Dynamic AED Registrybroeckel@uw.edu
Funding Disclosure • Food and Drug Administration, Silver Spring, MD; • Cardiac Science Corp, Waukesha, WI; • HeartSineTechnologies Inc., Newtown, PA; • Philips Healthcare Inc., Bothell, WA; • Physio-Control Inc., Redmond, WA; • ZOLL Inc., Chelmsford, MA. Investigator, Dynamic AED Registry.
Aims • To provide reliable, valid and sustainable postmarket surveillance of AEDs using UDI; • To provide important and timely information to patients, providers and others about quality of AEDs and quality of care for patients with OHCA; • To provide framework for prospective embedded studies of AED effectiveness; and • To provide a framework for surveillance of other MDs that are mobile in time and space.
Cumulative Sales of AEDs for Lay Use in United StatesNichol et al Circulation 2014 In Press
Methods • Link to existing municipal registries of AEDs in public locations • Crowdsource finding and reporting of AEDs via local scavenger hunt to increase proportion of AEDs registered • Apply unique 2D matrix code to each AED, then scan location and time into dynamic database. • Label rescanned when AED has clinical or non-clinical use.
Use of 2D Matrix Code As Unique Device Identifier for AED Surveillance Provisional Patent Assigned to UW # 61/498,424
Current Status • Grant of Authority from FDA for public health surveillance • Scavenger hunts running monthly across US • >5,000 AEDs reported • Able to link to clinical data