Dáil Éireann Debate, Wednesday - 3 March 2021
768. Deputy James Lawless asked the Minister for Health if he will examine regulation for AEDs in respect of both registration and maintenance (details supplied); and if he will make a statement on the matter. [11196/21]
View answerMy Department has liaised with officials in the Health Products Regulatory Authority (HPRA) with regard to this question. HPRA’s role is to protect and enhance public and animal health by regulating medicines, medical devices and other health products.
An automated external defibrillator (AED) is a medical device that analyses a person’s heart rhythm and, when needed, delivers a shock to sudden cardiac arrest (SCA) victims who are in a shockable heart rhythm.
All medical devices must BY LAW display a CE mark. If a defibrillator has a CE mark then you can be assured that it should, when used, stored and maintained properly, work as intended and be safe. Furthermore It is important to note as part of the CE marking process under the Medical Devices Directives 93/42/EEC and in the future under the Medical Devices Regulation 745/2017 that the AED manufacturer is required by legislation to supply with the AED details of the nature and frequency of the maintenance needed to ensure that the devices operate properly and safely at all times.
The HPRA prepared and published an information leaflet to provide advice on selecting and purchasing an AED for use in a community setting. The information leaflet also includes information on storing, training and maintenance in relation to the device. For ease of access to the leaflet please click here http://www.hpra.ie/docs/default-source/publications-forms/information-leaflets/hpra_external-defibrillators_web-final.pdf?sfvrsn=6.
The HPRA does not maintain a register of AEDs and their service status.
