The FDA reported yesterday that heart defibrilators have been faulty and crippled by design flaws for many years. They noted that these cardiac defibrilators have failed to work in life-and-death instances.
In 2009 there were 17 recalls of heart defibrilators by the FDA. According to Newsday, over 28,000 problems have been reported to the FDA for the last five years concerning these implantable defibrilators. These devices are commonly seen in airports, schools, gyms and offices in the form of AED's or automatic defibrilators.
The FDA argues that the manufacturers including Cardiac Science Corp., Philips Healthcare and others have failed to fix problems that forced the FDA to recall hundreds of thousands of the defibrilators. The chief of the FDA's medical device group, Jeffrey Shuren, M.D. said that these defibrilator problems are preventable and fixable.
One problem with the defibrilators has been faulty circuitry causing an inability to timely fire, or even misfire. Why are defibrilators useful? They attempt to fix the electrical signals going to the heart that are not correctly firing on their own. According to Newsday, the manufacturers refuse to fix the problem globally, preferring instead to address each on a case-by-case basis.
Here's a common dilemma for a patient with a known defective heart defibrilator:
The patient has the device implanted. They may have other co-morbid conditions that prevent or inhibit a doctor from removing the defibrilator. A risk v. benefit analysis must be conducted to see whether the patient is at risk for a defibrilator known to have design defects that could fail compared to surgically removing it.
If you have questions about whether your defibrilator may be defective and prone to failure or recall, I encourage you to pick up the phone and call me at 516-487-8207 or by email at [email protected]. I welcome your call.
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