Defibrillator Defects Frequently Asked by FDA

Business Club Dec. 30. U.S. federal health officials called for cardiac defibrillator manufacturers to address some of the long-standing deficiencies in emergency medical devices that have caused dozens of recalls in recent years.

US federal health officials are calling for defibrillator manufacturers to solve the long-standing problems of such emergency medical devices. These problems have caused dozens of recalls in recent years and caused several casualties.

On November 15th, the US Food and Drug Administration (FDA) stated that for many years, external defibrillators have suffered from design and manufacturing deficiencies, and occasionally they have been unable to work properly in life and death.

In 2009, the FDA issued 17 recall announcements for cardiac defibrillators, which was a significant increase over 9 times in 2005. More than 28,000 issues related to defibrillators have been reported to the FDA over the past five years.

When the patient is in danger of sudden cardiac arrest, the defibrillator uses shocks to return his heart to normal. External defibrillators were once considered a high-tech device for the emergency room. Nowadays such devices are found in airports, office buildings, stadiums, and schools.

However, the FDA said that companies manufacturing defibrillators (including Philips Healthcare, American Heart Science, and others) have not solved the related problems that have led to the recall of thousands of devices.

Jeffrey Shuren, director of the FDA's Center for Medical Devices, said: “We have seen that the prevalence of external defibrillator safety issues is unusual and it requires a comprehensive multi-pronged approach. Many of the issues we find are preventable and Correctively, they may affect patient safety."

FDA listed issues include: faulty circuits that can cause defibrillators to fail; cluttered designs that make the defibrillator difficult to use; and production standards that cause defibrillator defects.

Spokespersons for Philips Healthcare and American Heart Science did not comment on the matter. Other manufacturers of external defibrillators also include Defibtech and Welch Allyn.

According to FDA officials, manufacturers usually solve problems one by one, rather than solving the larger quality problems of the devices they produce.

For example, a company has tracked hundreds of reports that all have a common flaw in the defibrillators they produce. The company solved this problem for each device one by one, but it never issued an announcement to remind the owner of the defibrillator to pay attention to this issue.

The FDA also stated that it has found a problem with the circuit that causes the defibrillator to automatically shut down, which may have caused the death of several patients.

On November 15, the FDA sent a letter to all defibrillator manufacturers asking them to hold talks with the government to discuss the repair and improvement of defibrillators. According to the plan, the FDA will hold a public meeting with government, industry, and academic scientists on this issue next month.

The FDA is also reviewing its approval procedures for new defibrillators. Currently, if the new defibrillators are similar to those defibrillators already on the market, they can be approved by accelerating the approval process without having to accept new research work.

External defibrillators usually include two plastic pads attached to the patient's chest to detect whether the patient's heart has abnormal heart rhythm. If the problem can be corrected (approximately a quarter of the time it is), then the plastic pad will give a shock and return the heart to normal.

According to FDA data, nearly 300,000 people in the United States are dying each year because of cardiac arrest.

Dr. John Weisfeldt of Johns Hopkins Hospital estimates that because of the use of external defibrillators by patients, 500 lives are saved each year in the United States. In the past five years, about 1 million external defibrillators have been sold.

Ralph Sacco, president of the American Heart Association (AHA) and the University of Miami, said research has shown that external defibrillators have saved the lives of millions of victims of sudden cardiac arrest. “We deeply feel that stoppages can cause sudden cardiac arrest. In the most common abnormal heart rhythm, external defibrillators are the only effective treatment."

Dr. Douglas Zipes, the former chairman of the American College of Cardiology (ACC), helped inventing the implanted defibrillator. He said that he was convinced of the value of an external defibrillator. For this reason, a few years ago, he would The external defibrillator was installed at home in Indianapolis.

Zipes said: "It's like an oversized mailbox installed on my lawn."