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device failures 4 articles

Reports of AED failures prompt FDA to toughen approval standards on external defibrillators

The Food and Drug Administration (FDA) is strengthening its approval process for automated external defibrillators (AEDs) in hopes of curbing the outrageously high number of failures in the life saving devices. AEDs are portable devices used to deliver an electric shock to restore normal rhythm in patients experiencing cardiac arrest or heart rhythm problems. They are installed and ready to use in many public places. The devices can save lives if used promptly in emergency situations. But since 2005, the FDA says it has received 72,000 reports of the devices failing. There have also been numerous recalls of AEDs in ... Read More

Public access defibrillator recalled due to power/battery defect

Another public access cardiac defibrillator model is being recalled by the manufacturer due to a defect that could delay or prevent treatment to a patient during a cardiac event. The recall comes six months after the Food and Drug Administration (FDA) proposed more oversight for makers of emergency external defibrillators due to dozens of recalls of the devices and about 45,000 reports of device failures in the past seven years. Automated external defibrillators (AEDs) are life-saving devices that send a jolt of electric current to the heart of individuals who are unconscious and suffering from cardiac arrest. The jolt is ... Read More

Many more revision surgeries occur in patients with all-metal hip implants

Nearly 75 percent of revision surgeries to remove and replace a hip replacement within five years of initial implantation occur in patients who received a metal-on-metal device, according to a Canadian study. Researchers pored through data involving 60,000 hip replacements performed across Canada between 2003 and 2011. They found that the need for revision surgery was greater in patients who had large-diameter modular metal-on-metal implants compared to patients who had more common plastic devices. Traditional hip replacement systems are made with ceramic or plastic parts, and can last 20 years or more before needing to be replaced. In the past ... Read More

FDA proposes more oversight for makers of emergency defibrillators

The Food and Drug Administration (FDA) is proposing new rules for defibrillators, the portable machines that deliver an electric shock to the heart in emergency situations such as when someone is in cardiac arrest. The proposed guidelines come after about 45,000 reports of device failures in the past seven years. The new guidelines would require the manufacturers of both new and existing devices to provide clinical data or other evidence that proves their defibrillators are safe and effective in order to be approved or remain on the market. Defibrillator makers would also be required to provide inspection reports and inform ... Read More