FDA Approves Over-the-Counter Sales of Home Defibrillator

FDA regulators on Thursday approved over-the-counter status for Philips Medical Systems' HeartStart Home Defibrillator to treat cases of sudden cardiac arrest, the Boston Globe reports. The machine, which previously was allowed only as emergency equipment in certain public locations or in homes with a doctor's prescription, was approved for use on adults and on children who are at least eight years old or weigh at least 55 pounds (Smith, Boston Globe, 9/17). The decision endorses a July recommendation from an FDA advisory panel to remove the prescription requirement after federal advisers were satisfied that the device did not pose a safety risk to consumers (Haderson, AP/Philadelphia Inquirer, 9/17).

FDA based its approval on the device's safety, not because it is a better alternative to calling emergency professionals (Marcotty, Minneapolis Star Tribune, 9/17). HeartStart is similar to emergency devices installed in public areas and includes written instructions and a machine-generated voice to guide the person using it. The machine also takes a reading of the patient's heart to make sure it requires an electrical shock (Boston Globe, 9/17). HeartStart shocks the heart with an electrical current equivalent to what it would take to illuminate a 150-watt light bulb for one second (Minneapolis Star Tribune, 9/17).

In the United States, about 340,000 people die annually from sudden cardiac arrest, a malfunction in the electrical system of the heart that maintains regular pumping. About 80% of cardiac arrests occur at home. A heart under cardiac arrest must be shocked within four to six minutes of the first signs of the condition to increase the chances of survival, according to cardiologists (Boston Globe, 9/17).

When the shock is delivered within five minutes of the attack, 50% of people survive; 10 minutes after sudden cardiac arrest, a patient has a 1% chance of survival, according to Deborah DiSanzo, vice president and general manager of cardiac resuscitation at Philips. Ambulances typically arrive within nine minutes of an emergency call (Minneapolis Star Tribune, 9/17). Heart specialists recommend that anyone witnessing a cardiac arrest should first call paramedics and then use a defibrillator and sometimes perform cardiopulmonary resuscitation.

An FDA spokesperson said that regulations designed to protect trade secrets prevented the agency from disclosing whether other companies are seeking approval to sell defibrillators over the counter (Boston Globe, 9/17). HeartStart is expected to be the first of several such devices FDA will approve (Minneapolis Star Tribune, 9/17). HeartStart went on sale Thursday for $1,995 on a Philips Web site, and company executives expect units to be available in stores before the end of the year.

Phillips officials estimate that sales will exceed 20,000 devices next year, allowing prices to be lowered (Boston Globe, 9/17) DiSanzo said, "We need to choose outlets where there are people who can spend time with consumers and talk about sudden-onset cardiac arrest and defibrillators" (Heldt Powell, Boston Herald, 9/17).

Megan Moynahan, a head regulator in FDA's Division of Cardiovascular Devices said, ''We all see sudden cardiac arrest as a huge public health concern. By having the prescription language removed, we're making the devices more accessible to the public. We'll be able to save lives."

American Heart Association officials and some emergency medicine specialists said they were concerned about giving a full endorsement to the devices because the apparent ease of use might lead consumers to forgo training in handling cardiac arrest situations.

AHA said there is not sufficient scientific data to support making a recommendation either in favor of or against buying defibrillators for home use. AHA spokesperson Heather Maloney said, ''What we don't want to happen is for people to run out and buy AEDs, stick them in a closet, think they're prepared, and not learn CPR, not be trained in the use of the defibrillator. In that case, it does more harm than good."

Peter Moyer, medical director of Boston EMS, fire and police, said, "The danger is, number one, the machine is not totally intuitive, and in a death situation, people really panic. It's an emotional time. I would strongly encourage people if they do buy one of these to get formal training" (Boston Globe, 9/17).