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Automated external defibrillator
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===Reliability=== In 2012, AED's (automated external defibrillators) were under scrutiny by the U.S. [[Food and Drug Administration]] (FDA) which considered reclassifying AEDs as class III [[premarket approval]] devices. Technical malfunctions likely contributed to more than 750 deaths in the 5-year period between 2004 and 2009, in most cases by component failures or design errors. During the same period, up to 70 types of AEDs were recalled, including recalls from every AED manufacturer in the world. <ref>{{cite web|title=The Shocking Truth About Defibrillators|publisher=[[IEEE Spectrum]], March 2012. Retrieved 2012-07-28|url=https://spectrum.ieee.org/biomedical/devices/the-shocking-truth-about-defibrillators/0|archive-url=https://archive.today/20130415062356/http://spectrum.ieee.org/biomedical/devices/the-shocking-truth-about-defibrillators/0|url-status=dead|archive-date=April 15, 2013|date=2012-02-27}}</ref> In January and February 2015, the FDA issued this news release: "The FDA issued a final order that will require AED manufacturers to submit premarket approval applications (PMAs), which undergo a more rigorous review than what was required to market these devices in the past. The agency's strengthened review will focus on the critical requirements needed to ensure the safety and reliability of AEDs and their necessary accessories, including batteries, pad electrodes, adapters and hardware keys for pediatric use."<ref>{{cite web|title=FDA takes steps to improve reliability of automated external defibrillators|publisher=[[FDA News Release]], January 2015. Retrieved 2017-07-15|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431907.htm|archive-url=https://web.archive.org/web/20150131045045/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431907.htm|url-status=dead|archive-date=January 31, 2015}}</ref><ref>{{cite web|title=Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems; Republication|publisher=[[Federal Register]], February 3, 2015. Retrieved 2017-07-15|url=https://www.federalregister.gov/documents/2015/02/03/2015-02049/effective-date-of-requirement-for-premarket-approval-for-automated-external-defibrillator-systems|date=2015-02-03}}</ref> In the United Kingdom there is concern that poor maintenance may make public defibrillators unreliable. The ''[[Henley Standard]]'' reported on 21 July 2017 that more than half the defibrillators in [[Henley-on-Thames]] and the surrounding area were at risk of failing, either because of low battery power or because adhesive pads had deteriorated.<ref>{{cite news|last1=White|first1=David|title=Life-savers out of date|publisher=Henley Standard|date=21 July 2017}}</ref>
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