Automated external defibrillators (AEDs) are used in public and by laypersons. These “Good Samaritans” often have little or no training, and yet, through the instructions provided with the AED device are able to revive an unconscious person experiencing sudden cardiac arrest (SCA).
Despite the fact that AEDs are meant for use by those with little or no training, the US Department of Health and Human Services (DHHS)’ US Food and Drug Administration (FDA) classifies these devices as Class III medical devices.
If you are not familiar, there are multiple factors involved with the classification of medical devices. These include:
- The length of time for which the device will be used
- If the device is surgically invasive or not
- If the device is active or surgically implantable
- If the device contains medicinal substances.
In general, Class I devices are considered to be the lowest risk of all the medical devices, and therefore they have the lowest level of regulatory control. Class III devices, such as an AED, however, are generally considered to be the most complex medical devices and therefore, require more stringent regulatory controls to provide assurance of their effectiveness and safety.
Being a Class III medical device, AEDs require medical oversight and a prescription from a physician to obtain. But, how does one obtain such a prescription? And how do organizations and individuals ensure they are in compliance with all laws and maintain their device to prevent malfunction in case of emergency? PlusRx is the solution to this problem.
PlusTrac™ is a known leader in AED management solutions. They keep organizations worldwide in compliance and properly supported for all their AED needs. PlusTrac includes the Medical Authorization necessary to obtain an AED called PlusRX, to help partner doctors with organizations and individuals who want to protect themselves and the ones they love from Cardiac Arrest. PlusRx allows you to register and maintain your AED Prescriptions then print a copy of your Medical Authorization for your files.
With PlusRX, not only does finding a doctor to provide medical authorization and prescription for your AED become easier, it is also possible to obtain program management solutions through PlusTrac™ to ensure you have all the tools needed should a cardiac arrest occur at your location. In addition, you will ensure you are ready, compliant, and completely documented, while taking up as little of your time as possible.
Contact PlusTrac™ today via email or by phone at 1-866-352-5433 and see how PlusTrac™ can meet your program’s needs.