Medical Direction vs. an AED Prescription: An AED Prescription Doesn’t Fulfill All Statutory Medical Direction Requirements
SAN FRANCISCO, CA – Under section 201(h) of the Federal Food Drug & Cosmetic Act, Automated External Defibrillators (AEDs) are regulated by the Federal Drug Administration (FDA) and classified as Class III medical devices. Class III devices have the most stringent regulatory controls, but AED units have always been regulated through the 510(k) process, a pre-market pathway that is typically reserved for the far less stringently regulated Class I and Class II devices
Under FDA rules, most AEDs require that purchasers obtain a prescription from a physician. These are usually provided by the AED seller as a matter of course and used as a sales tool. A prescription alone, however, does not satisfy all legal duties in many jurisdictions.
Compliance with the bare FDA prescription requirements does not relieve a purchaser, the AED owner, from state AED medical oversight laws. Failure to comply with applicable state laws may result in loss of the state’s Good Samaritan Law protections. For example, all states require that AED owners have a licensed physician responsible for medical oversight. State laws may differ somewhat, but generally medical oversight is a program designed to assure state requirements are met, such as notification of the local EMS office of an AED acquisition, that an appropriate training program and proper EMS notifications are in place, and that data from AED utilization is forwarded to the proper agencies. In addition, states have varying requirements for maintenance, testing, training and reporting.
“Arch provides a state compliant medical direction program unsurpassed in the industry”, states Bob Taggart, Vice President of Communications and Government Affairs for Annuvia, one of the foremost nationwide emergency medical training companies. “Our panel of medical experts consists of specialists in the fields of emergency medicine, cardiology, cardiophysiology and electrophysiology working in tandem to provide the best possible level of support.”
“All AED units added to the Arch system, whether just one new AED for a church group or five-hundred AEDs for a large manufacturing company, are cross-referenced through a proprietary algorithm to determine which 911 call center should be informed of the new AED, so that the 911 agency has an opportunity to add this data into their Computer Aided Dispatch (CAD) system. Furthermore, Arch’s algorithm determines whether or not the location of the device requires an EMS form to be filed by state law. If so, Arch pulls the actual AED form used in the requisite jurisdiction, automatically populates the data fields required on the form (even complicated items like a physician’s signature), and automatically emails, faxes, or mails the EMS agency a copy of the form, depending on their preferences. Once sent, a time-stamped copy of the form is saved on Arch for future use,” says Taggart. Thus, Arch removes the burden of filing complicated paperwork for AED owners and AED distributors, yet ensures the requirement is met. Rather than just “saying” it’s being done, Arch does it and the proof is available online for all to see.