d Defibrillation, if delivered quickly enough, leads to a veryhigh survival rate. When delivered in 2 to 3 minutes, 75% ofpatients live compared with survival rates of 10% or lesswhen defibrillation is delayed 10 minutes or more (thesituation in most communities).

d AEDs are effective, safe, and their operation can be readilymastered by lay persons, usually with just a few minutes oftraining. (We’ve trained several hundred seniors using justa 10-minute video.)

d Patients resuscitated from VF generally make good recov-eries, and the shorter the time to defibrillation the better theneurologic outcome.

d Despite substantial efforts over the past 3 decades, there hasbeen no significant improvement in community mortalityfrom VF.I believe widespread dissemination of AEDs, especially in the

homes of higher-risk patients, offers the means to improve thecurrent grim mortality statistics. The main question is how bestto achieve this. Do we use the current medical approach ofdissemination, or do we use the consumer approach?

In the medical approach, which is what we have now,physicians control dissemination. The device is deemedpotentially dangerous; thus, prescriptions are required. Formaltraining curricula are set by national organizations. Reim-bursement by insurance companies may or may not occur.Cost-effectiveness studies, demanded by insurance companiesand [the Health Care Financing Administration], are nearimpossible to do because the target population is ever shifting asa result of changing indications for implantable defibrillators.Manufacturing costs and sale price to the patient remain highbecause of modest distribution and lack of competition. The neteffect is limited dissemination.

Contrast this to the consumer approach. Because the device isconsidered safe and training is simple, this committee decides torecommend over-the-counter status. Economies of scale lower thecost. Competition increases, and the effect is lower price. Like anyother consumer choice, the consumer decides whether there isadequate value for his or her money. I suspect many older adultswill consider several hundred dollars for a home AED as good aninvestment as optional side air bags, carbon monoxide monitors,home security systems, and other personal safety products.’’

Mickey Eisenberg, MD, PhDUniversity of Washington Medical CenterSeattle, WA

doi:10.1016/j.annemergmed.2004.09.029

Available online December 6, 2004.

Correspondence

Over-the-Counter Automated ExternalDefibrillators? Show Me the Data!

96 Annals of Emergency Medicine

defibrillators (AEDs). I believe this decision was driven bymarketing and testimonials rather than science. There are noempirical data to support the value of this strategy. There arehypothetical reasons to worry that encouraging indiscriminantacquisition of AEDs for the home may actually reduce ratherthan increase rates of successful cardiac resuscitation. Publicpolicy decisions should be based on well-designed clinical trials,not testimonials.

The following are excerpts from a letter I submitted to theFDA opposing this decision:

‘‘The argument in favor of over-the-counter sales ofautomated defibrillators goes something like this:

1. Heart disease is a major cause of death;2. Ventricular fibrillation (VF) is a major cause of deaths

due to heart disease;3. Rapid defibrillation is necessary to save victims in VF;4. AEDs allow rescuers with minimal training to deliver

defibrillatory shocks.5. Therefore, widespread deployment of AEDs in homes

will save thousands of lives after cardiac arrest.There is solid scientific evidence to support statements 1

through 4. There is no scientific evidence to support statement 5.Published studies on the use of automated defibrillators by

first respondersdfirefighters, police officers, and other publicsafety personneldhave yielded mixed results. Clinical trials thathave included a control group as well as a treatment group donot demonstrate the same degree of benefit reported by ‘before-after’ studies that use historical controls.

I led one of the first major controlled clinical trials of first-responder defibrillation by firefighters.1 Rather than equip allour fire companies with AEDs and compare their performanceto historical statistics, we equipped half of our companies withAEDs and retrained the other half to perform excellent qualitycardiopulmonary resuscitation (CPR) until paramedics arrived.

During our 2-year study period, the rate of cardiac arrestsurvival in our treatment (AED) group was twice what we hadobserved in our historical controls. However, survival doubledin the CPR (control) group as well. If we had failed to includea control group, we would have reached the erroneousconclusion that AED use doubled Memphis’ cardiac survivalrate. It didn’t. Simply conducting the study boosted cardiacarrest survival, because it motivated everyone to do a better job.

In another study, researchers examined what happened when19 urban and suburban communities in Ontario, Canada,enhanced their emergency care system by equipping firstresponders with AEDs.2 After this innovation, cardiac survivalincreased from 3.9% to 5.2%, a modest but statisticallysignificant difference. However, most of this improvement wasdue to a higher rate of survival from pulseless electrical activity(PEA), a condition that does not respond to early defibrillation.Again, it wasn’t the introduction of AEDs that made thedifference, but probably better CPR.

The data on the benefits of widespread deployment of ‘publicaccess’ defibrillators are even weaker than that reported for firstresponders. The 2 most widely cited studies involved placing

To the Editor:The US Food and Drug Association (FDA) recently

approved the ‘‘over-the-counter’’ sale of automated external

Volume 45, no. 1 : January 2005

Ultrasonographic Diagnosis of RetinalDetachment in the Emergency Department

To the Editor:A 35-year-old man with myopia and no history of trauma

presented to the emergency department (ED) with sudden,painless loss of vision in his right eye, which he described usingthe drawing shown ½F1� 4=C�in Figure 1. Retinal detachment wassuspected immediately, and external examination of the eye wasnormal. An ED ultrasonographic examination, using a smalllinear array vascular probe, was performed first on the un-affected eye (Figure 2A) and ½F2� 4=C�then the affected eye (Figure 2B).The diagnosis of an anterior-to-posterior retinal detachment(white arrow) was confirmed within 1 minute. The patient wasreferred to an ophthalmic surgeon for immediate repair.

The diagnosis of retinal detachment can be made rapidly andeffectively using almost any ultrasonographic probe, althoughwe prefer linear probes such as the 7.5- to 10-MHz probe used

Figure 1 (Lewin, Williams & Ahuja). Patient drawingillustrating loss of vision in right eye.

Correspondence

AEDs in casinos and on commercial aircraft. Both are singularenvironments that bear little resemblance to the ‘real world.’

Casinos are an ideal location for AEDs. They are covered bysurveillance cameras and feature roaming security officers whoare trained to perform CPR and operate an AED.3 Thisenvironment bears little resemblance to Main Street, USA. Thewidely cited study that put AEDs on the fleet of AmericanAirlines saved 6 lives.4 To achieve this benefit, the companytrained more than 24,000 flight attendants and transported over70 million passengers.

What do studies tell us about the benefits of placing an AEDin the home? Well, there aren’t any. To the best of myknowledge, the only published trial of placing a defibrillator inthe homes of high-risk cardiac patients produced negativeresults.5 A larger study is presently under way, but its findingsare not yet available.6,7*

For patients at significant risk for sudden cardiac death, animplantable defibrillator makes more sense because it operatesitself automatically. For the rest of us, the odds that we will everneed a defibrillator are quite small. If that time comes, the oddsthat someone will be nearby and know where the AED is keptare smaller still.

It is worth noting that having an AED in the home mightactually impair a person’s odds of survival.8 Will the family ofa cardiac arrest victim lose precious minutes searching for thedevice rather than calling 911? Will they focus so intently onoperating the AED that they forget to perform CPR? Willpeople who buy an AED place undue confidence in the device,and either skimp on preventive care or fail to dial 911 at theonset of cardiac symptoms?

Obviously, these are hypothetical concerns. At this point, theputative benefits of over-the-counter sale of AEDs arehypothetical as well. The FDA simply doesn’t have the data itneeds to reach an informed conclusion, one way or the other.

Clearly, this is an instance when the commercial imperativeto sell AEDs has outpaced scientific research on the subject.With nothing more than device performance data, you arebeing asked to authorize the unrestricted sale of a very expensivelottery ticket.

Americans are familiar with the expression, ‘Show me themoney!’ Before members of the FDA Circulatory SystemsDevice Panel authorize over-the-counter sale of AEDs, theyshould shout, ‘Show us the data!’’’

Arthur L. Kellermann, MD, MPHDepartment of Emergency MedicineEmory University School of MedicineAtlanta, GA

doi:10.1016/j.annemergmed.2004.10.008

Available online December 6, 2004.

*This study was not conducted at the time the FDA hearing was held.

Volume 45, no. 1 : January 2005

1. Kellermann AL, Hackman BB. Impact of first responder defibrilla-tion in an urban emergency medical service system. JAMA. 1993;270:1708-1713.

2. Steill IG, Wells GA, Field BJ, et al. Improved out of hospital cardiacarrest survival through the inexpensive optimization of an existingdefibrillation program. OPALS Study Phase II. JAMA. 1999;281:1175-1181.

3. Valenzuela TD, Roe DJ, Nichol G, et al. Outcomes of rapiddefibrillation by security officers after cardiac arrest in casinos.N Engl J Med. 2000;343:1206-1209.

4. Page RL, Joglar JA, Kowal RC, et al., Use of automated externaldefibrillators by a US airline. N Engl J Med. 1000;343:1210-1216.

5. Eisenberg MS, Moore J, Cummins RO, et al. Use of the automatedexternal defibrillator in homes of survivors of out of hospitalventricular fibrillation. Am J Cardiol. 1989;63:443-446.

6. The PAD Trial Investigators. The Access Defibrillation (PAD) Trial:Study design and rationale. Resuscitation. 2003;56:135-147.

7. The Public Access Defibrillation Trial Investigators. Public-accessdefibrillation and survival after cardiac arrest. N Engl J Med. 2004;351:637-646.

8. Brown J, Kellermann AL. The shocking truth about automatedexternal defibrillators. JAMA. 2000;284:1438-1441.

Annals of Emergency Medicine 97