By Lilly Fowler, Fair Warning
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 medical help.
Courtesy of Lilly Fowler / Fair Warning
A dual-mode defibrillator, capable of automated or manual operations.
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 U.S. 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 expert advice on automated defibrillators 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."
What’s more, more than a quarter of the members of the heart association committee that recommended the automated defibrillators had business ties with manufacturers of the devices.
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.”
Move made sense, in theory
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 basic models of the automated devices 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.
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 through 2013.
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.
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. Manufacturers have recalled tens of thousands of the devices.
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.”
Related story: Bad batteries in defibrillators tied to cardiac deaths
For hospitals, 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.
Monitoring crucial for in hospital use
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.
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 defibrillators, 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 was 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.
“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.”
FairWarning is a nonprofit, online news organization focused on safety and health issues.