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The U.S. Food and Drug Administration (FDA) has been criticized for its handling of medical device recalls. Although devices are labeled as 'recalled,' they often remain in use by doctors and hospitals. This practice has raised concerns, especially when the devices in question are linked to serious injuries or death. Recalls can involve 'removals,' where devices are taken from use or sale, and 'corrections,' where issues are addressed in the field. Despite the potential risks, the FDA and manufacturers sometimes permit continued use of these devices.
Former doctors who worked under UnitedHealth said they never received a satisfying justification for using its medical device to screen for artery disease. Here's how the company turned its questionable artery-screening program into a gold mine: https://t.co/s6wR6PcYuu https://t.co/IJ5MwNHiDR
The FDA said the medical device could cause serious injuries or death, and the manufacturer recalled it. But doctors and hospitals were allowed to keep using it. At the FDA, a recall is not always a recall. @DavidHilzenrath reports for KFF Health News & @CBSNews https://t.co/RszrH3SeGt
With medical devices, recalls are not always what they seem. In some recalls, including some of the most serious, the FDA and the manufacturers let doctors and hospitals continue to use the devices. https://t.co/3VN52Sp7dI
