The Transfusion Service where I work dispenses single red cell units or thawed plasma in a red insulated pouch. Before I started working there, the blood wastage was so significant that the company held a Kaizen work process session (think Six Sigma or Lean). It was decided instead on dispensing in clear ziplock/biohazard bags that the TS would purchase these red insulated pouches with two 5C gel cooler packs (made by Duramark advertised as an insulated pouch for specimen transport).

When these were brought in, they we validated to prove that they hold temperature for at least 30 minutes. Our wastage has gone significantly down-yay- however I'm concerned that they will be considered in the same line of thought as coolers that will have to be revalidated every six months (or is it a year? Brain fart). We have over 50 of these red pouch things and I really don't want to have to revalidate them.

In my mind they're just like a "super" version of the normal clear ziplock bag which we don't have to validate. These are definitely not storage. All of our return criteria are based on normal acceptability criteria:1-10 and visual inspection (not time ) regardless of if it was dispensed in a red thing vs. a bio bag.

Has anyone seen something similar to this before?

What's your take on this: do I have to revalidate these?

I love this idea!   Are you taking the temp when the unit is returned?

I disagree that your red bags are not storage.   I think the FDA would consider them as such.  Coolers are considered storage.  Transport is more defined - like I'm shipping some red cells to another hospital.  Temp range 1-10C.  Storage temp is 1-6C.  I know this topic has a lot of proponents on one side or the other.  I think you need to look at the regulatory guidances.  I'd call the FDA and/or your blood supplier to get their take on your red bags before I'd accept an acceptable return with temps greater than 6C.

 

Just my $0.02.

We don't perform continuous revalidation of our blood transport containers.

I validate the four coolers that are used by our outpatient transfusion clinic to make sure there are no cracks, lid issues, etc. that might affect their usage.  We just use Igloo coolers with two frozen icepacks and a basket between for the units.  Our blood supplier validates the boxes they send products in, which we use for ED, OR, etc, since we would never get the coolers back if we gave them out!

I disagree that your red bags are not storage.   I think the FDA would consider them as such.  Coolers are considered storage.  Transport is more defined - like I'm shipping some red cells to another hospital.  Temp range 1-10C.  Storage temp is 1-6C.  I know this topic has a lot of proponents on one side or the other.  I think you need to look at the regulatory guidances.  I'd call the FDA and/or your blood supplier to get their take on your red bags before I'd accept an acceptable return with temps greater than 6C.

 

Just my $0.02.

I completely agree that coolers are cosidered storage as they are validated for longer periods and the units are in not necessarily going to be transfused (temporary storage). There is a small excerpt in the 17th Technical Manual Edition: "The Food and Drug Administration considers coolers used to store blood and components in the operating room to be a storage situation" pg 289.

 

Do you consider the clear ziplock bags that most facilities for dispense to be storage? We use these red pouches just like these ziplock bags- just transport from the blood fridge to the patient's room.

 

I do have plans to call CAP/AABB to get their take on this situation- just stinks because I'm in Pacific Standard Time and in comparison they close so early!

 

Thanks!

I love this idea!   Are you taking the temp when the unit is returned?

We do take the temperature of all units upon return. Before the red pouches we were wasting almost every unit that was returned- even at ten minutes the units were coming back at 11C. With the red pouches our wastage has significantly gone down- at 30 minutes the units are coming back at 8 or 9C.

 

One of the locations I had worked at previously actually was adding a single 5C gel pack along with a single unit in a normal ziplock bag and even this helped with return wastage.

I don't see a need to validate the bags if used for transport only and temps are taken if blood is returned.  I would make sure you have validated the process and it sounds like you did.   Nursing and lab SOPs should address this process and clarify that it is for transport only and not for storage of blood at the bedside, nursing unit, OR etc. and include instruction that units shall not be removed until ready to transfuse.   Maybe put a time limit of return (you may have already done this) to eliminate possibility of the bags being used as storage.   You may also want to look at your reasons as to why so much blood is being returned to warrant the red bags.   I would make sure that the gel pack storage refrigerator temp is monitored. 

whether you validate the bags or not is really a moot point.  Since you take the temps of units returned I think  you need to determine what temp is acceptable for a returned unit to be placed back into active inventory. 

Thank heavens for the '30 minute' and '4 hour' rules in the UK...

Where can we get these red insulated pouches with the gel packs?  I like this idea considering that we, too, have experienced 'over the temperature limit' units that have been issued in a ziplock bag then returned 10 minutes later.

 

And I agree with some of these posts that ... 

 

a) The safest route is to take the temperature of the unit when it returns to determine acceptability regardless of how long it has been 'out'.

 

 Since there are regulations (at least here in the US) that state that if blood products are not under continuous temperature monitoring, the temperature needs to be recorded at least every 4 hours, then restrict the 'storage' time of these units 'outside the BB' to no greater than 4 hours (unless they are in one of those validated transportation boxes like the Red Cross has).

I completely agree that coolers are cosidered storage as they are validated for longer periods and the units are in not necessarily going to be transfused (temporary storage). There is a small excerpt in the 17th Technical Manual Edition: "The Food and Drug Administration considers coolers used to store blood and components in the operating room to be a storage situation" pg 289.

 

Do you consider the clear ziplock bags that most facilities for dispense to be storage? We use these red pouches just like these ziplock bags- just transport from the blood fridge to the patient's room.

 

I do have plans to call CAP/AABB to get their take on this situation- just stinks because I'm in Pacific Standard Time and in comparison they close so early!

 

Thanks!

 

 

To be honest, I don't consider them either.   They might just as well be Ziploc bags.  Using them as a temperature maintenance system . . . while it is a nice idea I think that rbcs signed out in these devices need to be treated just as if they were signed out in clear plastic bags.  You just need to determine the acceptable (to the regulatory guys) temperature that you can receive them back for reuse.  My take is that the regulatory guys are going to say 6C, not 10.

Where can we get these red insulated pouches with the gel packs? I like this idea considering that we, too, have experienced 'over the temperature limit' units that have been issued in a ziplock bag then returned 10 minutes later.

http://www.therapak.com/docs/Singapore_Catalog.pdf

We use the ConstantTemp Specimen Insulator bags with two of the gel packs which we keep in the blood refrigerator.

They work extraordinarily well and have been significant in decreasing our return wastage.

Where can we get these red insulated pouches with the gel packs? I like this idea considering that we, too, have experienced 'over the temperature limit' units that have been issued in a ziplock bag then returned 10 minutes later.

http://www.therapak.com/docs/Singapore_Catalog.pdf

We use the ConstantTemp Specimen Insulator bags with two of the gel packs which we keep in the blood refrigerator.

They work extraordinarily well and have been significant in decreasing our return wastage.

 

Will these hold more than one unit? How long will they hold 1-6 C temp?

With the two gel packs they will only hold one unit. Since we've decided to define these as "transport", we only validated them for 30 minutes for the 1-6C range.