Saline in a bottle not for injection?

PetiteOpRN · Sep 28, 2011

You can also make a few holes in the top with a blunt fill needle, invert, and squeeze for a quick, controlled irrigation.

JustBeachyNurse, LPN · Sep 28, 2011

Oooh I know the answer! Any solution that is marked "for injection" (parenteral) is required to be tested for endotoxin using an LAL assay, as per FDA guidelines in the US. Sterile solutions marked "not for injection" have not been tested for endotoxin, while they are considered sterile solutions from a microbiological standpoint the extra (very expensive) assay has not been completed and therefore the solution cannot be used for injection.

Parenteral solutions are also marked "non pyrogenic" which indicates all materials used are pyrogen free & have passed the endotoxin testing per industry guidelines.

I knew taking a temp job as an admin assistant in a QC Micro lab would come in handy.

References:

http://www.fda.gov/iceci/inspections/inspectionguides/inspectiontechnicalguides/ucm072906.htm

http://www.pacificbiolabs.com/compendial_microbiology.asp

(There are several other documents regarding the FDA requirements for endotoxin testing of parenteral solutions and medical devices)

xtxrn, ASN, RN · Sep 28, 2011

Are the percentages the same? And how big of a bottle?

3% saline is marked clearly, and would not be for reconstitutiong meds.

IVRUS, BSN, RN · Sep 28, 2011

Okay, let me muddy it up a little. In dialysis clinics they draw their flushes out of the bags of saline that are used during the treatments. I might add these bags are not changed out until they are empty. What I see on a regular basis is techs and nurses drawing flushes without swabbing the septum before inserting the needle. Any thoughts on this or any dialysis nurses out there who can shed some light on this practice?

MUDDY indeed.... The dialysis clinics which are practicing in this manner are doing so all-the-while jeopardizing patient care. It is NOT safe to be drawing from a Saline bag as #1. The bag has no preservatives in it #2. When an IV bag is in place, infusing on a pt, it MUST be discarded after 24 hours period. No matter how much is left in the bag.

In addition, NOT swabbing the injection port before accessing that port is introducing all manner of microbes into the solution, which is then drawn out and infused into the patient. In this case, you have a system which is consistantly being reentered and infused with bacteria, fungal matter and who knows what else. If you have knowledge of this practice on a personal level (you see it being done and not just rumored), report it immediatly to the powers that be... THEY should immediately stop this unsafe, and litigious process.

AJPV · Sep 28, 2011

Okay, let me muddy it up a little. In dialysis clinics they draw their flushes out of the bags of saline that are used during the treatments. I might add these bags are not changed out until they are empty. What I see on a regular basis is techs and nurses drawing flushes without swabbing the septum before inserting the needle. Any thoughts on this or any dialysis nurses out there who can shed some light on this practice?

Yikes! And they're treating really sick people with kidney disease (many of whom are immune-compromised uncontrolled diabetics)???

FLmomof5 · Sep 28, 2011

MUDDY indeed.... The dialysis clinics which are practicing in this manner are doing so all-the-while jeopardizing patient care. It is NOT safe to be drawing from a Saline bag as #1. The bag has no preservatives in it #2. When an IV bag is in place, infusing on a pt, it MUST be discarded after 24 hours period. No matter how much is left in the bag.
In addition, NOT swabbing the injection port before accessing that port is introducing all manner of microbes into the solution, which is then drawn out and infused into the patient. In this case, you have a system which is consistantly being reentered and infused with bacteria, fungal matter and who knows what else. If you have knowledge of this practice on a personal level (you see it being done and not just rumored), report it immediatly to the powers that be... THEY should immediately stop this unsafe, and litigious process.

I am not a dialysis nurse, but am thankful that you outlined this for those who are! :up:

Double-Helix, BSN, RN · Sep 28, 2011

Both the bottles and the IV saline bags say "preservative free". Both solutions are labelled "sterile" but of course neither would remain sterile once opened. I think the issue is more than that of concerns about sterility because the saline from the bottle of infusion saline could be kept sterile. The particulates answer makes sense to me.

Saline vials for injection are not opened. They have a plastic top that covers a rubber, self-sealing stopper. So as long as you are using a sterile needle and swabbing the top of the stopper before accessing it, the vial remains sterile.

With a bottle, you are opening the cap, exposing the solution to particulate matter in the air, replacing the same cap that might have been on a table or exposed to air, and there is always the risk that something (fingers, etc) would touch the inside or rim of the bottle.

belgarion · Sep 28, 2011

[quote=IVRUS;5679375]MUDDY indeed.... The dialysis clinics which are practicing in this manner are doing so all-the-while jeopardizing patient care. It is NOT safe to be drawing from a Saline bag as #1. The bag has no preservatives in it #2. When an IV bag is in place, infusing on a pt, it MUST be discarded after 24 hours period. No matter how much is left in the bag.

In addition, NOT swabbing the injection port before accessing that port is introducing all manner of microbes into the solution, which is then drawn out and infused into the patient. In this case, you have a system which is consistantly being reentered and infused with bacteria, fungal matter and who knows what else. If you have knowledge of this practice on a personal level (you see it being done and not just rumored), report it immediatly to the powers that be... THEY should immediately stop this unsafe, and litigious process.

Thanks for the excellent reply. I've already sent off a letter to the agency that handles complaints against dialysis facilities about this as well as the rather disturbing practice of employees walking into the lobby from the treatment area in full PPE. If we get caught leaving a pt room in PPE we get reamed good.

madwife2002, BSN, RN · Sep 30, 2011

I am a FM in dialysis unit and you would be surprised about the unsafe and unclean practices I have to deal with, every single day-and thats only what I see! I can only imagine when I go home or am off what actually happens!

Then when they get written up after numerous warnings they could come on allnurses and say how badly they were treated and how they dont understand why management is so mean to them!