Title: Re: Positive Pressure Caps & Opened Ended PICC Lines
Some thoughts  from my humble legal education/position. .. I see this as something that can not be determined abstractly. 
Please  realize that modifying a product could lead to transfer of  liability from the manufacturer to the person modifying the product... but I would never be able to make an evaluaiton of an adverse outcome with out more facts....
 
Investigation would have to carefully identify that any harm was absoutely related to the product modification by a particular person. ...and then a plaintiff  lawyer would have to show proof that was the actual cause of the harm.  A defense lawyer will argue to show other contributory facts... which the jury or judge will consider in determining the outcome of the case
 
Saying that does not address a circumstance when a nurse makes a modification based on a particular need...  more would need to be learned of the situation/ incident...
 
Many factors are considered in making the legal evaluaion ( including standards of care, training ( general / nursing / iV specific and for use of the product ) plus the  reason / situation of why the  person felt the need to make a product modification and  how easy was it to modify the product. 
 
There is no short answer... If there has been a law suit specifically noting the harm due to removal of a clamp, there may be some guidance in any reports of the case..but like LYNN I have no knowledge of such a case... (does not negate that it may have happend) and since 90+ % of law suits are settled - most often confidentially-  it is hard to identfy a case on this particular issue...
 
If you wish more info...try a web search on  Product Liability Case Law /
 
Ann Zonderman, JD, BSN, CRNI, LHRM
 
 
 
 
 
 
-----Original Message-----
From: [EMAIL PROTECTED] [mailto:[EMAIL PROTECTED]On Behalf Of Lynn Hadaway
Sent: Sunday, January 29, 2006 10:16 AM
To: [EMAIL PROTECTED]; Dee Gary; [EMAIL PROTECTED]; [EMAIL PROTECTED]
Subject: Re: Positive Pressure Caps & Opened Ended PICC Lines

Well, I don't think I am qualified to provide true legal commentary because I am not a lawyer. I have never had a case with facts even remotely related to a scenario where removed clamps have caused some serious outcome. However, I do have a case where the tubing was not adequately secured to a hemodialysis catheter and the patient exsanguinated and died. This was a very large catheter though. The clamps would be for the purpose of minimizing the risk of air embolus or exsanguination. I suppose it would be possible for a lawyer to argue that one of these events occurred because the clamp had been removed and the injection cap was not properly attached. But both of these actions would be required before the event could happen. A properly capped lumen would not be open to allow air or blood into or out of the lumen. If the cap was not adequately secured and there was no clamp, air could get in or bleeding could occur. But this could also occur if the administration tubing and/or injection cap came apart during an infusion. In this scenario the presence or absence of a clamp would not be the issue as it could not be used during an infusion. Hope you follow my thinking on this, Lynn

At 2:27 PM +0000 1/29/06, [EMAIL PROTECTED] wrote:
I know the answer to this question but would like some Legal commentary on PICC Nurses who "remove" the clamps to protect the patient and their PICC from staff who flush and clamp "incorrectly" resulting in costly and time consuming complications
 
--
Robbin K. George RN
Vascular Access Resource
Alexandria Hospital Virginia

-------------- Original message --------------
From: "Dee Gary" <[EMAIL PROTECTED]>
Thank you Lynn, that is what I suspected!!!
 
Dee

Lynn Hadaway <[EMAIL PROTECTED]> wrote:
It sounds to me like this rep is using unnecessary scare tactics to sell his product. However, there are many hospitals that prefer to have the catheter extension leg clamped during periods between infusions. When using a positive displacement needleless connector, clamping immediately will prevent the internal mechanism from working properly. In other words, the fluid held in the connector reservoir will not inject the refluxed blood out of the catheter lumen because the clamp is closed. The answer to this is to teach your nurses to wait a little bit of time after flushing and before clamping. This allows time for the positive fluid displacement to occur and then the catheter can be clamped. Lynn

At 6:04 AM -0800 1/28/06, Dee Gary wrote:
I have a question for both groups:

 
A medical device sales rep has been telling us that using positive pressure caps (i.e. CLC 2000, Ultrasite, etc.) with open ended PICC lines, which have clamps on the extension legs, are a safety concern.  He states that if a nurse forgets to clamp the extension leg, and the positive pressure cap comes off, then a bleed out situation could occur and this is a safety concern.

 
Can anyone that has had experience using positive pressure caps with open ended PICC lines please validate what we are being told?

 
Thank you very much!

 
Dee
               

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Lynn Hadaway, M.Ed., RNC, CRNI
Lynn Hadaway Associates, Inc.
126 Main Street, PO Box 10
Milner, GA 30257
http://www.hadawayassociates.com
office 770-358-7861


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Lynn Hadaway, M.Ed., RNC, CRNI
Lynn Hadaway Associates, Inc.
126 Main Street, PO Box 10
Milner, GA 30257
http://www.hadawayassociates.com
office 770-358-7861






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