FDA In Brief
This article was originally published in The Gray Sheet
Executive Summary
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)...