Validating igloo coolers that are used to 'store' blood in the operating room

A blood banker in Massachusetts is writing a policy/procedure for the use of igloo coolers to 'store' blood in the operating room for selected surgical cases. Since this is new to them, they are wondering what others do with regards to validation of the coolers to hold their temperature. The inquiring blood banker wants to know other institutional practice regarding whether each cooler is validated (or just a representative cooler), and whether the validation is done once upon initiating use of a cooler or on a scheduled basis such as semi-annually? The inquiring blood banker also wants to know if others validate each cooler according to the number of units to be 'stored' in them, i.e. one validation for igloo coolers intended to store 2 units versus a separate validation for igloo coolers intended to store 10 units?

The following responses were submitted:

1. The e-network might find the information at on a previous forum issue (one of our first postings on this web site, back in 1999!) to be germane to this discussion.
   
   
2. A blood banker reported that at her hospital they validate each cooler separately upon arrival in the Transfusion Service and annually thereafter. The validation involves placing the appropriate ice/refrigerant packs into the cooler and recording the temperature each hour. The cooler is deemed acceptable if it maintains a temperature of 1-10 deg. C during the entire 8-hour test period. Coolers failing the original test, have the testing repeated. Failure at both attempts results in the cooler being discarded. Each cooler bears a label indicating the date of validation, the techs initials, and the statement "QC acceptable".
   
   
3. A blood banker in Texas reports that they have the igloo coolers that come with 2 frozen and 1 cold "Brite-Ice 40" inserts and a holder for 1 - 6 units of packed cells. They validate the igloos by placing 6 units of blood in the holder and placing the frozen and cold inserts in place. They place a thermometer between 2 of the units and took the temperature every hour. The temperature went up to 8 deg C at 12 hours and they stopped the validation at that point. They will sign out the cooler for no longer than 12 hours. For larger coolers, they validate by placing the maximum number of blood units allowed in it and proceeding as above. Ten deg C is the temperature at which blood is no longer allowed to be returned to the blood bank for re-issue. They would choose a temperature below that for the cutoff and then set the corresponding time as the end time for the cooler's efficaciousness.

ADDENDA Feb. 15, 2007

4. 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 the e-Network Forum discussion "Monitoring temperature of blood products transported within the hospital" are germane to this topic.

Submit comments to the e-Network Forum at enetworkforum@cbbsweb.org

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

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

Elizabeth M. St. Lezin, MD
CBBS e-Network Forum Associate Editor & Moderator