Comments on: Defibrillators Malfunction at Shockingly High Rates

By: Wendy Clarke

Wendy Clarke — Sun, 24 Mar 2013 03:54:00 +0000

The Lifeline View defibrillator shows you
what to do in an emergency in full colour, high definition video, check it out
at http://www.defibtech.com.au/lifeline-view-aed/features-view-aed-defibrillator.htm

By: Drew

Drew — Sun, 04 Mar 2012 00:50:25 +0000

I guess having some AED’s around that work is better than having no AED’s. It’s like some CPR is better than no CPR.

By: Wil

Wil — Fri, 02 Mar 2012 04:12:31 +0000

I have been designing and making medical devices (in the U.S.) for 28 years. Over the past few years, the FDA has been hammering all defibrillator manufactuers in the U.S., large or small. There have been good reasons for the attention, but those reasons do not include the fact that the products were released via a 510(k), instead of a PMA.

Most medical device manufacturers put a great deal of time, money, and effort into a brand new device, until it gets a 510(k) or PMA clearance and goes onto the market. Then the engineers and the big budgets are diverted to the next brand new device, and the just- launched device stays pretty much the same, and ignored, for the next 10 to 30 years. This long product life span means that product redesigns (which would normally catch any design flaws) and new technologies do not find their way into the older products very often.

Over the past 40 years the FDA has gradually, and substantially, raised the bar. This is also true of the ISO international technical standards. Medical devices of the 1970′s that were considered brilliant, safe and were quickly cleared by the FDA, would be laughed out of the room today. This is also true of the processes used to design, validate, and manufacture the devices.

The main reason that a PMA is required for Class III devices isn’t that it is a superior process for catching design flaws than a 510(k) is. The first reason is that if a device is truly a new technology, then its safety and efficacy has to be proven in the human body. The second reason is that if a device is life saving, life preserving, or life extending, then it needs to pass a much more challenging testing regimen than if it wasn’t.

The defibrillators mentioned in the above article would have failed any testing what-so-ever, let alone a challenging testing regimen.

By: Sarah Zhang

Sarah Zhang — Thu, 01 Mar 2012 17:21:20 +0000

@Squirtly, you’re right the wording was a little sloppy. Fixed to clarify.

By: Rimai

Rimai — Thu, 01 Mar 2012 17:01:45 +0000

I´ve personally seen an automated defibrilator malfunctionig in resuscitation situation.
Luckily we took the decission to defibrillate manually after some five to seven minutes from the start of the resuscitation. The patient survived, but if we had trusted the device the outcome would have been different. The reason behind the malfunction was that the device couldn´t detect the ventricular fibrillation due to bad connection of a cable. In my opinion this kind of malfunction could be avoided with a better design of the defibrillator. Poorly designed defibrillators shouldn´t be allowed on the defibillating busines…

By: foci eredmények

foci eredmények — Thu, 01 Mar 2012 15:31:54 +0000

So there aren’t any other alternatives for AED? safer ones? Is so pathetic that even they know is a wrong procedure they still use it

By: plomeley

plomeley — Thu, 01 Mar 2012 10:18:39 +0000

Bad news, regs in Australia are no stricter and with the march of globalised regs are essentially the same. Note also we rely on FDA database for failure rate data – local info I
is not publicly available…

By: Brian Too

Brian Too — Thu, 01 Mar 2012 00:35:42 +0000

This problem may well be under-recognized for another reason. Victims in cardiac arrest/arrhythmia are in deep and obvious trouble. If the AED fails them it would be, ah, not unlikely that bystanders would assume they were beyond help.

By: Squirtly

Squirtly — Wed, 29 Feb 2012 22:29:55 +0000

No no no! Defibrillators are NOT used to shock a beatless heart back to life. They STOP hearts that have entered irregular rhythms (called fibrillations, hence the name DEfibrillator) in the hopes that they’ll start back up in sinus rhythm. This may be overly pedantic and irrelevant to the article, but it’s a very important distinction that nobody seems to get right. Zapping a stopped heart will only keep it silent.

By: jasvll

jasvll — Wed, 29 Feb 2012 21:23:47 +0000

After reading the argument put forward in the article, it’s clear to me that the solution to the problem of limited access to AEDs is updating the regulations to allow manufacturers to market those novelty handshake buzzers as AEDs. They’re much cheaper, making it possible for every home, possibly every individual, to have immediate access to an AED.