pacemakers

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The Food and Drug Administration is expected to release new data this morning which shows that the number of problems with defibrillators rose sharply between 1992 and 2002. According to the FDA, pacemakers have shown an improvement over the same time frame, with the number of problems reported showing a decline. Between 1990 and 2002, the agency said 62 people died as a result of the failure either pacemakers or defibrillator failure.  

Some observers are pointing at …

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 …

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. …

A developing story looks as though it has the potential to make life unpleasant for medical device manufacturer Guidant. There is word that a defibrillator the company makes has short circuited in some cases, leading to the death of at least one patient, a 21-year-old from Minnesota. The New York Times reports that the company put out an advisory to doctors yesterday warning on the Ventak Prizm Model 1861. The newspaper reports that the company knew about the problem at least …