Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

A Recalled AED is Better Than No AED


 
Cardiac arrest. CPR in progress. Do not use the AED, because it has been recalled!

Wrong.
 


 

HeartStart automated external defibrillators from Philips Healthcare have been recalled.

What does the FDA (Food and Drug Administration) mean by recall?

Well, why was the recall issued?
 

Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the U.S. Food and Drug Administration said today in a new safety communication for users of these previously recalled devices.[1]

 

A shock might not be delivered.

What does the FDA recommend?
 

“The FDA advises keeping all recalled HeartStart AEDs in service until you obtain a replacement from Philips Healthcare or another AED manufacturer, even if the device indicates it has detected an error during a self-test,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health.[1]

 

Do not take these AEDs out of service service until a replacement is present.

Why?

What about the lawyers?

But it’s defective!

Thinking is dangerous!
 

“Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator.”[1]

 

The benefit is greater than the risk.

There is risk with everything.

Anyone who tells you otherwise is selling something.

There is not benefit with everything.

Since the detection of an error during the self-test does not guarantee that the AED will not deliver a shock when needed, removing the AED without a replacement is more dangerous than leaving the AED in service.

These recalled AEDs are better than no AED.
 

Of course, if needed for use in an emergency, make every attempt to clear the error and use the device normally, as described in the Owner’s Manual.[2]

 

The manufacturer and the FDA agree that, in the case of these AEDs, something is better than nothing.

Are we really going to make a dead patient more dead by using a defective AED?

Footnotes:

[1] FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare
FDA News Release
For Immediate Release: Dec. 3, 2013
Media Inquiries: Jennifer Rodriguez, 301-796-8232, jennifer.rodriguez@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
News Release

[2] Philips HeartStart FRx and OnSite (HS1) automated external defibrillators (AEDs)
Phillips Healthcare
Maintenance Advisory

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Comments

  1. That brings up an interesting point in my mind. What if Physio, or Phillips, or Zoll had a massive recall of monitors, specifically those used in most ambulances? What would be expected then? You and I both know they wouldn’t have enough extras sitting in inventory to replace them. The expectation would be to continue to use them and just do your best, and wait for the fix/replacement. Why would it be any different with AEDs?

    • Toasted Medic,

      What if Physio, or Phillips, or Zoll had a massive recall of monitors, specifically those used in most ambulances? What would be expected then? . . . . The expectation would be to continue to use them and just do your best, and wait for the fix/replacement. Why would it be any different with AEDs?

      One big difference is that an AED really only does two things.

      1. Identify a shockable rhythm.

      2. Deliver a shock.

      ECG/12 lead/defibrillator/cardioverter/pacer/NIBP/EtCO2/SpO2 monitors do many different things, so there are many possible malfunctions.

      While there are many possible malfunctions, the systems are designed to be somewhat independent, so that a failure of any one system is not likely to cause a failure of all systems.

      When I put a monitor out of service for a malfunction, it is almost always a failure of one isolated system.

      You and I both know they wouldn’t have enough extras sitting in inventory to replace them.

      Even though I work for a small company, we have some backup monitors by a different manufacturer. A large company would have more of a problem, since their backup may all be from the same manufacturer.

      We can carry separate SpO2 and separate EtCO2 equipment. We already carry manual blood pressure cuffs.

      I would be surprised if a major problem could occur in such large numbers, in a way that it would affect the ability to use the monitor, without being noticed early.

      The difference with the AEDs is that they are not used often. Monitors are generally used several times per day, so problems are much more easily noticed.

      There is one possibility that might fit your scenario. A computer virus might be able to affect many monitors over a short time, but I do not know how vulnerable the computers in monitors are to that kind of threat.

      .

  2. I think the most significant part of why they’re recommending to keep them in service is because of the nature of the failure.

    It MIGHT fail to deliver a shock, in which case we’re at the same point as if we hadn’t tried to use it. There’s no downside to attempting to use it.

    I think the recommendation might be different if, say, it were shocking rhythms that it shouldn’t be, or shocking prior to the shock button being pressed.

  3. The school nurse and I used one of these recalled AED machines on a boy who collapsed and was unresponsive in my gym just 2 weeks ago. It worked, it advised us to shock, we administered the shock, did CPR until the paramedics arrived and my 2nd grade student’s life was saved.

    The downloaded report from the machine shows that it shocked him out of VF. It worked.

    We were not aware of the recall until today, December 5. The date we used the AED was the same date the Medical Device Safety Notice about the recall was made…November 19.

    It worked. Had our school district pulled it from service without a replacement he wouldn’t have survived.

    The benefit IS truly greater than the risk.

    My student is doing well, is back at school and is expected to make a full recovery after having a pacemaker/defibrillator implanted.

    • Ellen,

      It is great to learn about a recalled defibrillator being used to save the life of a student.

      One minor point that I don’t agree with is that you state he would not have survived without the AED. We do not know how well he would have done with just CPR until EMS arrived. The outcome might have been as good. CPR does work, especially when it is done well. There are many factors that affect this and we do not know what the outcome would have been if you had not resuscitated him.

      What we do know is that the rhythm was a shockable rhythm and you used the AED to shock him out of the rhythm and back to life.

      Excellent work.

      .

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