News item # 1:
The United States Food and Drug Administration issued an injunction in April against the heart defibrillator manufacturer Physio-Control, Inc., which is a daughter company of Medtronic, Inc. The permanent injunction was in relation to Automatic External Defibrillators (AEDs) which are
“…portable devices used to restore normal heart rhythm to patients in cardiac arrest (heart attack). Heart attacks can cause ventricular fibrillation, where the heart’s electrical signals are uncoordinated and ineffective, resulting in a lack of blood pumped from the heart to the rest of the body. AEDs are applied outside of the body and deliver an electric shock that stuns the heart for a moment, giving it the chance to resume beating effectively.”
News item # 2:
In the city of Zurich close to where I live, they started a pilot project in May wherein AEDs were placed in 13 telephone booths all over the city. This project is probably a part of the preparations for the upcoming European Football Championships in June 2008. The location of the booths was chosen based on their proximity to public viewing areas as well as squares where crowds tend to gather. The project will last for a year after which it will be evaluated to determine whether AEDs should become a fixture in the phone booths of Switzerland`s biggest city a well as other urban areas.
You have seen defibrillators in movies and TV shows – that device that is applied to a person`s chest during a heart attack. We can only hope and pray that our encounter with this device is limited to this as-seen-on-screen experience and not in real life.
There are many types of defibrillators. What you see in emergency rooms are the state-of-the-art ones which require expert knowledge to operate. However, defibrillators are actually found in many places outside the hospital – in emergency vehicles such as ambulances and fire trucks, for example.
What we are not aware of is that they may be present in churches, school houses, conference halls, and during sports competitions. And, in the case of Zurich, in telephone booths. In other words, they can be found in places where large number of people tends to gather. There is where AEDs come in. They are portable and they can be operated by almost anybody.
So why are ordinary people without medical training given access to defibrillators? Because in emergency situations, AEDs can save lives. The CDC estimates that 47% of cardiac deaths occur before delivery of emergency services or arrival at the hospital. In other words, an AED might be the only thing that stands between life and death.
Now back to the injunction. According to the FDA, the AEDs concerned have manufacturing deficiencies
“including failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions.”
For these reasons, the FDA issued the injunction and demanded for removals and corrections.
And rightly so. In order for AEDs to save lives, it has to be safe, effective, and reliable.