Monitoring temperature of blood products transported within the hospital
A transfusion medicine physician in Virginia reports that they would appreciate knowing how others transport blood products within their own hospital. At the inquiring Virginian's institution, the nurses transport blood products from the laboratory to the patient care areas in biohazard bags, but do not perform temperature monitoring during the transport or once the products reach their destination. The locations in the Virginia hospital where transfusions are carried out are about 8-10 minutes from the laboratory. At a recent inspection, it was recommended that the inquiring physician's hospital set up a system to monitor the temperature of transported products, so that in the event a product is returned to the laboratory, it can be reissued at a later time/date. The inquiring physician favors using some kind of temperature monitoring device and wonders if any e-network colleagues would share suggestions.
In response to the above question, the e-Network Forum Editor & Moderator recommends revisiting one or more of the following related issues from the archives of the e-Network Forum:
The following responses were received.
- A blood banker from a Sunbelt state responds as follows (quoted as submitted): "On our last FDA inspection, the question of coolers and blood storage became an issue. We were using the igloo coolers for Cardiovascular-OR heart cases. Most times, the cooler would go to cardiovascular ICU by the bedside until the patient was stable. When the box was returned, many times the temperature in the box was 7-9 (rarely 10) degrees C. We were issued a Form 483. We were using the guide line that 1-10C for a transport box was OK. The definition we were told of a transport box was to transport blood from one facility (place) to another. Therefore, once the cooler reached CV/OR it was at its destination and then it became a storage container where the temperature range should be 1-6 C. We were using ice blocks and this was not keeping the temperature between 1-6C. We have eliminated the use of boxes except for medical emergencies. If we do use a box, we use wet ice and have validated that these coolers stay between 1-6C for 24 hours. We allow them to be out only for 8-10 hours. It takes approval by the pathology dept. to keep the box longer; in that instance the box temperature is checked and the ice refreshed. I would love to hear comments about this. And by the way, if this is true - what good are temperature indicators that monitor the bag of blood from 1-10C. This would make me think that there should be temperature indicators for 1-6C also."
ADDENDA Sept. 16, 2002
- A Los Angeles blood banker reports that it is his understanding of the requirement for temperature maintenance in a cooler used to transport blood units to a site outside the Blood Bank, say an OR suite, that a range of 1-10 C must be maintained during the period of TRANSPORT. He adds the following "Now, if that transport cooler becomes the storage device for the blood while it's in the OR (instead of a monitored refrigerator plugged into a wall outlet), then I've heard it rumored that the FDA will consider the cooler (while it sits in the OR) NO LONGER a transport device, but rather "PERMANENT" storage container in which the temperature range must be 1-6 C. I suspect that many protocols used to validate a cooler's ability to maintain a certain temperature range, whether it be 1-6 C or 1-10 C, are based on an endpoint that is the cooler's ability to maintain the specified range for a defined length of time WHILE REMAINING UNOPENED. However, if the FDA is indeed looking at a stationary cooler off site as a device that must maintain a 1-6 C range, then it would be unreasonable to expect such a device to remain unopened for any length of time. Certainly, personnel would be in and out of that box perhaps several times during its hypothetical stay in the OR. Considering this, wouldn't a protocol designed to validate a cooler capable of serving as a 1-6 C storage device also need to take into account repeated entry into the device (and the presumed introduction of relatively warm air), and document the cooler's ability to return to 1-6 C within a certain amount of time after being re-closed, as well as its overall ability to function as a 1-6 C device from beginning to end of it's time as a "storage" container? Has anyone addressed this issue of a cooler needing to serve as a 1-6 C storage device (as opposed to a 1-10 C transport device), and validated such, taking into account the repeated entry that is sure to happen?"
ADDENDA Sept. 18, 2002
- A transfusion medicine physician in Florida suggests that instead of ruminating on 'rumors' that FDA cited a facility for how they stored blood in their coolers, or what might be the opinion of a single surveyor, that some type of ruling should be solicited from the FDA on this issue, perhaps via the AABB/FDA liaison process. The Floridian is certain that use of coolers is widespread, given the distrust of placing blood into refrigerators outside the blood bank, and that a requirement that blood in coolers be maintained at 1-6C (versus 1-10C) will make a big difference in his practice, if this truly represents official FDA policy. He is perplexed over such a possibility, since if it takes 12-15 hours to ship blood via air express, and 1-10 C is acceptable during that transport, why shouldn't the same apply to blood being held in an OR or critical care area for shorter duration?
ADDENDA May 12, 2006
- A colleague in Taiwan reports that their medical center uses the accreditation requirements and guidelines issued by various United States organizations (FDA, College of American Pathologists and AABB) as 'self inspection' tools. Their hospital uses Igloo coolers that have been validated to allow RBC units to be kept in the operating room between 1-10C during surgery. Their coolers were validated using a single unit of RBC because in their experience a cooler that is filled to capacity with RBC units will hold the temperature better than a cooler that has empty (air) space in it. The Taiwan colleague feels that a cooler validation should be done according to a worst case scenario, which is why they validate their coolers using a single RBC unit. Using their scheme, they found that their coolers can maintain a temperature between 1-10C for up to 8 hours. They are concerned, however, with recent comments attributed to FDA, according to an excerpt (see below) from the April 28th AABB weekly report which implies that coolers kept in the operating room should maintain the temperature of RBCs between 1-6C.
Clarification Offered for Storage Versus Transport of Blood Components in Monitored Cooler
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:
Question: 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
Answer: According to Sharyn Orton, PhD, deputy director of the Division of Blood Applications at the Center for Biologics Evaluation and Research (CBER), 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) “Temperatures 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 110° C. In addition, if blood is being transported from storage and is being shipped somewhere, the blood should be maintained at 110° C.
However, blood should be stored at 16° 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 16° C. Therefore, for 1) 110° C would be adequate and for 2), 16° C would be appropriate.
The Taiwan colleague acknowledges that their cooler can only maintain a temperature of 1-6C for about 3 hours, which in their experience is not a long enough time for many surgeries. They would like to know if any colleague uses a cooler system that can store RBCs for longer time periods while maintaining the temperature within a 1-6C range?
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Ira A. Shulman, MD
CBBS e-Network Forum Senior Editor & Moderator
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Elizabeth M. St. Lezin, MD
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