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SEL Number:
09ME-03-DEAE
Title:
Defibrillator, Automated External
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Last Updated:
11/30/2023 2:08:18 PM
Previous SEL Number:
09ME-03-DEAE
Description:
Simple device that enables rapid application, automated assessment, and (when necessary) delivery of corrective electrical impulse for lethal cardiac dysrythmias. Use of AED by practitioners with minimum or no training.
ImportantFeatures:
Water resistance, if product will be used in or near water rescue operations.
Operating Considerations:
Consider ease of use for practitioners with minimal or no training. Consider products with clear, concise voice prompts; products with automated data storage and download features; products providing interoperability with advanced cardio/defibrillation devices. Consider adult/pediatric applications; weight and storage requirements; disposal cost of adjuncts/electrodes. These devices require special batteries supplied by manufacturers. Note battery life and need for electrical recharging units during protracted incidents. See also 09MS-06-PROB.
Training Requirements:
Core Training: ASTM F1031-22,
NFPA
National Fire Protection Association
450,
NFPA
National Fire Protection Association
470 (within medical scope of practice).
Initial Training: Minimal (<1 day)
Sustainment Training: Minimal (<1 day) per certification cycle
Mandatory Standards:
Applicable Standards and References:
21 CFR 870.1025 (FDA), Arrhythmia Detector and Alarm (including ST-segment measurement and alarm)
21 CFR 870.5300 (FDA), DC-defibrillator (including paddles)
ASTM F1031-22 Standard Practice for Training the Emergency Medical Technician (Basic)
NFPA 450: Guide for Emergency Medical Services and Systems, 2021 Edition (planned for incorporation into NFPA 455)
NFPA 470, Hazardous Materials/Weapons of Mass Destruction (WMD) Standard for Responders, 2022 Edition
MSSL:
HazMat: Response Team
Maritime
Law Enforcement Mobile Field Force
Preventive Rad/Nuc Detection
Law Enforcement: SWAT/Tactical Team
Basic Life Support
Advanced Life Support
Pre-Hospital
Hospital
Medical Disaster Stockpile
Mass Care / Shelter