ADDENDA May 22, 2006

5. At the Editor's hospital (LAC+USC Medical Center) portable blood transport/storage coolers are validated to maintain 6 RBC units at a temperature of 1-6C for up to 10 hours using a form of commercial 'blue ice' that is reusable, dishwasher safe, and made of non-toxic FDA-approved materials (see attached PDF files: cooler with label, cooler with 'blue ice' ). The coolers are also validated to maintain 2 RBC units without any ice to simulate the situation that might occur near the end of a long surgery. Without ice the coolers maintain a 1-6C range for at least 2.5 hrs. During each validation exercise, temperatures were taken and Hemotemp® labels were inspected every 30 minutes; this repetitive inspection of the coolers' internal temperature simulates the OR setting where a nurse or anesthesiologist might temporarily open a cooler to inspect the products within. Based on the above validation data, the OR is allowed to keep in the operating room coolers containing as many as 6 RBC units for up to 8 hours without replacing the ice. If the case lasts more than 8 hours, the ice needs to be replaced before the case exceeds 10 hours.

ADDENDA May 24, 2006

6. A colleague in New York reports that in his hospital they store blood that is sent to the operating room in coolers that have been validated to maintain RBCs at 1 - 6C for up to 6 hours. Each cooler is individually validated annually. The validation process assures that RBC units are maintained within the required 1 - 6C range at 2 hours, 4 hours and 6 hours after issuance from the blood bank. They also simulate opening the coolers to obtain a unit of blood, at the aforementioned intervals, to assure that opening and closing the coolers does not adversely effect the temperature control.

ADDENDA Feb. 5, 2007

7. The transfusion service supervisor for a mid-sized VA in California writes that their facility implemented the use of a commercially available cooler system for transport and temporary storage of blood in the Operating Room. In their experience, this system can maintain the temperature of blood products between 1 - 6 C for up to 24 hours. The system includes cooling blocks, plastic caddies to hold blood units, an insulated transport container with a handle and wheels, and an onboard temperature monitoring device with software to facilitate the downloading and printing of the data.

They report that the temperature monitoring device can be programmed for specific requirements and once activated will provide an ongoing record of the internal cooler temperature. Although it has an audible alarm to indicate an out-of-range temperature, it is not very loud and could be easily missed in the Operating Room environment. However, when the information in the temperature monitor is downloaded, out-of-limit temperatures are clearly indicated in red. In addition, a graph can be printed which also clearly shows the temperature recordings for the entire storage period. This makes it easy to evaluate cooler performance and the acceptability of any returned units and to document storage for compliance with FDA regulations.

The responding colleague's hospital validated the system using worst case OR usage scenarios (repeated opening of cooler, leaving lid open, etc) and found that it responded well to these stresses and continued to maintain the blood units within the required temperature range.

In addition, they attach a commercially available temperature indicator to each unit. They comment that the use of the temperature indicator provides additional assurance that the blood unit was not removed from the cooler for an extended period of time.

ADDENDA Feb. 15, 2007

8. The Editors believe that the discussion with Alan Williams from the 2006 Ask the FDA Session under "Storage and Transportation" (AABB Membership required to access) and that the e-Network Form discussion "Validating igloo coolers that are used to 'store' blood in the operating room" are germane to this topic.

Please submit comments to the e-Network Forum.

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Assistant Editor & Moderator