Some things just never change. Take, for example, this question from the “Ask the FDA” session at the October 2008 AABB Annual Meeting in Montreal. Today, another year later, we find our blood banking colleagues still challenged with defining the exact differences between transport and temporary storage.
As an example, you could send a unit of blood to two different locations – one is considered “transport” and the other is considered “temporary storage.” The defining difference is thatone may be returned and the other may not. One is inside the existing hospital, and the other is to a location outside the blood bank/hospital – even if the use is exactly the same.
These same questions came up at the 2008 AABB, where the CFRs were once again discussed – in an effort to help clarify the interpretation as it relates to:
- where the blood is going,
- what it is used for, and
- whether or not it is coming back.
The inconsistency between the CFRs is what has historically generated some of the confusion.
As you can read the 2008 “Ask the FDA” transcript below, transfusion medicine experts continue to explore this topic to provide clearer definition and guidance for those of us to whom the CFRs apply.
Ed Sharpless, VP Product Development
The following two questions and answers about blood temperature monitoringrelated to 21 CFR 640.2(c) and 21 CFR 610.15(a) have been excerpted from the“ASK THE FDA SESSION” at the 2008 AABB in MONTREAL. The questions and answers specifically address:
The recent requirement to measure and record the temperature of blood when in ‘outside storage’, such as Igloo design coolers, and
The storage versus transport temperature requirements that tend to contradict each other, especially for RBCs.
ANSWER: Judy Ellen Ciaraldi, BS, MT(ASCP), DBA/CBER/FDA. “Let’s start with a definition, FDA’s definition, of storage and transport. And, let’s use red blood cells because that’s the example in the question. Red blood cells are required to be stored at 1 to 6 degrees. This is in the regulation 640.11a. We consider storage to when blood is in inventory, or at rest, waiting to be transfused, or awaiting to be packed and shipped to another location. Once the blood is in movement, or being moved from the storage situation to another site, then it meets the definition of transport. During shipment red blood cells must be placed in an environment that maintains the temperature between 1 and 10 degrees. This requirement is found in the CFR 600.15a. Concerning evaluating blood that’s returned back to the blood bank, in this case the blood is going from a temporary storage environment to another storage environment within the blood bank. To be considered acceptable for reissue, the blood must be stored continuously between 1 to 6 C. And that’s in the regulation cited in the question. So it’s against the 1 to 6 degree temperature range that their product has to be evaluated, to be considered acceptable for reissue. If however, the OR, or the transfusion site is located offsite, like in a separate facility, and the blood has to be shipped out there and shipped back to the blood bank using your standard qualified shipping procedure, the red cells then must be evaluated according to their shipping temperature which is 1 to 10 degrees. So the blood must have been maintained no warmer than 10 degrees in order to be considered acceptable for reissue.”
MODERATOR: H. Allene Carr-Greer, MT(ASCP)SBB, AABB. “Judy I think that maybe the emphasis in this question, because it’s just heard again, questioner posed that you know blood can come back to the transfusion service in the same hour from two different locations: one unit is acceptable at 10 degrees the other one is not. I think maybe the emphasis of the question is there, they’re asking for a forum to ask about the practical aspects of these standards and maybe I would add to that, is there maybe plan to draft some change to the current regs?”
ANSWER: Judy Ellen Ciaraldi, BS, MT(ASCP), DBA/CBER/FDA. “Thank you for elaborating on that. Right now there is no forum being developed to discuss the difference between storage and transport and the temperatures. The question asked ‘why are there two standards?’ ‘Why is it different?’ There is literature available, many, many inTRANSFUSION in fact, about the impact of temperature on storage lesions. In the interest of time, I would recommend that those articles be reviewed to see what their content is and their message on this. In a general sense, blood that is maintained at 1 to 6 degrees, red blood cells, shows that the storage lesions are at a much lower number We understand that we know that there is the confusion but right now there isn’t a forum set, but we are aware of the issue and are trying to make consistent definitions for transport and for storage, meaning temporary storage. When the blood was stored in an OR refrigerator things were very clear but now the Igloos or other temporary storage environments are being used. And in some cases Igloos are the same devices that are used to transport blood that is being shipped to another hospital, for instance, and not the just shipped upstairs to the operating room or distributed to the operating room, so the line has become gray, and we understand that and we are discussing it, but we haven’t planned a forum.”