Hello,

We have a hospital-based-donor center.

We used to use Baxter, then Fenwal came in and is not interested in our market (10,000/yr). So we validated JMS, Fresenius and Terumo. All passed. And we went for a bid. JMS did best. Now Terumo has lowered their price, as it is bid-time again.

I validated the bags, my way???

1. Are there any standards how to validate collection bags?

2. Do you use the triple with SagM/Adsol and sampling site?

3. If you don't use a sampling site, how do you take your sample for screening?

Thanks

Liz

How did you validate your bags? I do not believe there is a "procedure" for bag validation . . .your "process" should define your validation study. If it is reasonable, there should be no adverse ramifications.

I checked the integrity of the bag, the length of the needle-tubing.

I cultured the CPD and the Sagm.

I prepared the components.

I checked the FFP bag for integrity after freezing , for cracks etc

I cultered the RBCs afer a week.

I measured the components stated to be in the CPD and SAGM.

Finding discrepencies I wrote to the company which sent me a valid justification.

Now I am told by our Quality Officer that this validation does not hold for the same brand but with a sampling site. Is that true?

Liz

The bags are the same except for the sampling site . . . might just need to validate your sterility, but otherwise I see no need to repeat all the other things.

ok, thanks

so what bag you currently using?...just curious

JMS until negotiations are through.

Hi Liz,

Are you using these bags on the Alyx instrument?

We have an Alyx and are having a hard time getting the RBC/Plasma bags from Fenwal. I didn't know another company mades bags for the Alyx.

Phyllis

ppicha@ajh.org

Hi Liz,

Are you using these bags on the Alyx instrument?

We have an Alyx and are having a hard time getting the RBC/Plasma bags from Fenwal. I didn't know another company mades bags for the Alyx.

Phyllis

ppicha@ajh.org

No, we were discussing bags for whole blood collection.

Where are you from, why are you having a hard time getting bags from Fenwal ?

Liz

Hi Liz,

Are you using these bags on the Alyx instrument?

We have an Alyx and are having a hard time getting the RBC/Plasma bags from Fenwal. I didn't know another company mades bags for the Alyx.

Phyllis

ppicha@ajh.org

We were discussing whole blood collection bags.

Why are you having a hard time, where are you based?

Hi Liz,

Baxter was bought by Fenwal. Fenwal has moved their production facility to Puerto Rico and for some unknown reason the Alyx RBC/Plasma bags are now difficult to obtain.

I'm from a small hospital in Newburyport, Ma.

We have a double bid system while procuring our items. Once we approve a bid on technical grounds, the price bids R opened & the lowest quoted is usually selected afterfurther price negotiations. In our case if we had technically approved JMS & Terumo then both wud B eligible for price bid & lower bid of the two wud get selected.

Hi Angie,

Thank you but that was over a year ago and the situation has resolved itself.

Phylliis

Hi Angie,

Thank you but that was over a year ago and the situation has resolved itself.

Phylliis

ooops, I noticed the date much after I had posted