HealthBanks uses the only FDA-approved sterile (and Heparin free) collection bag for use in C-sections. Using this FDA approved sterile collection bag is necessary to maintain a sterile operating room. Furthermore, HealthBanks uses the FDA and NDA approved anticoagulant Citrate Phosphate Dextrose Solution* (CPD), a cell protector, also recommended by the Department of Health and Human Services, Center for Biologics Evaluation and Research, Guidance for Industry.**
CPD preserves stem cell metabolism, unlike Heparin, allowing the cells to maintain their integrity between the time of collection to processing, as well as result in a significantly higher total nuclear cell count (TNC) before and after cord blood processing.***
*HealthBank’s collection bag containing CPD is FDA NDA approved and CE marked under the Medical Devices Directive for the collection of placental/umbilical cord blood. https://www.pall.com/medical_41560.asp
** During collection of cord blood, we recommend that you use an appropriate closed, sterile container sealed in a manner that prevents cell loss and contamination. We recommend that you use only citrate-based anticoagulants.” U.S. Dept of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Guidance for Industry – Minimally Maninpulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hemapoietic Reconstitution for Specified Indications, October 2009
***Blood (ASH Annual Meeting Abstracts) American Society of Hematology “Cord Blood Units Collected with Liquid CPD Appear to Contain Significantly More Nucleated and CD34+ Cells Than Units Collected with Dry Heparin” Morey Kraus*,1, Karen Foster*,2, AsimenaRigas Bridges*,3 and Mark C. Walters, MD 4 2009 114: Abstract 4227
https://abstracts.hematologylibrary.org/cgi/content/abstract/114/22/4227