Jump to content

Expiration Dates


Recommended Posts

Now I am curious how my blood supplier pool their cryos. Our current expiration time is 4 hours, and if possible, it's best to extend to 6 hours where applicable.

What is SMW and SCD? =S

I do not know what SMW is but yes, SCD is a sterile connecting device (a means of attaching two separate pieces of tubing, without an open system; it has a wafer that does a very fast splice of the 2 segments, then brings them together and heat seals them; nice, but expensive).

Brenda

Link to comment
Share on other sites

Cryo 10 packs are pooled together using a sterile docking procedure so the expiration date should be the same as thawing 1 unit of Cryo, which is 6 hrs. I don't know of anything in writing that supports this thinking.

Link to comment
Share on other sites

Cryo 10 packs are pooled together using a sterile docking procedure so the expiration date should be the same as thawing 1 unit of Cryo, which is 6 hrs. I don't know of anything in writing that supports this thinking.

See my responses which direct you to the Technical Manual. While the Technical Manual is not a regulatory book per se, it was trying to elaborate on regulations for this. As the reply from the FDA/AABB stated, the FDA wrote their regulation before their were pre-pooled Cryos. so they need to revise theirs.

Brenda Hutson, CLS(ASCP)SBB

Link to comment
Share on other sites

See also AABB Technical Manual 16th ed page 958: Note 2 for method 6-12 "Thawing and pooling cryoprecipitaed AHF" very clearly states that pre-pooled cryoprecipitate should be given an expiration of 4 hours whether it was created in an open or a closed system.

Link to comment
Share on other sites

See also AABB Technical Manual 16th ed page 958: Note 2 for method 6-12 "Thawing and pooling cryoprecipitaed AHF" very clearly states that pre-pooled cryoprecipitate should be given an expiration of 4 hours whether it was created in an open or a closed system.

I can only reply in this way:

1. The Guidance I cut and pasted in previous responses, came directly from the AABB and FDA Regulatory divisions.

2. Both the AABB and FDA state that the wording needs to be clarified

3. Until both regulatory agencies clarify their wording, it is up to you all to decide if you want to choose 4 hours, just to be on the safe side. I only passed on what I was told.

Brenda Hutson, CLS(ASCP)SBB

Link to comment
Share on other sites

See also AABB Technical Manual 16th ed page 958: Note 2 for method 6-12 "Thawing and pooling cryoprecipitaed AHF" very clearly states that pre-pooled cryoprecipitate should be given an expiration of 4 hours whether it was created in an open or a closed system.

Just looked up your reference. You are correct; the 16th Edition doesn't get much clearer than that!!

I will go back to the AABB Regulatory person regarding this. This confusion is disheartening. There is a large, local, well known Medical Center (you would know it if I said the name), where I used to work; they are getting pre-pooled Cryo and are giving it a 6 hr. expiration after thawing.

I will not rest until I know the answer (even though I do not yet receive pre-pooled Cryo.)!

Brenda

Link to comment
Share on other sites

Just looked up your reference. You are correct; the 16th Edition doesn't get much clearer than that!!

I will go back to the AABB Regulatory person regarding this. This confusion is disheartening. There is a large, local, well known Medical Center (you would know it if I said the name), where I used to work; they are getting pre-pooled Cryo and are giving it a 6 hr. expiration after thawing.

I will not rest until I know the answer (even though I do not yet receive pre-pooled Cryo.)!

Brenda

Wow, this is sad; I am replying to my own e-mail! In this same Edition of the Technical Manual, page 294 also "clearly" states: thawed single and closed-system-pooled cryoprecipitate concentrates should be transfused within 6 hours of thawing.

This is all very conflicting and very confusing! Maybe by the time I get pre-pooled Cryo., they will have it figure out!

Brenda Hutson, CLS(ASCP)SBB

Link to comment
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now
  • Recently Browsing   0 members

    • No registered users viewing this page.
  • Advertisement

×
×
  • Create New...

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.