Using igloos for the storage of blood in the operating room

A transfusion medicine physician in Los Angeles comments that at the "Ask the FDA and Health Canada" session on Monday, October 6, 2008 at the AABB 2008 Annual Meeting in Montreal, Quebec, Canada, the following panel discussed various topics, including the question below which addressed using igloos for the storage of blood in the operating room. The panel included the following individuals:

FDA
Jay Epstein, MD, Director, Office of Blood Research and Review, Center for Blood Evaluation and Research
Judy Ciaraldi, Consumer Safety Officer, Division of Blood Applications, OBRR, CBER
Sheryl Kochman, Chief, Device and Review Branch, DBA, OBRR, CBER
Jaroslav Vostal, MD, PhD, Chief, Laboratory of Cellular Hematology, Division of Hematology, OBRR, CBER
Paul Mied, PhD, Deputy Director, Division of Emerging and Transfusion Transmitted Diseases, OBRR, CBER
Sharon O’Callaghan, CSO, Division of Inspections and Surveillance, Office of Compliance and Biologics Quality
Ellen Lazarus, MD, Medical Officer, Division of Human Tissues, Office of Cellular, Tissue and Gene Therapy, CBER
Leslie Holness, MD, Chief, Blood and Plasma Branch, DBA, OBRR, CBER

CMS
Penelope Meyers, CLIA Program, Centers for Medicare and Medicaid Service

HEALTH CANADA
Peter Ganz, PhD, Director, Centre for Biologics Evaluation, Biologics & Genetic Therapies Directorate Health Canada
Francisca Agbanyo, PhD, Chief, Blood, Tissues, Organs, Xenografts Division Center for Biologics Evaluation

Moderator
M. Allene Carr-Greer, director, Regulatory Affairs, AABB

Question 10: When red cells are issued/transported to the OR in a validated cooler and then returned to the blood bank, at what temperature range should the products have been maintained in order to be suitable for reissue? It appears in 21 CFR 640.2(c) that blood can be kept at both 1 – 6 C and 1 – 10 C depending on how one defines the storage or transport mode. How should storage versus transport be defined? Will there be a forum to discuss the practical aspects of maintaining red cells at 6 C versus 10 C? Why are there two different standards for red cells?

MS. CIARALDI: Let's start with FDA's definition of storage and transport, and let's use red blood cells because that is the example in the question. Red blood cells are required to be stored at one to six degrees. This is in the regulation 640.11(a). We consider storage to be when blood is in inventory or at rest waiting to be transfused or waiting 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 one and ten degrees. This requirement is found in the CFR 600.15(a). Concerning evaluating blood that is 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 have been stored continuously between one and six degrees. That is in the regulation cited in the question. It is against the one to six degree temperature range that the 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 one to ten degrees, therefore the blood must have been maintained no warmer than ten degrees in order to be considered acceptable for reissue.

THE MODERATOR: Judy, I think maybe the emphasis in this question, because we just heard again what the questioner posed, is that blood can come back to the transfusion service within the same hour from two different locations. One unit is acceptable at ten degrees, the other one is not. I think maybe the emphasis of the question is whether there is a forum to discuss these practical aspects of these different standards and maybe I would add to that, is there may be a plan to draft some change to the current regulations to address that?

MS. CIARALDI: 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 in Transfusion, in fact, about the impact of temperature on storage lesions and in the interest of time, I would recommend that those articles be reviewed to see their content and their message on this. However, in a general sense, blood that is maintained at one to six 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 is not 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. I think the confusion exists because devices normally used to transport blood are now being used for the storage activity.

When the blood was stored in an OR refrigerator, things were very clear. The purpose of the validated igloos in the OR is to replace the blood bank refrigerators that were used in the OR. The igloos are performing the same activity as the OR refrigerators: They are holding (storing) blood until the OR patient needs it. Therefore the igloos must store the blood at the same temperatures as the BB refrigerators and blood returned to the blood bank should be judged in the same manner as if it was returned from the BB refrigerator in the OR.

DR. EPSTEIN: If this is becoming a significant practical issue to the blood community, we will certainly find a forum to address it. Whether we need a workshop or an advisory committee or if you convene a meeting we can come as a liaison, however we need to approach it. We are happy to do that if this has become a problem.

THE MODERATOR: Thank you, Judy and Jay, for that offer.

The Editors believe that colleagues might find the information in the following prior discussions to be of historical interest:

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