Re-release from October 2005 AABB Annual Meeting “Ask the FDA” Session
In response to several recent inquiries regarding the proper temperature for blood components during cooler storage or transportation, the association has re-released information from an “Ask the FDA” session at the October 2005 AABB Annual Meeting.
In the following scenarios, when is blood considered to be in transport with a temperature requirement of 1-10°C, and when is blood considered to be in storage with a temperature requirement of 1-6°C?
The two scenarios are:
- transferring blood in a monitored cooler for inventory between two hospitals in the same system.
- blood sent to surgery or the emergency/trauma area while in a monitored cooler.
According to Sharyn Orton, PhD, deputy director of the Division of Blood Applications at the Center for Biologics Evaluation and Research (CBER) in 2005, FDA realizes that the current regulations are not completely clear, noting that two of the regulations actually conflict. Orton points to 21 CFR 600.15(a) “Temperature During Shipment – Products,” noting that blood being transported from the collecting facility to the processing facility should be maintained at a temperature that allows cooling towards 1-10°C. In addition, if blood is being transported from storage and is being shipped somewhere, the blood should be maintained at 1-10°C.
However, blood should be stored at 1-6°C if it is being stored in a temporary location or in a temporary vehicle (i.e., cooler) for the intent or the potential intent of product storage for the life of the dating period. For example, if one is using a cooler to take blood to the operating room because of a lack of refrigeration, that is considered an extension of the storage refrigeration with the possible intent of additional storage time.
When electricity is temporarily out and it is necessary to store components in a cooler, FDA considers this a potential means to store for the life of the product, and the blood should be stored at 1-6°C. Therefore:
Scenario 1: 1-10°C would be adequate for transferring blood in a monitored cooler for inventory between two hospitals in the same system, and
Scenario 2: 1-6°C would be appropriate for blood sent to surgery or the emergency/trauma area while in a monitored cooler.
Reprinted from the AABB WEEKLY REPORT April 28, 2006
AABB Copyright 2006