AED Legal Landscape
From federal guidelines outlined by the Food and Drug Administration (FDA) to state-specific Good Samaritan legislation, the web of regulations surrounding AED deployment, maintenance, and use requires meticulous attention. Organizations must carefully consider many factors, including proper device placement, adherence to training protocols, and compliance with both federal and state-level standards according to:
The FDA is a federal agency in the United States responsible for regulating and ensuring the safety and effectiveness of medical devices, including AEDs.
The AHA provides guidelines and recommendations for AED use based on scientific evidence.
Some jurisdictions may specify that individuals using an AED are protected under Good Samaritan laws only if they have undergone proper training in AED use and CPR.
AEDs in workplaces are subject to OSHA regulations, which is a federal agency in the United States that sets and enforces workplace safety and health standards.
State (and local) health departments establish specific guidelines and requirements for AED use within their jurisdiction.
Premedics Compliance Sync™
Our exclusive PremedicsMD™ service is the backbone of Compliance Sync™, providing essential medical director leadership and oversight. This service includes the necessary AED prescription, post-event services, and medical quality control to meet the stringent requirements of the FDA and state Good Samaritan legislation.
In the unfortunate event of an AED usage, PremedicsMD™ steps in to provide post-event services that exemplify our commitment to readiness. We offer overnight-shipped, ready-to-go, loaner AED units, ensuring your organization remains prepared and fully equipped even after an emergency.
As part of our commitment to ongoing compliance, Premedics takes charge of monitoring all AED recalls, corrective actions, manufacturer recommendations, and the latest science guidelines from the American Heart Association (AHA). This proactive approach ensures that your organization remains in sync with the evolving landscape of pre-EMS readiness, maintaining the immunity afforded by your state's Good Samaritan laws.
With Compliance Sync™
- Any AED software updates are installed for you
- All regulations from the AHA, FDA, and any other AED requirements are automatically adhered to
- AED regulations are monitored for changes and implemented automatically
- Doctor prescriptions are included
- Loaner AEDs are overnighted in the case of usage
- EKG event data is downloaded, reviewed, and shared with emergency responders
- Medical quality control
- Staff training certification tracking
- Peace of mind that your AED management program is compliant
Without Compliance Sync™
- Need to monitor and implement AED software updates independently
- You manage adherence to AHA, FDA, and other AED regulations
- Your team needs to check for regulatory updates and oversee implementation
- Doctors must be sourced and prescriptions requested to buy AEDs
- You must supply a backup AED device post-usage
- Your team downloads EKG event data and sends it to the appropriate parties for medical and emergency review
- Need third-party medical oversight
- Manual tracking of trained staff and certification expiration
- Time, energy, and stress keeping track of AED compliance
Malls are a great example of a large, heavy-foot trafficked, public space that must represent top-tier AED implementation. Failure to maintain compliance could not only result in death but also immense legal scrutiny. This Premedics client was put under pressure when police marched into their safety manager’s office demanding to see AED program information immediately. Their team called us, very panicked, unsure of what to do. The good news was that everything they needed was readily available in their Premedics system! Within 10 minutes, they had all AED usage and upkeep reports printed and in the police officers’ hands. The police instantly respected the clearly comprehensive readiness and were more than satisfied with their AED compliance.