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Air Aid: Medical Kits Reach New Heights

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Jan 1, 1998, 3:00:00 AM1/1/98
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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:
* the defibrillator can physically withstand in-flight environmental
demands, such as vibration and variations in temperature and
altitude
* the device will not electronically interfere with the airplane's
instruments
* the airplane's instruments will not electronically interfere with
the functioning of the device.

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:
* bandages
* compresses for applying pressure, moisture, heat, or cold
* antiseptic swabs
* arm and leg splints
* tape
* scissors.

An airplane's medical kit must be accessible to the flight crew, but
is for use only by medical professionals. It must include:
* blood pressure cuff
* stethoscope
* plastic airways to deliver oxygen to help with breathing
* nitroglycerin tablets for chest pain
* dextrose solution for hypoglycemia
* epinephrine for asthma or allergic reactions
* injectable diphenhydramine HCl for serious allergic reactions
* hypodermic needles
* protective latex gloves.

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:
* licensed medical staff qualified to administer cardiac care and
life support, who are fluent in the language spoken by most of the
passengers and crew
* adequate infirmary space based on the ship's size
* wheelchairs, stretchers, cardiac monitor, portable defibrillator,
and other important equipment and emergency medications.

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:
* discussing your travel plans with a doctor
* carrying adequate supplies of medications you may need
* calling the cruise line's medical department to make sure the ship
can accommodate your special medical needs.

--T.N.

FDA Consumer magazine (January-February 1998)
_________________________________________________________________

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References

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2. http://www.fda.gov/fdac/198_toc.html
3. http://www.fda.gov/fdahomepage.html
4. http://www.fda.gov/fdac/198_toc.html

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