ISMP jeers CDRH
This article was originally published in The Gray Sheet
Executive Summary
The Institute for Safe Medication Practices condemns FDA's device center "for its continued failure, despite patient deaths and injuries," to ban "from all health care settings" infusion pumps without free-flow protection. CDRH's inaction on the issue prompts ISMP to include the center on the negative end of its 1998 list of "Cheers and Jeers." Last spring, the organization called on CDRH to withhold approval of pumps lacking a fail-safe mechanism designed to prevent uncontrolled free-flow of intravenous fluids ("The Gray Sheet" May 18, p. 34)