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Defibrillator maintenance: AED and functional verification

By Cristiano Antonino On Mar 5, 2023

The defibrillator is a life-saving device that performs a correct analysis on the patient to recognise the presence of any heart rhythms that should be defibrillated

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The functional verification of a defibrillator: why it is essential

If it recognises probable arrhythmias, it will charge a capacitor, emitting an electrical discharge of the right energy which, passing through the patient’s heart, will momentarily interrupt cardiac activity so that it can be resumed correctly.

To verify that the defibrillator does all this correctly and adequately, it must undergo an annual technical check.

During the check, by means of a special device, the analyser, a cardiac arrest with different types of arrhythmia will be simulated, causing the defibrillator to deliver an actual discharge, and then accurately measuring the amount of energy delivered and the timing of delivery.

In Europe functional verification is compulsory, and must be performed annually on all defibrillators in the health service, emergency and no less important for out-of-hospital defibrillators, according to CEI 62-148, CEI 62-13 EN 60601-2-4 guidelines, under penalty of a fine and/or criminal sanctions.

Standard CEI 62353, with regard to periodic inspections and tests to be carried out after repair work on electro-medical equipment, states that the frequency of functional safety inspections must be established by the manufacturer and indicated in the user manual.

If not indicated in the defibrillator user manual, CEI EN 62353, in Annex F, indicates that for devices that generate and apply electrical energy to directly influence the activity of the heart, such as defibrillators, the interval between functional checks should never exceed 2 years.

The safety assessment of the defibrillator must be carried out by technicians specialised in electrical safety, who have had adequate training in the tests to which the defibrillator must be subjected.

All tests performed must also be documented.

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The expiry date of the functional verification can be seen on the sticker on the right-hand side of the defibrillator, where the month and year of expiry can be viewed

All defibrillators must be maintained in an operational condition; the battery must have sufficient charge to ensure operation; batteries and adhesive pads must be replaced when due, which is generally two years for pads and five years for batteries.

AED owners may enter into agreements with health authorities or private entities for them to maintain the equipment, with the costs being borne by the owner.

For Italy and Europe: Official Gazette of the Italian Republic of 20/07/2013 converted into law Annex (E) Point 4.3 Maintenance and signage (Page 13/24): https://www.gazzettaufficiale.it/eli/gu/2013/07/20/169/sg/pdf

Point 4.3 Maintenance and signalling: AEDs must undergo functional checks, inspections and periodic maintenance in accordance with the deadlines set out in the user manual and in compliance with current regulations on electro-medical equipment.

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