We have run into a problem. Our anesthesiologists insits that they can inject drugs/medications into an IV line (in the OR) that is running only blood or blood products. We (the lab) tell them this is strickly forbidden: that only normal saline can be infused into a blood line. They claim they have never heard of this rule, they do it "all the time", and that this practice is OK'd by the American College of Anesthesiologists!

We have shown them the AABB regulations to no avail. Isn't this an FDA and JACHO rule as well?

I know if you have only one line it is allowed to flush, give meds, and then flush again but they are injecting right into the blood line during transfusions.

My pathologist has emailed the AABB for clarification. Any comments or suggestions? Are there approved drugs other than injectable saline allowed?

My understanding is that anything other than normal saline has the possibility of hemolyzing the RBC's. I recently saw a case study on this where this caused a transfusion reaction.

Buggie,

I have some information for you. My wife is a nurse who has worked in ICU more than 20 years and had 2 year experiences in Paris, France.She tells me that the anesthesists and reanimaters used to inject drugs/meds into an IV line ONLY IN EMERGENCY for the reason of saving the patients, because they have not enough time to inject another IV line or wait for finishing transfusion. Of course, in the non-emergent cases, they do not do so!

Edited October 30, 200816 yr by paulis

Having been in surgical suites on multiple occasions, I can tell you that they routinely piggyback blood products into lines running drugs, Ringers, etc. They justify it by saying the flow rates are quite high, so the intermix time is low. My opinion is that anytime blood and something other than saline is in the tubing at the same time, it's bad ...

I once was called in to check a "clotted" FFP bag, only to discover that the calcium in the Ringers was causing the plasma to clot before reaching the patient! Their response was "Oh ..."

There is an FDA reg specifically addressing not to add Lactated Ringer's Injection U.S.P. solution to Red Blood Cell products.

You could also email the FDA and ask them to clarify and give you regulations.

I believe that there's also a very lovely picture in a fairly recent issue of Transfusion that shows red cell aggregates in an IV line with an incompatible solution. A picture is worth a thousand words!

If you read the circular of information, it states that no medication or solutions may be ROUTINELY added to or infused through the same tubing with the exception of 0.9% NACL, unless a) they have been approved for this use by the FDA or There is documentation available to show that the addition is safe and does not adversely affect the blood or component.

Couple of issues are addressed here. Obviously in an emergency you can infuse medication through the tubing, as long as this does not become a routine procedure.

If the FDA approves a drug to be administered with blood, then it will state it in the drugs package insert. If it doesn't state it in the package insert, then it is not approved by the FDA.

If the anesthesiologists can provide documentation, and by documentation I mean more than one article/study than this should be presented to the Transfusion Committee for approval.

I would suggest that you find out what medications that they are using and call the company to see if they have FDA approval for mixing /infusing with blood, and that you need documentation of such. They may tell you or send you a letter stating that they do not reccomend this practice, which would then have to be brought to the attention of your legal department as this exposes the hospital and physicians to possible litigation in the future.

If there is a policy in the Blood administration procedure, not to infuse any medication other than 0.9% NACL, then of course the physician's are not following this procedure and either the Physicians must stop or the policy needs to be changed.

In my experience, we had a continuing issue with micro clots in blood being adminsitered in the Labor and Delivery room. When we investigated this issue, we found that they were using a single line tubing with a bulb attached so that they could infuse solutions into patients very quickly. Since they didn't want to change lines when they had to transfuse blood, they were flushing the line with saline and then transfusing the blood. every single time the units had clotted, they had used ringers lactate immediately before hand and then flushed with saline. We got the manufacturer of the tubing used involved and they sent us a letter stating they can not recommend this practice as even flushing the line still allows some ringers lactate to adhere to the inside of the tubing which could then negate the effects of the anticoagulant in the blood and caused the micro clotting. The physicians immediately stopped this practice and changed the lines when they had to transfuse.

Now that JCAHO is adding new requiremnts for transfusion of blood, the onus is on the anesthesiologists to prove the safety of their practices and that these practices are approved practices included in the blood administration policy.

conwaysbb,

could you provide a copy of the manufacturer of the tubing letter?

this would be really good as ammo. fax 410-414-4764.

I am aware of a case which may have contributed to a neonatal demise. Surgery ran epinephrine through the same line as platelets. If you remember your coagulation testing, epinephrine is one of the platelet activators used in platelet aggregation testing, so this mix could cause DIC.

The anaesthesiologist said there is nothing in their training or literature prohibiting this practice. The anaesthesiologist also polled other anaesthesiologists who said they also will run blood products through the same line as other IV fluids when there is limited access.

I would guess this is more common than blood bankers think. The platelet + epinephrine mix is a bad one. I don't recall ever seeing this reported in the literature. It might be worth warning your ER and OR staff.

If you read the circular of information, it states that no medication or solutions may be ROUTINELY added to or infused through the same tubing with the exception of 0.9% NACL, unless a) they have been approved for this use by the FDA or There is documentation available to show that the addition is safe and does not adversely affect the blood or component.

Couple of issues are addressed here. Obviously in an emergency you can infuse medication through the tubing, as long as this does not become a routine procedure.

If the FDA approves a drug to be administered with blood, then it will state it in the drugs package insert. If it doesn't state it in the package insert, then it is not approved by the FDA.

If the anesthesiologists can provide documentation, and by documentation I mean more than one article/study than this should be presented to the Transfusion Committee for approval.

I would suggest that you find out what medications that they are using and call the company to see if they have FDA approval for mixing /infusing with blood, and that you need documentation of such. They may tell you or send you a letter stating that they do not reccomend this practice, which would then have to be brought to the attention of your legal department as this exposes the hospital and physicians to possible litigation in the future.

If there is a policy in the Blood administration procedure, not to infuse any medication other than 0.9% NACL, then of course the physician's are not following this procedure and either the Physicians must stop or the policy needs to be changed.

In my experience, we had a continuing issue with micro clots in blood being adminsitered in the Labor and Delivery room. When we investigated this issue, we found that they were using a single line tubing with a bulb attached so that they could infuse solutions into patients very quickly. Since they didn't want to change lines when they had to transfuse blood, they were flushing the line with saline and then transfusing the blood. every single time the units had clotted, they had used ringers lactate immediately before hand and then flushed with saline. We got the manufacturer of the tubing used involved and they sent us a letter stating they can not recommend this practice as even flushing the line still allows some ringers lactate to adhere to the inside of the tubing which could then negate the effects of the anticoagulant in the blood and caused the micro clotting. The physicians immediately stopped this practice and changed the lines when they had to transfuse.

Now that JCAHO is adding new requiremnts for transfusion of blood, the onus is on the anesthesiologists to prove the safety of their practices and that these practices are approved practices included in the blood administration policy.

I see the info in the Circular, but the AABB manual seems to contradict this statement. On pg. 530 of the 15th edition of the technical standards, it states " AABB Standards for Blood Banks and Transfusion Services and the Circular of Information for the Use of Human Blood and Blood Components are explicit in stating that medications must not be added to blood or blood components". While it also goes on to state that other solutions may be added as long as they're cleared by the FDA, the AABB manual seems to prohibit medications being added. Is this a matter of semantics or an actual rule and what are we supposed to go by?

The 16th edition has a bit more on this:

Compatible IV Solutions

No medications or solutions other than 0.9%

sodium chloride injection (USP) should be

administered simultaneously with blood

components through the same tubing. Solutions

containing dextrose alone may cause red

cells to swell and lyse. Lactated Ringer's solution

or other solutions containing high levels

of calcium may overcome the buffering

capacity of the citrate anticoagulant in the

blood preservative solution and cause clotting

of the component.

AABB Standards allows exceptions to the

above restrictions when 1) the drug or solution

has been approved by the FDA for use

with blood administration or 2) there is documentation

available to show that the addition

is safe and does not adversely affect the

blood or component. Acceptable solutions

according to these criteria include ABO compatible

plasma, 5% albumin, or plasma

protein fraction. Certain solutions are compatible

with blood or blood components as

noted on the package inserts reviewed by the

FDA, including Normosol-R pH 7.4 (Hospira,

Inc, Lake Forest, IL) and Plasma-Lyte-A injection

pH 7.4 (Baxter Healthcare, Deerfield,

IL). There are several formulations of

Plasma-Lyte that are not isotonic or that contain

calcium; package inserts must be checked

to confirm compatibility with components.

The literature reports the safe use of

morphine, hydromorphone [Dilaudid (Abbott

Laboratories, North Chicago, IL)], and meperidine

administered as a bolus in the same

tubing as red cells. However, high doses of

meperidine added to the RBC bag have

caused hemolysis. The literature is not

extensive, so this practice should be used with

caution and only when there is no other

venous access available to allow separate

administration.

I have attached a copy of the current Circular for reference. Also I assembled all the FDA blood-related regs (21 CFR 600, 800, 1270 series and CLIA (42 CFR 493) into one file, which is attached.

21CFR600-800-1270_42CFR493.pdf

coiwnv0702.pdf