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Boston Scientific Urges Labeling Warnings For Reprocessed Devices

This article was originally published in The Gray Sheet

Executive Summary

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

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FDA In Brief

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)...

FDA In Brief

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)...

Left To Its Own Devices? Olympus Recall Pushed Into Spotlight

Olympus America is conducting a telephone campaign to aid the Melville, New York company's recall of 15 models of its bronchoscopes that contain a design flaw

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