Reporters with the U.K. newspaper The Daily Telegraph and the British Medical Journal visited a Slovakian firm as part of an undercover investigation into the European Union’s approval process for medical devices. The firm, EVPU, is one of the private companies authorized to license medical implants for the EU.
Posing as representatives of a fictitious Chinese company, the reporters presented plans for an all-metal artificial hip joint. Those plans were overtly ...
continue reading...The U.S. Food and Drug Administration has issued a Class 1 recall for certain models of the HeartSine Samaritan 300/300P Public Access Defibrillator.
According to the FDA, the problematic models were manufactured and distributed from August, 2004, through January, 2011.
The problems with the devices are twofold.
Some of the devices have been found to intermittently turn on and off, which may eventually deplete the battery. Also, certain devices that contain early versions of the battery management software may misinterpret a temporary drop ...
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New research indicates that strokes are affecting younger people when compared with rates 20 years ago, according to a story on WEKU Public Radio out of Kentucky.
The study was published in the online issue of Neurology, the medical journal of the American Academy of Neurology, and examined occurrences of strokes in people between the ages 20 and 54 in the Greater Cincinnati/Northern Kentucky area. The analysis included only first-ever strokes.
Researchers ...
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Illegal practices by a Pennsylvania-based company called Synthes have been linked to the deaths of five patients. But according to a story on the affair by Fortune magazine, those practices are common among manufacturers of medical devices.
Four high-ranking executives are doing jail time for their role in “off-label marketing” of a bone cement called Norian XR. That occurs when manufacturers specifically market a product for a use not approved by ...
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A story in the Boston Globe says congressional representatives investigating a deadly fungal meningitis outbreak have called FDA Commissioner Dr. Margaret Hamburg to testify at a House Energy and Commerce Committee hearing.
Hamburg is also scheduled to testify at a U.S. Senate hearing on the issue.
A co-founder of the New England Compounding Center, the Massachusetts-based specialty pharmacy behind the outbreak, has been invited to testify as well.
The ...
continue reading...Massachusetts has shut down another pharmacy of the type linked to a deadly meningitis outbreak, the New York Times reports.
The Bureau of Health Care Safety and Quality at the Massachusetts Public Health Department ordered the closing of a pharmacy called Infusion Resource, after a surprise inspection cast doubt on the sterility of its products.
Like the New England Compounding Center, the pharmacy linked to the meningitis outbreak, Infusion Resource is a ...
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