In 2013, Dutch automatic external defibrillator manufacturer DefiTeq, entered the UK market with its Telefunken AED. Offering competitive price points and a simple user interface, the unit made a successful impression, and was adopted by a wide range of public and private sector organisations. Fast-forward four years, and the cracks had started to show.
Many distributors across Europe had suspended their support for the AED, and DefiTeq subsequently withdrew their CE mark from the device. Some European health organisations, such as Ireland’s HPRA, went as far as to publish public safety notices against the Telefunken AED; advising owners and users of the device to source an alternative product. We’re now midway through 2019, and there still has been no official guidance for UK based organisations and first responders who may still be holding Telefunken AED stock. Is it time we followed suit?
The AED market has matured considerably in recent years, with traditional voice prompts and metronome functions being enhanced by adult/child use switching, reducing the requirements for additional expensive consumables. Quality CPR features now measure both depth of compressions and recoil to provide real-time feedback on the quality of chest compressions being administered. Wi-fi connectivity has even been added on some models to offer remote unit monitoring.
All of these improvements, however, come at a price. Customers that would have been attracted by the Telefunken’s economical pricing can be assured that cost-effective alternatives are available on the market, providing both a robust feature set and assured patient defibrillation.
One of the most commonly asked questions when discussing changing from one particular brand of AED to another, is whether training is required. The financial implications of retraining users on the use of any new medical device can be prohibitive. With regards to AED’s, this is fortunately not the case. While it is good practice to be trained on the use of any medical device, legally, there is no requirement for users to be trained in the use of AED’s.
One of the largest factors driving uptake for these life-saving devices is public access to non-trained lay responders. In the event of a sudden cardiac arrest, speed of response is critical. Positive patient outcomes reduce by 10% for every minute which passes without the patient receiving defibrillation. With this in mind, it is vital that any bystander would be able to access a public AED and effectively follow the unit’s voice prompts without having received any formal training.
In the unlikely event of a lay responder misdiagnosing a sudden cardiac arrest over any other condition, users can be confident that the AED will only administer a shock after analysing and determining if the patient is in a shockable arrythmia. Asystolic or pulseless rhythms require surgical intervention, but a lay responder will never know the difference without first applying the defib unit.
To date, there has not been one successful prosecution against any first responder, trained or otherwise, following an unsuccessful attempt to resuscitate a patient with the use of an AED in the UK.
Even with the recent announcement of Zoll’s acquisition of Cardiac Science, there is still a wealth of options available on the market. The training burden on AED usage is minimal, and only restricted by the operational policies of individual organisations. In summary, where does this leave the UK market?
The Medicines and Healthcare Regulatory Agency, (mhra.gov.uk), is responsible for ensuring that medical devices meet applicable standards of safety, quality and efficacy, as well as helping to educate the public and healthcare professionals about the risks and benefits of medical devices, leading to safer and more effective use. When contacted with regards to the HPRA safety warning issued against the Telefunken AED’s, an MHRA spokesperson said:
“We are aware of the HPRA communication and we are currently investigating the situation. Please be reassured that even though we can’t provide details of ongoing investigations, all concerns about the safety of medical devices received by the MHRA are assessed by our specialists and action is taken, as appropriate, to protect public health.”
While we still do not have official guidance on the issue from the MHRA, the fact remains that without a valid CE certificate, any Telefunken AED owners will be unable to source new batteries for their units which will be reaching their 3-year shelf-life. Therefore, it seems market conditions will drive this particular shift in the marketplace ahead of any official regulatory guidance.
If you have any questions on the issues surrounding this topic, please contact our customer services team or your Reliance Medical representative directly. A wide range of AED awareness and familiarisation resources is also available for your review on our dedicated AED website: www.mediandefib.co.uk.
 HPRA Safety Notice SN2019(08), issued 4th April 2019