defibrillators
Lawmakers want more data on heart devices
On Wednesday, Sen. Charles Grassley (R-Iowa) and Rep. Edward Markey (D-Mass.) said they will call for new rules requiring the FDA to collect more data on defibrillators and pacemakers. Critics have charged that not enough information is gathered from manufacturers, making it difficult for regulators to reliably assess the risks involved with specific models. Health plans and other providers have argued for a long time that they need access to the information in order to better compare …
... Read more...FDA knew about Guidant defibrillator flaw
The Food and Drug Administration was aware of a problem which caused some defibrillator units made by Guidant to short-circuit long before a recall was issued in June. The New York Times reports that the regulatory agency learned that one model was short-circuiting at a rate of about one per month when the company turned in a detailed report on its defibrillators in February. Critics said the disclosure is evidence that the FDA needs to monitor safety data more closely and …
... Read more...Guidant reintroduces defibrillator line
Guidant is making its return to the market for defibrillators for patients with congestive heart failure. On Friday, the Indianapolis-based company won FDA approval for a fix for a defect which caused a small number of units to malfunction. The highly expensive devices, which cost around $30,000 each, were pulled from the market in June. Guidant shares rose in response to the news this morning, climbing 4 percent to $71.62 in morning trading.
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... Read more...Guidant clarifies defibrillator recall
Things keep going from bad to worse for limping medical device maker Guidant. This morning the company said it is rethinking its original advice to doctors treating patients who have its VENTAK PRIZM and VITALITY AVT defibrillator models. Guidant now says a programming change it had recommended to solve a glitch with the units can lead to problems in its own right. On Thursday, the company reported second-quarter profits down 15 percent, largely as a result of its recent defibrillator …
... Read more...Guidant releases another defibrillator warning
Shares in device maker Guidant stumbled slightly this morning as Wall Street heard that the medical device manufacturer had reported new problems affecting its popular defibrillator lines. The company is warning cardiologists that a design flaw, which it describes as "a possible degradation in the hermetic sealing component," may cause serious health risks to patients who have the devices. Some analysts think the news could put "additional pressure" on Johnson & Johnson's plans …
... Read more...Medical device monitoring network runs short on funding
Despite well-publicized problems, such as Guidant's defibrillator recall last month, the government is putting plans to expand a computer network intended to provide advance warning of potential problems with medical devices on hold. The FDA had proposed expanding the MedSun network, which monitors data on stents, defibrillators and pacemakers. Now officals are saying those plans will have to wait. Advocates say that isn't a particularly good idea, especially in light of recent problems. …
... Read more...ALSO NOTED: Penn. cuts Medicaid; Long Island hospital alliance; and much more...
> In a late night vote, lawmakers in Pennsylvania passed legislation approving cuts to the state's massive $4.5 billion Medicaid budget. Story
> On Long Island, North Shore and Nassau Health Care announced a five-year alliance. Story
> In a new survey on women's health, Kaiser Family Foundation …
... Read more...Guidant to recall five more defibrillator models
Wall Street did not react positively to news that Guidant is withdrawing an additional five defibrillator models from the US market on concerns of safety issues similar to those which prompted an earlier recall. The affected models are specialized devices classified by most analysts as high-end. Each costs somewhere between $25,000 and $35,000. The news effectively hands the $2.3 billion market for patients with congestive heart failure to rivals Medtronic and St. Jude. There was …
... Read more...ALSO NOTED: HIPAA requirements at hospitals; Defibrillator guidelines prepared; and much more...
> A medical society representing cardiologists who implant defibrillators in patients said it is preparing guidelines for device makers after Guidant's problems. Story (Wall Street Journal sub. req.)
> Investor's Business Daily looks at the IT changes hospitals are being forced to make to meet HIPAA requirements. …
... Read more...Guidant recalls 53,000 defibrillators
On Friday, Guidant corporation announced that it will recall 53,000 implantable defibrillators after evidence emerged of a second death linked to problems with the devices. That news puts thousands of patients who have had the units surgically implanted in a very delicate position. Most will be forced to decide if their peace of mind is worth the risk of having surgery to have the defibrillator removed. Predictably, attorneys for a patient who filed a class action suit against the …
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