ECRI responds to FDA public health advisory on i.v. free-flow.
OBJECTIVE
In a Public Health Advisory issued on March 1, 1994 ("Avoiding Injuries from Rapid Drug or i.v. Fluid Administration Associated with i.v. Pumps and Rate Controller Devices"), FDA stated that it had received reports of injuries and deaths from uncontrolled, rapid infusion of medications and/or fluids associated with i.v. pumps and rate-control devices. The Advisory focuses on uncontrolled gravity flow, or what is commonly referred to as free-flow. However, it does not adequately describe free-flow protection mechanisms and makes suggestions that are misleading unwarranted, hazardous, or expensive to implement. One suggestion places patients at greater risk than the problem it is intended to prevent.


CONCLUSIONS
ECRI recommends against purchasing electronic infusion devices (EIDs) that do not have infusion set-based free-flow protection, and we provide conditions for use of EIDs with unprotected infusion sets in this article. We strongly disagree with the FDA's suggestion to limit drug concentration and see no substantiation for its suggestions to place warning labels on EIDs, use limited-volume reservoir chambers, or change the regular inspection and preventive maintenance (IPM) schedule. The FDA Public Health Advisory is intended to be used only as guidance; it does not have the force of law.
D004582:Electronics, Medical / Q000592:standards; D004868:Equipment Failure; D004869:Equipment Safety / Q000592:standards; D007260:Infusion Pumps / Q000009:adverse effects* / Q000592:standards; D011682:Purchasing, Hospital / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*