FDA In Brief
This article was originally published in The Gray Sheet
Vascular hemostasis devices: FDA will conduct research over the next couple of years comparing the complication rates of vascular hemostasis devices and manual compression, the agency reports in its latest patient safety news broadcast. FDA says that since 1996 it has received more than 3,000 reports of adverse events related to the use of vascular hemostasis devices. In 1999, the agency issued a "Dear Colleague" letter outlining steps physicians should take to minimize complications with the devices (1"The Gray Sheet" Oct. 18, 1999, p. 28)...
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Reprocessors of single-use medical devices (SUDs) should be required to warn users about the increased risk of using the devices without full knowledge of corrective actions or recalls by the original equipment manufacturer (OEM), Boston Scientific recommends
Third-party reprocessors may lack the capacity to fulfill the demands of hospitals unable to comply with FDA's regulatory requirements for single-use devices (SUDs), scheduled to take effect Aug. 14.
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