When we issue red cells in a cooler we include a dummy bag with a temperature indicator - these are lead pellets inside of parafilm.  They supposedly fall when the cooler is exposed to temps outside of the allowed range.

These pellets are no longer manufactured.

We move away from established processes slowly here.   We looked at some of the modern temperature indicators and did not have much luck validating them.

What do others who issue large numbers of coolers do when returning products?

Does anyone use one of these?

https://www.hampshirecontrols.com/rapid-response-temperature-verification-system.htm

Safe-T-Vue on each unit issued to surgery cooler.  Safe-T-Vue for our trauma O Neg's kept in the trauma refrigerator.

Hemo Temps do not stay activated very long.

1 hour ago, Cliff said:

Does anyone use one of these?

https://www.hampshirecontrols.com/rapid-response-temperature-verification-system.htm

Have been using and will continue to use TEMP-CHECK (albeit an older version) for years.  We check units individually.

Same as Limper55.

16 hours ago, Dansket said:

Have been using and will continue to use TEMP-CHECK (albeit an older version) for years.  We check units individually.

Doesn't tell you what happened to the unit while it was out of your control. 

We have been playing with several different types of temp dot / stickers over the years and find them all difficult to deal with and unreliable.  I think our discard rate would skyrocket due to indicators being touched or otherwise falsely activated.

We use Safe-T-Vue for emergency release and anytime we issue anything in a box or cooler.  Usually Or just takes one unit at a time.  There have been a few techs with big thumbs, but I try to train most to just touch the edges and they work well for us.  We also TEMP-CHECK to check single units that are returned in less than an hour.  

 

We place Hemo-Temp stickers on every red cell issued.  They stay activated for 10-12 hours.  This can verify what happened to the unit while it was out of BB control.

We did have to discard some that came back from OR because the surgeon took them out "just in case" and then changed his mind and put them back in the cooler.  The units were cold when returned to BB, but the Hemo-Temp flower was unacceptable.

5 hours ago, Cliff said:

We have been playing with several different types of temp dot / stickers over the years and find them all difficult to deal with and unreliable.  I think our discard rate would skyrocket due to indicators being touched or otherwise falsely activated.

We have gone through 3 temperature indicators and our wastage increased significantly (due to falsely activated, most likely). Ended up with the safe-t-vue since it was the most reliable temperature activation-wise, but still is a struggle for staff to not falsely activate when applying.

On ‎11‎/‎11‎/‎2016 at 10:54 AM, pbaker said:

We place Hemo-Temp stickers on every red cell issued.  They stay activated for 10-12 hours.  This can verify what happened to the unit while it was out of BB control.

We did have to discard some that came back from OR because the surgeon took them out "just in case" and then changed his mind and put them back in the cooler.  The units were cold when returned to BB, but the Hemo-Temp flower was unacceptable.

 

those hemotemp II stickers are for transport, not storage.  Coolers are storage as per the FDA . . . my current facility uses them just like you do.  An astute inspector would cite you . . .  You could argue that they are better than nothing.  I have found the 6C monitor devices to be unreliable. 

On ‎11‎/‎11‎/‎2016 at 2:45 PM, pinktoptube said:

 

 

1 hour ago, David Saikin said:

 

those hemotemp II stickers are for transport, not storage.  Coolers are storage as per the FDA . . . my current facility uses them just like you do.  An astute inspector would cite you . . .  You could argue that they are better than nothing.  I have found the 6C monitor devices to be unreliable. 

 

The product description on the package insert states "HemoTemp II Indicator is ....for blood during transit and storage outside the blood bank."  We just had our CAP inspection and they didn't say a word.

Most CAP and AABB inspectors know how ridiculous the differentiation between storage and transport is without a time limit for transport.

20 hours ago, pbaker said:

The product description on the package insert states "HemoTemp II Indicator is ....for blood during transit and storage outside the blood bank."  We just had our CAP inspection and they didn't say a word.

I understand.  But storage is 1-6 and transport is 1-10. The hemotemp IIs turn at 10 (actually it is a little over 11 - at least in my validation studies) Because the manufacturer makes a statement doesn't make it regulatory accurate.  Just commenting. like I said, my current employer uses them the same way.

Where did FDA address transport containers (coolers) as storage?

On ‎11‎/‎10‎/‎2016 at 1:47 PM, Cliff said:

Does anyone use one of these?

https://www.hampshirecontrols.com/rapid-response-temperature-verification-system.htm

I do and I love it. Plus since it is digital, Biomed has to do the temp calibration/verification when necessary.

I also use the Hematrax BT-10 temperature indicators. Very simple to use and not too costly. $100 for 100, but you do not have to really do anything to them except "pop" the bubble and attach to the unit. If the core temperature of the unit exceeds 10C, the indicator turns blue, and this is irreversible.

 

We use the new Timestrip temp indicators.  They store at room temp and you "pop the bubble" and have not encountered any issues.  We used to use the Safe-T-Vue but several folks couldn't keep their sticky fingers off of the indicators and they turned pink while they were packing the units.  The Timestrip indicators also stay active for several days so if the units come back unused you can put them in the 'fridge and issue them again if needed.  They are a little more expensive than the Safe-T-Vues but I think they are worth it.  They come in 6 and 10 degree indicators.

have you folks using alternate devices validated the temp changes?  Just curious. 

There was a spate of responses to topics on coolers as transport or storage.  I asked the FDA directly.

On ‎11‎/‎14‎/‎2016 at 6:41 AM, MAGNUM said:

I do and I love it. Plus since it is digital, Biomed has to do the temp calibration/verification when necessary.

you still don't know what happened to your blood outside of your control.  Only that it returned in temp.

On 11/10/2016 at 0:47 PM, Cliff said:

Does anyone use one of these?

https://www.hampshirecontrols.com/rapid-response-temperature-verification-system.htm

We used something similar but much,much older.  The problem with this is that if the blood was left on the counter and allowed to warm above 6oC and then returned to the cooler you would never know but then there is a case for ignorance is bliss.

We use a combination of the Temperature indicators and the Temp-Check thermometer.  If issued in coolers, we use the place the temp indicator on the unit prior to issuing.  If it has started to turn when returned, then we take the temp to determine whether to quarantine or not.  If the unit is not issued in a cooler, we use the thermometer to check temp if returned in a reasonable time frame (less than 15-30 minutes or so) and again determine whether to quarantine.  (We don't use the 30 minutes to determine acceptance, just if we will bother checking the temp.)  This may be a bit of overkill, but I don't trust ED or OR to not remove units from the coolers.  Like was mentioned previously, they could have repacked it in time for it to turn cold again.