The federal Food and Drug Administration has unveiled a plan to track high-risk medical devices.
A Wall Street Journal report on the policy says that it would require the high-risk devices to carry identification numbers. Jeffrey Shuren, director of the FDA’s medical-device center, described the plan as “a major game-changer” and said the agency plans to ramp up efforts to identify malfunctioning medical devices early.
For a long time, public safety advocates ...
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Members of a U.S. Food and Drug Administration panel that recently discussed metal-on-metal artificial hip implants said they wouldn’t recommend that patients get them, although the FDA as a whole has so far stopped short of an official ruling on the devices.
Still, the FDA Website has a section advising orthopedic surgeons who are performing metal-on-metal hip implantation surgery. And the FDA’s recommendations clearly reflect concerns about the devices shedding toxic ...
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Use of metal-on-metal hip implants has been declining in recent years, in response to concerns that they may pose a safety risk for patients who receive them.
According to a Bloomberg report, use of the devices peaked in 2006 and 2007, when the metal-on-metal variety accounted for an estimated 30 percent of the market. Now the all-metal implant, with both a ...
continue reading...According to a story on WLFI out of Indiana, most members of a U.S. FDA panel said they would not recommend metal-on-metal implants for patients who needed hip replacement surgery.
The report quotes a physician on the panel as saying: “I do not use metal-on-metal hips, and I can see no reason to do so.”
At the FDA’s request, the 18-member panel of experts met for two days this week to discuss ...
continue reading...The U.S. Food and Drug Administration says patients who received Johnson & Johnson’s all-metal hip replacements need more frequent testing, according to Bloomberg.
In light of almost 16,800 reports of problems with all-metal hip implants since 2000, federal regulators hope that precaution will help prevent risky replacement surgery for some recipients. The FDA recommendation was part of a report advising members ...
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A recent report in Scientific American takes a look at a faulty heart device that’s been responsible for at least 20 deaths.
According to the article, implantable defibrillator leads are wires that connect defibrillators – devices similar to pacemakers – to the heart. “Over the past decade, the $10 billion heart device industry has seen several high profile cases of malfunctioning products that posed severe risks to patients,” the article states.
The ...
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