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Jan Fuller
Power Injection Limits on PICCs

I have been told by a sales rep that all PICCs are required to be tested for ten Power Injections by the FDA and that is why their literature states 10 Power Injections because no one has tested a PICC past this FDA requirement.  The brand I am currently using is supposed to be Power Injectable for as many times as the pt may need it and has no limit on the injections.  A lot of my patients are using PICCs for cancer treatments and they get a lot of tests that require Power Injection.  I am concerned about using a PICC that has limits on this and if all PICCs should never be power injected more than 10 times, who is responsible for keeping up with this?  Any advice or reference would be appreciated.

lynncrni
I do not know if the FDA sets

I do not know if the FDA sets a max number of testing or if they do, what that number is. However, when a sales rep makes such a statement I would expect to see it in writing from his company or I would not believe it, simple as that. I do know there are other power-injectable PICCs currently on the market that have labeling for less than 10 but I do not know about more than 10. I would also want to see a written statement from any company stating that their PICC could be used for an unlimited number. Once again, if this is coming from a sales rep without written evidence of this statement, don't believe it. As far as tracking the number of CT over the life of a PICC, I have not heard anyone discuss a good method for that. So I am eager to see if someone can add to this issue. Lynn

Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI

Lynn Hadaway Associates, Inc.

PO Box 10

Milner, GA 30257

Website http://www.hadawayassociates.com

Office Phone 770-358-7861

Chris Cavanaugh
Closely check the Instructions for use

Every PICC manufacturer and catheter manufactuer places a limit on the number of injections a catheter has been tested for...no one can logically test a catheter for an unlimited amount of times...eventually the catheter will fail. 

This is not to say a catheter can only be injected that number of times, it depends on the rate and pressure of each injection and the viscosity of what is being injected. 

10 was chosen by manufacturers because most humans cannot tolerate more than 10 doses of contrast in a short period of time, their kidneys will fail. Once this number was used, it became a benchmark for future catheters cleared by the FDA.

There are manufacturers who provide tracking sheets with each catheter that can be placed in the patient's chart in the Radiology section, perhaps, that track the number of injections the catheter has been used for.  If you would like, I can email you an electronic copy, please contact me directly.  [email protected]

 

Chris Cavanaugh, RN, BSN, CRNI, VA-BC

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