Thermometers for taking temp of returned blood products

[fanilhas]

For those of you who take the temperature of blood products that have been returned to you to determine if they are acceptable for reissue, what type of thermometer do you use? 

[David Saikin]

right next to your post is an ad for digitrax temp-check.

I do not accept returns after 15 minutes.  My study shows rbcs achieve >10C after that amount of time.

Edited March 25, 2021 by David Saikin

[John C. Staley]

20 hours ago, David Saikin said:

right next to your post is an ad for digitrax temp-check.

I do not accept returns after 15 minutes.  My study shows rbcs achieve >10C after that amount of time.

I used something similar but about 30 years older!!!  Glad to see it's been up graded.  I had a number of inspectors that did not like it because they had never seen anything like it.  They couldn't say to much about it, I had all the records showing it was verified just like all the rest of my thermometers on the same schedule. 

[MAGNUM]

I use the temp-chek, if they are issued in a cooler, otherwise 15 minutes.

[Sonya Martinez]

We use Blood Temp 10 devices plus if we forget to put an indicator on the unit or it's a room temp product we use a an infrared thermometer which are calibrated annually.  

[Sonya Martinez]

Oh, I forgot we discard are returned products in syringes regardless of how long they've been out since we can't take the temp.

[jayinsat]

We use one from Fisher. It is certified and we replace it every 2 years when the certificate expires. I am curious, for those who have the 15 minute limit, did you validate that in all scenarios in your hospital?

[sgoertzen]

We use Safe-T-Vue 10 indicators on RBCs/FFP issued in a cooler, and the Fluke 561 infrared thermometer to take the temp on products that come back that weren't issued in a cooler.

[Joanne P. Scannell]

I'm also wondering how one manages to validate that all units of blood remain within temperature range when the ambient temperature and handling is not consistent.

We can't even validate our coolers for the same reason ... and one never knows if the cooler is left open or the units are removed then replaced.

Are you using 1-10oC or 1-6oC?

FDA instructed us to use 1-6oC for the coolers because they are really 'in storage'.

If not in a cooler, we can go up to 10oC because they are 'in transit'.  I haven't implemented that part yet, but I will be soon.

[jayinsat]

23 hours ago, Joanne P. Scannell said:

I'm also wondering how one manages to validate that all units of blood remain within temperature range when the ambient temperature and handling is not consistent.

We can't even validate our coolers for the same reason ... and one never knows if the cooler is left open or the units are removed then replaced.

Are you using 1-10oC or 1-6oC?

FDA instructed us to use 1-6oC for the coolers because they are really 'in storage'.

If not in a cooler, we can go up to 10oC because they are 'in transit'.  I haven't implemented that part yet, but I will be soon.

We use 1-6 for coolers, however, the BT-10 only shows breach above 10 so, there's that. We place a NIST certified thermometer in the cooler to show that it is 6 or below upon return. We do not scan these units with the temp gun.

It's 1-10 for anything returned not in a cooler. 

[Sonya Martinez]

On 3/31/2021 at 5:51 AM, Joanne P. Scannell said:

I'm also wondering how one manages to validate that all units of blood remain within temperature range when the ambient temperature and handling is not consistent.

We can't even validate our coolers for the same reason ... and one never knows if the cooler is left open or the units are removed then replaced.

Are you using 1-10oC or 1-6oC?

FDA instructed us to use 1-6oC for the coolers because they are really 'in storage'.

If not in a cooler, we can go up to 10oC because they are 'in transit'.  I haven't implemented that part yet, but I will be soon.

We recently switched to MaxQ coolers which are pre-validated by the company at storage temp.  Then we validated at transport temp and storage temp and use that for when the cooler needs to be returned for fresh ice.  Our policy specifically states this and that we consider them transport coolers.  We really like the MaxQ coolers and have seen a huge decrease in waste due to temp issues on return of the coolers.  The lids close by themselves.  They even have coolers that have temp monitoring integrated but they're super expensive.  

[John C. Staley]

Just a thought.  With an issue like this you have to come to a point of realizing that you can only do so much especially when much of the process is out of your control.  You can drive yourself crazy playing the "what if " game!  Once you've done the best you can for your situation then accept that there will probably be a fallible human somewhere in the process who will come up with a creative work around.  A nurse will put a unit in the medication refrigerator until she's ready for it or they will put it back in the cooler in OR after it's been setting next to the patient during the procedure, just in case!  Accept that you don't have complete control and never will, you'll live longer!  

[jayinsat]

18 hours ago, Sonya Martinez said:

We recently switched to MaxQ coolers which are pre-validated by the company at storage temp.  Then we validated at transport temp and storage temp and use that for when the cooler needs to be returned for fresh ice.  Our policy specifically states this and that we consider them transport coolers.  We really like the MaxQ coolers and have seen a huge decrease in waste due to temp issues on return of the coolers.  The lids close by themselves.  They even have coolers that have temp monitoring integrated but they're super expensive.  

We just switched to the MaxQ MTP coolers and love them! My validations showed it held temps for 24 hours, even when opening the lid every 15 minutes for the first 2 hours and hourly after that. Plus, we filled the cooler with warm FFP (4 units @37C) and cold RBC (4 units @4C). The cooler cooled down the FFP units to 6C within 3 hours. The RBC'S never went above 5C. 

Edited April 2, 2021 by jayinsat
complete a sentence

[David Saikin]

On 3/31/2021 at 8:51 AM, Joanne P. Scannell said:

I'm also wondering how one manages to validate that all units of blood remain within temperature range when the ambient temperature and handling is not consistent.

We can't even validate our coolers for the same reason ... and one never knows if the cooler is left open or the units are removed then replaced.

Are you using 1-10oC or 1-6oC?

FDA instructed us to use 1-6oC for the coolers because they are really 'in storage'.

If not in a cooler, we can go up to 10oC because they are 'in transit'.  I haven't implemented that part yet, but I will be soon.

What are you going to use in lieu of a cooler?  I think if you are using a transport box the FDA would still consider int storage if it is just hanging around in the OR or wherever.

[Joanne P. Scannell]

On 4/1/2021 at 8:49 PM, John C. Staley said:

Just a thought.  With an issue like this you have to come to a point of realizing that you can only do so much especially when much of the process is out of your control.  You can drive yourself crazy playing the "what if " game!  Once you've done the best you can for your situation then accept that there will probably be a fallible human somewhere in the process who will come up with a creative work around.  A nurse will put a unit in the medication refrigerator until she's ready for it or they will put it back in the cooler in OR after it's been setting next to the patient during the procedure, just in case!  Accept that you don't have complete control and never will, you'll live longer!  

I agree ... but, unfortunately, along comes that occasional inspector who doesn't see it that way.

[Mabel Adams]

On 4/1/2021 at 5:49 PM, John C. Staley said:

Just a thought.  With an issue like this you have to come to a point of realizing that you can only do so much especially when much of the process is out of your control.  You can drive yourself crazy playing the "what if " game!  Once you've done the best you can for your situation then accept that there will probably be a fallible human somewhere in the process who will come up with a creative work around.  A nurse will put a unit in the medication refrigerator until she's ready for it or they will put it back in the cooler in OR after it's been setting next to the patient during the procedure, just in case!  Accept that you don't have complete control and never will, you'll live longer!  

I read an article a few years back that showed that blood really didn't do anything terrible if it got a few degrees outside of our range for a bit.  That gave me comfort for dealing with these slight deviations.  That said, we once had a nursing unit return a unit of plasma that they found in their meds fridge a month or so after we issued it. 

[AMcCord]

On 4/15/2021 at 6:29 PM, Mabel Adams said:

I read an article a few years back that showed that blood really didn't do anything terrible if it got a few degrees outside of our range for a bit.  That gave me comfort for dealing with these slight deviations.  That said, we once had a nursing unit return a unit of plasma that they found in their meds fridge a month or so after we issued it. 

Makes you wonder how often they clean up their fridges, doesn't it?

[JeanB]

On 3/30/2021 at 9:03 AM, jayinsat said:

We use one from Fisher. It is certified and we replace it every 2 years when the certificate expires. I am curious, for those who have the 15 minute limit, did you validate that in all scenarios in your hospital?

I was under the impression that infrared thermometers measure SURFACE temperature and not core? Are we allowed to use this? 

[exlimey]

2 hours ago, JeanB said:

I was under the impression that infrared thermometers measure SURFACE temperature and not core? Are we allowed to use this? 

How do you suggest measuring the "core" temperature without compromising the bag ?

[David Saikin]

On 4/1/2021 at 2:12 PM, Sonya Martinez said:

We recently switched to MaxQ coolers which are pre-validated by the company at storage temp.  Then we validated at transport temp and storage temp and use that for when the cooler needs to be returned for fresh ice.  Our policy specifically states this and that we consider them transport coolers.  We really like the MaxQ coolers and have seen a huge decrease in waste due to temp issues on return of the coolers.  The lids close by themselves.  They even have coolers that have temp monitoring integrated but they're super expensive.  

If you store blood in the coolers when they get to their destination,they cannot be considered transport (if blood stays in them wherever you send them and no matter what your consideration is).  This per the FDA.  If you are CAP and/or AABB your assessor/inspector should remind you of this.

[JeanB]

23 minutes ago, exlimey said:

How do you suggest measuring the "core" temperature without compromising the bag ?

We used to use infrared thermometers as well, but I believe that using temperature indicators such as Safe T Vue, HemoTempII etc is going to be more accurate.  

[JeanB]

22 minutes ago, David Saikin said:

If you store blood in the coolers when they get to their destination,they cannot be considered transport (if blood stays in them wherever you send them and no matter what your consideration is).  This per the FDA.  If you are CAP and/or AABB your assessor/inspector should remind you of this.

I believe the most recent Technical Manual addresses this now. I guess facilities will need to define what constitutes as storage vs temperature. Absolutely agree with @David Saikin that coolers that go in the OR should follow 1-6C.    

[exlimey]

On 4/30/2021 at 2:40 PM, JeanB said:

We used to use infrared thermometers as well, but I believe that using temperature indicators such as Safe T Vue, HemoTempII etc is going to be more accurate.  

Forgive my ignorance, but are the above stuck to the outside of the bag, and therefore measuring/indicating the surface temperature of the blood product ?

The "storage vs transport" hairball will be debated well after we're all dust.

[Darren]

We use the TimestripPlus BT-10s. We also have a tiny infrared thermometer and there's always the certified thermometer that we can wrap around a unit and take a reading. We don't often get returns or have to mess with coolers so it's not that big of an issue for us thankfully.

[Sonya Martinez]

Dave Saikin and JeanB.  My policy actually lists that the MaxQ coolers are validated to hold a storage temp for X hours and a transport temp for X hours (dependent on each cooler) but we choose to call them transport coolers.  All the coolers are back in 12 hours and their ice packs changed which is within the validated storage and transport temp so we should be safe.  Also, FDA and AABB have both reviewed our policies prior to the use of MaxQ coolers multiple times and never said a word.  I think it's the very lengthy validation we do at RT and >30C monitoring the temp inside the cooler, using BT10s, and each individual saline/glycerol bag every hour until it reaches 10C at max and min volumes.  For the last 15 years I've been here we've always called them transport coolers.