AED Medical OverSight; AED Program, Medical Authorization for AED, Automated External Defibrillator; Medical Prescription, Medical Oversight

Sep 8, 2010

Implementing an Automated External Defibrillator (AED) Program may seem like a challenging task, but it definitely doesn't have to be. With our 7 step guide to implementing an AED Program, any organization can successfully complete this task. Today, we will take a look at the fourth step in this process, “Obtain Medical Oversight”.


In today’s technologically advanced world, there are numerous items which we purchase with little or no knowledge of how to operate. So, in order to effectively utilize and/or navigate our new gadget, we must invest in a technical support plan.


Therefore, since most AED Program Coordinators do not have an extensive knowledge of automated external defibrillators (AEDs) or deploying an AED Program, having a technical support plan is a necessity. In our Industry, this technical support plan is referred to as “Medical Oversight”. Medical Oversight can either be obtained through a local Physician or a National Company who specializes in providing Medical Direction. In either case, your chosen Medical Director should provide the following:


  • Signed Medical Prescription (FDA Requirement to purchase an AED)
  • Site Analysis and AED Placement Recommendation
  • Assistance with EMS Registration
  • Review of Policy & Procedure Manual
  • Review of Training Program
  • Post Event Review & Feedback

Furthermore, your Medical Director should also be a sounding board and a mentor to the Program Coordinator.


HOW SHOULD YOU OBTAIN MEDICAL OVERSIGHT?


First and foremost, if you can find a local physician who has AED Program knowledge, this is your best option as you will have the ability to interface with him/her in person. Furthermore, a local Physician will have a tie to the community and a vested interest in the success of the program.


If you are unable to find a local Physician, contracting with a National Medical Oversight Company is the next best thing. Since their primary business is providing Medical Oversight, their physicians and support staff will have the latest information on laws, regulations and trends in the AED industry.


DO LAWS REQUIRE MEDICAL OVERSIGHT?


At the Federal Level, currently, there are no laws requiring Medical Oversight. However, there are certain states that do require it. To find out more about your state’s requirement, contact your local state legislature to obtain details about the requirements in regards to medical oversight.


WHAT IF I OPT NOT TO OBTAIN MEDICAL OVERSIGHT?


If your State does not require Medical Oversight, you are still obligated by the Food & Drug Administration’s Code of Federal Regulations Title 21 Section 801.109 to provide a signed medical authorization. A medical authorization is a physician prescription authorizing you to purchase an AED. If you do not have a physician to provide this form, there are numerous National Medical Direction Companies who can produce on your behalf. As you know, there is always an exception to every rule. In 2005, Philips Medical received clearance from the FDA to sell the Philips Onsite over the counter without a medical authorization. Currently, this is the AED on the market which can be obtained without a medical authorization.


ARE THERE LIABILITY ISSUES ASSOCIATED WITH NOT HAVING MEDICAL OVERSIGHT?


Federal & State Good Samaritan Laws protect individuals and organizations from liability if they do the following:


  1. Notify local emergency response personnel or other appropriate entities of the most recent placement of the device within a reasonable period of time after the device was placed.
  2. Properly maintain & test the device according to manufacturer’s recommendations.
  3. Provide appropriate training to any employee who may be reasonably expected to use device.

As you can see, Good Samaritan Laws do not mention Medical Oversight as a requirement. However, having Medical Oversight will help to insure that the Good Samaritan Laws are accomplished!


Having deployed over 2000 AED Programs across the US, we have found that our most success programs have Medical Oversight. Why have they been more successful than those who have not? The answer is simple…knowledge is power and those who have employed Medical Directors have empowered themselves with the technical knowledge to be successful.


Contact HeartSafe America today to find out more about medical oversite and how to implement an AED Program for your organization. Heart Safe America’s goal is to educate the public about Sudden Cardiac Arrest (SCA) and how AEDs can increase the survival rate.

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