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piccmasters
Declotting P&P

May I ask from the members what is the legal standing of the hospital's P&P with the use of the smaller size syringe to instill tPA, < 10cc syringe, if it caused a ruptured catheter or clot embolus? Would this P&P, support or protect  the nurse for occurence if it happened?

I am trying to change our practice to use the recommended size (10ss syringe) to instill the tPA. But I am having difficulty to change the practice cuz, nothing happened bad yet for all this years we been doing with smaller size syringe. I know the INS recommended 10cc syringe, but can't convince the heads for looking to change. Any cases that any one of you can share, that I could get to be more effective to bring to the table?

lynncrni
First a correction - there

First a correction - there is no statement at all in the INS standards of practice recommending a certain syringe size for anything. 

 As a testifying expert in infusion related legal cases, I always expect to see the hospital policy and procedures pertaining to all issues in a case. So if I was reviewing a case involving a ruptured or fractured catheter, I would look for a declotting procedure that was documented and then ask for that P&P. Syringe size is one of the factors I would consider and bring to the attention of the attorney I was working for, explaining the physics of the issues. 

All facts in the case would be considered. Did the nurse follow the P&P? If not, what was the deviation? Plus all other issues related to the actual circumstances in the case and each case is very different even with the same complication. If there is a poorly written P&P or a deviation from that P&P, both would be discussed in the deposition. Even if the deposing attorney does not specifically ask about an issue, they generally ask if the expert has any other criticisms of nursing practices or the hospital. They do not wish to be surprised at trial. If it went to trial, the weight of the evidence is in the hands of the jury and no one can guess what a jury is going to decide!!

So, the bottom line is that for a declotting procedure, syringe size is important and would be considered. 

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

www.hadawayassociates.com

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

Lynn Hadaway Associates, Inc.

PO Box 10

Milner, GA 30257

Website http://www.hadawayassociates.com

Office Phone 770-358-7861

Karen Day
Karen Day's picture
I have an additional

I have an additional question, even if the hospital chooses to write a policy stating a syringe smaller than 10cc could be used and the nurse instilling the tPA follows the P&P to a T, wouldn't it still be considered "off-label" use from the manufacturer who recommends a 10 - 12cc syringe and therefore be a riskier situation for the jury to sway against the facilities decision to allow this practice?  In this case, would the nurse be covered(because he/she followed protocol) but the facility would fall under bigger scrutiny?  It is my understanding that when these large drug companies do these studies and trials, they have many legals involved and when they provide a certain recommendation, we should follow them.  I realize that no one knows exactly how a jury will decide, but in order to be doing best practice or evidence based practice, shouldn't we follow manufacturers recommendations?  Just some additional curiosity thoughts in addition to the original question.  thanks.

 

lynncrni
Off-label use typically

Off-label use typically applies to the indications for use for a drug or device. But performing a procedure in a manner that is not in accordance with the complete instructions is a risky situation and as such would increase the liability for both the nurse and the facility. If such a case went to trial, the jury would be presented with information from both sides about this issue of syringe size and it just depends upon which expert the jury chooses to believe. I can see this having a great influence on a case of a fractured and embolized catheter, however the syringe size would not matter in a case where the outcome was not directly linked to the syringe size as an issue. So yes, you should be following all IFU's unless there is some compelling reason to deviate from those instructions. 

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

www.hadawayassociates.com

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

Lynn Hadaway Associates, Inc.

PO Box 10

Milner, GA 30257

Website http://www.hadawayassociates.com

Office Phone 770-358-7861

piccmasters
Thanks to Lynn's response.

Thanks to Lynn's response. But, I would like to enter this comment, that when I referred to the INS standard, S60 "CATHETER CLEARANCE", the INS states, 60.1, 60.4-stating the "instillation, aspiration,and flushing of vascular access devices shall be perofrmed using a method that is within the manufacturer's maximum pressure limits in pounds per square inch (PSI).

The manufacturer of Cathflo, recommends 10-12 cc syringe use to instill the tPA. So, when the hospital's P&P is uisng smaller size syringe (1cc) than what the recommended size by the manufacturer, and if a case goes to court, would this support the nurse,  because the nurse followed the hospital's written P&P? Would the nurse be covered with the P&P, as evidenced based practice with the use of 1cc syringe to instill tPA?

amaguila2009
I do some work for Genentech

I do some work for Genentech and I do not recall any recommendations to the size of syringe that should be used for the declotting procedure. Even upon review of the PI, there is no mention of a syringe size recommendation as well. 

The syringe size is actually from the catheter manufacturers or as indicated in each institution's P&P.

Angelo M. Aguila, MSN, RN, VA-BC
Vascular Access Nurse
[email protected]

Kevertsz
I can not believe Cathflo
I can not believe Cathflo would make a recommendation regarding the size syringe to instill their medication.  Irregardless, I would think that the size syringe you use would be dependent on the catheter manufacturer's recommendations.  After all, it's the pressure applied to the catheter that will cause the rupture, not the medication being instilled.  If I were on a jury, I would expect the nurse to know the equipment she is using and with that, she should know the recommendations and limitations of the catheter.  Therefore, if she chooses to use something that is directly contraindicated (1cc syringe), I would charge her with negligence regardless of the P&P.  If the hospital has a P&P in existence that blatanly jeopardizes patient safety, then it should be reviewed and revised before a bad outcome is encountered.
piccmasters
I am back againto thank

I am back againto thank those who follows this question, Re: use of smaller use of syringe for declotting central lines.

Yes, if you read a copy of the cathlo administration card  insert, in #7 step, says, "instill the appropriate dose of cathflo into the occluded catheter using a 10-12 cc syringe".If you have their booklet, its in #6 instillation instruction. To me this is what I read and understand as the recommended size that Genetech, manufacturer of cathflo, its clearly printed. you can go on line www.cathflo.com, you see it there too.

So, I am trying to clarify this from the rest of the experts, to what is the best practice.

This in a effort to attempt to change the old practice,even if it has been over 30 years, but why wait for a case to happen?

rivka livni
(speaking about adult

(speaking about adult patients only), When it comes to syringe size for cathflo, (or anything else for that matter) it seems logical for Genetech to recommend 10cc because there are so many different catheters being used out there. I am still surprised to hear (and see) that some instituions still use silicon catheters, some use polyuerathane with a distal valve, some use power PICC with open ended etc etc...

Since the new Power PICC came to market, I am not aware of any studies comparing the durability of the different catheters, but it seems that those power catheters can tolerate quite a bit of PSI. I took one Power PICC 6.0 FR Dual lumen, attached a 5cc syringe to each lumen, kinked well the distal end and tried to "rupture" the catheter by flushing both syringes at the same time as hard as I could, the syringe broke, but I could not get the catheter to rupture. I did the same with a 5.0 FR single lumen from a different company, and got the same results.

Part of our problems as practitioners is that there are so many different catheters out there, some of the research and studies we base our practice on was done on old catheters, which does not apply to the new ones. It is so confusing and frustrating.

As for cathflo (all our catheters are Power)when we get a complete occlusion we use the stopcock methode with a 3cc syringe to instill the cathflo, leave it overnight, and in the morning we usually get full patency, (it rarely fails).

Now, that does not answer your question, but it is something to think about. Any thoughts, or comments on the subject are wellcome.

amaguila2009
To picc master: Which

To picc master:

Which Cathflo material are you referring to? I checked the full Prescribing Information and did not find anything about a 10mL syringe. Please clarify. Thanks.

 

 

Angelo M. Aguila, MSN, RN, VA-BC
Vascular Access Nurse
[email protected]

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