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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.
YOU MUST HAVE MEDICAL AUTHORIZATION
TO LEGALLY PURCHASE AN AED
WE
PROVIDE FREE MEDICAL AUTHORIZATION
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.
RECEIVE PRESCRIPTION, ONLINE TRAINING & ONE
YEAR MEMBERSHIP IN OVERSIGHT PROGRAM
FREE WITH PACKAGED UNIT
ONE YEAR OVERSIGHT
MEMBERSHIP 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
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