The FDA is hoping to fix reliability issues with defibrillators avoiding further recalls
External defibrillators are great lifesaving tools. They are often used for those that go into cardiac arrest, but they do tend to fail often enough to really worry some regulators.
The automated external defibrillators or AED’s are used immediately on those that are suffering cardiac arrest. The device delivers an electrical shock to the heart, starting it back to the normal rhythm. Since they need to be administered immediately, it gives no time for failure.
There have been reports of failure during a rescue attempt and it has either harmed the patient or contributed to the death.
Even with malfunctions taking place, the FDA continues to fight to have these in place. They are working on a solution and ways to improve patient safety.
The AED is manufactured by a few different companies, including Phillips Medical Systems, Defibtech, Heartsine Technologies, and Physio-Control to name a few.
The industry has had many recalls in the past few years, affecting hundreds of thousands of AED’s. From January 1, 2005 to July 10, 1010 there were 68 recalls.
Due to all the issues with AED’s, the FDA has introduced a program that will help all these companies improve the product, making it safer and more effective. The FDA plans to layout the details of this program some time today.
