Report: FDA Should Improve Defibrillator Communication

Law360, New York (September 29, 2006, 12:00 AM EDT) -- An association of doctors who implant defibrillators and pacemakers has recommended that the U.S. Food and Drug Administration enhance existing post-market surveillance databases and better communicate with the public about device malfunctions.

The Heart Rhythm Society issued a report Thursday saying that greater transparency in post-market surveillance can improve the identification of devices that aren’t working and may pose a danger to patients.

The issue of the devices is a hot topic. Three of the largest pacemaker and defibrillator makers issued recalls or advisories over the...
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