From the May 2015 issue of HealthCare Business News magazine


An estimate from the FDA states that roughly 2 million of those AED systems are currently out in the market. Many of them spend years buried in closets gathering dust; like most fire extinguishers, they happily pass the time unneeded. Unfortunately, that can lead to operability problems.

After years of planning, a change in regulations
The FDA estimates that 72,000 reports associated with AED failures were submitted, (although not validated) between January 2005 and September 2014. Over that same period, 111 manufacturer recalls on defibrillators were implemented.
Previously subject to 510(k) approval, AEDs and ALS devices with automatic mode functionality have officially been up-classed to pre-market approval (PMA) processes. After a long period of speculation and planning, the change in policy took place this year. Regulation changes apply to any device that has an advisory algorithm to decide if a heart rhythm is shockable or not. White says that that means all AEDs – and the majority of ALS devices – will need to submit newly required paperwork to keep their devices FDA compliant. Strictly manual defibrillators and internal defibrillators however, are not subjected to the change.

“We’ve been talking to the FDA about this for many years so it’s not a surprise to the industry,” says White, who regards the change in policy as a good thing. Defibtech’s Ford agrees that the new regulations are good for the industry and does not anticipate them interfering with their business or their customers. Despite the number of recalls and failures reported, White says AEDs are very straightforward designs and generally reliable devices, “It’s not like a car with a lot of moving parts.”

Most defibrillators have two or three key failure points – which can be replaced – and an overall average usability cycle of eight or nine years, which can be made even longer by diligently keeping up with recommended self-testing, says White.

“Installing the battery pack so self-tests can be performed, checking the active status indicator and listening for audible cues so action can be taken if necessary,” are ways Ford says one can ensure the systems are in working order.

“Other recommendations include storing the AED under specific environmental conditions, and should the AED be dropped, mishandled, or otherwise compromised, a manual self-test can be initiated to assess its condition,” she says.

An inside job
While AEDs can be found all over, and ALS devices can be found in crash carts, hospitals, and some ambulances, there is another kind of defibrillator that can be installed inside the human body. Transvenous implantable cardioverter defibrillators (ICDs) utilize a transvenous wire lead which stretches from a pulse generator beneath the shoulder and down into the heart to automatically detect any cardiac arrhythmias and deliver a life saving shock when necessary.

May 2015 Magazine

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