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14 posts / 0 new

Fri, 10/19/2007 - 20:22

Stephen Harris

Power PICC valves

We are currently trialing several Power PICC manufacturers and I would like to know what everybody is using for endcaps. We love the RyMed valve but are wondering what valves are FDA approved for power injection.Â Any suggestions or comments appreciated.

Stephen HarrisÂ RN,CRNI

Sun, 10/21/2007 - 15:11

IVMan

The saline only cap that

The saline only cap that comes in the bard power pic kit is FDA Approved and I believe there is another out there. I've seen it in the past I just cant recall the name. There is also a new saline only power pic from bard. You could use any cap with that.

Mon, 10/22/2007 - 16:18

IVMan

See below for ultrasite that

See below for ultrasite that comes in the Bard kit.

High Pressure Rated
Pressure rated up to 300 psi for use in applications such as power injection of contrast media.

http://www.bbraunusa.com/index.cfm?uuid=592372E5D0B759A1E338E1AD183CFE21

Mon, 10/22/2007 - 18:28

Peggy McDaniel

We are pleased to announce

We are pleased to announce new labeling for the SmartSite^® valve (Model 2000E) and SmartSite^® extension sets Models 20019E, 20039E, and 20041E which have been validated for use with low pressure power injectors up to 325psi and maximum flow rate of 10 ml/second. The FDA recommends that only needle-free valves and extension sets labeled with the appropriate PSI and flow rate should be used for power injectors. The new expanded use for the SmartSite^® needle-free valve (Model 2000E) and SmartSite^® extension sets 20019E, 20039E, and 20041E will help provide your facility the flexibility to standardize on extension tubing hospital-wide. For additional copies of the tip sheets on using the 2000E, 20019E, 20039E, and 20041E with low pressure power injectors up to 325psi and maximum flow rate of 10 ml/second, contact your Cardinal Health Product Sales Consultant or call our Customer Care Department at 1-800-482-4822.

Peggy McDaniel RN BSN

Infusion Practice Manager, Western Region

Cardinal Health

Peggy McDaniel RN BSN

Infusion Practice Manager, Western Region

CareFusion

Tue, 10/23/2007 - 02:13

Tom Billings

All ICU Medical Needleless

All ICU Medical Needleless connectors, CLAVE, MicroCLAVE and CLC2000 are validated for high pressure injection. There are also large and small bore High Pressure ext sets in numerous configurations. We believe maintaining a closed hug and infusing through the connector is an important factor in eliminating CR-BSI's.

http://www.icumed.com/Docs-Clave/CLAVE%20High%20Pressure%20Tubing%20Extension.pdf

http://www.icumed.com/Docs-CLC2000/CLC2000%20Use%20with%20Power%20Injector.pdf

-Tom Billings, RN

PSR Hospital Division-New England

ICU Medical, Inc.

[email protected]

Tue, 10/23/2007 - 13:16

Stephen Harris

I would like to be clear in

I would like to be clear in my question. What valves are FDA approved for power injection on power PICC's? Do the terms validated and new labeling mean FDA approval or are they just manufacturing terms? Thanks in advance for your input

Stephen Harris RN, CRNI

Tue, 10/23/2007 - 13:45

(Reply to #6) #7

lynncrni

The FDA does not "approve"

The FDA does not "approve" any device. This word implies some level of clinical performance and that is not the case for most products given the requirements under the 510(k) section of the law. All a manufacturer has to prove is substantial equivalence to a predicate device, or a device that is already on the market. Labeling is another requirement that must be factual. The term validated would mean that it has been tested under those pressure conditions so the manufacturer can make the claim of tolerating those pressures. This does not imply any level of real-world clinical performance. That would require clinical trials that are usually not required for 510(k) devices. The manufacturer's label could not state this if it had not been acceptable to the FDA. 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

Tue, 10/23/2007 - 23:41

Stephen Harris

Lynn, I would like

Lynn,

I would like to take this opportunity to thank you for sharing your knowledge on this forum. Your level of expertise continues to amaze me with each of your responses. As a new CRNI(As of 9/28/07) I am grateful to be able to "pick your brain". You have set the bar high and I just wanted to say thanks.

Stephen harris RN, CRNI

Wed, 10/24/2007 - 16:21

(Reply to #8) #9

lynncrni

Thanks Stephen and a huge

Thanks Stephen and a huge congratulations on becoming a CRNI!!! 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

Wed, 10/24/2007 - 20:47

#10

Peggy McDaniel

To follow up, Lynn is

To follow up, Lynn is completely correct about the FDA "approval" for use. However, only Alaris and BBraun have applied for, and received FDA 510k clearance. Therefore, the Alaris SmartSite and extension sets in my previous post are labeled for use with low pressure power injectors up to 325 psi and maximum flow rate of 10ml/second. Other manufacturers may state their products are "validated" but the FDA clearance requires their rigorous standards be met. This is not just an internal testing and validation. When reviewing products, this should be taken into consideration.

Peggy McDaniel RN BSN

Infusion Practice Manager, Western Region

Cardinal Health

Peggy McDaniel RN BSN

Infusion Practice Manager, Western Region

CareFusion

Wed, 10/24/2007 - 22:38

(Reply to #10) #11

lynncrni

Peggy, I am a little

Peggy, I am a little confused by how you are using the phrase "low pressure power injectors". These have always been referred to as high pressure injectors. Can you clarify this? Thanks, 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

Wed, 10/24/2007 - 23:08

#12

Peggy McDaniel

Good Question! I don't

Good Question! I don't know the answer. Let me check and I'll get back to you.

Thanks!

Peggy McDaniel RN BSN

Infusion Practice Manager, Western Region

Cardinal Health

Peggy McDaniel RN BSN

Infusion Practice Manager, Western Region

CareFusion

Thu, 10/25/2007 - 15:57

#13

Peggy McDaniel

Low pressure – up to

Low pressure – up to 325psi. Used for diagnostic CT scan procedures

High pressure – between 325psi – 1500psi. Used in Cardiac Cath Lab, Special Procedures and OR. They increase the psi and decrease the volume to be able to visualize blood flow and veins for special procedures (i.e. stent placement, introduction of guidewire, etc.).

I hope that helps clarify the difference. Thanks!

Peggy McDaniel RN BSN

Infusion Practice Manager, Western Region

Cardinal Health

Peggy McDaniel RN BSN

Infusion Practice Manager, Western Region

CareFusion

Thu, 10/25/2007 - 16:58

(Reply to #13) #14

lynncrni

Yes, thanks, 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

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