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TRENTON, N.J. (AP) - In a July 30 story about reprocessing of medical devices designed for one-time use, The Associated Press reported incorrect data about difficulties with the devices. Based on erroneous information supplied by the Food and Drug Administration, the AP reported that since early 2004, the FDA had received 13 reports of patient deaths and 421 other trouble reports, including 130 involving serious patient harm.
The FDA said Thursday that, contrary to its initial report, no patient deaths were caused by the reprocessing of single-use devices, and that fewer than 10 serious injuries and fewer than 10 device malfunctions were attributable to reprocessed single-use devices during that period.
In addition, the story discussed the case of an infant who was permanently injured by a tracheal tube that was damaged when it was reprocessed by a hospital. The FDA did not regulate reprocessing at hospitals when the infant was injured in 2001, and hasn't authorized reprocessing of tracheal tubes.
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