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 increase transparency, allowing public access to product performance records. An FDA-organized panel of heart experts will meet later this week to discuss potential safety problems with medical devices and potential solutions, including a push by reformers to release information which the agency currently classifies as proprietary corporate data.
- see this story from The New York Times