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Class I Device Reprocessing Costs Prohibitive For Most Hospitals, AHA Claims

This article was originally published in The Gray Sheet

Executive Summary

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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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)...

CMS Keeps Pace With FDA, Rethinks Payments For Reprocessed Devices

Hospitals seeking reimbursement for reprocessed single-use devices under Medicare's outpatient prospective payment system (OPPS) will be obliged to demonstrate cost savings to CMS.

CMS Keeps Pace With FDA, Rethinks Payments For Reprocessed Devices

Hospitals seeking reimbursement for reprocessed single-use devices under Medicare's outpatient prospective payment system (OPPS) will be obliged to demonstrate cost savings to CMS.

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