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FDA issues reminder for R.T.s.

The U.S. Food and Drug Administration (FDA) has issued a reminder of the potential for serious patient injury when vascular access devices not designed to tolerate high pressures are used for power injection of CT or MR contrast media.

Over the past several years, the FDA has received more than 250 adverse event reports in which vascular access devices have ruptured when used with power injectors to administer contrast media as part of CT or MR studies. The FDA stated that these events have continued to occur despite rupture reports in the literature, letters from manufacturers and warnings in power injectors' labeling.

To help prevent the rupture of vascular access devices, the FDA recommended that users of power injectors check the labeling of each vascular access device for its maximum pressure and flow rate. If none is provided, then the user must assume that the device is not intended for power injection and should not be used. The FDA also recommended that users know the pressure limit settings for power injectors and how to adjust them. Power injector users also should ensure that the pressure limit set for the injector does not exceed the maximum labeled pressure for the vascular access devices. More information is available at www.fda.gov/medwatch/report.htm.

ASRT recently adopted a position statement concerning catheter lines or ports for power injectors. The statement, entitled, "Peripherally Inserted Central Catheter Lines or Ports for Power Injectors" reads: "The ASRT recognizes the use of power injectors with a Peripherally Inserted Central Catheter (PICC) line or ports for power injectors is within the scope of practice for radiologic technologists with the appropriate clinical and didactic education and when an FDA-approved PICC line catheter or port specifically for power injectors is used and manufacturer guidelines regarding infusion rate and pressure are followed, where state and/or institutional policy permits."

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Title Annotation:RESEARCH & TECHNOLOGY; Radiologic Technologists; Food and Drug Administration
Publication:Radiologic Technology
Article Type:Brief Article
Geographic Code:1USA
Date:Jul 1, 2005
Words:311
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