Liz Posted July 19, 2008 Share Posted July 19, 2008 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?ThanksLiz Link to comment Share on other sites More sharing options...
David Saikin Posted July 21, 2008 Share Posted July 21, 2008 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. Link to comment Share on other sites More sharing options...
Liz Posted July 22, 2008 Author Share Posted July 22, 2008 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 etcI 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 Link to comment Share on other sites More sharing options...
David Saikin Posted July 22, 2008 Share Posted July 22, 2008 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. Link to comment Share on other sites More sharing options...
Liz Posted July 23, 2008 Author Share Posted July 23, 2008 ok, thanks Link to comment Share on other sites More sharing options...
redstaff2003 Posted November 24, 2008 Share Posted November 24, 2008 so what bag you currently using?...just curious Link to comment Share on other sites More sharing options...
Liz Posted November 25, 2008 Author Share Posted November 25, 2008 JMS until negotiations are through. Link to comment Share on other sites More sharing options...
PHYLLIS Posted November 26, 2008 Share Posted November 26, 2008 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.Phyllisppicha@ajh.org Link to comment Share on other sites More sharing options...
Liz Posted November 27, 2008 Author Share Posted November 27, 2008 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.Phyllisppicha@ajh.orgNo, we were discussing bags for whole blood collection.Where are you from, why are you having a hard time getting bags from Fenwal ?Liz Link to comment Share on other sites More sharing options...
Liz Posted November 27, 2008 Author Share Posted November 27, 2008 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.Phyllisppicha@ajh.orgWe were discussing whole blood collection bags.Why are you having a hard time, where are you based? Link to comment Share on other sites More sharing options...
PHYLLIS Posted November 28, 2008 Share Posted November 28, 2008 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. Link to comment Share on other sites More sharing options...
angie Posted October 28, 2009 Share Posted October 28, 2009 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. Link to comment Share on other sites More sharing options...
PHYLLIS Posted October 28, 2009 Share Posted October 28, 2009 Hi Angie,Thank you but that was over a year ago and the situation has resolved itself.Phylliis Link to comment Share on other sites More sharing options...
angie Posted October 29, 2009 Share Posted October 29, 2009 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 Link to comment Share on other sites More sharing options...
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