Defibrillators and Defective Medical Deviced

(9/5/17)- A report released by the office of the inspector general for the Health and Human Services (HHS)estimated that Medicare paid at least $1.5 billion from 2005 thru 2014 for 7 different heart devices that were defective and had to be replaced. The report is the first time the government has tried to assess the cost involved for defective medical devices.

Patients paid $140 million in out-of-pocket costs to replace these devices. The report did not name the manufacturers of the 7 devices.

The report estimated that nearly 73,000 people on Medicare had one of the 7 devices that needed to be replaced because of recalls, premature failures, medically necessary upgrades or infections.

(2/2/11)- The U.S. Justice Department filed a civil lawsuit against Boston Scientific Corp, and its Guidant subsidiary, alleging that the Medicare program paid for defibrillators that the company knew were faulty as early as 2002. Please see our item dated 1/18/11 below.

The suit did not specify an amount being sought in damages. It is intervening in a connected private lawsuit filed previously by a Guidant defibrillator patient in New York who was implanted with a defibrillator in 2002 that allegedly malfunctioned.

(1/18/11)- Judge Donovan W. Frank, of the U.S. District Court in St. Paul agreed to accept Guidant Inc.'s guilty plea, after rejecting it earlier in April. Guidant's subsidiary, Boston Scientific had pled guilty to two misdemeanor charges and agreed to pay a $296 million fine in November 2010 to settle a Justice Department inquiry in connection with hiding defects in its implantable defibrillators.

Prosecutors had alleged that officials at Guidant learned as early as 2002 that some of the defibrillators had a tendency to short-circuit and cause deaths. The company did not disclose the defects for more than 3 years.

Boston Scientific halted all sales of heart-rhythm devices in March 2010 because of an erroneous filing with regulators. The FDA approved sales of defibrillators by the company about a month later.

Judge Frank accepted the earlier penalties but added the placement of the company on a three-year probationary period.

"There were decisions made deliberately to advantage the company by withholding information and misrepresenting information, said Robert Lewis, an assistant U.S. attorney.

(1/11/11)- Each year about 100,00 defibrillators are implanted in patients in the United States. According to the results of a recent study that was conducted by researchers who examined the medical records of 111,707 patients who received the implants at 1,227 hospitals in the United States from January 2006 to June 2009, many of those recipients of the defibrillators did not need them according to the guidelines set up for doctors to use in determining if the procedure should be performed..

The records were part of a national registry, and the National Heart, Lung and Blood Institute paid for the study.

The researchers found that more than 25,000 people, or 22.5% of all those who got the defibrillators did not match the guidelines for those who should be getting them.

Physician fees for the implantation are only about $1,500, but the device itself costs about $20,000 to $30,000, and the hospital fees for the procedure are generally about $10,000.

Professional societies set the guidelines that specify when the device should be used, based on studies showing which patients they help.

The results of the study were published in a recent edition of The Journal of the American Medical Association. Dr. Sana M. Al-Khatib, an associate professor of medicine at Duke University was the lead author of the study.

"I didn't expect the rate (of misuse of the guidelines) to be that high." Especially when "Two randomized controlled studies show that defibrillators do not benefit patients who just had a heart attack."

Even so, 37% of the devices were implanted outside the guidelines to people who had had heart attacks in the previous 40days.

Dr. Alan Kadish, a cardiologist who is president of Touro College in New York, and who wrote an editorial accompanying the article said that the problem of people who need defibrillators and don't get them is even worse. He estimated that about 100,000 who need the device don't get them.

Most of the recipients of the defibrillators were patients in the 64 years old to 68 years old age category.

(4/23/10)- Boston Scientific Corporation announced that the FDA was allowing the company to resume sales of its defibrillator after a one-month halt caused by the company's failure to notify regulators about manufacturing changes it had made to its devices.

Both the FDA and the company said the changes were unrelated to the safety of the devices. The company had made two manufacturing changes to the devices, but the suspension period of time was the minimum expected after it occurred.

Sales of these devices accounted for $1.25 billion in revenues for Boston Scientific, or about 15% of its total sales of $8.2 billion in 2009.

(9/23/09)- Researchers at Providence Hospital and Heart Institute and Medical Center in Southfield, Mich. concluded that defibrillators did not appear to benefit women as much as it did men. Their study pooled data from five clinical trials involving 930 women and 3,770 men.

The studies showed that the device reduced the likelihood of sudden death among male patients with congestive heart failure, and other heart problems, but was not as effective in saving women's lives with the same conditions.

The study was published in a recent edition of the Archives of Internal Medicine.

(7/6/08)- One thousand Americans suffer a sudden cardiac arrest every day. It can happen to young healthy people as well as to older folks. 95% of the victims die before emergency personnel arrive.

Defibrillators come as small as laptops and can cost as little as $1,300. They can be operated easily by untrained bystanders, since the device itself determines if a shock is needed and delivers it, after telling bystanders to stand back. They are available for home usage and no prescription is needed in order to be able to obtain one.

(4/10/08)- The long-awaited results of a clinical trial that was reported on at the recent meeting of cardiologists in Chicago showed that there was no increase of survival rate with the usage of automated external defibrillators in the home. The equipment has been marketed to health-conscious consumers for its ability to provide life-saving jolts of electricity to people whose heart have stopped beating, or are beating so rapidly that they could die within minutes

The results of the study were published in the online edition of the New England Journal of Medicine. The report noted that the devices clearly save lives in hospitals, emergency vehicles and in busy public settings like airports and casinos where trained employees are on duty.

The study included more than 7,000 people at risk of having seizures because of previous heart attacks found that patients in homes equipped with the gear died at the same rate as those without it.

The seizures, known as sudden cardiac arrest, strike about 125,000 Americans each year in their homes and 40,000 in public settings outside of hospitals. Some studies have shown that the survival rate from such seizures in the home to be as low as 2%.

The government-supported clinical trial used the HeartStart Home Defibrillator from Phillips Medical System, which costs $1,300 and is approved for sale over-the-counter.

Four of the 14 patients whom the HeartStart deemed in need of a shock and who then were given it, survived, according to the researchers. But the numbers were too small to be statistically significant.

(3/9/08)- A recent incident in which an American Airline passenger died has brought to the forefront the issue of oxygen masks and defibrillators aboard airline flights. In this particular incident there is a great deal of differences between what the deceased's cousin, who was aboard on the plane and what American Airline officials state what happened.

American was the first U.S. airline to put defibrillators aboard its planes in 1997, which occurred before federal regulations mandated it. The airline said that the device has saved the lives of 80 people in the intervening period of time since it first was installed in their planes. The airline further asserted that its attendants are trained every year on the use of medical equipment and medical procedures.

In November, a VirginAtlantic crew used a defibrillator to re-start the heart of British member of Parliament Pat Keetch after he suffered a heart attack.

There are different classifications for types of oxygen used in flight. One type supplies passengers with oxygen from an overhead drop down mask when the flight is having an emergency. There are also first-aid oxygen bottles, such as the kind to be used in a medical emergency, and oxygen supplied to pilots and flight attendants, whose requirement is mandated by the Department of Transportation.

Medical experts feel that the administration of oxygen during a heart attack is unlikely to revive someone suffering from a heart attack.

(2/6/05)-CMS officials are expanding reimbursement of implantable cardiovascular defibrillators (ICDs) to a much larger group of people than previously covered by Medicare. This decision came as a result of data from a study called Sudden Cardiac Death in Heart Services (SCD-HeFT) which determined that the devices could help prevent death in moderate heart failure patients, or those who had not had cardiac arrest.

At the same time Medicare will establish a registry of patients who will receive the devices. Manufacturers of the devices and many physicians had originally opposed the registry, but Medicare agreed that physicians would not be required to explain why a particular device was being used. The National Institutes of Health, Medtronics (a defibrillator manufacturer) and Wyeth primarily funded the study.

ICDs can cost $30,000 or more for the most advanced models, and some medical analysts said that the cost could exceed $3 billion a year to Medicare. The decision covers both ischemic and non-ischemic heart failure. Ischemic hear failure refers to disease caused by blocked arteries while non-ischemic heart failure can be caused by other factors. The study found that both types could benefit from the defibrillators.

In addition, CMS expanded coverage to Class IV heart failure patients who meet all current CMS coverage requirements for a cardiac resynchroniazation therapy (CRT) device. These devices, made by all the big ICD manufacturers, treat heart failure as well as provide the traditional life-saving shock of an ICD.

The ruling will also mean coverage for patients with Class II and Class III heart failure with ejection fractions of up to 35%. An ejection fraction refers to the heart's ability to pump, with lower ejection fractions signaling sicker patients.

It is estimated that there are as many as 500,000 Medicare beneficiaries who may benefit as a result of this expansion of coverage under the system.

(11/21/03)-On average, more than 1,200 people die from cardiac arrest in the U.S. before they can be admitted to a hospital. One of the keys to survival rate has been the time it takes for emergency medical technicians to reach them. Some recent studies have shown that the survival rate is improving with the placement of defibrillators in public areas, along with the training of ordinary citizens in the usage of the equipment.

Doctors have trained many airline and other workers in public places in how to use the defibrillators. An electrical shock is oftentimes the only chance for survival for a person having a cardiac arrest attack. The National Heart, Lung and Blood Institute, a federal agency in Bethesda, Md., paid for a study in which about 1,500 defibrillators were placed in 993 malls, centers for the elderly and other community sites in 24 cities in the U.S. and Canada.

The study organizers had nearly 20,000 volunteers take a two-to-four hour course in the usage of the device. Half were taught to compress the chest as part of cardiopulmonary resuscitation; the other half were taught to use the defibrillators. In a 21-month period of time, 232 people suffered cardiac arrests, and 44 survived. Of those, 29 had received shocks from defibrillators and 15 had initially received only CPR. The study concluded that cardiac arrest patients were twice as likely to survive in places where defibrillators are publicly available, and volunteers have been trained in usage of the device.

Tom Scully, administrator for the Centers for Medicare and Medicaid Services announced that the Medicare program would expand coverage for the match-book-sized defibrillators that are used to shock the heart back into its normal rhythm. Guidant Corp. the major manufacturer of the device had hoped to gain much wider acceptance and payment for the devices than what was approved.

Scully's ruling will mean that about 10,000 more patients will be covered by Medicare for the device whereas the manufacturers and some heart specialists were hoping to have about 30,000 more patients covered. The device costs about $25,000 to $30,000 apiece, with the total cost running about $40,000 per patient. Scully also stated that Medicare would reevaluate its position next year after the conclusion of a NIH trial involving defibrillators.

Medicare already pays for about 45,000 patients with defibrillators for patients with certain heart problems. Guidant sponsored a study to see if expanded coverage was needed. Those who received the devices in the study had suffered heart attacks that left their heart muscle's pumping function damaged. In some of the subject the electrical system in the heart that tells the lower chamber to pump also was impaired before receiving the device. The Medicare officials approved payment of the device for those patients who had the impairment in the heart's electrical system.

The Federal Aviation Administration issued final rules on airline emergency equipment on Thursday April 12, 2001. These rules require that airline medical kits include antihistamines, aspirin and inhalers as well as putting defibrillators on all domestic and international flights. These defibrillators are the size of a toaster and are intended to treat the most common cause of sudden cardiac arrest, fibrillation. Fibrillation is a rapid, uncoordinated series of contractions of heart muscle, causing weak, and irregular, and ineffectual heartbeats. A defibrillator uses electric shock to make the heart resume beating normally.

According to Richard Hamburg, director of governmental relations for the American Heart Association, "The availability of a defibrillator is a life-and-death matter for someone suffering cardiac arrest". The American Heart Association estimates that ventricular fibrillation kills about 225,000 people each year. Each minute that a person does not receive treatment for cardiac arrest, the chances of survival drops 10 percent.

The cost of these portable defibrillators ranges from $2500 to $4000. Flight attendants will have to be taught to use this device. Many airlines have already begun using this device, and the rest will have three years to put them on all airplanes. 

A non-profit organization called Start-A-Heart has announced that it plans to install 120 Automatic External Defibrillators (AEDs) in four Los Angeles area airports by early 2001. The defibrillators have been designed for use by lay people. Hopefully professionals will be available to operate the equipment, but in an emergency lay people will be able to operate them.

This rule was the outcome of a one-year survey instituted by the FAA. It stems from hearings conducted by Congress in which medical personnel associated with the airlines industry testified positively about the value of the defibrillator. The study showed that the average age of "medical events" occurring in flight was 62 years, and of 177 of these "events" 119 involved problems related to the heart. It concluded that the defibrillator could save lives of people who are unconscious in cardiac arrest.

Many airlines, as we previously mentioned, have installed defibrillators, with American Airlines taking the lead. Trans World Airlines and American West have not begun the process i. e are checking out suppliers of these devices. The rule should go into effect in September 2000, but the airlines will have a three years phase in period. The rule also has a Good Samaritan clause, which exempts those who help in these situations from negligence suits.

The medical device for ill passengers on airlines could be the installation of a device that can transmit electrocardiograms from an ill patient to a medical center on the ground. This device, (examples include the Micromedical Biolog monitor and the Tempus 2000), is linked to the seatback telephone that transmit data to a satellite and then to a twenty-four hour medical team that would recommend treatment on board the plane or possibly diversion of the plane to nearest airport. We know of no domestic airline that has such a device, but understand that British Airways and Virgin Atlantic have plans to add this device to their in-flight medical armentarium to insure some quality of in-flight medical care to their passengers. We are sure that other airlines will follow suit in the future if they are interested in the comfort and welfare of their riders.

At the same time, passengers must realize that the level of care available on airplanes is not up to the level provided by their primary care physician. They should not take chances with their health because of the availability of medical devices on airplanes.

Airlines are taking steps to increase emergency medical care on all their flights. Currently, the FAA requires the following medical equipment to be available on all flights: a first-aid kit with bandages, scissors, smelling salts and an emergency medical kit that includes nitroglycerin pills, epinephrine, inhalers and other life-saving equipment. The latest addition to these kits, latex gloves, was mandated 13 years ago. The newest addition is the defibrillator to be used in cases of cardiac arrest.

Figures from the FAA indicate that there were 97 medical emergencies on board planes in the first six months of 1999. Half of the individuals died either in-flight or after admission to a hospital. How many of these deaths could have been avoided with the presence of an on-board defibrillator is unknown, but is surely more than one.

Data from 9 US airlines collected in 1996 indicated that only one in 58,000 passengers experienced a medical problem in-flight, with dizziness/fainting the most common medical problem followed by respiratory problems and chest pains.

With more individuals flying each year and the population growing older, it would seem appropriate that all airlines take the step of installing a defibrillator. The cost varies from $2000 to $3000 plus the cost of training entire flight staff. Advanced technological breakthroughs have made defibrillators relatively easy to use.

The following airlines were reported by The Wall Street Journal (Aug. 16, 1999) to be equipped with defibrillators: Quantas Airways, British Airways, Virgin Atlantic and American Airlines. United Airlines is preparing to install this equipment. We suggest that our readers contact their favorite airline or if they are shareholders in airline stock, notify the company of their desire to see defibrillators on each plane in the company's fleet. Simply put: good cardiac care makes sense.


Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated October 5, 2017

To e-mail: hrubin12@nyc.rr or

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