Expiration of platelets divided into a transfer bag using a sterile docker

[Mabel Adams]

What is the expiration used for platelets that are divided into a transfer pack/bag using a sterile welder (closed system)?  Do you use the original expiration or does the plastic of the transfer bag not allow oxygen transfer like a platelet bag so they have to have a shorter expiration?  If the latter, how long of an expiration is permitted?

[tcoyle]

Hi Mabel,

Best to check the package insert that came with the aliquot bag.  There is a new AABB standard:  

5.7.2.1.3

 

Regardless of the integrity of the weld, if no storage time limit is specified in the package insert or the package insert is not available, the component shall have an expiration time of 4 hours after transfer from original container.

[Mabel Adams]

Does anyone know a manufacturer of transfer packs that stipulates expiration times?  I find nothing online for Fenwal bags and the box doesn't list expirations.  Four hours isn't even enough so the product is still in-date at the end of the usually allowed 4 hour infusion time.

[jshepherd]

We use Charter Medical 150ml syringes and 150ml transfer bags, and they do not stipulate an expiration either. Regarding the 4 hour time, we have always followed the rule that the unit must be issued from the blood bank before expiration time. In the age of Epic for nursing documentation, the nursing staff must start the documentation (scanning the 4 barcodes on the unit) before the expiration time as well. The fact that it is infusing past the expiration time is fine, as long as it's infused within 4 hours of being spiked by the nursing staff. 

[Mabel Adams]

1 hour ago, jshepherd said:

We use Charter Medical 150ml syringes and 150ml transfer bags, and they do not stipulate an expiration either. Regarding the 4 hour time, we have always followed the rule that the unit must be issued from the blood bank before expiration time. In the age of Epic for nursing documentation, the nursing staff must start the documentation (scanning the 4 barcodes on the unit) before the expiration time as well. The fact that it is infusing past the expiration time is fine, as long as it's infused within 4 hours of being spiked by the nursing staff. 

I just got information back from Fresenius (now maker of Fenwal transfer packs) that their bags are good for red cells through the unit outdate but that they are not approved at all for platelets.  Do you know if Charter Medical says that their bags are approved for platelets?  We use their 60 ml syringes and they are listed as okay for platelets so I assume their 150 ml syringes would be but wasn't sure about their bags.

[Mabel Adams]

Update:  apparently AABB is changing this standard to an interim standard.

Proposed Interim Standard Focusing on Sterile Weld for the 33rd edition of Standards for Blood Banks and Transfusion Services (aabb.org)

If the integrity of the weld is complete, and the compo­nent is in a container approved by the FDA or Competent Authority for storage, then the original shall have an expiration date/time shall apply, consistent with the storage requirements for the blood or blood component. assigned in accordance with the FDA- or Competent-Authority-approved package insert for the storage container. Standard 5.1.4 applies.

Regardless of the integrity of the weld, if no storage time limit is specified in the package insert or the package insert is not available, the component shall have an expiration time of 4 hours after transfer from the original container.

Confused yet?  I am.

[Sonya Martinez]

I contacted AABB directly about  the added standard 5.7.2.1.3 because it requires the vendors to provide expiration dates of the transfer bags even if the weld is complete which for us is a huge issue.  I'm glad they are reversing this.  That all being said, as long as the weld is complete we keep the expiration date/time of the product placed in the transfer bag.   We only keep platelets in the mother bag and take aliquots from it for transfusion.  We do change the expiration time to 4 hours when we place them in a syringe.