The U.S. Food and Drug Administration said Medtronic Inc. has agreed to comply with FDA rules in manufacturing its external heart defibrillators.
The FDA said Medtronic, its Physio-Control Inc. subsidiary and two high-ranking executives signed a consent decree calling for a permanent injunction involving the company's automatic external defibrillators manufactured by Physio-Control.
"The consent decree prohibits the manufacture, distribution and export of specified AEDs at or from Physio-Control's facility in Redmond, Wash., until the devices and facilities have been shown to be in compliance with the Food and Drug Administration's current 'Good Manufacturing Practice' requirements, as set forth in the … regulation for devices," the FDA said in a statement.
AEDs are portable devices used to restore normal heart rhythm to people who suffer heart attacks that produce ventricular fibrillation. The AEDs deliver an electric shock that stuns the heart for a moment, giving it the chance to resume beating effectively.
FDA inspections revealed deficiencies in the manufacturing process. Although those deficiencies don't necessarily mean that the defibrillators on the market will harm patients, the FDA said it is requiring corrections to "ensure the continued availability of safe, effective and reliable products."
Copyright 2008 by United Press International
Related stories:
FDA OKs first compact heart-assist device
The U.S. Food and Drug Administration announced approval of a compact heart-assist device that's the first to be designed for a small-sized adult.
Microwave treatments for enlarged prostate cause blood pressure surges
Many men who receive microwave therapy for enlarged prostates experience significant surges in blood pressure that could raise their risk of a heart attack or stroke, according to new research findings published recently in
Mayo Clinic Proceedings.
New technique for treating blocked coronary arteries shows promise
George W. Vetrovec, M.D., chair of cardiology at the Virginia Commonwealth University Medical Center, known nationally for his study and treatment of coronary artery disease, says a new technique for treating blocked coronary arteries shows promise, but is best performed by experienced physicians.
Welch Allyn AED-10 defibrillators recalled
The U.S. Food and Drug Administration announced the recall of Welch Allyn AED-10 automatic external defibrillators due to possibly defective circuit boards.
Natural polyester makes new sutures stronger, safer
With the help of a new type of suture based on MIT research, patients who get stitches may never need to have them removed.
Noise-immune stethoscope helps medics hear vital signs in loud environments
A new type of stethoscope enables doctors to hear the sounds of the body in extremely loud situations, such as during the transportation of wounded soldiers in Blackhawk helicopters. Using ultrasound technology, the kind used to generate images of internal organs, muscles and unborn fetuses, the new stethoscope design will be presented later this week at the Fourth Joint Meeting of the Acoustical Society of American and the Acoustical Society of Japan, which will be held at the Sheraton Waikiki and Royal Hawaiian Hotels in Honolulu, Hawaii.
Measuring fetal oxygen does not reduce Caesarean rate, researchers find
Measuring the amount of oxygen in the blood of a fetus during labor has no bearing on whether a Caesarean section is performed and does not affect the health of the newborn baby, researchers at UT Southwestern Medical Center have found in a multicenter study.
'Crabby' compound that skewers bacteria could prevent medical implant infections
A chemical compound found in crabs and shrimp that has long been known to have certain medicinal value also can act like a "bed of nails," fending off microbes seeking to colonize wound dressings, catheters and other implantable medical devices, according to Montana State University researchers. Using the compound to coat these medical devices, they say, could help prevent thousands of bacterial and yeast infections annually.