AEDs are manufactured and sold under guidelines approved by the Food and Drug Administration. Current FDA rules require someone who purchases an AED to present a physician's prescription for the device.

MINIMIZE LIABILITY WITH TRAINING, DOCUMENTATION, RECORD KEEPING & MAINTENANCE SCHEDULE

Facilities Generally Require

Post-event Service. We provide seamless transfer, storage, management, and reporting of AED patient data, with easy download, post-event clinical review, and transmission to the state EMS office, attending physicians, and others as appropriate.

STATE REGISTRATION AND NOTIFICATION
Some states require notification of the local EMS office about AED acquisition, while others require significant paperwork and registration fees. We help complete and file all forms and fees, inform you promptly of changes in regulations, and help ensure your program meets all local, state and federal requirements.

TRACKING AED PROGRAM DETAILS
We help you track information such as dates for training and for replenishment of electrode pads and batteries.

MAINTENANCE
General maintenance and supply replenishment are included, with just one number to call, and the assurance that problems will be efficiently solved.

Legal & Medical Requirements

Good Samaritan liability protection is different for responders and owners of AEDs.
Risk and liability are the two most compelling concerns for both organizations and responders when it comes to implementing an AED Program and even using the equipment.

To Purchase or Not to Purchase? That Is the Question!
All companies must evaluate risk versus reward for themselves when considering any program that affects employee and visitor welfare. You should speak with your organization's legal counsel and risk managers to determine what course of action is appropriate for you.

While there are significant risks to organizations with AEDs that do not comply with federal and state guidelines, there have been no judgments for negligent or improper use of an AED. Conversely, suits have been brought against organizations for failing to make an AED available to treat a victim of SCA.

While these suits are few and far between, standards of conduct are changing toward having AEDs available for use. In addition, common carriers, innkeepers and virtually all other commercial business establishments have a legal duty regarding negligence to conform to standards of conduct towards others. On a daily basis, we are seeing more organizations implement AED programs, from the federal government and multi-national conglomerates to school systems and communities.

Acquiring the AED
The FDA has classified AEDs as restricted medical devices. This means that to acquire an AED and comply with federal regulations, you must have a prescription from a licensed physician in the state where the unit will be located and physician oversight to use the device. In addition, state laws and regulations may also require that you register each unit with a state regulatory agency.

Legal Compliance for Owners of AEDs
Laws and regulations governing AED use and liability vary from state to state. It is important that any AED program you initiate meet both federal guidelines and the laws and regulations of the state(s) where your facilities reside. Some states provide few, if any requirements for owners of AEDs. Others outline strict requirements regarding medical oversight, documentation, training and record keeping. For example, some states, like Virginia, require training on a semi-annual basis. Others, like Maryland, require a backup battery and a third set of electrode pads.

Medical Oversight
Medical oversight is a key element that is often overlooked. Actual requirements vary from state to state, but in general, medical oversight helps assure that your program meets state requirements, that proper training has been performed, that correct response protocols are in place and that incident data is forwarded to the proper authorities.

Good Samaritan Liability Protection
You have probably heard about “Good Samaritan” laws. They protect people from legal liability for any harm caused when helping individuals in need. Many states have laws that provide this protection to AED users, and the federal Cardiac Arrest Survival Act extends protection to users in states that don't. But don't assume that this same protection automatically extends to owners of AEDs.

Good Samaritan legislation typically identifies two separate classes of people, those who own AEDs and those who use AEDs. Often, for AED owners to qualify for protection under Good Samaritan laws, certain requirements regarding training, equipment maintenance and documentation must be met. These requirements change on a state-by-state basis.

In addition, many of your employees won't know that they are covered by Good Samaritan legislation. The first rule of thumb in any emergency response is to protect yourself. It is important that you provide information to your responders regarding this legislation as it can help overcome hesitancy to assist those in need.

Minimizing Risk
Quite simply, you can minimize the risk your organization faces by implementing a complete, consistent program at all of your facilities. “General rules governing negligence cases suggest that organizations that carefully adopt and implement early defibrillation programs face a lower legal liability risk than those that do not."

As you begin to design your program, be sure that:

• All AEDs you acquire have a prescription, trained users and physician oversight. In addition, each unit may need to be registered with an oversight agency in the state that the unit is placed.
• You comply with the laws and regulations of the state in which the AED is located.
• You regularly service and maintain all of the equipment used during a response to an SCA so that it is in a constant state of readiness.
• You document all activities associated with the implementation, use, upkeep and management of the program for use as an audit trail.

OVERSIGHT PROGRAM AVAILABLE FOR $99 PER YEAR AND INCLUDES:

• 1) COORDINATING ISSUE OF PRESCRIPTION
• 2) COORDINATION AND NOTIFICATION OF LOCAL EMS
• 3) Q&A SUPPORT
• 4) SITE SURVEY AND PLACEMENT ASSISTANCE
• 5) EVENT REVIEW FOR ALL USAGES
• 6) ON SITE SERVICE AND FREE LOANERS
• 7) 24/7 CUSTOMER SERVICE
• 8) FULL PROMOTIONAL MATERIALS, I.E. WINDOW STICKERS, POS MATERIALS
• 9) MONTHLY SAFETY AND OPERATIONAL TESTING MONITORING
• 10) PUBLIC AND EMPLOYEE PRESS RELEASES & PUBLIC RELATIONS CAMPAIGN

OPTIONAL:

• 1) Online Training of Additional Employees
• 2) In House Training of Employees