From the desk of
Ed Sharpless, VP of Product Development
Email us with your comments:
Ed Sharpless, VP of Product Development, eds@williamlabs.com
September 2011
Transport Cooler Validation and Blood Product Temperatures
“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)
ARCHIVES
September 2010
Combining Blood Banks and Tissue Banks: Are they as similar as they seem?
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. Read more >>
June 2010
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. Learn more.....
February 2010
Redefining Transport & Storage Temperatures
Summary from "Ask the Standards Committee" at AABB 2009
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. more...
October 2009
Clarification Offered for Storage vs. Transport of Blood Components in Monitored Coolers
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. more...
September 2009
Update: Storage vs. Transport of Blood Components
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. more...
