Cooler Validation Survey Results – March 2012

March 2012

The Cooler Validation Survey conducted in late January drew participation from over 70 blood banking professionals. You and your peers were generous and forthcoming with your ideas, concerns and procedures. For that, we are genuinely grateful.

Although we didn’t ask the specific question, it appears from the survey responses that we had participation from a wide range of facilities. That said, the single strongest “take away” message from the survey is that there is significant variation in validation procedures, including the equipment used as “transport coolers,” as well as the assorted devices/items used to perform validation. The validation protocols themselves appear to be unique to each organization, with an expressed need for clear guidance and more commonality.

Here is a “Quick Look” at the survey results. The actual survey response data is presented further down in this post. Note: Because we did not design the survey with statistical controls, it’s not a strict scientific study, but it has certainly proved to be both fascinating and insightful!

Quick Look: Cooler Validation Survey Results

  • 88% validate with 1-2 units (minimum number), but the maximum number varies greatly.
  • A majority use an Igloo®-style cooler of variable sizes.
  • Frozen cold packs are the most common packing choice.
  • Thermometers are twice as common as temperature recorders for measuring temperature.
  • A majority place the probe/thermometer between the bags, not in the bags.
  • A resounding 91% use cooler validation protocols/procedures from their hospital/blood bank.
  • Many respondents expressed frustration, concern and bewilderment at the time-consuming procedure, as well as at the lack of validation standards.

In our quest to simplify and demystify cooler validation, this survey has been enlightening and highly valuable. We are making significant progress on Validation Kit development, and the information that you provided in this survey has been crucial to developing a product offering, inclusive of suggested procedures and equipment, that can help alleviate some of the frustrations and concerns we learned about via the survey.

As always, we thank our survey participants for partnering with us to ensure that we help “deliver the best” – in our common challenge to ensure safe blood product management.

Ed Sharpless
Vice President Product Development

Cooler Validation Survey Results

This report summarizes the responses to the survey conducted by William Labs in late January 2012. The survey was designed to provide a “snapshot” of practices and to highlight important issues. It was not structured to be statistically representative. Seventy-one people participated in the survey, however, not all people answered all questions. Because we did not design the survey with statistical controls, it’s not a strict scientific study, but it has certainly proved to be both fascinating and insightful!

If you would like a PDF of this report, please email us.

1. How many coolers does your facility validate each year?
Percentage*
4 or less per year
50%
5-11 per year
25%
12 – 50 per year
25%
Total
100%

*Percentages are approximate

2. How many bags do you use in your cooler validation procedure?
1 2 3 4 5 6
Minimum number of bags used
28* 28 1 5 0 2
44%* 44% 2% 8% 0% 3%
Maximum number of bags used
4 14 0 20 2 26
6% 21% 0% 30% 3% 39%

*Top number is the count of respondents selecting the option.
** Bottom % is percent of the total respondents selecting the option.


Frequent Comments & Generalizations:

Eighty-eight percent (88)% validate with 1 or 2 units.
Many never issue more than 2 units at a time, have policies that limit to 2 units.

3. What type of transport container do you use?
Total Responses Response Ratio
Small Igloo-style cooler
30
44.7%
Large Igloo-style cooler
35
52.2%
Small specialized container
9
13.4%
Large specialized container
9
13.4%
Other
25
37.3%

Frequent Comments & Generalizations:
ThermoSafe® was most often mentioned for specialized container or “Other”
A variety of shipping/Styrofoam™/insulated boxes were reported as “Other”

4. What do you pack the container with for cooling? (check all that apply)?
Number of Response(s) Response Ratio
Frozen cold packs
42
62.6%
Chilled cold pack
26
38.8%
Wet ice
22
32.8%
Other
12
17.9%
Total
67
100%

 

5. What do you use to measure temperature? (check all that apply)? Number of Response(s) Response Ratio
Thermometer
40
60.6%
Electronic temperature recorder
19
28.7%
Other*
22
33.3%
Total
66
100%

Frequent Comments & Generalizations:
Among responses of “Other”, six (6) use HemoTemp® and four (4) use Safe-T-Vue® to monitor temperature during validation
or concurrent with temperature measurement
. Four (4) use infrared thermometers to measure temperature.

6. Where do you place the temperature probes/thermometers? (check all that apply)?
Number of Response(s) Response Ratio
Inserted into the bag fluid
12
17.9%
Placed between the bags
47
70.1%
Other
16
23.8%
Total
67
100%
7. What Validation Protocol do you use? (check all that apply)? Number of Response(s) Response Ratio
Procedure from my hospital/blood bank
61
91.0%
Procedure from cooler/container manufacturer
6
8.9%
Other
5
7.4%
Total
67
100%

8. Please feel free to share any ideas or suggestions relative to the topic of cooler validation.
Frequent Comments & Generalizations:

“Wish there was an easier way….”
“Tough!”
“Process is primitive…”
“Too time consuming…”
“Help needed!”
“Concerned….”
“Challenging…”
“Searching…”
“Standardized process/kit would be an improvement…”
“Would be nice to have an AABB-approved procedure…”

Please feel free to contact us with any questions or suggestions.
Ed Sharpless, VP Product Development
eds@williamlabs.com
1-800-767-7643

Transport and Storage Cooler Validation Kit: Report on our Beta Trial Sites

January 2012

Share what you know – and learn from your peers

We are several weeks into our Cooler Validation Kit trials, and one thing is for certain. We’re learning a lot!  And we want to learn more – and share it with you.

Significant variability in many aspects of validation

Again, we want to thank our trial sites for testing our kit and for graciously participating in pre-trial and post-trial phone interviews. Before the trial began we gathered some basic information, including current cooler validation procedures, size of their facility, and the types and number of coolers in use. We also heard about “successes and challenges” – what do they have “down pat” and where could they use a better mousetrap?  Even though our sample size is relatively small, we heard significant variability in everything from the number and orientation of bags used in validation, to placement of the temperature probes, to packing techniques and revalidation practices.  All this information combined with their feedback on our trial validation kit is helping us to improve the kit that we will ultimately offer.

In the absence of national or international blood bank organization standards for cooler validation, our goal is to develop and share helpful information for our colleagues in the blood banking world.

Please participate in our short online survey about cooler validation

We’d like to ask you (and your blood bank colleagues at other institutions) to participate (anonymously) in a quick online survey.  Then, we will consolidate and share the results with you. We plan to use this information to further shape our Validation Kit development and will make the information public for your consideration and possible use, as we do in our Support section of the William Labs website. Upon completion of the survey you will be asked for your email address so that we can send you an advance copy of the results.

Thank you for your participation in the survey, and please feel free to forward this to your colleagues.

For now, I’d like to share with you our Transport and Storage Cooler Tips (PDF), with some helpful ideas and reference information regarding cooler validation procedures and documentation. You can also view this information as a web page.

 

Update from AABB 2011: Transport and Storage Coolers used in Blood Banks

November 2011

Hearing your shared experiences, perspectives and concerns

One of our primary goals at AABB in San Diego was to learn more about cooler validation procedures. Thank you to all who shared their experiences, perspectives and concerns! I wanted to take this VUEPOINT opportunity to share with you what we learned, and then tell you more about how William Labs is working to make cooler validation easier and more useful.

Learning about your challenges

The conversations about cooler validation were eye opening! We learned so much from blood bankers, medical technologists and other colleagues in the field. In particular, we heard about a variety of cooler validation protocols, the challenges and flaws in current procedures, and quite honestly, a lot of frustration.

The single most common theme, not surprisingly, was that of the time demands on blood bank staff and how the cooler validation procedure can be a real drain on them. Everyone understands the importance of cooler validation, but the time commitment was, across the board, the single biggest issue.

As an example, what seems to be a fairly typical validation technique of using a thermometer and timer is time consuming for a variety of reasons. Many told us that if they were interrupted by an unexpected urgent need, or distracted with other tasks, or simply forgot to accurately time the process, that they would have to restart the entire procedure. Then there was the issue of manually documenting the temperatures at the appropriate intervals, to create that needed permanent record.

What we’re doing to help

William Labs has developed a Cooler Validation Kit that is currently being used on a trial basis by several blood banks and hospitals around the U.S. We are grateful that we have an enthusiastic group of trial sites that we can rely on to give us credible feedback from different sizes and types of institutions with a wide range of cooler validation needs and challenges. We will use their experiences and observations to fine-tune our Validation Kit before formally introducing it in 2012.

In short, the Validation Kit automatically tracks time and temperature so that you can essentially set it up, start the validation procedure, and get back to work. Except for items that are common in all blood banks, the kit includes everything need for cooler validation, including electronic temperature recorders, calibrated temperature probes, simple instructions, plus validation documentation and labels that you can customize to your needs, along with some other “handy” items to simplify the process.

If you’d like to hear more about the trial and what we learn, or want to be on the announcement list for the Validation Kit release, please email us and let us know you are interested. We’ll be sure to keep you informed. If you weren’t able to visit us at AABB but would like to share your thoughts on cooler validation, we would appreciate hearing from you.

For now, I’d like to share with you our Transport and Storage Cooler Tips (PDF), with some helpful ideas and reference information regarding cooler validation procedures and documentation. You can also view this information as a web page (link).

Beth Sharpless, B.S.N.
Product Support Specialist

Update: Storage vs. Transport of Blood Components

September 2009

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
William Laboratories

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.

  • 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?
  • 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.”

    Transport Cooler Validation and Blood Product Temperatures

    September 2011

    “If we use a temperature indicator inside the cooler, can we eliminate the step of checking the temperature every 4 hours?”

    At the Ask the FDA session at the 2010 AABB meeting, this was one of the questions asked referencing a new requirement1 to check the temperature of blood products every 4 hours when being transported in a validated cooler. The answer at the session was “yes,” if using a temperature indicator inside the cooler. As a manufacturer of blood bag temperature indicators, this was good news. However, our curiosity was piqued about ‘how difficult can it be to validate a cooler?’

    Given the discussion around this topic, we asked blood bankers about their cooler validation practices and equipment, checked blogs, and generally surveyed how blood bank coolers were being validated. We learned some things. One of them being that there is a wide range in validation procedures, some using ‘good science’ that takes into consideration the real world uses of blood transport coolers. For example, we found validation procedures and practices that included:

    • Taking into consideration the periodic removal of blood units during the transport time period
    • Careful inspection of coolers during the annual validation procedure
    • Temperature measurement of TWO bags – the top bag and the bottom bag – when multiple bags may be transported in the cooler

    Establishing a ‘cold start’ for the bags before placing them in the cooler ( as low as possible).

    Back in our lab at William Laboratories, we already knew that cooler packing is the key to keeping blood products cold as along as possible. Using a two-channel datalogger, we found that our ‘Igloo®-style’ validated cooler kept 2 bags at nearly identical temperatures for long periods of time. However, we were surprised at the results when there were 4 bags in the cooler. We found that the measured temperatures of the top and bottom bags of a 4 bag layer were dramatically different. The top bag measured 3°C higher than the bottom bag when the bottom bag reached 6°C. We are continuing this work to learn more, and plan to publish our findings for you in upcoming VUEPoint issues and via AABB regional meetings.

    Given the range of validation procedures in use, we are in the process of combining the best practices and necessary equipment into a cooler Validation Kit with simple instructions. Our goal is to simplify and demystify this often frustrating validation requirement for busy blood banks, transfusion services and hospitals. The validation kit will have everything you need, in one easy-to-use kit.

    We welcome your comments and ideas on cooler validation. In the coming weeks, we are providing test kits to a selected group of hospitals and blood banks for their evaluation.

    If you are attending AABB next month in San Diego, and have questions or ideas about portable cooler validation please come see us at Booth 742.

    See you in San Diego –

    Ed Sharpless, VP Product Development William Laboratories, Inc.

    References:
    1American Association of Blood Banks, Technical Manual (16th Edition), 5.1.8.1.2
    American Association of Blood Banks, Standards for Blood Banks, (27th Edition)
    FDA 21CFR600.15(a)

    Combining Blood Banks and Tissue Banks: Are they as similar as they seem?

    September 2010

    As we approach AABB 2010, I thought it would be a good time to revisit and refresh ourselves on a topic that will likely be up for conversation amongst our Blood Bank and Tissue Bank stakeholders. ‘Hospital Tissue Services: Compliance with Standards and Regulations,” was presented by Ellen F. Lazarus, Scott A. Brubaker, and Mary Ghiglione at the 2009 AABB. A PDF of this presentation is included for your reference, and serves as background for this VUEPoint position. View PDF

    Coming from the William Labs’ blood management perspective and expertise, we have taken particular interest in conversations that blood management and tissue management have a lot in common. There is a perception that there is similarity in their record-keeping requirements, which has generated the idea of hospitals possibly combining Tissue Banks and Blood Banks.

    This perception reminds me of a boss I once had who, for almost any project, had a standard comment… ‘All you gotta do is…’ As developers and suppliers of products designed to help ensure compliance to blood management regulations, our perspective is that the “real world compliance requirements” for blood products and tissue have some significant differences. There are at least 15 different tissue types defined as ‘tissue.’ For each of these types there are written procedures for acquisition, receipt, storage, and issuance.

    Software used to manage the data is also an area of concern. Blood banks have some software choices that have been tested and implemented by a fairly large number of blood banks, providing good input on which software will work best for any given blood bank environment. On the other hand, the software available to meet compliance requirements for tissue offers few choices and limited implementation. The most successful software implementations appear to be from in-house development between the blood bank and tissue departments.

    There are also somewhat different definitions for tissue storage conditions to be learned. For instance, in tissue regulations “ambient temperature, or colder” is identified as ‘just above freezing’, with an upper endpoint for “ambient” that can vary, depending on various processing/preservation methods and graft packaging configurations used by the tissue bank. And tissue handling responsibility includes everything from ordering and supplier qualification to adverse event reporting.

    The American Association of Tissue Banks (AATB) offers a Guidance Document for Identifying, Reporting and Investigating Tissue Recipient Adverse Reactions. The presentation cited in this VUEPoint also offers a host of useful information for blood banks and tissue services who may be considering combining. Mary Ghiglione, Director of Blood & Tissue at Swedish Medical Center in Seattle, Washington, has been part of an implementation team, and her presentation is also included in the PDF presentation. Like the AABB, the AATB offers a ‘Standards’ publication that is available at the AABB bookstore.

    See you in Baltimore!

    Ed Sharpless, VP Product Development
    William Laboratories, Inc.

    Authors of Presentation:
    Scott A. Brubaker, CTBS, 1320 Old Chain Bridge Road, Suite 450, McLean, Va, 22101, USA, 7038279582, brubakers@aatb.org

    Mary Ghiglione, RN, BSN, 747 Broadway, Seattle, Washington, 98122, USA, (206) 386-3544, mary.ghiglione@swedish.org

    Ellen F. Lazarus, MD, CAPT, USPHS FDA CBER, 1401 Rockville Pike HFM 775, Rockville, MD, 20852, US, (301) 827-6031, Ellen.Lazarus@fda.hhs.gov

    Temperature Sensitive Labels for RBCs

    Article from the American Journal of Pathology Compares Performance

    This article entitled ‘Temperature-Sensitive Labels for Containers of RBCs’, is a study of the ‘suitability of temperature-sensitive labels fixed to the exterior surface of blood containers for monitoring the temperature of blood components outside of the temperature-monitored refrigeration’. The authors evaluated Safe-T-Vue, Hemo Temp II, and Spot Check. Figure II is an insightful display of the variation of temperatures across blood bags as they warm, using 5 different starting temperatures, the lowest being 3.3 and the highest 5.0. The display underscores the importance of maintaining blood refrigerators as cold as possible. I believe you will find the paper is filled with useful information.

    Abstract

    Full Text Article (PDF): Temperature-Sensitive-Labels

    Redefining Transport & Storage Temperatures

    Summary from “Ask the Standards Committee” at AABB 2009

    February 2010

    To quote the Moderator, this was a “familiar topic.” At Session 9417-TC of the 2009 AABB, “Ask the Standards Committee,” the Standards Committee leadership addressed recent changes in the 26th Edition Standards for Blood Banks and Transfusion Services, as well as questions submitted to the committee.

    The response to Question #26 from the session (see right), and a follow-up question from the audience both clearly illustrated that blood bankers and transfusion services have long been confused about Standard 5.1.8.1.2 (Storage). This is particularly true with how the standard applies to blood products transported to the OR and held in transport containers. The interpretation of the standard, as explained in this session (and in their response to Question #26), clearly took the view that blood products in coolers are in TRANSPORT, not in STORAGE – as stated by Dr. Price in the session transcript that follows below. And Transportation is actually covered by Standard 5.1.8.2.1 (not 5.1.8.1.2).

    Click here to link to the transcript of of this Q & A exchange.

    5.1.8.1.2 Storage Conditions
    For storage of blood products, the temperature shall be continuously monitored or the temperature shall be recorded at least every 4 hours. (Changed from ‘and’ in 2008 to ‘or’ in 2009)

    5.1.8.2.1 Transportation
    Containers (e.g. portable coolers) used to transport blood components issued for transfusion shall be qualified and the process validated for the appropriate transport temperature.

    Case in point. A question posed by one of the attendees, with a sound of frustration and confusion, again reiterated that many blood banks/transfusion services use 1-6 degrees as the standard for “storage” of blood in validated coolers in the OR, resulting in a great deal of waste if the blood product exceeds 6 degrees. Dr. Price responded by saying that 1-10 is acceptable, because the Standards Committee considers products going to the OR in a validated cooler as TRANSPORT. This is a clear departure from the earlier 2005 FDA interpretation.

    Essentially, it was stated that even though 5.1.8.1.2 (Storage) states that temperature shall be monitored or recorded at least every 4 hours, this simply does not apply if you are using a cooler that is validated for the appropriate temperature and time period, since that is considered Transport. The container validation assures that the appropriate temperature is maintained, and thus does not require checking every 4 hours.

    Practically speaking, we should keep in mind that the cooler may be opened and closed multiple times over the course of several hours. We know from talking to our blood bank customers that there is a great deal of concern about the blood being maintained at proper temperature once it reaches the OR. Primarily, those two concerns are:
    1) blood removed from the cooler and then returned may have exceeded 10 degrees, and
    2) improper re-packing of the cooler can result in improper temperature maintenance, particularly units in the upper layer of the cooler.

    As Dr. Price stated (in the transcript below), these concerns must be taken into consideration when validating the cooler for such environments.
    Judy Ciaraldi, an FDA representative to the Blood Bank Transfusion Committee, acknowledged that the concerns and confusion expressed in 2008 were heard. She stated that in the near future a workshop would be held to explore this topic, and decide which changes and clarifications should be made to the regulations.

    Transcript from Session 9417-TC, 2009 “Ask the Standards Committee”

    • Thomas H, Price, MD – BBTS Standards Committee Chairman
      Puget Sound Blood Center
    • Thomas H. Carson, MD – BBTS Standards Committee Incoming Chairman
      Children’s Hospital New Orleans

    Question #26 (submitted):
    “If AABB considers blood products in a cooler in an operating room to be stored products and requires them to be maintained at 1-6 C, do you also require that the temperature be documented at least every 4 hours? If yes, can you offer a suggestion on how a busy service (over 30 coolers) can record temps on coolers that are out of the blood bank for as long as 8 hours?”

    Response from Thomas H. Carson, MD, Children’s Hospital New Orleans:
    “For the other part of it about storage, that if you have a container that you’ve sent over to OR with blood products, if you have validated that container to maintain the acceptable temperature for a given length of time, be it 4 hours, 8 hours, 12 hours, then you don’t need to monitor it continuously or check every 4 hours.
    However, I would say you have to validate container as to how long it will maintain temperature and the containers do require re-validation on a routine basis.”

    Follow-Up Question from Audience:
    “Now if you are considering the refrigerators in the blood bank storage, and you require monitoring continuous or every 4 hours, so how come that doesn’t apply to the coolers that are considered storage in the OR. I mean, it’s mixed messages.”

    Response – Dr. Carson:
    “I see what you’re saying, but at this point we really, as Dr. Price said earlier, are not defining, if you will, those containers in the OR as storage. We still view them as being transport.”

    Audience:
    “So then, because, I’m wasting a lot of products because I monitor 1-6 (degrees), and you’re saying I should go back to 1-10?”

    Response – Dr. Price:
    “You don’t have to, 1-6 is fine.”

    Audience:
    “No, because if you consider 1-6, sometimes you don’t know what happens in the OR. They open the cooler….then when the cooler comes back it is over 6, I discard the product. So if you don’t address the issue do I still consider it still 1-10, or 1-6 then? If you consider it 1-10 then I don’t waste a lot of products. If you consider it 1-6, then I am wasting a lot of product. And this is what a lot of my colleagues all over having the same problem who have a lot of liver (and) heart transplants, who issue a lot of coolers. Right now I am discarding a lot of products because I am taking it as 1-6. Because in the OR if they open the cooler, you don’t know. Maybe they open it 15 minutes, 20 minutes, they take product, they put it back. I mean, it’s really confusing.”
    Dr. Price:
    “So if you have refrigerators in the OR, then that’s storage.
    From the Standards point of view, If you’re just talking about these coolers going back and forth, we’re considering that to be transport; but validating that cooler, including in that validation would be some sort of consideration of how often people open it up, and….so in spite of all that stuff you have to validate it, that it’s going to maintain the temperature where you want it.

    But at least from that point of view, and you heard what Judy said about that, that it’s being reevaluated by the FDA. But at least from the standards point of view and considering that to be transport, then 1-10 is o.k.”

    Clarification Offered for Storage vs. Transport of Blood Components in Monitored Coolers

    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.

    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:

    1. transferring blood in a monitored cooler for inventory between two hospitals in the same system.
    2. 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) 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