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[U.S. Food 
and Drug Administration]

Air Aid: Medical Kits Reach New Heights

by Tamar Nordenberg

"Is there a doctor on board?" Not one, but two doctors responded to the plea when, on April 23, 1995, Benjamin Talit suffered sudden cardiac arrest in flight. Despite the medical expertise of a heart-lung surgeon and the other doctor who came forward, the 43-year-old Talit died en route to Los Angeles aboard Northwest Airlines flight 339.

Ben--"a thoughtful, loving husband of 20 years, exemplary father, valued professional, and truly good citizen"--died needlessly before reaching medical help on the ground, his wife Lynn told Congress at a May 1997 hearing about airplane medical kits, because the plane did not carry a device called a defibrillator to restart his heart. It is a "bitter irony," she said, that Ben, himself a volunteer firefighter and emergency medical technician, died "for the lack of exactly the preparedness he supported and practiced every day of his life."

Based on Federal Aviation Administration surveys, an average of 15 medical emergencies may occur daily on U.S. airlines. Medical emergencies have more than doubled in the last decade, according to FAA, which says the increase may be due at least in part to improved airline accommodations for medically-at-risk disabled and elderly passengers.

"The number of emergencies is small in the statistical sense," says Jerry Hordinsky, M.D., head of FAA's aeromedical research division. "But when an event does occur, with a person potentially dying in flight because of a lack of medical equipment, it is very dramatic and attracts a great deal of public attention."

Lynn Talit disagrees. Because airlines are not required to report medical emergencies, people underestimate their scope, she told Congress, pointing out that the number of people who die in flight each year "far exceeds" airline crash deaths.

Cardiac Care Aloft

Along with neurological problems such as strokes and seizures, heart-related problems rank among the most common types of emergencies. In sudden cardiac arrest, the heart stops pumping blood, often without warning in people like Ben Talit with no known heart problems.

According to the American Heart Association, more than 250,000 Americans die each year from sudden cardiac arrest. "And not all of them happen to suffer their cardiac emergency in a hospital waiting room," Lynn Talit says.

Fewer than 7 percent of those suffering cardiac arrest outside a hospital survive, a statistic which the association attributes to the unavailability of a defibrillator, a device that restarts the heart by delivering an electric shock.

As David McKenas, M.D., American Airlines corporate medical director testified before Congress, a person's chance of survival drops 7 to 10 percent with each passing minute. Even if someone's heart stopped right after the plane left its gate, McKenas said, it would be too late to save the person by the time the plane returned to the gate. An on-board defibrillator would offer the best chance of survival.

In September 1996, the Food and Drug Administration cleared an "automatic external defibrillator" (commonly called "AED") for in-flight use and has since cleared another. While defibrillators have been used in ambulances and other nonhospital settings since the 1960s, the unique environment of a plane in flight prompted FDA to require additional testing.

According to Carole Carey, a scientific reviewer in FDA's division of cardiovascular and respiratory devices, the maker of a defibrillator for airplane use must show FDA that:

Based on this evidence, a defibrillator's labeling was permitted to state that the device was environmentally tested for use in planes. Only after FAA added its approval could the device actually be used in flight.

In July 1997, American Airlines became the first U.S. airline to carry automatic external defibrillators and the third internationally, after Britain's Virgin Atlantic and Australia's Qantas airlines. American put defibrillators on its planes that fly over-water routes to Europe, Japan, the Caribbean, Central and South America, and some domestic destinations.

Manufactured by Seattle-based Heartstream Inc. and sold under the brand name ForeRunner, the new model purchased by American weighs about 4 pounds, half the weight of most defibrillators. And the ForeRunner has a longer-lasting battery and requires much less maintenance than older models, according to Carey.

It's also easier to use, she says, making it possible for trained flight attendants to deal with some cardiac emergencies. "Flight attendants obviously aren't physicians, nurses or paramedics. But to use this prescription device, they must receive training in emergency care and use of the defibrillator."

Flight attendants can use the ForeRunner with minimal training because, unlike most defibrillators, it comes with simple pictures and a digital voice to guide a rescuer through the steps. The rescuer simply puts two pads on the victim's chest and rib area. The device measures the heart's rhythm to check for ventricular fibrillation, which requires a shock to the heart, then directs the user to push a button if a shock is needed.

American has trained 2,300 lead flight attendants in use of the defibrillator and plans to train its other flight attendants, according to Nestor Kowalsky, M.D., American Airlines' Chicago area medical director. At least one trained person will be on each flight that carries the device, he says.

American has not decided whether to add the device to the medical kit on all its domestic aircraft. "Right now, the airline is following this first phase of the program to see how successful it is," Kowalsky says. "Then a decision will be made about expanding it to other airplanes."

Several other U.S. airlines have said they are considering carrying defibrillators on their aircraft.

Medical Minimum

Most U.S. airlines carry little more than the medical equipment currently required by FAA: one to four first-aid kits, depending on the number of passengers, and one medical kit per aircraft.

Each first-aid kit must be accessible to the flight attendants and include:

An airplane's medical kit must be accessible to the flight crew, but is for use only by medical professionals. It must include: The goal during serious in-flight medical emergencies is to stabilize the patient while further emergency care is sought. The pilot may decide to make an emergency landing, called "diverting" the plane, depending on factors such as the passenger's apparent medical condition, weather conditions, turbulence, air traffic, and the distance from adequate ground medical facilities.

To help with medical decisions, most airlines have 24-hour access to a physician on the ground. In the future, airlines may decide to use a computerized system developed by a Michigan surgeon for air-to-ground transmission of passengers' vital signs.

But "there is nothing the people on the ground could tell the doctor on board if the right equipment doesn't exist," says Talit, who wants Congress to require enhanced medical kits that would include defibrillators.

One airline voluntarily carrying defibrillators on its overseas flights is not enough, according to Talit. The automated defibrillator, she says, "should be as commonplace as fire extinguishers, and as accessible in case of emergency. Not every public building catches fire--few do--but do we not have a fire extinguisher in these public places?"

Joan Sullivan Garrett, who is president of MedAire Inc., a firm that provides emergency medical guidance to commercial airlines, is also in favor of updating the federal regulations. "Emergency physicians and flight crews," she told Congress, "are using first-aid kits circa 1924 to deal with 1997 realities."

In addition to the automated defibrillator, her recommendations include an automated blood pressure cuff and stethoscope so laypersons can check a person's pulse and an albuterol metered-dose inhaler in case someone suffers an asthmatic attack.

At press time, Congress was still exploring whether to require additional on-board medical equipment, including defibrillators. FAA is working with the airline industry to evaluate the costs and health benefits of additional medical tools on board. But, Hordinsky says, until FAA gets more information, the agency cannot impose additional rules.

So, for now, it is up to the airlines if they want to upgrade their medical kits beyond legal requirements. Regardless of what medical equipment is on board, people with medical conditions that put them at risk should consult their doctors before flying. They should also bring their own medications on board. Even the best-equipped airlines have limited medical capabilities. As MedAire's Garrett testified at the congressional hearing, "It's important to remember that an aircraft cannot be a flying hospital."

Tamar Nordenberg is a staff writer for FDA Consumer.


Sick at Sea

More than 4 million passengers took a cruise in 1996, according to the Cruise Line Industry Association. The organization estimates that by the year 2000, cruises will attract as many as 7 million passengers each year.

Based on the sheer volume of travelers, some are bound to get sick. "In addition to seasickness and sunburn, which are the big leaders, we see all the things you would normally see in an emergency department on land," says Theodore Harrison, M.D., who heads the cruise ship and maritime medicine section of the American College of Emergency Physicians.

While Coast Guard regulations cover the safe navigation and design of a cruise ship, the government does not regulate the quality of on-board medical treatment. In 1996, the American College of Emergency Physicians and a major industry group, the International Council of Cruise Lines, developed the first meaningful standards for cruise ship medical facilities.

Under the ICCL guidelines, a ship should have:

Harrison says that most cruise ships already meet the voluntary guidelines, and he expects that virtually all the ships will meet them in time. "Before the guidelines, everybody was pretty much on their own in determining what medical capabilities were needed. The guidelines leveled the playing field for everybody."

The guidelines may help cruise medical staff address the day-to-day medical needs of passengers, but for complicated cases, many cruise lines are associated with a hospital that can provide emergency consultation 24 hours a day. "We help the ship's medical staff make a decision when they call us about an unusual condition," says Abdul Memon, M.D., the associate director of the emergency department of Florida's Jackson Memorial Hospital, which provides medical emergency advice to Royal Caribbean Cruise Lines.

"The medical care will be pretty good on most cruise ships, under the circumstances," Harrison says. But he cautions travelers to not expect the level of medical care they could get in a New York City hospital. "A cruise ship is just a one or two thousand person little town out there. And people should expect the same medical care as they would expect in a little town in the middle of nowhere."

To help ensure a safe cruise, passengers may want to take some precautions. If you have medical concerns and are considering going on a cruise, Memon recommends:

--T.N.

FDA Consumer magazine (January-February 1998)


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