Replies to post #33080 on CBA Florida Inc. (fka CBAI)

[MrLong]

Hello dianebRN, a few things have changed in the cord blood bank industry since 1997. As you already know prior to 05' there were both vials and bags being used to store blood. Since 05', AABB stepped in with accreditation enhancements that changed the lack of uniformity.

Here:
As of 1 May 2005, AABB updated their cord blood accreditation criteria and required all banks to be re-inspected. The revised standards now require that the cord blood should be stored with "integrally attached segments" for testing purposes. Most blood bankers interpret the "integrally attached" criterion as requiring AABB banks to use bags for long term storage, where the tube leading into the bag can have sections crimped to hold integrally attached testing segments. The new AABB standards became mandatory in January 2007. By then, those cord blood banks which had been using vial storage had switched to bag systems.
http://parentsguidecordblood.org/content/usa/medical/accreditations.shtml

Along with AABB CBAI meets ASHI accreditation too. The Pall bag is FDA NDA approved. As I stated before NDA falls under IND. Today two choices for a private bank to need an NDA approved bag: expansion technology will later manipulate the cord sample and require an IND filing or maybe unrelated blood is going to be stored in them from the creation of a public bank. Public banks will need to file an IND for allogeneics.

At first glance the BioE bags are FDA 510(K) cleared for Cord Blood Processing Systems but no where in the literature does it state these devices are also NDA compliant.

So is there a difference between them and is NDA

The bag technology prior to 05' had many using vials because at -196 degrees some bank operations did not know if the bags would fail. Today bags are more sterile due to the compartmentalization feature that allows for seperation of bio material with virtually no air contaminants.

If you read up on Pall I think some the separation time is reduced by 50% so production increases.

Maybe if you provide a link for the 1997 Umbilicap device I can look at it and provide even greater detail regarding the differences, but I am confident that testing standards and industry uniformity with respect to testing are superior today than they were in 1997.

I did a quick search and found no such device named Umbilicap used by cord blood banks: www.parentsguidecordblood.org
nor could I locate using the FDA website. BioE and Pall filters however were listed as cleared devices on the FDA website.

Again,

Thanks.