Medical Device ClassificationMedical devices fall under one of three FDA classifications:
- Class I: Devices that have little or no potential to harm users
- Class II: Medical appliances that pose a medium to high risk of potential harm
- Class III: High-risk medical devices that are usually used to maintain or support life
The first AED was introduced in 1978. This device was an improvement over earlier defibrillators in that it automatically detected ventricular fibrillation before applying an electric shock. Following its launch, newer types used the grandfathering clause of the Medical Devices amendment Act and were exempt from the rigorous PMA process.
Unfortunately, many AED devices failed to operate when required. Often the reason was simply a lack of preventive maintenance such as flat batteries. Other reasons for failure included software bugs, electronic failures and lack of training in how to use them. According to the FDA, there were 111 different AED recalls between 2005 and 2015 and 72,000 failure reports.
Why AEDs Are Now Fully Classed as FDA Class III
Although the overall reliability of AEDs had significantly improved, in 2013 the FDA began reviewing the way medical devices were approved for sale. Faced with increasing concern about the number of failures and reported incidents, in 2015 the FDA amended AED laws to close legislative loopholes and decreed that all AEDs, including existing models, be subject to a PMA. Vendors have until January 29, 2020 to obtain approval for current devices, while all new devices must go through PMA before release.
Why Do I Need Medical Director and a Prescription
Part of being a Class III medical device is the requirement for a Medical Director to authorize its use as seen in the Code of Federal Regulations - Sec. 801.109 Prescription devices.
"A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which ``adequate directions for use`` cannot be prepared…" (source)
The role of the medical director extends beyond writing a prescription for the device to coordinating and managing training, AED maintenance and use. It's vital someone with the requisite training is always available. Additionally, device location must be known. AEDs also need to be periodically inspected and regular maintenance, such as battery and pad replacement, performed.
PlusRX Program Helps Ensure AED Devices Are Ready
While in principle, the above requirements are relatively simple, in practice an AED program entails a fair degree of administrative work and record keeping. This was the reason behind the founding of the PlusTrac™ AED Management Program. This AED neutral program ensures that AED programs are well designed, properly implemented and compliant with relevant state AED laws. The PlusRX program simplifies registration and maintenance of AED prescriptions as well as providing users with a printed copy of the Medical Authorization. Make certain your AED program is in compliance and avoid potential lawsuits by contacting PlusTrac today.