Bethesda, Md—Data on what happens to medical devices after they are implanted in patients, as well as information on how patients respond to the implants, is essential for improving devices such as pacemakers, intraocular lenses, and artificial joints, reported a National Institutes of Health (NIH) technology assessment panel last month.
But setting up a universal system for the long-term study of experience with such devices would be cost-prohibitive and, even if funds were available, would not be feasible, said the consensus panel, which was sponsored by the Office of Medical Applications of Research and the National Heart, Lung, and Blood Institute. Too many barriers—even if not all are insurmountable—would have to be overcome. Such barriers include patient confidentiality, threats of litigation, and ethical and cultural concerns about such issues as retrieving a device from a patient after death.
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