Automatic defibrillator approved for sale without prescription
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《英国医生杂志》
The US Food and Drug Administration granted "over the counter" status to Phillips Medical's automatic external defibrillator (AED), on 16 September.
US families will now be able to buy defibrillators, which are usually only available in public places (above) for use in the home
Credit: TIM BOYCE/GETTY IMAGES
This is the first time that an AED has been approved for sale without a prescription. It can be used for adults and for children aged 8 years or older or who weigh at least 3 stone 13 pounds (25 kg).
About 95% of the 340 000 annual US adult deaths from sudden cardiac arrest occur outside hospital, says the American Heart Association. "Many of these events occur in the home," said Dr Graham Nichol, chairman of the association's AED task force. "Out of hospital sudden cardiac arrest is common, lethal, debilitating, and costly."
Dr John Billi, chairman of the association's emergency cardiovascular care committee, told the BMJ that the association had "supported widespread use of AEDs, along with cardiopulmonary resuscitation training as part of a comprehensive programme and one of the links in the chain of survival."
The association has received funding from Philips Medical Systems and other makers of AEDs.
However, Dr Arthur Kellermann, chairman of the department of emergency medicine at Emory School of Medicine, Atlanta, Georgia, submitted a dissenting view during FDA hearings in July. He told the BMJ, "Although it is true that ventricular fibrillation is a major cause of death due to heart disease and it is true that AEDs allow rescuers with minimal training to deliver shocks, there is no scientific evidence to support the claim that widespread deployment of AEDs in homes will save thousands of lives following cardiac arrest."
Dr Billi agreed with Dr Kellermann that risk assessments need to be made about where to place defibrillators. "We support a thoughtful approach to the deployment of defibrillators... Some people will buy them for their homes, and for people who are at high risk that would be appropriate, but we encourage family members to learn cardiopulmonary resuscitation. We would agree that for a family at low risk for heart disease purchasing an AED would probably not be the best investment."
The lack of studies on home use of AEDs concerns Dr Kellermann: "There is only one study to date of defibrillator use in the home. That study was of high risk patients—and the outcome was negative." He said that without scientific evidence of benefit it was irresponsible to promote the use of AEDs in homes.
"There is too much we don't know," he said. "Will a high risk individual opt for an AED when what they really need is an implantable defibrillator? Will there be worse outcomes because family members will run around looking for the device instead of calling 911 ? Will adolescents use them to pull a prank on friends and find a way to shock someone? Until these questions are answered, we don't know if the widespread placement of AEDs could cause more harm than good."
Dr Kellermann added that the best way to prevent sudden cardiac death is to prevent it. "If families have $2000 burning a hole in their pockets, they might do a lot better to spend it on a membership at the gym and on a good diet or on smoking cessation than on an AED."
US families will now be able to buy defibrillators, which are usually only available in public places (above) for use in the home
Credit: TIM BOYCE/GETTY IMAGES
This is the first time that an AED has been approved for sale without a prescription. It can be used for adults and for children aged 8 years or older or who weigh at least 3 stone 13 pounds (25 kg).
About 95% of the 340 000 annual US adult deaths from sudden cardiac arrest occur outside hospital, says the American Heart Association. "Many of these events occur in the home," said Dr Graham Nichol, chairman of the association's AED task force. "Out of hospital sudden cardiac arrest is common, lethal, debilitating, and costly."
Dr John Billi, chairman of the association's emergency cardiovascular care committee, told the BMJ that the association had "supported widespread use of AEDs, along with cardiopulmonary resuscitation training as part of a comprehensive programme and one of the links in the chain of survival."
The association has received funding from Philips Medical Systems and other makers of AEDs.
However, Dr Arthur Kellermann, chairman of the department of emergency medicine at Emory School of Medicine, Atlanta, Georgia, submitted a dissenting view during FDA hearings in July. He told the BMJ, "Although it is true that ventricular fibrillation is a major cause of death due to heart disease and it is true that AEDs allow rescuers with minimal training to deliver shocks, there is no scientific evidence to support the claim that widespread deployment of AEDs in homes will save thousands of lives following cardiac arrest."
Dr Billi agreed with Dr Kellermann that risk assessments need to be made about where to place defibrillators. "We support a thoughtful approach to the deployment of defibrillators... Some people will buy them for their homes, and for people who are at high risk that would be appropriate, but we encourage family members to learn cardiopulmonary resuscitation. We would agree that for a family at low risk for heart disease purchasing an AED would probably not be the best investment."
The lack of studies on home use of AEDs concerns Dr Kellermann: "There is only one study to date of defibrillator use in the home. That study was of high risk patients—and the outcome was negative." He said that without scientific evidence of benefit it was irresponsible to promote the use of AEDs in homes.
"There is too much we don't know," he said. "Will a high risk individual opt for an AED when what they really need is an implantable defibrillator? Will there be worse outcomes because family members will run around looking for the device instead of calling 911 ? Will adolescents use them to pull a prank on friends and find a way to shock someone? Until these questions are answered, we don't know if the widespread placement of AEDs could cause more harm than good."
Dr Kellermann added that the best way to prevent sudden cardiac death is to prevent it. "If families have $2000 burning a hole in their pockets, they might do a lot better to spend it on a membership at the gym and on a good diet or on smoking cessation than on an AED."