Solutions tailored to the regulatory context!

AEDMAP has developed a platform dedicated to AED monitoring to enable public and private operators to easily manage their fleet of defibrillators in accordance with regulations.

Visio and Visio + solutions can monitor an entire set of defibrillators with a few clicks. All information regarding maintenance to be performed are available on internet.

Traceability

The AEDMAP user interface lists all the defibrillators in a set, their serial numbers, reports any problems and warns of upcoming maintenance.

Recalls  at the initiative of manufacturers or health authorities (FDA,…) are easily managed through comprehensive defibrillators listing in the AEDMAP database.

Interoperability

AEDMAP has developed powerful web services that make it easy to connect the defibrillators management database with websites, mobile applications and business applications (GIS, …).

Information regarding defibrillators are easily shared with the users or the general public.

AED, a public access medical device

Automated External Defibrillators (AED) are class IIb medical devices that have the particularity of being used by the general public in many countries. This participated in the defibrillation market development.

Increasingly defibrillators were introduced in businesses and public places but poorly informed operators have not implemented inspection policy and maintenance of their defibrillators.

In many cases the traceability of the material is not managed, although manufacturers and health authorities regularly conduct lots recalls.

These factors have led to a real degradation of the installed base. It is unfortunately not uncommon today to find defibrillators whose pads are outdated or batteries discharged..

90% of AED owners received no recalls alert while the majority of manufacturers have reported some over the same period

Dr Paul DARDEL, MD
Dr Paul DARDEL, MD

Regulatory Environment

The maintenance and use of defibrillators are governed by several regulatory and law texts depending on the country. In most countries, defibrillators it is mandatory to have a maintenance policy.

Guidelines usually cover the following topics: need for an equipment inventory,  maintenance records and installation locations tracking. The objective of the guidelines text is to help users and make them aware that the defibrillator is a medical device.

Guidelines examples

2012 – State Legislators have become actively involved with this issue in the past six years. Most commonly, the recent state laws encourage broader availability, rather than creating new regulatory restrictions. Most of the bills enacted from 1997 to 2001 included one or more provisions to:

  • Establish legislative intent that an “automatic external defibrillator may be used by any person for the purpose of saving the life of another person in cardiac arrest.”
  • Encourage or require training in the use of AED devices by potential users.
  • Require AED devices to be maintained and tested to manufacturer’s standards.
  • Create a registry of the location of all such defibrillators, or notification of a local emergency medical authority.
  • Allow a “Good Samaritan” exemption from liability for any individual who renders emergency treatment with a defibrillator.
  • Authorize a state agency to establish more detailed requirements for training and registration.

Cardiac Arrest Survival Act of 2013 – Amends the Public Health Service Act to expand immunity from civil liability related to automated external defibrillator devices (AEDs), including by giving immunity to: (1) a person who owns, occupies, or manages the premises from which an AED is taken or at which an AED is used or attempted to be used on a victim of a perceived medical emergency; and (2) the owner-acquirer of an AED for any harm resulting from the use or attempted use of such device, unless the harm was proximately caused by the failure of the owner- acquirer to properly maintain the device according to the guidelines of the device manufacturer. Applies immunity regardless of whether: (1) the AED is marked with cautionary signage or registered with any government; or (2) the person who used or attempted to use the AED complied with such signage, had received training on such use, or was assisted or supervised by any other person, including a licensed physician.

  • Train staff to use the AEDs
  • Designate a person responsible for monitoring the DAE
  • Establish a maintenance register
  • Register the defibrillator with the manufacturer and EMS
  • Map the installation site defibrillators
  • Install the defibrillator in a visible and accessible place
  • Regularly check the external condition of the defibrillator
  • Regularly check the proper functioning indicator