News Category: Regulatory news
Tuesday 28th November 2017: The Health Products Regulatory Authority (HPRA) is today stating that an estimated 583 automated external defibrillators (AEDs) require urgent safety updates in Ireland. Without these updates, the cardiac devices across the 5 affected models may not work as intended in an emergency situation. The devices ongoing safety and any updates which may be required are monitored as part of the manufacturer’s post-market surveillance; they may require a software upgrade or the replacement of a component part within the defibrillator device. The number of devices which require updates has dropped by 22 percent compared to the same period in 2016.
The HPRA is calling on all organisations and individuals in possession of an AED to check that their device is not one of the models affected. This 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.
The 5 AED models which require corrective actions are:
AED Name Manufacturer
LIFEPAK 1000 defibrillator Physio-Control, Inc. USA
Life-Point Metsis Medikal Teknik Sistemler Elektronik Otomoti
Samaritan PAD 500P Physio-Control, Inc. USA
Zoll AED Plus Zoll
Samaritan Pad PAD 300, PAD 300P Physio-Control, Inc. USA
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. Speaking about the HPRA’s call to action for owners of the devices, Anne Tobin, the HPRA’s Medical Devices Vigilance Manager said,
“This year, over 583 automated external defibrillators in Ireland require an urgent update, without which the devices may not perform in a life threatening emergency. We know that the majority of cardiac arrests occur outside of the healthcare environment, where these devices offer an important first response intervention. We would urge those in possession of a device which needs to be upgraded to contact the manufacturer and 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.
“As well as ensuring devices are updated as required, it is also so important to store and maintain AEDs as instructed by the manufacturer. During winter months in particular, 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 appropriately.”
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.
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.