Rigel Medical Warns Over Latest Faulty Heart Defibrillator Report
26th November 2012

Recent warnings over faulty heart defibrillators have again highlighted the urgent need for regular testing of in-service health equipment, says a leading supplier of medical device testers and analysers.

Tens of thousands of Automatic External Defibrillators (AED) in public places like shopping centres and airports may not work because of defective components that could unexpectedly fail warns the FDA (Food and Drug Administration, USA) and MHRA (Department of Medicines and Healthcare Products Regulatory Agency, UK).

The defibrillators are used to provide life-saving treatments to people having a cardiac arrest but both FDA and MHRA warn that unexpected component failure including batteries, make them inoperable at times when you most need them.

Indeed the MHRA warned only last week over faulty heart defibrillators, reporting that more than 1,300 emergency AEDs in public places like shopping centres may not work because of battery related problems.

John Backes, associate director at Rigel Medical, which manufactures and supplies equipment used to test the safety of electrically operated medical devices, says the news highlights a problem facing potentially thousands of automatic defibrillators installed across UK and an even greater number globally.

He’s stressing the need to ensure AEDs are regularly checked and tested as people’s lives could be placed at risk by faulty or failing equipment.

“This is the latest report of problems associated with this type of medical device used in public places, so it’s vital they are properly checked and maintained.”

“Many people are under the (false) impression that these automatic defibrillators have an auto test function that can highlight component failures but both FDA and MHRA reports clearly show that this is not always the case.”

“Testing these AED’s is easy, relatively inexpensive yet vital and owners and operators could benefit by using the latest generation of easy to use, portable and lightweight analysers to quickly and easily verify the safe operation and functionality of equipment.”

The Rigel Medical Uni-Pulse defibrillator analyser, for instance, features advanced measurement technology, the battery powered analyser offers both manual and automatic test programs for the safe testing of all mono-phasic, bi-phasic and pulsed waveform defibrillators and AEDs.

Bluetooth and USB has been incorporated for improved connectivity, enhanced memory capacity for the storage of results, defibrillator waveforms and test programmes and a clear, easy-to-read colour graphics display screen. An optional paddle adaptor box includes a version with variable loads from 25 – 200 Ohms for compliance with IEC 60601-2-4 requirements.

The colour LCD provides easy navigation around the functions and simulations including defibrillator waveform capture, accurate energy measurements, cardio synch times, peak voltage and current.

A 12-lead ECG simulation with substantial variation of atrial and ventricular arrhythmias and performance wave forms provides faster, easier and more accurate testing of defibrillators with built-in monitoring functions.

Automatic test programs for AEDs leads to fast and effective testing of AED response, interpretation and performance.

 
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