jbhpy Posted October 11, 2012 Share Posted October 11, 2012 Hello to All,My lab currently uses the ARC pooled cryo of 5. We dispense these products in a closed system so it has a 6hr expiration. What is your policy if the product is returned to the lab greater than 30min but within the 6hrs at room temp? Link to comment Share on other sites More sharing options...
jayinsat Posted October 12, 2012 Share Posted October 12, 2012 Hello to All,My lab currently uses the ARC pooled cryo of 5. We dispense these products in a closed system so it has a 6hr expiration. What is your policy if the product is returned to the lab greater than 30min but within the 6hrs at room temp?Curious: being that it is a pooled product, albeit prior to freezing, shouldn't it have a 4hour expiration upon thawing?In response to your question, our policy would be that the product could be reissued and transfused as long as it was done prior to expiration. That never happens though. We usually end up wasting the product. Link to comment Share on other sites More sharing options...
jbhpy Posted October 12, 2012 Author Share Posted October 12, 2012 According to the ARC Transfusion Practice Guidelines, if it the thawed pooled cryo is from a single unit ( which is what we have, the Cryo pool of 5) or units pooled using a sterile docking (FDA approved), it can be transfused within 6 hours of thawing. (Closed system) Link to comment Share on other sites More sharing options...
David Saikin Posted October 12, 2012 Share Posted October 12, 2012 The cryo pool (pooled cryo) is good at RT for 6 hrs post thaw. You can use it up until its exp time. Link to comment Share on other sites More sharing options...
SMW Posted October 12, 2012 Share Posted October 12, 2012 According to the ARC Transfusion Practice Guidelines, if it the thawed pooled cryo is from a single unit ( which is what we have, the Cryo pool of 5) or units pooled using a sterile docking (FDA approved), it can be transfused within 6 hours of thawing. (Closed system)I know this is not addressing your original question, but if the label of the frozen pooled Cryo product indicates that saline has been added, the pool was prepared in a open system since a sterile connecting device is not used for the addition of the saline. Even though the cryo units may be added using a sterile connecting device, the saline addition initiated the open system therefore the pool and subsequently thawed Cryo product remains an open system and has a 4 hour expiration date from the time of thawing. Link to comment Share on other sites More sharing options...
jayinsat Posted October 12, 2012 Share Posted October 12, 2012 (edited) According to the ARC Transfusion Practice Guidelines, if it the thawed pooled cryo is from a single unit ( which is what we have, the Cryo pool of 5) or units pooled using a sterile docking (FDA approved), it can be transfused within 6 hours of thawing. (Closed system)Interesting. That seems to be in conflict with the AABB technical manual 16th ed. pg 958: "Prepooled Cryoprecipitated AHF may be prepared by pooling 4 to 10 units at the time of initial preparation.....Pooling can also be performed with the use of a sterile connection device. However, the expiration date cannot be increased when the pooling is performed with the sterile connection device. Prestorage pooled Cryoprecipitated AHF has an expiration time 4 hours once thawed."I would love to be proven wrong on this. We changed from 6 hours to 4hours based on this manual and critique from inspection. Edited October 12, 2012 by jayinsat 4-6 hour error Link to comment Share on other sites More sharing options...
jbhpy Posted October 12, 2012 Author Share Posted October 12, 2012 Yes, in reviewing the technical manual, there is a conflict between the two...... Link to comment Share on other sites More sharing options...
SMW Posted October 12, 2012 Share Posted October 12, 2012 Yes, in reviewing the technical manual, there is a conflict between the two......Please remember both of those documents are textbooks and do not confer standards or regulations. See 28th edition of AABB Standards Reference Standard 5.1.8A--Requirements for Storage, Transporation, and Expiration, Item 27, Pooled Cryoprecipitated AHF (after thawing). Pooled in an open system: Expiration 4 hours. Also footnote 1 to expiration in 5.1.8A: If the seal is broken during processing,.....components stored at 20 to 24 C shall have an expiration time of 4 hours,.... Essentially the same information is in the FDA Code of Federal Regulations. 21CFR 606.122(n)(5). (5) Instructions to store at room temperature after thawing and to begin administration as soon as possible but no more than 4 hours after entering the container or after pooling ......Since the seal is broken when the saline is added during the beginning of the pooling process, it's an open system from that point on. Link to comment Share on other sites More sharing options...
jayinsat Posted October 12, 2012 Share Posted October 12, 2012 Please remember both of those documents are textbooks and do not confer standards or regulations. See 28th edition of AABB Standards There's a 28th edition????:-O Link to comment Share on other sites More sharing options...
SMW Posted October 12, 2012 Share Posted October 12, 2012 There's a 28th edition????:-OEffective November 1, 2012. But the 27th edition states the same: Pooled in an open system: 4 hours Link to comment Share on other sites More sharing options...
jayinsat Posted October 12, 2012 Share Posted October 12, 2012 Effective November 1, 2012. But the 27th edition states the same: Pooled in an open system: 4 hours16th Edition is the highest I have. I guess my powers-that-be don't see the necessity in keeping up to date since we are not AABB accreditied. Link to comment Share on other sites More sharing options...
Moncada Posted October 12, 2012 Share Posted October 12, 2012 [ATTACH=CONFIG]650[/ATTACH]We consulted with our ARC supplier about the expiration of 5 unit pre-pooled Cryo. Per their guidance and the attached ARC official Brochure, we assign this product a 4 hour expiration post thaw.Refer to the following on the attached ARC brochure:* Shelf life is one-year in frozen state; four hours after thawing Link to comment Share on other sites More sharing options...
jbhpy Posted October 15, 2012 Author Share Posted October 15, 2012 I too consulted with our ARC supplier. See statement below:I met with our Medical Director, as well as consulted with ARC and AABB materials and here is your official answer and it is best described in the 2010 edition of the "Compendium of Transfusion Practice Guidelines" on p.52.... "If pooled cryo is from a closed single unit or has been pooled using an FDA-approved sterile connecting device, it should be transfused within six hours of thawing. If it is an open system or if units have been pooled after thawing by entering the containers, it should be transfused within four hours." The pooled cryo that we (ARC) manufacture is in a closed system and is obviously frozen upon arrival as five single units into one bag so upon thawing in your water bath you have six hours of shelf life to transfuse. Link to comment Share on other sites More sharing options...
SMW Posted October 17, 2012 Share Posted October 17, 2012 I too consulted with our ARC supplier. See statement below:I met with our Medical Director, as well as consulted with ARC and AABB materials and here is your official answer and it is best described in the 2010 edition of the "Compendium of Transfusion Practice Guidelines" on p.52...."If pooled cryo is from a closed single unit or has been pooled using an FDA-approved sterile connecting device, it should be transfused within six hours of thawing. If it is an open system or if units have been pooled after thawing by entering the containers, it should be transfused within four hours."The pooled cryo that we (ARC) manufacture is in a closed system and is obviously frozen upon arrival as five single units into one bag so upon thawing in your water bath you have six hours of shelf life to transfuse.Just be careful if the label of the frozen pooled Cryo product you're receiving indicates that saline has been added. I would suggest you inquire specifically about how the saline was added to the pool. If a sterile connecting device was not used for the addition of the saline (and I do not believe there is currently a saline vial that is configured to permit the use of a sterile connecting device), the pool was prepared in a open system. Even though the cryo units may be added using a sterile connecting device, the saline addition initiated the open system therefore the pool and subsequently thawed Cryo product remains an open system and has a 4 hour expiration date from the time of thawing. If saline has not been added (not contained on the labeling), then you're likely good to go with the 6 hours. Although 2 hours may not seem like a significant time period, in light of all the recent coverage about meningitis associated with the use of steroids processed by a compounding pharmacy and the additional scrutiny likely to be placed on manufacturing activities, it may be worth another inquiry--particularly since someone has provided another document that indicates the expiration period is 4 hours. Link to comment Share on other sites More sharing options...
jbhpy Posted October 17, 2012 Author Share Posted October 17, 2012 Thanks for your reply! All will be considered and looked into further....... Interesting enough, my ARC supplier sent me some additional information regarding the Cryoprecipitated AHF Pools including the brochure posted. There is a difference in expiration time as it has 6hrs instead of 4hrs on the brochures sent to me from the ARC Distribution Dept. Again further investigation will be done as you have made very good points. Link to comment Share on other sites More sharing options...
apfelblosm Posted October 20, 2012 Share Posted October 20, 2012 It also states in the 28th edition that the expiration is 6 hours if pooled using a sterile connection device in the same table you are referring to. ARC uses sterile doc, so we also use 6 hours for our pools from ARC Link to comment Share on other sites More sharing options...
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