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The HPRA is issuing this advice as it says it has identified some 940 defibrillators in Ireland, incorporating five particular models, where a corrective action remains outstanding. Updates to these AEDs are needed immediately to ensure that the devices will work as necessary in a life-saving situation. In addition, the HPRA warns that weather temperatures will affect a defibrillator’s performance and all AED devices should be stored correctly and regularly checked during the winter months ahead.
The HPRA states that with the development of easier to use, automatic, portable and affordable defibrillators, there has been a significant increase in the number of AEDs in Ireland with sporting venues, schools, hotels, restaurants, businesses and shopping centres now having them on their premises in case of emergencies.
It is estimated that there are up to 5,000 sudden cardiac deaths in Ireland each year with over 70 per cent of all cardiac arrests occurring outside of the hospital environment. While AEDs can improve a person’s survival chances following sudden cardiac arrest, the HPRA states that if the defibrillator is not maintained, stored or serviced correctly it may not work in an emergency. To ensure good working order at all times, correct storage and regular checks are required. Most importantly, the HPRA stresses that if an update or other action is identified and communicated by the manufacturer to the AED owner – through the publication and distribution of what is called a field safety notice (FSN) – then this should be undertaken immediately. Otherwise the AED may not work properly when it is needed. All field safety notices for defibrillators are also published on the HPRA website.
According to Ms Anne Tobin, the HPRA’s Medical Devices Vigilance Manager, there are many reasons why an AED may not work including the device requiring an upgrade as highlighted in an outstanding FSN; the batteries may be beyond their shelf life and not replaced; or the devices may not be stored and maintained correctly.
“It is estimated that there are some 10,000 AEDs in Ireland. We know that almost 950 of these have the potential to not work effectively in an emergency because a corrective action as deemed necessary by the manufacturer has not been completed. We know that the manufacturers concerned have attempted to contact the owners directly with some also using national advertising to highlight the importance of carrying out the required upgrade or battery check,” says Ms Tobin.
“We are urgently calling on defibrillator device owners to now check if they have an affected AED and where necessary to contact the manufacturer or supplier immediately to ensure the correction required for their defibrillator is carried out without further delay.”
“Even if an AED has received all the updates required, all owners should remember that as we enter the winter months it is critical they store their AEDs appropriately. Defibrillators and their accessories can be badly affected by the weather and other environmental conditions. The user manual supplied with an AED provides detailed information from the manufacturer about its use and maintenance and the HPRA’s own advice leaflet highlights key issues around the purchase, care and use of AEDs. We urge people to read these and act upon the advice provided,” she concluded.
The HPRA has a section its website outlining the implicated AEDs that need corrective action. It also has an advice leaflet on AEDs available to download from www.hpra.ie.