FDA OKs Defibrillator Without Prescription

By DIEDTRA HENDERSON

AP Science Write

September 17, 2004, 8:29 PM EDT

WASHINGTON -- People worried about sudden cardiac arrest no longer need a doctor's prescription to buy devices that jump-start the heart. The Food and Drug Administration for the first time agreed Thursday to let consumers go online and purchase the $2,000 devices for home use. Some 80 percent of the instances of sudden cardiac arrest, which is best treated by a shock from a defibrillator, happen at home.

Until now, people needed a prescription if they wanted to have a HeartStart home defibrillator to use in those crucial minutes after calling 911 and before an ambulance arrived.

The FDA endorsed a July recommendation from its advisory panel to remove the prescription requirement after federal advisers were satisfied that people could use the machines safely at home.

The agency approved HeartStart for use without prescription for adults and children at least 8 years old and weighing at least 55 pounds. A device used on younger children still requires a prescription. HeartStart can only be used when the individual does not respond to shaking and is not breathing normally.

In addition, the agency will help the manufacturer, Philips Medical Systems, design a study to track the devices' use to ensure that no unexpected problems arise once the machines are more widely used.

Sudden cardiac arrest is an electrical malfunction of the heart that triggers fatally abnormal heart rhythm. Often, it is the first hint of heart disease and accounts for roughly 340,000 deaths outside of health care settings each year.

HeartStart delivers a jolt of energy equivalent to what it takes to illuminate a 150-watt light bulb for one second.

When the shock is delivered within five minutes of the sudden cardiac arrest, 50 percent of individuals survive, said Deborah DiSanzo, vice president and general manager of cardiac resuscitation at Philips Medical Systems.

Ambulances typically arrive within nine minutes of a 911 call. Once 10 minutes have elapsed since sudden cardiac arrest, the patient has a 1 percent chance of survival, DiSanzo said.

The division, part of Andover, Mass.-based Philips Electronics North America, said it has sold more than 6,000 devices from November 2002, when the FDA first approved their use, through this past Wednesday.

Waiving prescriptions could raise sales beyond 20,000 per year and perhaps cut a few hundred dollars from the $1,995 price, DiSanzo said. By Christmas, consumers should be able to purchase the devices at electronic stores and elsewhere.

Dr. Graham Nichol, chairman of the American Heart Association's automated external defibrillator task force, surveyed scientific journals published since 1966 and found no reports to suggest these devices were unsafe.

"Furthermore, there is no evidence the prescription requirement increases safety," Nichol said.

Still, because of the lack of "sufficient scientific data," the organization said it could not endorse or caution against use of the devices in homes.

The FDA's mandated study may help fill that data gap.

If other people have experiences similar to Jim Baum's, the device will prove a lifesaver. Last November, Baum went into cardiac arrest shortly after he purchased defibrillators for each of his three homes. A friend used one of the devices to bring Baum back from the dead, he said.

"Without that defibrillator, I would not be here," said the 65-year-old, who lives most of the year in California.

But Dr. Arthur Kellermann, chairman of the department of emergency medicine at Emory School of Medicine in Atlanta, said he had "substantial reservations" about the FDA's actions.

"We have no scientific evidence to support the decision and I don't think that's a good way to make health policy," Kellermann said.

Kellermann said the devices were "very expensive lottery tickets" because there is "a remote possibility" a family may save a life by owning one.

Opponents argue that families could reduce survival chances by wasting precious time looking for a defibrillator rather than calling an ambulance.

Dr. Mickey S. Eisenberg, a professor of medicine at the University of Washington Medical Center, disagreed.

"I just don't buy that argument. It's the same argument as saying 'Does a smoke detector impede people from calling the fire department?'" Eisenberg said.

* __

On the Net:

Food and Drug Administration: http://www.fda.gov

Philips Medical Systems: http://www.medical.philips.com/index.html

Copyright © 2004, The Associated Press

FDA Gives The OK For Home Defibrillators

BY DELTHIA RICKS

STAFF WRITER

September 17, 2004

FDA tosses out prescription requirement for consumer purchase of the portable machines used in shocking a heart stricken by arrest

Consumers can now buy without prescription a portable device that is capable of shocking a failing heart into a life-sustaining lub-dub, the Food and Drug Administration announced yesterday.

About 80 percent of cardiac arrests occur at home and the FDA's decision largely was in response to consumers who wanted over-the-counter equipment to use in the critical moments before assistance arrives. Before yesterday's decision, anyone who wanted an in-home automatic external defibrillator -- an AED -- required a doctor's prescription.

FDA officials approved the device for use on adults and on children who are at least 8 years old and weigh 55 pounds or more. The device, which costs $1,995, is similar to the AEDs increasingly seen in airports, sports arenas, malls and other sites. Medicare will reimburse the cost for people with heart disease, according to the device manufacturer.

About the size of a hefty dictionary, the defibrillator is used when a patient is in fibrillation -- cardiac arrest. Cardiac arrest is not a heart attack, but an electrical malfunction of the heart. Patients in arrest for 10 minutes have only a 1 percent chance of survival. An estimated 340,000 people in the United States die annually of cardiac fibrillation.

The machine can distinguish between a heart attack and cardiac arrest. With a heart attack, caused by blocked arteries, the heart is not in electrical chaos. It is the electrical dysfunction that queues the machine to correct the fibrillation.

A computerized voice in the machine "talks" laypeople through the procedure. When the device's soft pads are placed on the chest it can instantly tell whether a patient is in fibrillation. The machine sends a reviving electrical jolt through the heart. The Louis Acompora Foundation in Northport, established after the cardiac arrest death in 2000 of the 14-year-old lacrosse player, was behind an earlier push in New York to get AEDs installed in public places.

Dr. Graham Nichol, chairman of the American Heart Association's AED task force, examined reams of medical studies and found no indications non-prescription use would be unsafe. A device called HeartStart currently is the only AED made for home use.

"We believe they are safe, which is the primary question the FDA was asked ... ," Nichol said. "There's no evidence the prescription requirement increased safety or the ability to use the device, so we supported removing the prescription requirement."

In November, California resident Jim Baum, 65, went into cardiac arrest shortly after purchasing defibrillators for each of his three homes. A friend used one of the devices to revive Baum, he said. "Without that defibrillator, I would not be here," he said.

HeartStart is manufactured by Philips Medical Systems, in Andover Mass.

Deborah DiSanzo, a vice president, said the device must be purchased directly from the company. "You can buy them directly from us at heartstarthome.com, and we're driving to have them on retail store shelves by Christmas," DiSanzo said.

She said the device comes with a training video and information about more comprehensive training with the American Red Cross, the American Heart Association or Medic First Aid Group International.

This story was supplemented with a wire service report.

Copyright © 2004, Newsday, Inc.

'They brought me back from the dead!' Defibrillator law makes a difference

Kenmore school nurse Mary Rose Laux, left, and Kenmore police officer
David Stapleton used a defibrillator to revive parent Kristin Colucci,
who passed out in the school library during an open house event.
» view video

An 11-year-old West Canada Valley boy, a 37-year-old Kenmore mom and a 56-year-old Spackenkill retired teacher all share a heartfelt appreciation for a law that requires a defibrillator in every school building.

This year they were all saved by one - and a variety of well-trained guardian angels, including a custodian, a physical education teacher and a school nurse. These latest saves bring the total number of people revived by school defibrillators to 11 in the last year and a half, since the state Legislature passed a law fervently supported by New York State United Teachers.

On Jan. 22, Kenmore mom Kristin Colucci went into cardiac arrest while attending an evening storytelling event called "Bedtime Bonanza" with her two children, ages 3 and 6.

They were in the western New York library when Colucci suddenly collapsed. School nurse Mary Rose Laux, scheduled to read stories that night, rushed in to find Colucci on the floor and not breathing. She immediately performed CPR and called for the school's defibrillator. With help from a Kenmore police officer called to the emergency, Laux administered two shocks and got Colucci's heart beating again.

"I'm very thankful that the school had a defibrillator and someone who knew how to use it, Colucci said. "I later found out it was Mary Rose's birthday and she gave up going out for dinner to attend the storytelling night."

Colucci said the experience was especially traumatic because her husband died of a stroke just two years ago. He was 43. "If it can happen to me, it can happen to anyone," Colucci said. "I had no family history, no chest pains, not even high cholesterol."

In May, halfway across the state in West Canada Valley Elementary School,

11-year-old James McCooey was swimming laps in gym class when he went into cardiac arrest. Quick thinking by a handful of people including James' twin brother Jacob and the presence of the school defibrillator made the difference. Jacob and physical education teacher Steve Porter got James out of the pool and Barb Ellis, another phys ed teacher, began cardiopulmonary resuscitation. School nurse Millie Ritter came running with the defibrillator and applied it to James, who had no pulse and wasn't breathing. It revived him.

"It was the scariest situation I've ever been in and I wasn't even in the pool," said West Canada Valley TA President Michael Potter. "What's really scary is it could have happened the week before on a field trip to the Utica ballet and we wouldn't have had that device or trained personnel. Our next focus will be training more staff on how to use it. And I'd encourage any schools not complying with the law to get AEDs."

Within 24 hours of the West Canada incident, a defibrillator also proved life-saving at Spackenkill High in Dutchess County. Head custodian Ed Tannini happened to stop at the school around 7:30 p.m. after a last-minute trip with the girls' softball team. "I walked in and somebody yelled, 'Call 911,'" Tannini said. "I immediately went for the AED. When I got there, I saw a man on the floor who wasn't breathing."

It turned out to be retired teacher Steve Nash, who was attending a softball league umpires meeting. Tannini and another umpire at the meeting, retired Pine Plains phys ed teacher Bob Stevenson, administered the AED and performed two-man CPR. "After three times, he started breathing again on his own and then the paramedics came and took over," Tannini said. "I'm convinced the AED saved his life. I don't know if CPR alone would have done it."

"They brought me back from the dead," Nash said. "It's a little ironic. My mother died of a heart attack 20 years ago almost to the day. I wish there had been defibrillators around back then."

Nash said his doctors found the blockage that caused the heart attack and put in a stent. "I feel better now than I did before," he said.

Spackenkill TA President Blanche Wisniewski said the district got the defibrillators after the state law requiring them was approved. "The district has one in every building and has made training available to anyone who wants it," she said. Last year the district offered training during an in-service day and many staffers participated.

"It was a matter of being in the right place in the right time," Tannini said. "And having the right equipment right down the hallway."

- Sylvia Saunders

Eau Claire North Coach Resuscitated, Thanks to Defibrillator

Associated Press (Chippewa Falls, WI)

January 8, 2004

A defibrillator at a high school helped resuscitate a coach when he fell to the floor during a high school girls basketball game, a day after his team was ranked first in the state.

Dan Sippel, 56, the Eau Claire North girls basketball coach, fell face-first to the court Tuesday night with about two minutes left in the fourth quarter of a 48-28 North victory as his team remained undefeated in 10 games.

On Monday, Eau Claire North was voted first in the Associated Press state Division 1 high school basketball poll.

Sippel was hospitalized in stable condition Wednesday after collapsing from a heart attack at a game against Chippewa Falls.

Eau Claire superintendent Thomas Fiedler said Sippel also cut his forehead when he fell and was unconscious until he was revived with a cardiac defibrillator. Fiedler said the coach underwent surgery.

Eau Claire North Assistant Principal Becky Davis said the defibrillator was installed at the school last February at the urging of a school nurse who has since retired.

Sue Johnson, a nurse who had returned to the main gym after watching her daughter play in a freshman game, started mouth-to-mouth resuscitation as another nurse, Brenda Layman, started chest compressions. She was asked if Sippel needed defibrillation.

"I knew that's what was needed, but I didn't realize they had it at the school," Johnson said.

Two Eau Claire Fire Department members who were at the game took over. Dave Gee said he took over the mouth-to-mouth resuscitation while Lance Hanson set up the defibrillator.

Sippel "came around" after the first shock, Hanson said. "Within 15 to 20 seconds his eyes started blinking, and he started breathing." Dr. Stuart Bergen, medical director of the state Project ADAM at Children's Hospital of Wisconsin in Wauwatosa, said it was the first time a school participating in the program used a defibrillator to resuscitate someone.

The program is named for Whitefish Bay High School student Adam Lemel, who collapsed and died during a 1999 basketball game from an undetected heart condition. It gives schools information on defibrillators and helps get them training for using the equipment.

Dr. Douglas Terpstra, an Eau Claire orthodontist who also was among those who offered help, said Sippel was lucky.

"What struck me, when I look back, is how fortunate he was that it happened at a high school with a defibrillator, where there were people trained in CPR," he said. "Had Sippel fallen anywhere else other than a hospital, there would have been some more serious problems." Although there was time remaining in the game, Chippewa Falls coach Jeff Dahl immediately told the referees he had no interest in continuing.

Sippel was given a standing ovation as he was wheeled out of the gym.

"All of our thoughts, prayers and wishes are with Sip right now," North forward Molly Anderson said. "We are the team we are because of him."

Sippel works in campus security at North, and his wife, Diane, is a general assistant at the school. On Wednesday, she thanked everyone at the school for their help.

"The defibrillator at the high school saved his life, and we are so glad it was there for Dan," she said.

Dan Sippel served as an assistant coach for eight years before taking the head coaching job before the 1999-2000 season. He has also been an assistant coach for the North football and softball teams for the last 13 years.