100% leukoreduced

[Brian]

Why hasn't the FDA mandated the leukoreduction of all blood components? Wouldn't this make life easier for all blood bankers?

Brian

[Cliff]

Brian, I suspect FDA would not mandate such a thing, that would getting involved in the practice of medicine.

I'd rather see a fully leukoreduced inventory too.

[Jane]

It definitely made it easier for us when ARC went 100% leukoreduced!

[Cliff]

We are moving toward 100% irradiation, first we need another irradiator though. Is anyone considering that?

[David Saikin]

I understand and agree with 100% leuko reduction, cliff, but why 100% irradiation? And are you billing for irradiated products to everyone who gets them regardless of the medical necessity?

[Cliff]

The patient should only be getting billed for the features of the product they require, similar to antigen negative units.

The reasons are very complicated. We transfuse about 50,000 products / year. We have a very large oncology transfusion population and identifying these patients can be complicated. Our IS system has a few triggers to help, but sometimes these patients sneak into the OR or ER and get transfused. Irradiated products can't hurt anyone; however, the disaster from a patient who needs it but doesn't get it...

[John C. Staley]

To answer the initial question. The FDA will NEVER do anything that makes our lives easier. That's not in their charter.

Cliff you are setting a very nasty presidence with 100% irradiated but I do understand the rational. Simplify and reduce the chance of a problem. Makes sense in a wierd sort of way. Are you using a gamma irradiator or an x-ray irradiator?

[Cliff]

John,

We currently use a Nordion Gamma Irradiator, it is a few years old and at 3 minutes 36 seconds. Might seem quick, but it adds up fast when we transfuse at the volume we do. We are considering replacing it or adding an additional unit - possibly the CIS.

I don't agree with the statement about FDA and also let's try and remember that some employees of FDA might also be members of this forum. I agree that it is not part of their mission to make our lives easier, their only mission should be to protect the public.

[JamesRiggio]

AFter several years of universal leukoreduction in England, data has been published indicating that this additional expense has not been justified by clinical outcome benefits. There are many here in the US that also believe that this practice is not warranted.

[Dawn]

Hey John, just to add to Cliff's post. We won't be the first to go with 100% irradiated. Our Medical Director came from a facility where that was their policy.

It is a painful thought. We transfuse about 36,000 red cells per year. Currently only 50% are irradiated. It does make sense given our patient population.

[John C. Staley]

I suppose the only reasonable solution to all of this is a truly artifical blood substitute.

As far as my statement about the FDA, if anyone can site an occasion when a decision was made that actually made our lives easier and that was a goal of the decision I'll glady apologize. The only thing I can think of that comes close is the universal donor questions. Bottom line, you want universal leukoreduction you need a better reason that making our lives easier.

[George Hobbs]

Brian,

From a suppliers perspective....

First and easiest solution (from my point - no idea what it takes to actually initiate this!) is to change your hospital policy to using only leuko reduced products. I have several customers now that have that requirement.

As a supplier I am expected to meet a customers needs. I can not think of time I have been unable to meet their need - have had techs forget and send regular red cells, but leuko were always available. If you are dealing with a supplier that isnt 100% leuko reduced I would recommend having alternative sources or procedures in the event of non availability of product.

Am now curious if we have ever failed to meet this need - customer survey question time.

[yarivs@yahoo.com]

AFter several years of universal leukoreduction in England, data has been published indicating that this additional expense has not been justified by clinical outcome benefits. There are many here in the US that also believe that this practice is not warranted.

Can you please indicate where some of this data may be found? I am under the impression that in the EU in general, ULR has been beneficial both medically and financially for the country doing it. Canada made the same study and found the same thing. Ultimately doing 2 types of manufacturing, stock/time management etc... it is cheaper to do it one way.

[boothega]

Speaking from the supply side, I find it interesting that facilities are performing 100% irradiation of their inventories. My guess would be that these are facilities who do not buy on consignment, as they would be unable to return any modified, short-dated inventory to the supplier.

What do the facilities do in regards to K+ sensitive patient populations, like neonates, pediatrics, cardiac patients etc? Are you able to provide fresher units versus older consistently? Do you irradiate at time of use or do you irradiate at time of import processing (when you bring the inventory into your system)?

[Gloria Lucchese]

Not all patients have indications for leukoreduced units. It is practicing medicine and I feel we need to leave that in the hands of the physician to order the appropriate products. Red Cross went 100% before they could deliver the products. After a year, they now say it isn't indicated in all cases. Also, you can't charge for a product that is not needed.

[David Saikin]

Our Medical staff voted unanimously to go 100% LR years ago . . . and we did.

[Melanie]

ok, Cliff, Why not make the Doctor's responsible for ordering the correct products for their patients? Why make the blood bank responsible? This is a huge expense with Radsure's costing $2.00 a label and the tech time it takes to Irradiate units?

[boothega]

To add to Melanie's comments concerning expense, irradiation shortens the shelf life of a commodity that is already is short supply. Experience demonstrates that units set up are not always transfused, so in effect, 100% irradiation decreases the shelf-life of an inventory supply that in most communities is critically low at any given time (i.e. group O units). You may (unintentionally) be having a negative impact on your local supply by promoting such a policy.

[MWilchek]

In regards to leukoreduction, we carry two inventories of RBCs, both leukoreduced and non. Since we are a smaller institution, it is easier to handle... I wouldn't want to tackle it at a larger hospital.

As for 100% irradiation, do you have any problems with the potassium getting too high in the units as they age?

[Julie Ann Tisler]

100% LR does make inventory management a bit simpler but has the reimbursement issue been solved yet? I know this was a huge issue for hospitals. Even though data was produced showing that 100%LR can reduce costs by reducing the amt of transfusion reaction work ups (febrile mostly) and certain surgery stays were proven to be decreased, administrators had a hard time taking the hit to the bottom line to pay for LR products.

[Maureen]

We are moving toward 100% irradiation, first we need another irradiator though. Is anyone considering that?

I've started to look into an additional irradiator, and CIS still services, but at this time cannot sell new units. They directed me to a Canadian firm, and I've heard very positive and very negative references regarding the performance of their equipment in place.

Any suggestions on where to get educated on this acquisition, beside the sales reps?

[donellda]

My former employer was not 100% irradiated for all blood products but we irradiated all platelets. It made life a bit difficult because we had to pool them first then irradiate them which subtracted from 4 hour expiration time.

[Eagle Eye]

100% irradiation ....K+ goes up after irradiation..usually 3 days after irradiation...how do you deal with this issue...and also inventory management. You have all your Red cells with only 28 days on it???

[csjuarez]

I believe that there are many pros (prevent WBC alloimmunization, prevent many febrile reactions from WBC alloimmunization and presence of cytokins, prevent transmission of CMV, reduce immunomodulation effect) and no cons for the use of 100% leukoreduction. The real issue that prevents this is MONEY! Even though all patients don't "require" leukoreduced RBCs, it is not detrimental to any and their use can prevent some future problems.

If I needed a transfusion, I would WANT to have leukoreduced products!

[Sandy Jo]

Regarding 100% leukoreduction I think the study info I have read has been supportive of the product, so I agree it is a better product in general for all patients. We currently provide leukoreduced for patients in which it is specifically requested, but our supplier is going to convert to 100% leukoreduced in the future (after ISBT). This will solve the issue for us, since we won't be able to supply non-leukoreduced blood. It also solves billing issues, as that is the only product we will be able to obtain.