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Cook Medical as well for
turboflo is cleared by the FDA however they have indication for a one time usage
under 1.9cc / sec.
kathy From: [EMAIL PROTECTED] on behalf of Blackburn, Paul Sent: Tue 2/7/2006 7:24 AM To: [EMAIL PROTECTED] Subject: power injectable PICCs clarification Dear List Serve Members,
I just wanted to clarify a couple of things from
yesterdays message. First, the Rita Medical product that has been cleared
by the FDA for power injection of contrast media is called the OmniPICC
PI. Second, the ProPICC has not been cleared by the FDA for power
injection of contrast media, although it is marketed as such. Essentially
the company did not file with the FDA for an indication for power injection
using this product, or at least I have been unable to find any documentation to
that end. It is important to remember that the FDA has issued a strong
warning not to use PICCs for power injection of contrast media, unless the PICC
has been cleared by the FDA for this indication. Several negative patient
issues have risen in situations where PICCs have been used inappropriately for
power infusion of contrast media. In short, Bard Access Systems,
AngioDynamics and RITA Medical have the only PICCs on the market that are
cleared by the FDA for power injection of contrast
media.
Paul
Paul L. Blackburn, RN, MNA
Manager, Clinical Education Office: 800-443-5505, ext 4981 Mobile: 801-598-1657 Email: [EMAIL PROTECTED] 
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