29 January 2019: In light of the forecasted drop in temperature over the coming weeks, the Health Products Regulatory Authority (HPRA) is today urging owners of automated external defibrillators (AEDs) to check that the recommended safety and maintenance updates on their device have been undertaken. Irish sporting venues, schools, hotels, restaurants, offices, shopping centres, and all individuals who are in possession of an AED are advised to urgently check if their device is one of the models below. If they have an affected AED, the HPRA urges the owners to contact the manufacturer or the HPRA to ensure their AED receives all necessary updates.
An estimated 614 AEDs by four different manufacturers require urgent updates in Ireland, to ensure they will work correctly in an emergency situation. Without these updates, the AED may not work as intended. The devices may require a software upgrade – similar to upgrading software on your phone or computer – or the replacement of a component part within the AED.
As part of the ongoing maintenance of an AED it important to consider if or when it will need to be replaced as AEDs like most pieces of equipment will have an expected lifespan. At the time of purchase, the manufacturer should be able to provide this information along with details of the warranty period which will help ensure that the AED is kept up to date. Safety related updates to AEDs are normally offered by manufacturers independent of whether the AED is still under warranty.
Since the HPRA’s previous announcement in November 2017, 95 AEDs have had completed updates that were outstanding at that time and the HPRA is now calling on other owners to do the same. Commenting today, Anne Tobin, Medical Devices Vigilance Manager of the HPRA, highlighted the positive progress made by owners who are proactively liaising with the manufacturers.
“It is very encouraging to see that manufacturers are reviewing their devices, identifying shortcomings, and taking action. We are urging owners of AEDs to be vigilant and to check if they have one of the affected AEDs and, if they do, to liaise with manufacturers to ensure the devices are updated without delay. This year, 614 automated external defibrillators in Ireland require an urgent update, without which the devices may not perform in a life threatening emergency’’.
“Even if your AED has been fully updated, it is essential to store and maintain AEDs appropriately. Particularly during winter months, these devices may be affected by dropping temperatures and environmental conditions so it is particularly important this time of year to ensure devices are stored and maintained well. It is important to know the age and expected lifespan of your AED device and consider if or when the AED may need to be replaced.
“We would urge those in possession of a device which needs to be updated to contact the manufacturer or the HPRA to organise the necessary updates as soon as possible. This action could be the difference between life and death for whomever next requires treatment with the AED. These devices offer an important first response intervention and we know that the majority of cardiac arrests occur outside of the healthcare environment.”
Over the past 12 months, corrective actions have been identified for a further three AED models by one manufacturer which account for 294 devices on the Irish market. Of these, 148 devices still require updates.
As a result, the updated list of six AED models which have corrective actions still outstanding are:
AED Name Manufacturer
Life-Point Metsis Medikal Teknik Sistemler Elektronik Otomoti
Samaritan PAD 300/300P Physio Control, formerly HeartSine
Telefunken HR1 Telefunken
Philips HeartStart FRx, Heartstart HS1 (Onsite), Heartstart HS1 (Home) Philips
Information may be found by looking at the dedicated AED webpage on the HPRA’s website which includes essential information on safety notices published by the manufacturers of affected devices, as well as details on how to contact the manufacturer directly to organise device updates. The HPRA also has an information leaflet on AEDs available to download online with printed copies also available to order.
It is estimated that 70 percent of all cardiac arrests occur outside of the healthcare environment, where the correct operation of an AED may be a life-saving intervention.
In recent years, defibrillators have become easier to use, automatic, portable and affordable, which has resulted in a significant increase in the number of AEDs in Ireland. All organisations with an AED on their premises should provide the manufacturer of their device with their correct contact details to ensure that the manufacturer can inform them of the need for safety upgrades if required.
FOR FURTHER INFORMATION:
Weber Shandwick PR 01 679 8600
Siobhan Molloy/ Jo Twamley 086 817 5066/ 085 143 8320
ABOUT THE HEALTH PRODUCTS REGULATORY AUTHORITY:
The Health Products Regulatory Authority (HPRA) protects and enhances public health and animal health by regulating medicines, medical devices and other health products. The products under its remit include human and veterinary medicines, medical devices, blood and blood components, tissues and cells, organs for transplantation and cosmetics.
NOTES TO THE EDITOR:
The HPRA’s guidance on AEDs includes:
- CE Mark – All medical devices including defibrillators must carry a CE mark which ensures that when used and stored properly, the device should work as intended and be safe.
- Review the product manual for the device and its accessories to identify the conditions that could affect its performance, such as:
- Storage temperature
- Exposure to moisture and damp (environmental humidity)
- A copy of the manual should be stored with the defibrillator and be accessible AT ALL TIMES.
- A maintenance plan and schedule should be put in place. It is very important that someone familiar with the operation and storage of the defibrillator is given the task of keeping the plan up to date.
- A defibrillator may need to be updated or changed during its time in use. For example, it may require new software.
- Regular servicing and maintenance is essential and must be carried out in accordance with the guidance given by the manufacturer.