The Health Products Regulatory Authority (HPRA) is today highlighting that approximately 750 automated external defibrillators (AEDs) in Ireland require urgent safety and maintenance updates. Updates to these AEDs are identified as being required through the ongoing post market surveillance of the manufacturers. Some of these upgrades are in the form of a software update or the replacement of an AED component. These updates are needed immediately to ensure that the devices will work as necessary in a life-saving situation. If the AEDs are not appropriately updated, the devices across the seven affected models may not work as required in the event of an emergency.
The HPRA is calling on all organisations in possession of an AED to check that their device is not one of the models affected by these outstanding actions. This can be done by looking at the HPRA dedicated AED webpage.
The seven AEDs models which require corrective actions are:
AED Name Manufacturer
AED Plus Zoll
Samaritan 300P Physio-Control (Formerly HeartSine)
Samaritan 500P Physio-Control (Formerly HeartSine)
Lifepak 1000 Physio-Control
Lifepak CR Plus or Lifepak Express AED Physio-Control
Fred Easyport Schiller AG
The HPRA has a dedicated section on its website detailing the implicated AEDs that need corrective action. This information contains links to the manufacturers communications (titled Field Safety Notices) detailing the updates for the above models and manufacturers contact details. The HPRA has also published its own safety notices in relation to various AEDs, links to which are on the AED webpage. It also has an advice 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 addition to the updates, the HPRA is highlighting that all AED owners should ensure that their devices are stored correctly and regularly checked during the winter months.
Anne Tobin, the HPRA’s Medical Devices Vigilance Manager said, “Of the estimated 10,000 AEDs in Ireland, we are aware of approximately 750 of these that may not operate as required in an emergency situation. We know that each of the AED manufacturers concerned are contacting the owners directly to gain access to the devices to ensure that the updates are completed. We are urgently calling on all device owners to check if they have one of the affected AEDs and, where necessary, to contact their manufacturer or supplier immediately to ensure the correction required is carried out without further delay
Another key aspect to ensuring that these devices operate when required is good storage and maintenance according to the manufacturer’s instructions. “Even if an AED has received all of the updates required, owners should remember that as we enter the winter months, it is critical that they store their AEDs appropriately. Defibrillators and their accessories can be badly affected by the weather and other environmental conditions,” added Ms Tobin.
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. Many Irish sporting venues, schools, hotels, restaurants, businesses and shopping centres now have the cardiac devices on their premises in case of emergencies. 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/ Rachel Galligan: 086 817 5066/ 087 7919901
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. Formerly known as the Irish Medicines Board (IMB), it became the Health Products Regulatory Authority on 1 July 2014.
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.