The findings, reported in the August 9 issue of The Journal of the American Medical Association (JAMA), suggest the need for a more reliable system to locate and repair potentially defective devices in a timely fashion.
"Though they are simple to use, AEDs are, in fact, complex medical devices," explains the study's senior author William Maisel, MD, MPH, director of the Pacemaker and Defibrillator Service at Beth Israel Deaconess Medical Center (BIDMC) and Assistant Professor of Medicine at Harvard Medical School. "It is therefore not surprising that they may occasionally malfunction. An AED recall rate of 1 in 5 over the past decade, however, is too high."
The portable units provide voice commands, automated heart rhythm analysis, and if necessary, shock delivery to resuscitate victims of cardiac arrest. Their ease of operation -- coupled with their clinically proven ability to improve the survival of cardiac arrest victims -- has resulted in their widespread use in recent years.
"During the period we followed – between 1996 and 2005 – the annual number of AEDs distributed increased almost 10-fold, from fewer than 20,000 in 1996 to nearly 200,000 in 2005," says Maisel. Many public areas such as airports, sports arenas, casinos, schools and churches are now routinely outfitted with AEDs, and certain AED models have even been approved by the U.S. Food and Drug Administration (FDA) for use without a prescription, enabling consumers to purchase them more easily.
In their study, Maisel and coauthor Jignesh Shah, MD, of BIDMC's Cardiovascular Division determined the number and rate of AED safety alerts and recalls (collectively referred to as "advisories") as well as the number of actual AED malfunctions by analyzing weekly FDA Enforcement Reports and reports of AED-related adverse events. (The FDA routinely issues such "advisories" to notify the public about potentially defective medical devices.)
Their comprehensive analysis showed that between 1996 and 2005, a total of 52 advisories affecting 385,922 AEDs or critical AED accessories were issued. They also found that device malfunctions occurred during attempted resuscitation in 370 patients. Device recalls were most often issued due to hardware malfunctions, which may result in a failure of the AED to power on, to charge, or to successfully deliver a shock.
"AEDs are responsible for saving thousands of lives," notes Maisel. "Time to defibrillation is the most important determinant of survival for patients who have suffered a cardiac arrest." However, he adds, as AED distribution continues to increase, the number of devices prone to malfunction can also be expected to increase.
"Unlike implantable cardiac defibrillators (ICDs) which are routinely registered with the manufacturer at the time of implantation, no such process reliably occurs with AEDs," Maisel explains. "Our study demonstrates that there is an urgent need to develop a more reliable system to identify and repair potentially defective AEDs in a timely fashion and to better notify AED owners when their devices are recalled."
Bonnie Prescott | EurekAlert!
Nanoparticles as a Solution against Antibiotic Resistance?
15.12.2017 | Friedrich-Schiller-Universität Jena
Plasmonic biosensors enable development of new easy-to-use health tests
14.12.2017 | Aalto University
DNA molecules that follow specific instructions could offer more precise molecular control of synthetic chemical systems, a discovery that opens the door for engineers to create molecular machines with new and complex behaviors.
Researchers have created chemical amplifiers and a chemical oscillator using a systematic method that has the potential to embed sophisticated circuit...
MPQ scientists achieve long storage times for photonic quantum bits which break the lower bound for direct teleportation in a global quantum network.
Concerning the development of quantum memories for the realization of global quantum networks, scientists of the Quantum Dynamics Division led by Professor...
Researchers have developed a water cloaking concept based on electromagnetic forces that could eliminate an object's wake, greatly reducing its drag while...
Tiny pores at a cell's entryway act as miniature bouncers, letting in some electrically charged atoms--ions--but blocking others. Operating as exquisitely sensitive filters, these "ion channels" play a critical role in biological functions such as muscle contraction and the firing of brain cells.
To rapidly transport the right ions through the cell membrane, the tiny channels rely on a complex interplay between the ions and surrounding molecules,...
The miniaturization of the current technology of storage media is hindered by fundamental limits of quantum mechanics. A new approach consists in using so-called spin-crossover molecules as the smallest possible storage unit. Similar to normal hard drives, these special molecules can save information via their magnetic state. A research team from Kiel University has now managed to successfully place a new class of spin-crossover molecules onto a surface and to improve the molecule’s storage capacity. The storage density of conventional hard drives could therefore theoretically be increased by more than one hundred fold. The study has been published in the scientific journal Nano Letters.
Over the past few years, the building blocks of storage media have gotten ever smaller. But further miniaturization of the current technology is hindered by...
11.12.2017 | Event News
08.12.2017 | Event News
07.12.2017 | Event News
15.12.2017 | Power and Electrical Engineering
15.12.2017 | Materials Sciences
15.12.2017 | Life Sciences