Last year, a Supreme Court ruling came down that will affect thousands of Americans, even if they were not aware of the ruling. Building on a ruling that declared manufacturers of medical devices could, in some cases, enjoy immunity status if the device turned out to be defective, last year’s case determined that no patient could challenge a manufacturer in state court if it had been approved at the federal level.
In 2012, the FDA received almost 900,000 adverse event and medical error reports from consumers—but only 5 per cent of those reports concerned children less than 18 years of age.
However, reporting adverse effects in pediatrics can help shed important light on these products, especially since most pediatric clinical trials only contain a small number of patients. In addition, a product may be studied in one age group and approved for widespread use but affect another age group in a different way.
According to the FDA, a federal judge declared that a Californian company must stop manufacturing drugs and dietary supplements for domestic commerce—at least until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act.
Titan Medical Enterprises, Inc. continuously failed to comply with Good Manufacturing Practice for drugs or Good Manufacturing Practice for dietary supplements. In addition, the company violated the Act by distributing unapproved new drugs.
Apnea in Greek means “without breath”. When a person has sleep apnea their breathing involuntarily stops while they are sleeping. This stopping can happen hundreds of times up to a minute or longer at a time. Most of the time the person is not aware of their breathing stopping hence making death a quiet inevitable occurrence when not treated.
According to a recent article published by www.massdevice.com, St. Jude’s has recalled their Amplatzer TorqVue FX delivery system because of concerns about fractures in the core wire.
The FDA has issued the highest-risk label on the recall of the delivery system produced by St. Jude Medical.
The new lead free implantable heart defibrillator, invented by Boston Scientific Corp, should not be used on a regular basis until more data is available, according to a story in the Chicago Tribune. Defibrillator leads have often caused problems for device makers.
Back in 2010, the FDA sent an open warning letter to DePuy Orthopaedics Inc., because the company had started producing and marketing their metal-to-metal joint replacement device Trumatch without an FDA approval. The company was also marketing a hip replacement device in cases where it had no approval for doing so.
Portable bed rails give the impression that they will be protective. Yet according to the Biomedical Safety & Standards, bed rails actually increase injury and death. The Federal Trade Commission has been asked to demand that manufacturers stop using false advertising. Consumers have filed 525 deaths to the U.S. Food and Drug Administration involving the bed rails.