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mary ferris
power ports

With all the power ports on the market and all coming with thier own needle what are hospital  stocking. We are in an area tha we could get aleast 3 differnt power ports if not fourdiffernt power port  into our hospital.

It is hard to stock all different huber  port needles.

BARD

Angio dynamics

Navalyst

Smith????

Thanks

Mary Ferris

bthompson96
We use BARD's PowerLoc for

We use BARD's PowerLoc for the PowerPort (this is what our docs are putting in).  We use SafeStep Huber Needle for all others (this is now a Bard product).   BARD now has a power injectable version available, but I do not know the name.

Thanks,

Becky

Timothy L. Creamer
The SafeStep power

The SafeStep power injectable version is called Power Loc Max. It has a universal indication for any power injectable port.

Hope this helps. 

Timothy L. Creamer, RN

Clinical Specialist, Bard Access Systems

Florida Division

Timothy L. Creamer RN, CRNI

Clinical Specialist, Bard Access Systems

Florida Division

daylily
I was told by two different

I was told by two different company reps. (Angiodynamics & Bard) that they received FDA approval for the port and the needle together (bundled) and we could not use a different power needle in their port.

They were basically saying that if a patient was injured and we did not use the approved products, and that was the cause of the injury, it would be on us.

Timothy L. Creamer
You are correct, in order to

You are correct, in order to receive FDA approval the power injectable port required a power injectable Huber type needle set to provide a complete safe power injectable system. Resulted in brand specific requirements in IFU's. Safe Step Power Loc Max has approval/indication for any power injectable port.

Timothy L. Creamer, RN

Clinical Specialist, Bard Access Systems

Florida Division

Timothy L. Creamer RN, CRNI

Clinical Specialist, Bard Access Systems

Florida Division

lynncrni
We should be careful about

We should be careful about language when referring to the FDA. The word "approval" is not correct when applied to devices. This implies that there has been some level of performance assessment with each device and this is not the case. Most IV related devices comes through the FDA as the 510K process. This simply states that the product is substantially equivalent to another device of the same nature already on the US market. The phrase is "cleared for market", rather than any "approval." This is thoroughly discussed in the new INS textbook that has been released for purchase and will be available at the conference next week. 

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

www.hadawayassociates.com

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

daylily
So, would an institution be
So, would an institution be released from liability if they chose any power injection needle in any power injectable port as long the PSI rating was followed, rather than port and needle provided by each manufacturer?
lynncrni
There is really no such

There is really no such concept as being "released from liability." In our system, anyone can bring a lawsuit for any reason. This means naming a variety of parties in lawsuits involving infusion therapy and vascular access. The process of working through the court system is what determines who is removed and who continues to be named. Power injectable ports and access needles that have gone through the FDA clearance process as devices that have only been tested together require labeling that calls for their use together. The national standard of practice is to follow the manufacturers instructions for use on products. So if the labeling on the port did not specify use with any particular brand of port needle and the port needle instructions did not specify that it must only be used with a certain brand of port, then your institution may not be found liable at the outcome of the case, but this does not mean that the institution would not be named in the case at the beginning. 

 

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

www.hadawayassociates.com

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

Timothy L. Creamer
Thank you Lynn, I misspoke

Thank you Lynn, I misspoke "approved".  Appreciate the guidance, you explained what I meant to say so clearly. Thanks again. 

Timothy L. Creamer, RN

Clinical Specialist, Bard Access Systems

Florida Division

Timothy L. Creamer RN, CRNI

Clinical Specialist, Bard Access Systems

Florida Division

Donna Fritz
I do not understand why one
I do not understand why one would need to use a specific power injection compatible non-coring needle with specific brands of power ports (term used generically).  Maybe I'm oversimplifying, but the basics are that the needle set has to be able to withstand the pressure; the port has to be able to withstand the pressure.  The only area that these two meet is the noncoring needle in whatever gauge you have used.  I believe the non-coring needle is a standard design.  What am I missing?
lynncrni
You are only missing the

You are only missing the specific instructions for some manufacturers to only use the needle made by their company for their power port. Some engineers may be able to address any true clinical issues associated with using brand A power port with brand B needle, as long as that needle is rated for power injection. 

 

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

www.hadawayassociates.com

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

SusanBrown
We use Bard's PowerLoc for

We use Bard's PowerLoc for all Power ports and we use MiniLoc for all other ports. I would think that it shouldn't matter what brand of huber you are using as long as it is a non coring  huber needle.

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