Medical Solution Story

Challenges

Cord blood banks have traditionally used two types of collection models. One model employs the use of an obstetrician or midwife to perform the collection during the third stage of labor. The second method is performed by a cord blood bank staff member who receives the placenta after it has been delivered and brings it into a separate room to perform the collection. With the growing number of cesarean section deliveries, the need arose to perform the harvest in a sterile surgical field.

The only bags previously available did not have a sterile exterior and thus were not able to be used in these situations. The most common option available was to use a sterile extension set that needed to be assembled and then placed in the sterile field so that the collection bag remained outside of that field. Pall Corporation has subsequently manufactured a Cord Blood Sterile Collection Bag that has a sterile exterior that can be used during vaginal or cesarean collections and requires no extra manipulations during the collection.

Solution

The Pall Cord Blood Sterile Collection Bag can be used during vaginal or cesarean section deliveries because both the fluid path and the exterior are sterile. Alternatively, a sterile extension set can be used that is placed in the sterile field and connected to a collection bag with a non-sterile exterior. Both methods are safe and efficient.

A sterile exterior allows the collection bag to be placed into a surgical field without adding risk of contamination from the exterior of the collection bag. Cord blood collected during a cesarean section occurs in a sterile surgical environment. Bags without a sterile exterior cannot be placed into the sterile field without the use of sterile extension sets which require assembly and subsequent connection to the collection bag. Pall’s Cord Blood Sterile Collection Bag can be placed directly into this field. Collection staff can use this bag during vaginal or cesarean section harvests, eliminating the need for additional parts such as extension sets. This eliminates the need to use different supplies for vaginal and cesarean section collections. Because the Pall sterile collection bag was designed to be used in a sterile field, its packaging is also configured for ease of use in a surgical field.

Results
The implementation of Pall's Cord Blood Sterile Collection Bag eliminates the need for extension sets or questions about sterility. Additionally, Pall's Cord Blood Sterile Collection Bag is suitable for all cord blood collections whether within a sterile field in a cesarean section, or for cord blood collection during a vaginal birth. The Sterile Collection Bag accommodates either delivery method at a moment's notice with no additional parts or assembly required for use.

The Cord Blood Sterile Collection is the efficient solution for the collection of umbilical cord blood from either a vaginal birth or within the sterile field of a cesarean section. Anticoagulant type and volume can be specifically selected for cord blood collection to ensure a robust and easy-to-use process. The bag can hold 250 mL fill volume and its set contains 35 mL of Citrate Phosphate Dextrose (CPD) anticoagulant. Equally important, it is designed to collect up to 210 mL of cord blood. An in-line sterile air vent aids in recovery of cord blood from the tubing, and the unique bag shape helps to maximize the recovery of cell-rich plasma.

The bag’s innovative design also allows the technician to maximize the final cell number. Manufactured to cGMP using validated manufacturing processes that ensure safe, consistent, and reliable product performance. Each bag is visually inspected prior to release and is fully traceable by lot number.

When designing the Cord Blood Sterile Collection Bag, Pall took the safety of both the patient and the caregiver in account. The innovative packaging and the sterilization process result in a collection bag that can be used safely within the sterile surgical field. And the needle contains a finger-friendly contoured hub with a “bevel up” indicator to facilitate a secure needle stick into the umbilical vein. While the in-line DonorCare® Needleguard ensures safer cord blood collection by providing an added level of safety for collection staff against accidental needle-stick injuries. With safety first, you get an increased sense of comfort from both patient and caregiver.

The Cord Blood Sterile Collection is FDA NDA approved and CW marked under the medical Devices Directive for the collection of cord blood. As a key supplier to the cord blood banking industry, Pall provides a full range of bag sets that are used to prepare cord blood stem cells for cryopreservation and treatment. For more information on the Cord Blood Sterile Collection Bag or any of its complementary products, contact a Pall Medical representative today.