Questions regarding an AED

What is an AED?

An AED is a device used to administer an electric shock through the chest wall to the heart.  Built-in computers assess the patient’s heart rhythm, judge whether defibrillation is needed, and then administer the shock.  Audible and/or visual prompts guide the user though the process.

Why do we need AED’s?

The American Heart Association estimates that in the United States, over 400,000 people die every year from Sudden Cardiac Arrest (SCA), often because defibrillation, the only effective treatment for SCA, does not reach these victims in time.  The most effective weapon against SCA is defibrillation, which can be delivered with an automated external defibrillator (AED).

Why is calling 911 not enough?

Calling 911 is critical but often response time is not fast enough to save someone in cardiac arrest. In order to be effective, defibrillation must occur within minutes of SCA.  The chance of an SCA victim’s survival decreases by about 10 percent with every minute that passes.  Having an AED in close proximity increases the survival rate for SCA victims.

Can I hurt someone by using an AED?

The Philips AED analyzes the heart’s rhythm’s through the electrode pads placed on the victim’s chest and advises whether a defibrillation shock is needed.  Therefore, delivering a defibrillation shock requires very little decision making on the part of the rescuer.  Once the electrode pads are placed, it is a two-step process to deliver a shock.  To become a “certified user” of an AED, you usually must complete a training class.  Training is available through many organizations.  Most programs offer CPR/AED user certification with approximately four hours of classroom training.

What are Good Samaritan Laws?

Good Samaritan laws grant immunity to volunteers who assist strangers in emergency situations, including using an AED on another person.  These laws vary from state to state but generally limit or eliminate the liability of a volunteer rescuer.  Under most of these laws, liability is also limited or eliminated for the physician who provides medical authorization, the trainer and the deployment personnel, the premises owners and other enablers of an AED program.  Good Samaritan AED legislation has been passed in all 50 states and in the District of Columbia.  In addition, Federal Good Samaritan Legislation has been enacted under the Cardiac Arrest Survival Act (CASA).

Is there liability for failure to have an AED or an emergency response plan?

There have been lawsuits brought alleging negligence for failure to have AED’s and other elements of emergency response plans available.  Some of these actions have resulted in settlements of dismissal on technical grounds, but there has not been any definitive judicial ruling on this issue to date.  AED’s use is rapidly gaining acceptance as the standard of care.  Given the advances in AED technology, their low cost and their proven ability to save lives, it is possible that judges and juries may be more likely to sanction a business for failing to adopt an AED program.

Assessment of Risk

Any analysis of the legal liability risks associated with the deployment of any AED program should consider the following and any other issues that are relevant in your state or to your circumstances.

*A victim of sudden cardiac arrest (SCA) will die unless an external defibrillator is promptly used.  In some instances, the victim is already technically dead.  An AED, properly used, can only help.

*AEDs are easy to operate and difficult to misuse.

*Good Samaritan laws in every state limit liability.

*In addition to state laws, Good Samaritan protection is offered under Federal law.

*The failure to have an AED program may cause greater legal exposure than the potential misuse of one.  AED use is rapidly becoming the standard of care.

*Other laws such as Worker’s Compensation and Strict Products Liability may reduce liability for the organization implementing an AED program.

*Planned selection, maintenance, and training are key to successful deployment of an AED program.

Questions regarding emergency medical oxygen

1.  Why is emergency medical oxygen so important during a medical emergency?

Life-threatening medical emergencies are usually accompanied by low tissue oxygen levels (not enough oxygen supply to tissue and organs).  If this progresses, the brain will begin to die first, with other organs following.  Additionally, low oxygen levels to the heart may lead to cardiac arrest.  After AIRWAY, supplemental oxygen is the most important step of treatment.

2.  Who should receive emergency medical oxygen?

Any victim of potentially life-threatening illness or injury – without exception

3.  How is emergency medical oxygen employed?

For the victim who is breathing, emergency oxygen via a mask increases the oxygen concentration of the inhaled air.  For the victim who requires rescue breathing, emergency oxygen fed into a CPR mask enriches the oxygen concentration of the breath being blown into the victim by the rescuer.  In either case the amount of oxygen available to the victim is greatly increased.

4.  When should emergency oxygen be started?

Emergency oxygen should be started IMMEDIATELY AFTER a clear and open AIRWAY is established.  However, if there is a delay in retrieving an oxygen unit and CPR is required, conventional mouth-to-mouth (or mouth-to-barrier device) rescue breathing should be performed until the oxygen unit is available.  Use of an automated external defibrillator (AED) obviously takes priority over oxygen (and should be administered as soon as possible). However, oxygen may greatly enhance the effectiveness of defibrillation.

5.  Can oxygen ever be harmful in a medical emergency?

Oxygen is NEVER harmful during a medical emergency.  It always enhances the likelihood of a better outcome for the victim.  The potential harmful effects of oxygen occur after prolonged use (more than 5 hours).  New research (started in the 1980’s) and publications find that oxygen DOES NOT suppress respiratory drive, and is important to ALL victims of sudden life-threatening illness or injury.

6.  Will emergency oxygen substitute for rescue breathing?

NO!  In the non-breathing victim, application of oxygen without rescue breathing will not benefit the victim.  It must be coupled with rescue breathing via a resuscitation mask or an oxygen/bag valve mask combination.

7.  Is oxygen still needed after the arrest victim revives from CPR/AED?

YES!  Oxygen should be continued until the EMS arrives.  Maintaining oxygen on the revived victim may prevent relapse into cardio respiratory arrest.

8.  Is oxygen still needed after the victim who is breathing improves or “recovers”?

YES!  Oxygen should be continued until EMS arrives.  Maintaining oxygen on the improved or “recovered” victim may prevent relapse into cardio respiratory arrest.

9.  Will emergency oxygen substitute for the Heimlich Maneuver?

NO!  The airway must be cleared of the obstructing food or object.  Oxygen alone will not help the victim.  Once the obstruction is cleared (A=Airway), oxygen should be applied to aid in recovery.

10.  If I am not sure whether the victim is breathing, should I perform rescue breathing, or should I put the oxygen mask on the victim and wait and see?

If it is unclear as to whether the victim is breathing or not, start rescue breathing (preferable with emergency oxygen).  By responding in this manner you will not harm the person if he/she is breathing.  However, do not put an oxygen mask on and “wait and see” if they are breathing.  If breathing is too little or not moving any air (agonal) they may deteriorate to full arrest.

11.  If the victim has not had a respiratory or cardiac arrest but appears to have difficult breathing, should I apply emergency oxygen?

YES! If the victim has labored breathing applying emergency medical oxygen is one of the most important responses you can make to potentially prevent an arrest.

12.  If the victim cannot tolerate the oxygen mask on his/her face what should I do?

Hold the mask adjacent to the face.   Much of the oxygen will still get into the victim’s mouth and nose.

13.  Does emergency oxygen require a doctor’s prescription?

NO!  Oxygen is a drug when it is given in concentrations beyond what is ambient air and when used for medical treatment.  The Food and Drug Administration (FDA), the regulating government agency for oxygen, requires a prescription for medical oxygen, but has EXEMPTED this requirement for emergency applications since 1972.  Since September of 1996 the FDA requires all medical oxygen sold in the U.S. to bear the following statement on the label: “For emergency uses only when administered by properly trained personnel for oxygen deficiency and resuscitation.  For all other medical applications, CAUTION:  Federal law prohibits dispensing without a prescription.

In order to be considered as an over-the-counter (OTC) device, i.e. “non-prescription”, the oxygen device must provide a minimum flow rate of 6 liters per minute for a minimum time of fifteen minutes.

14.  Who can provide emergency oxygen?

Anyone properly instructed in its use (listed in the above FDA labeling requirement).  FDA, FAA, OSHA and other concerned agencies DO NOT determine what constitutes proper training.  Providers should be familiar with the manufacturer’s directions and instruction materials.

15.  What are the legal requirements for maintaining an emergency oxygen unit?

Federal regulations (under DOT) regarding refillable oxygen cylinders require hydrostatic testing of the cylinder every five years (but only if and when the cylinder is refilled).  This is accomplished by the refilling agency.  Unless you are a certified refilling site, you should NOT refill your own cylinders.  Disposable cylinders do not have this requirement, but MUST NOT be refilled under any circumstances.

16.  Isn’t oxygen dangerous?  Can’t it catch fire and explode?

Oxygen does not “catch fire” or explode!  It supports and accelerates combustion.  Oxygen is perfectly safe when handled and used properly.

17.  How much oxygen should I have on-hand?

A good rule of thumb is to determine what the average EMS response time is to your facility and have enough to last twice as long as the response time.  In most circumstances one half hour to one hour supply is sufficient.

18.  Does OSHA have any specific regulations regarding emergency oxygen?

NO! It must be stored and handled in compliance with all compressed gases.

19.  What about the OSHA Bloodborne Pathogen policy (CFR Title 29. part 1910.1030)?

Although it is not specifically a part of the standard, it is important to follow the standard should your unit or its components (i.e. CPR mask) become contaminated with blood or other potentially infectious materials, and dispose of or clean as required.

20.  If I am not sure whether to give emergency oxygen, what should I do?

GIVE IT!  It is far better to over-use it than to under-use it and miss the opportunity to improve the victim’s condition.  REMEMBER, it is not harmful and may save a life!

Ohio Board of Pharmacy Statement and Policy

Ohio State Board of Pharmacy
77 South High Street, 17th Floor
Columbus, Ohio 43266-0320
08/04/95-             RECORD OF PROCEEDINGS                      -016-


RES. 96-021

Medicinal Oxygen For Emergency Use By Laypersons (Non Medical Personnel!

WHEREAS, the present legal status of medical oxygen is that it is a prescription
drug and is required to bear the legend:  “Caution:  Federal Law prohibits dispensing
without a prescription.” and

WHEREAS, the Federal Food and Drug Administration’s Compliance Policy
Guide 7124.10 dated October 10,1980 provides that devices intended for the
administration of medical oxygen in an emergency may be sold over the counter
without a prescription provided such devices are designed so that they do not
pose a danger to the public if used by laypersons: and

WHEREAS, the Ohio Board of Pharmacy believes that it is in the best
interest of the citizens of the state of Ohio if such devices continue to be
readily available in emergency situations which may occur in such
places as the workplace, schools,and churches:  therefore

BE IT RESOLVED that the Ohio Board of Pharmacy does not recognize
such a dangerous drug provided that the device is labeled and/or
meets the criteria:

(1)   the device is promoted and sold for use by non-medical personnel
in the event of an emergency.

(2)   the device is designed to that it delivers a 6 liter per minute set
for at least 15 minutes without any adjustments needed by medically
trained personnel.

(3)   the device contains no more than 80 minutes (480 liters) of USP
Oxygen: and

BE IT FURTHER RESOLVED that such devices may be purchased
and sold 
without a prescription by persons not registered with the
Ohio Board of Pharmacy as a dangerous drug distributor.

Approved (Aye 8/Nay-0)