FairWarining Investigates

Bad Shock: Automated Devices for Jolting Hearts May Save Fewer Lives in Hospitals


Just over a decade ago, hospitals around the country began spending millions of dollars to buy automated defibrillators to save the lives of more patients who go into sudden cardiac arrest. The purchases were spurred by a recommendation from an American Heart Association committee that decided the new equipment would bring patients speedier emergency help.

But today the costly equipment switchover increasingly seems to have been a mistake. The latest, most extensive research suggests that the new gear, now found in nearly all hospitals, saves fewer lives than the old, lower-tech defibrillators.

By one estimate, the shortcomings of the automated equipment mean that close to 1,000 more hospital cardiac arrest patients die every year in the U.S.

A FairWarning review of the decision that prompted the switch reveals that the pivotal committee recommendation was made without clinical research answering a crucial question: Did the new devices, when used in hospitals, produce better results than the old equipment?

Instead, committee members endorsed automated defibrillators largely on the unproven theory that they would improve response times because even less-skilled hospital staffers could operate them.

“I think they jumped the gun,” said Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic in Ohio. “Why would we want to dumb things down to a level of having a machine do the thinking for us?”

Or, as Dr. Roger D. White, who was on a heart association subcommittee that provided advice on the defibrillator decision in 2000, put it: “We just assumed that we were going to make a difference.”

White, an anesthesiologist at the Mayo Clinic in Rochester, Minn., added, “What we thought would work, hasn’t worked so far.”

“It is extremely unwise to be spending all this money on intervention that may not prove to be of benefit, and may actually be doing more harm than good.”

    — Dr. Gordon Guyatt, a health policy expert at McMaster University in Hamilton, Ontario

What’s more, the recommendation came amid a network of business relationships between equipment makers and some members of the committee that endorsed the new gear.

The heart association said its policies in place at the time “prevented undue industry influence on its guidelines recommendations.” A science editor for the heart association, Mary Fran Hazinski, who was a member of the key decision-making committee in 2000, added that the recommendation was “very carefully considered and based on the evidence available at the time.”

In theory, getting the new defibrillators made sense. Committee members were alarmed about the amount of time it took at many hospitals to provide shocks to patients who went into cardiac arrest. A big part of the problem was that, although critical care nurses typically knew how to work the traditional defibrillators, many nurses in general wards did not. The devices, using pads placed on a patient’s chest, deliver a shock that can restore a heart’s normal rhythm.

The new equipment, which provides step-by-step voice instructions, figured to be easier for more people to operate.

And the cost was modest, by hospital equipment standards. The widely used basic automated models begin at around $1,600. The dual mode equipment — which can run automated or manually, like the older generation devices – can cost more than $10,000.

Automated defibrillator hanging on hospital wall.

In crafting the recommendation in 2000, the committee itself acknowledged that research had not yet proven that the new devices improved survival rates for hospital patients. Instead, committee members said, they acted based largely on evidence that the simpler version of the new devices – often known as automated external defibrillators, or AEDs – saved lives in non-hospital settings such as airports.

In its recommendation, the committee scolded hospital administrators for failing to stock up on the new generation of defibrillators. “An unacceptably high percentage of hospitals,” the heart association’s 2000 guidelines read, “have not made significant attempts to improve the availability” of automated defibrillators.

Purchases of the devices zoomed after those guidelines were released. U.S. hospitals bought close to 100,000 of the basic automated models between 2000 and 2010, according to the consulting firm Frost & Sullivan.

The firm projects that sales of those basic models to hospitals will keep rising 9 percent to 12 percent annually over the next few years, and that purchases in 2013 will surpass 14,000. That would translate into spending of $21.8 million for the year.

Soon after the recommendation came out, however, product quality flaws began to emerge, a major problem even if it wasn’t the biggest issue hospitals faced with the defibrillators. Manufacturers have recalled tens of thousands of the devices.

An assessment published in August in the Annals of Emergency Medicine found that more than 1,000 cardiac arrest deaths between 1993 and 2008 were connected to the failure of the automated devices in hospitals and other settings. In many instances, the devices failed to turn on, or they turned off unexpectedly.

An industry group, the Advanced Medical Technology Association, said that companies are working with the U.S. Food and Drug Administration to improve the safety of the devices. But it added that the agency “continues to advocate the use of external defibrillators and is not recommending any change to current use practices for these devices.”

A defibrillator with both automated and manual modes.

For hospitals, however, an even worse problem than the equipment failures is that automated defibrillators often appear to be poorly suited for many of their patients. That issue was spotlighted by a broad analysis completed last year by Dr. Paul S. Chan, a cardiologist with St. Luke’s Health System in Kansas City, Mo. His critical study, funded by the heart association and published in the Journal of the American Medical Association, tracked 11,695 patients in 204 hospitals who suffered cardiac arrest between 2000 and 2008.

Cardiac arrest causes the body’s electrical pump, the heart, to abruptly lose function, much like a house that suddenly loses power when struck by lightning. In the population at large, an electrical shock, or defibrillation, often is the only cure.

But Chan noted that hospital patients who suffer cardiac arrest tend to be sicker than the average victim, and may have complex medical problems that are interfering with their heart. They are more apt to suffer “non-shockable” cardiac arrest – in other words, episodes that can’t be fixed with the electrical shock delivered by a defibrillator. Chan’s research showed that 82 percent of hospital cardiac arrests are non-shockable.

To treat those patients, a defibrillator still may be needed to provide readings on how a patient is responding to CPR. Ordinarily, CPR is applied, and then periodically interrupted so that the defibrillators can provide those crucial readings.

A big drawback to the automated machines is that they require longer interruptions – or “hands off” periods – to make those readings, and the lost seconds of CPR can make the difference between life and death in some cases.

On top of that, Chan said, statistics show that hospitals equipped with the new defibrillators have failed to achieve one of the major aims of buying the equipment – delivering the first shock to patients in cardiac arrest more quickly. The hospitals failed to foresee that many less-skilled nurses apparently find it intimidating to operate any defibrillator, and balk at using even the simpler, newer machines.

They have “psychological and emotional” barriers, said John Stewart, a Seattle-area nurse and resuscitation specialist.

All told, Chan calculated that cardiac arrest patients treated at hospitals with automated defibrillators survived only 16.3 percent of the time. By comparison, the survival rate, though still modest, was a somewhat higher 19.3 percent over the same time period when hospitals used manual equipment to shock patients.

Given that automated defibrillator equipment is used in about one in six of the approximately 200,000 annual cases of cardiac arrest in hospitals, the lower survival rate would translate into about “965 fewer patients potentially who may be alive” every year in the U.S., Chan said.

For Dr. Gordon Guyatt, a health policy expert at McMaster University in Hamilton, Ontario, the bottom line is clear: “It is extremely unwise to be spending all this money on intervention that may not prove to be of benefit, and may actually be doing more harm than good.”

Manufacturers and others counter that research shows that patients at individual hospitals, particularly those with a shortage of staffers with the training to use manual defibrillators, benefit from the automated devices. They say that the advantages of automated devices will grow as new, faster-working versions come out.

Ad in medical journal advocating hospital use of automated defibrillators.

“I think it would be a mistake to throw out a blanket statement hospitals shouldn’t be using an AED,” said Dr. Dana Edelson, a board member of the nonprofit Sudden Cardiac Arrest Foundation and an assistant professor at University of Chicago Medical Center. “It depends who is there in the middle of the night.”

Interviews and documents show that at least three people on the 11-member committee that recommended the in-hospital use of automated defibrillators had ties to device manufacturers.

Dr. Richard E. Kerber, chair of the committee and currently a University of Iowa medical school professor, said in an interview that, at the time, he was receiving defibrillator research support from Agilent Technologies, which used to make the devices.

Dr. Peter J. Kudenchuck, committee vice chair and a medical school professor at the University of Washington, disclosed at the time that he had conducted research for Medtronic.

Dr. Richard O. Cummins, a science editor for the committee and a professor of emergency medicine at the University of Washington, said in a 1995 article published in the Annals of Emergency Medicine that he had received research support from Physio-Control, Zoll and other makers of automated defibrillators.

He also disclosed he had received honoraria and travel and accommodation compensation from automated defibrillator manufacturers for participating in conferences. Cummins was also compensated for testifying for Laerdal Medical Corp., another automated defibrillator maker, in a federal court trial.

Kerber and Cummins said they no longer have records indicating how much money they received from the industry, and Kudenchuck failed to respond to repeated email and telephone requests for comment.

In an email, Cummins dismissed the idea that financial considerations could have influenced his thinking. “Certainly didn’t occur with me,” he said, adding that “I still endorse the idea.”

Most of the financial support for the heart association’s 2000 emergency cardiac care conferences also came from makers of automated defibrillators. The association declined to indicate how much it received from the companies.

Committee members, however, say the impetus for recommending the automated defibrillators stemmed from the sometimes prolonged delays in reaching cardiac arrest victims, documented by a 1995 analysis, as well as other studies showing that more nurses could be trained to use the automated devices.

The heart association, which updates its guidelines every five years, will have the chance to revisit the issue in 2015. The association isn’t offering any clues on whether its posture will change, but indicated that it doesn’t consider the Chan study persuasive enough by itself to warrant revisiting the issue. “Guidelines,” the association said, “are based on the entire body of evidence.”

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Lilly Fowler

About the author

Lilly Fowler is assistant editor at FairWarning.

12 comments to “Bad Shock: Automated Devices for Jolting Hearts May Save Fewer Lives in Hospitals”

  1. Rob

    The devices in this article referred to a the newer, simple to use machines are called Automated External Defibrillators (AEDs).

    Most hospitals have installed (AEDs) in the common areas of their campuses. These units in those areas have saved lives. Those people that were saved would probably have died if the AED was not located where it was. If this article results in a single AED that is installed in a common area of any hospital away from manual defibrillators (Cafeteria, gyms, etc.) to be removed and a person in that area suffers a cardiac arrest and is not resuscitated, the person or committee who made the decision to remove the AED is responsible for their death.

    If a hospital administration has determined to install AEDs in other clinical areas where clinicians are expected to resuscitate patients in cardiac arrest it is incumbent on the hospital to train all employees on the available equipment and to require them to demonstrate proficiency. If clinicians of any education, certification and skill level does not feel comfortable resuscitating patients in cardiac arrest, they need to be told by the hospital to find a different means of earning a living. Resuscitating people is arguably the most important thing any healthcare provider will do in their profession.

    Certain AEDs deliver a shock in a matter of seconds. A competent CPR instructor with the appropriate type of training unit should be able to show any adult, especially a nurse how to use an AED and deliver a shock very fast. What kind of unit the hospital provides for the nurses to use in clinical areas is their decision.

    I have provided above a link to our YouTube channel: https://www.youtube.com/user/TeamEmergency I would encourage interested parties to watch the AED Demonstration video. My company, Team Surgical, distributes AEDs to physicians and lay responders alike and many of them have saved lives with these devices.

    My Background:

    I have been in the medical device industry for 25 years.

    I have been hired by a large hospital organization to teach their staff, including physicians how to use AEDs.

  2. William Schafer

    As a survivor who was brought back by timely use of an AED at O’Hare airport twelve years ago, I can assure you that these devices do work. It took 14 minutes for EMTs to arrive on the scene since it is not possible for emergency vehicles to manuever to the end of a concourse. Without the AED and bystanders willing to try I would not be here today. Medical people can argue all they want about in hospital usage but I want AEDs placed where large number of normal citizens congregate and suffer an arrest. Then the device can be used by any bystander who has taken a familiarization class. With this device it is not a medical procedure. It is a lefesaving procedure. Then the medical people can perform their skills in improving the life that was restored. Keep improving the AED tool.

  3. James Dunford, MD

    This is old news – the article was published in the Annals of Emergency Medicine on November 17, 2010.

  4. Brian Farrell

    Leave it to a half baked and poorly investigated article to sum up more than 50 years of history regarding commerically available defibrillators! And to imply these devices haven’t had a significant impact on patients who have had a sudden cardiac arrest event. You might want to interview just a few of the 1,000s of individuals that have been saved by one!

  5. James W Taylor

    Mr. Stewart –

    I don’t have any argument with you, or your reasoning, which I’ve followed for at least 15 years now, where you’ve published. I just don’t think there is any hint of the scandal in the research or any reason for the vitriol in the original article.

    The typical opinion that I’ve run into in hospitals and here at AHA is that the ALS response is adequate in hospital. It doesn’t appear that that is true, given the response time, the survival rates, or the wide variation from system to system. We both know that there are confounding factors – but in ten years of study, trying to control for those factors, the result seems to stand. I’d much rather understand that result and, yes, as a technologist, if the problem is solvable with technology I would work on that solution. AEDs may not be the right answer, but I suspect that people and training are not the whole answer, either.

  6. John Stewart RN, MA

    Mr. Taylor’s assertion that AEDs (or dual-mode defibrillators) have not been widely adopted by hospitals conflicts with my own experience as a hospital nurse, at least in the Seattle area. In any case, the Chan study compared AED use with manual defibrillator use in the hospitals reporting data.What difference does it make to the results if AEDs have not been widely deployed throughout the country?

    Yes, there are quite a few journal article about AED use in hospitals, and I believe I am familiar with most if not all of them. Those with conclusions favoring AED use tend to be small and/or seriously flawed (the Zafari article with the link in the FairWarning article is particularly weak). The best studies are the Chan study cited in the article and two other recent before-and after studies, in which large hospitals implemented hospital-wide use of AEDs. These two studies found essentially the same results as the Chan study. References:

    Forcina MS, et al. Cardiac arrest survival after implementation of automated external defibrillator technology in the in-hospital setting. – Crit Care Med – 01-APR-2009; 37(4): 1229-36.

    Roger J. Smith, et al. Automated external defibrillators and in-hospital cardiac arrest: Patient survivaland device performance at an Australian teaching hospital. Resuscitation, in press.

  7. James W Taylor

    I also want to point out that the work being referred to does *not* involve failed devices. It refers to devices that did not improve the rate of survival from cardiac arrest in the hospital. What also remained unstated is that the reason to deploy AEDs in the first place was that in-hospital cardiac arrest patients have consistently had worse survival than patients having witnessed arrests outside the hospital – treated with the same AEDs derided in this article. So much so, that at the time (2000) responsible physicians were saying that you had a “better chance of survival calling 911 from your hospital bed”, at least in some areas of the hospital.

    That all said, the other fact missing from this article is that generally AEDs have not been widely deployed in the hospital. They have been deployed for studies in a number of hospital systems to provide the “evidence” that this article hotly demands. That evidence is being presented publicly at AHA this week, as in earlier meetings, and many, many journal articles are freely available on-line from Circulation (from the AHA) as well as Resuscitation and others.

    Much of the cost of that deployment is borne by industry, and is the bulk of the “support” that is accepted by the researchers. In the course of studies and research, industry also defrays the cost of travel and meetings … which of course is absolutely appropriate and no less then I would expect for an academic researcher supervising a study of this sort. The point is to disclose the relationship, which this particular reporter certainly found attached to every published article from the researchers mentioned.

    Poor investigation, poor article, poor reporting of the issues: yellow journalism at its worst.

  8. Lisa Levine, CAE

    The public should not lose sight of the fact that in cases of “out-of-hospital” sudden cardiac arrest (where the national survival rate is a dismal six percent), AEDs are still the most effective way to restore normal electrical activity to the heart and thereby increase survival. Studies show that if early defibrillation is provided within the first minute, the odds are 90 percent that the victim’s life can be saved. After that, the rate of survival drops ten percent with every minute.

    The author also mentions a potential benefit behind newer high-tech AEDs in the hospital setting is to expand knowledge and usage by any medical employee (not just doctors, nurses and other trained professionals) so as to decrease response time. Again, when applied in the out-of-hospital setting, we should remember that AEDs have an overwhelmingly high success rate, even when used by lay bystanders without prior experience or lifesaving skills. Bystander assistance in the form of CPR and shocks administered by an AED drastically change the landscape of SCA; as many as 30 to 50 percent of patients would likely survive if CPR and AEDs were used within five minutes of collapse.

    It is my hope that upon considering the valid points in this article addressing rates and outcomes of SCA in-hospital, the public will not feel less inclined to intervene during a medical emergency outside the hospital.

  9. John Stewart RN, MA

    The AHA’s push for in-hospital use of AEDs actually started long before the committee decision in 2000. Below is the full text (minus references) of a letter from me that appeared in the January 1996 issue of Annals of Emergency Medicine:

    Rapid defibrillation is widely recognized as the most important determinant of survival after cardiac arrest, and many early-defibrillation programs across the country have led to significant increases in out-of-hospital survival rates. The American Heart Association (AHA) has strongly supported these prehospital programs for some years; however, the AHA has only recently begun to address the serious and widespread problem of delayed fibrillation in hospitals. This recent attention is certainly welcome, but AHA writings on the subject show a disturbing tendency to limit prematurely the scope of discussion about possible solutions, most prominently in the current (1994)
    edition of the Textbook of Advanced Cardiac Life Support. The problem of delayed in-hospital defibrillation warrants open discussion of a variety of possible remedies. The AHA should issue a clear position statement to that effect, thereby modifying the narrow perspective evident in the Textbook.

    In its current edition, the Textbook for the first time clearly recognizes the problem of delayed in-hospital defibrillation–and then immediately proposes a single solution. In fact, the heading of the relevant section, “In-Hospital Use of AEDs: Delays in Defibrillation,” announces the remedy even before naming the problem. The text recommends that hospitals purchase and use automated external defibrillators (AEDs) to deal with delayed defibrillation. The authors fail to address possible alternatives using existing equipment.

    By presenting AEDs as the only solution, the authors imply that a deliberate, rational assessment of the problem has determined that speed of defibrillation cannot be improved with currently available equipment. However, a review of the literature strongly suggests that delayed in-hospital defibrillation is not due to heretofore inadequate technology but rather to the failure of the health care community to recognize the problem. Moreover, the literature indicates that rapid in-hospital defibrillation is indeed feasible with the manual defibrillators that are standard equipment in most hospital units.

    The 1994 Textbook also appears to endorse a policy change by the AHA that would require hospital staff to undergo AED training by making it a standard part of basic life support training, which is already required of licensed caregivers. Such a change would make additional training for manual defibrillation harder to justify, in effect promoting the purchase of AEDs by hospitals.

    The AHA should encourage objective evaluation of innovative approaches to treatment, particularly those that involve new technologies, before they gain widespread acceptance: “In the emotionally charged atmosphere of medical care, the momentum of a new technology too often puts the burden of proof on those who question the evidence for it, rather than on those who propose it. The result is that the technology quickly becomes the accepted thing to do [and] further attempts to test it are subject to the charge of being unethical . . . ”

    AED manufacturers will keep the AED option in the forefront of discussions about delayed in-hospital defibrillation; as a public service organization the AHA should actively encourage consideration of a broad range of alternatives. There may be ways to achieve the goal of rapid in-hospital defibrillation less expensively–and much sooner–than by making progress contingent on the successful marketing of AEDs to hospitals. A clear statement from the AHA would do much to counter the narrow focus on AEDs found in the Text book of Advanced Cardiac Life Support and at the same time encourage action to remedy this serious and long-neglected problem.

    John A Stewart RN , MA
    Seattle, Washington

  10. betty mcgraw

    I HAVE BOTH PACE MAKER AND DEFRIBULATOR PACE MAKER 2001 MEDTRONIC………DOCTORS MADE ME WAIT TILL PACEMAKER END OF LIFE…………FINALLY 2011 AFTER BEGGING 3 YEARS IT DIED……..BRINGING MY EJECTION FRACTION FROM 65% to 40 % defribulator on recall 6949..can not be removed..fractured wires can kill me………….put in 2005 on recall at the time.it..will one day when heart gets weaker will go off and maybe take mylife they dont know……….. so these devices make you live on borrowed time…no hope bitsy

  11. Louis Lombardo

    Bravo! To save more lives, please keep following the corporate money influencing medical care.

  12. Bob Trenkamp

    This article would have been a lot more helpful if it went a little further. AEDs fail for several reasons – most frequently because of a failure of the owner to perform the maintenance required. (i.e., replace the battery and the pads when they expire, check the unit periodically) To say that an AED’s failure – when it’s really a matter of improper maintenance – caused a death is like saying that the cement sidewalk caused the death of a person who jumped off a building.

    Further, I think you will find that recalls were not found equally across all manufacturers, and making a blanked statement that AEDs have been recalled is misleading unless you point out that some brands have been recalled and some have not.

    Also, the assertion that “The hospitals failed to foresee that many less-skilled nurses apparently find it intimidating to operate any defibrillator, and balk at using even the simpler, newer machines.” if true only is relevant to there not being an increase in survival rate. I isn’t relevant to any increase in death rate: there is no indication that these nurses slowed down their calling ‘code blue’ because an AED was available.

    If you don’t think AEDs are effective, tell me why the Phoenix airport has seen a 75% average survival rate in witnessed sudden cardiac arrests over the past ten years.

    Even if half the AEDs were not serviceable – and that is not true – calling 911 and doing nothing else would be worse for the victim than calling 911 and using a nearby AED.

    No, I don’t like what you are doing. It’s about as helpful as the “cough CPR” or “stick out your tongue” email messages in current circulation. Those emails can kill people, and I fear that your article will disuade people from using an AED when they otherwise would have. I have no objection to reporting the facts and applaud those that do, but reporting part of the story in a way that changes the average reader’s perception of reality is not a good thing.

    I’m not suggesting that you stop investigating issues. I’m just asking that you do so with greater diligence.


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