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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)...

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Vascular hemostasis devices

FDA "Dear Colleague" letter issued Oct. 8 recommends that the devices not be used on patients with "suspected double-wall punctures," and that users "carefully weigh the risk of bleeding at the puncture site" in patients medicated with platelet glycoprotein IIb/IIIa receptor inhibitors. While two adverse events, involving a myocardial infarction and ruptured pseudoaneurysm, are cited as examples by FDA, an increase in overall adverse event rates for the devices has not been observed recently, staffers note. Manufacturers include Datascope (VasoSeal), and Kensey Nash (Angio-Seal)




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