Approved Medical Devices

AED Selection & Purchase Specifications

Automated external defibrillators (AEDs) are classified by the U.S. Food and Drug Administration (FDA) as restricted devices and require labeling stating these devices are restricted “to use by or on the order of a physician.”  Medical devices such as AEDs generally require a physician serving as the medical director or medical oversight for the person or organization purchasing and/or operating the devices in order to achieve compliance with FDA rules regarding the sale and use of these restricted devices. 

All agencies and organizations purchasing and using AEDs under the Medical Direction or Medical Oversight of the Austin/Travis County Office of the Chief Medical Officer (OCMO) must purchase AEDs meeting the current Selection & Purchasing Requirements effective February 14, 2023. Contact the OCMO AED Coordinator for specific guidance on Approved AED devices for Public Safety Agencies under OCMO medical direction. OCMO no longer approves specific AED models for public access AED’s. Instead, OCMO now provides very specific design, feature and configuration requirements for AEDs.

AED Purchasing Guidelines

In an effort to expedite the purchasing of new AED’s for public access deployment, the following criteria has been established for public safety automatic external defibrillators (AED’s).
1.    Must be FDA approved;
2.    Must operate within current AHA guidelines;
3.    Must provide audible & visual instructions for pad application;
4.    Must provide audible step by step instructions;
5.    Must provide real-time CPR bio feedback;
6.    Must be able to be utilized on adult and pediatric patients;
7.    Must allow for the export of data for quality improvement initiatives.

Previously approved devices currently in operation may remain in operation until the end of their existing service life, provided they are able to be kept current with existing AHA guidelines and appropriately maintained in good working condition. 

Public Access Defibrillation Programs (PADs)

The Office of the Chief Medical Office can help guide you through the PAD Program process if your organization is within the City of Austin or Travis County. Please use the following link to learn more: PAD Program Information

Approved AED's for Public Access

The following devices have been evaluated and are pre-approved by the Chief Medical Officer.
•    Zoll AED 3 BLS
•    Cardiac Science Powerheart G5
•    HeartSine Samaritan PAD 450P Aviation AED

Maintenance & Upkeep

All AEDs are inspected and maintained in accordance with the manufacturers’ recommendations.  Anytime an AED fails to meet any of the visual inspection items noted below, the AED will be immediately removed from service until it is ready for use.

Once per month, the floor safety captain or building manager should conducts and documents a visual inspection of the AED to ensure: 
•    AED is in a ready status
•    AED pads are present, unopened, not expired and in the required quantities
•    AED battery is not in indicating a need for replacement and is not expired
•    No obvious AED damage is noted

AED readiness indicates the AED has passed its last self-test and the AED indicates it is ready for use. If upon inspection the AED Pads or device is within 90 days or expiration or required service, the building manager or purchasing authority for the device shall be notified so that supplies or maintenance can be ordered to ensure the device remains in service.