See on Scoop.it – Defibrillation

Portable, heart-shocking defibrillators are not fail-safe.

Like any machine, automated external defibrillators, or AEDs, need to be maintained. Batteries run down and need to be replaced.

Electrode pads that attach to a patient’s chest also deteriorate and have to be replaced every year or so. Circuitry can fail. And maintenance can be spotty.

The U.S. Food and Drug Administration has received more than 45,000 reports of “adverse events” associated with failure of AEDs between 2005 and 2012, although only some of the events involved the fully automated devices put in public areas. The others were defibrillators limited to medical use. Manufacturers also conducted more than 80 recalls during the seven-year period.

The number of AEDs sold in the U.S. has been rising steadily, from around 100,000 a year in 2010 to between 500,000 and 1 million this year, according to the Sudden Cardiac Arrest Foundation and industry officials. There are about 2.5 million deployed.

“Survival from cardiac arrest depends on the reliable operation of AEDs,’’ said Dr. Lawrence DeLuca, a professor of emergency medicine at the University of Arizona in Tucson.

He led a 2011 review of more than 40,000 AED malfunctions reported to the FDA between 1993 and 2008. The analysis found that 1,150 deaths occurred during those failures.

No one knows exactly how often someone attempts to use an AED, but with an average survival rate of 2 percent to 4 percent from sudden cardiac arrest outside a hospital, according to studies, the devices help save roughly 3,500 to 7,000 lives each year, although not all of the rescues are performed by untrained bystanders. If AEDs were more widely available, the number of saved lives could triple or more, experts say.

“AEDs can truly be lifesavers, but only if they are in good working order and people are willing to use them,’’ said DeLuca, who had a personal experience with batteries failing on a device when he was trying to revive a fellow guest at a resort in 2008.

It took nine minutes to retrieve a second AED, which did work. The patient was not revived.

Problems with pads, cables and batteries accounted for nearly half the failures — mistakes that could have been due to poor maintenance. Forty-five percent of failures linked to fatalities occurred when the device was attempting to charge (power up) and deliver a recommended shock to someone in cardiac arrest, DeLuca said.

But there also were incidents reported to the FDA when the devices shut down without analyzing a patient’s heart rhythm.

Regulators and watchdogs believe some victims were not revived when the machines failed, but it’s difficult to say whether any particular patient would have had heartbeat restored.

The FDA said the most common malfunction reports involved design flaws and manufacturing of the devices using poor-quality parts such as capacitors and software.

AED failures have raised enough concern that the FDA is ending the medium-risk status that AEDs have had since they first became widespread more than 20 years ago.

Now, they’ll be classified high-risk equipment that reflects their use to support and sustain human life — and their greatly increased sophistication over the years. Manufacturers will have to provide more safety evidence and FDA inspectors will be allowed to inspect plants where parts are made.

The tighter rules don’t mean the public should lack confidence in the lifesaving devices. Dr. William Meisel, the FDA’s chief scientist for devices, stressed the essential role AEDs play when he announced the new rules in March.

“These devices are critically important and serve a very important public-health need,” Meisel said, noting that none were being taken out of service beyond the recalls manufacturers have already issued. “Patients and the public should have confidence in these devices and we encourage people to use them under the appropriate circumstances.”
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See on Scoop.it – Defibrillation

Sudden cardiac arrest — when, without warning, the heart instantly stops beating — kills 350,000 Americans of various ages and occupations a year, according to the American Heart Association.

Yet now, with high school sports teams beginning their fall seasons, now is when we are most aware of these fatalities because of a tragic drama: A young football player in peak condition, who has never flunked a physical or shown the faintest symptom of cardiac problems, suddenly collapses.

Death is usually all but instantaneous — but it is not necessarily inevitable, not if a device called an Automated External Defibrillator, or AED, and someone willing to use it are close at hand.

Sudden cardiac arrest is not the same as a heart attack, which usually is caused by blocked arteries and often gives some advance warning. Sudden cardiac arrest occurs when the electrical impulses that control the heart suddenly misfire.

The mild electric shock from an AED “resets” the heart and allows it to resume normal function. Bystanders revive several thousand people this way each year. More widespread use of the devices could save at least 20,000 more, according to the American Red Cross.

Since their introduction in the 1950s, AEDs have become smaller, simpler and basically foolproof; in one study, sixth-graders mastered them quickly and easily. There are about 2.5 million AEDs in the country, far short of the 30 million experts say are needed just to cover metropolitan areas and far short of the Red Cross goal of having every person in America within four minutes of an AED.

There are no good reasons why AEDs are not now widely and readily available. They should be and the solution may require a certain amount of public outcry and political attention.

Uniform national standards need to replace the often complex and inconsistent state and local rules on where and how AEDs are placed — ordering that they be placed prominently, like fire extinguishers, and regularly maintained.

The AEDs should clearly display the good Samaritan legal exception — all states have them — that protects from liability for injury or wrongful death people who voluntarily and in good faith try to save a life.

Says one manufacturer of AEDs, “It’s kind of blunt, but the bottom line is that when you’re in cardiac arrest, you’re dead before you hit the ground. There’s no way you can cause that victim any more harm using that device. You’re trying to bring them back.”

Unlike TV hospital dramas, AEDs do not have paddles that administer massive jolts. Two adhesive leads attach to the chest and the shock, if the machine’s diagnostics say one is needed, scarcely causes the patient’s chest muscles to twitch — and the newer devices will talk the user through the process.

An American public that had no problem mastering smartphones should have even less difficulty with AEDs once they are highly visible and readily accessible.Click here to edit the title
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