Safe-T-Vue 6

[mld123]

So we recently validated and switched from the Safe-T-Vue 10 to the 6 for our OR coolers.  I know there has been much talk about coolers being storage and not transport and I decided to switch to the 6.  Our OR coolers are validated to maintain temperature between 1-6 C.  We also use the Safe-T-Vues in case the OR decides to remove the units and leave them out for a while and return them to the cooler.  The problem is, the 6's are really causing us issues with turning red as soon as we put them on the units prior to issue.  We do not know when an OR issue is going to happen so cannot put the indicators on first and place the units back in the refrigerator.  Does anyone have any other hints to using these indicators?  We never had any issue with the 10's.

 

Thanks!!

[David Saikin]

Classic problem with the 6 degree monitors . . . there is another 6 degree monitor out there.  I could not validate them as they seemed to turn at about 5C.  I had heard about the problem you define with the safe t vues so I did not even try them out.

[BankerGirl]

Try leaving the units and the temp indicators in the refrigerator while you put them on.  Be extremely careful not to touch any part of the indicator except the outside edges.  Then prepare your coolers and be sure that the indicators are not touching any room temperature materials in the cooler.  Good luck.

[sblanchard]

This topic comes up often at the AABB inspector CE events.  The AABB says that the facility gets to decide if the cooler is transport or storage.  Blood supplier boxes are packed sometimes for many hours and are considered transport.   If you define your cooler has transport (even if it is in OR for several hours) the temperature range would be 1-10.  We also have a refrigerator in the OR (with Safe-T-Vue 10 on them).  We monitor the refrigerator for 1-6 but the indicators are to see if the unit was out too long and increased above 10.   Basically, you get to define "cooler" for your facility and as long as you stick to the appropriate range and your SOP, there should not be any citation from AABB or anybody else.

[kirkaw]

I have 2 related questions to this topic:

Does anyone use and automated cooler validation kit, such as the Val-A-Sure kit? If so, how do you like it?

How frequently do you validate your coolers?

As an aside, we have deemed our coolers 'blood storage', as blood is likely to sit in them for hours in the OR without going anywhere. That seems more 'storage' than 'transport' to me.

[NLiveris]

Digi-Trax offers a 6 degree temperature indicator that you may want to try.  Call us at 800-356-6126 or email us at info@digi-trax.com for more information.

[AMcCord]

On 11/18/2016 at 0:12 PM, mld123 said:

So we recently validated and switched from the Safe-T-Vue 10 to the 6 for our OR coolers.  I know there has been much talk about coolers being storage and not transport and I decided to switch to the 6.  Our OR coolers are validated to maintain temperature between 1-6 C.  We also use the Safe-T-Vues in case the OR decides to remove the units and leave them out for a while and return them to the cooler.  The problem is, the 6's are really causing us issues with turning red as soon as we put them on the units prior to issue.  We do not know when an OR issue is going to happen so cannot put the indicators on first and place the units back in the refrigerator.  Does anyone have any other hints to using these indicators?  We never had any issue with the 10's.

 

Thanks!!

I got the suggestion to leave the unit and indicators laying on a refrigerated gel pack while you are working with them.

My refrigerators were running at approx 4 to 4.5 C and I could never get the 6 C temp trackers to work. They turned even when I placed the temp tracker in the refrig prior to applying it and then applied it to a unit in the fridge. Because my refrigerator temps had been drifting a bit higher over time, I'm in the process of having both of them adjusted down in temp. Decided to have them adjusted to 3 to 3.5 C. I'll try the indicators again at that temp and see if they work any better. It would be nice if I could get them to work because we'd use them for mass transfusion protocols.

[mld123]

2 minutes ago, AMcCord said:

I got the suggestion to leave the unit and indicators laying on a refrigerated gel pack while you are working with them.

My refrigerators were running at approx 4 to 4.5 C and I could never get the 6 C temp trackers to work. They turned even when I placed the temp tracker in the refrig prior to applying it and then applied it to a unit in the fridge. Because my refrigerator temps had been drifting a bit higher over time, I'm in the process of having both of them adjusted down in temp. Decided to have them adjusted to 3 to 3.5 C. I'll try the indicators again at that temp and see if they work any better. It would be nice if I could get them to work because we'd use them for mass transfusion protocols.

I actually tried this yesterday after contacting the company.  It seems to work if you put the indicator on the unit with it placed on the cold gel pack you are going to use in the cooler.  They also said not to activate it (snap it closed) until getting ready to place it in the cooler.

[Brenda K Hutson]

Yes, that is the tough part about the Safe-T-Vue 6 when it comes to units going to OR (at last minute.....of course if OR is next day, you could put them on ahead of time....but it is those last minute ones or having units added on that creates issues).  And while I know some places use Safe-T-Vue 10, you are correct that blood sitting in a cooler in OR for an "in case" transfusion, is considered Storage (that is my understanding anyway) and therefore should be monitored with Safe-T-Vue 6 monitors (I do not know whether FDA cites people for monitoring at 10C or not......I have chosen not to find out and just use the Safe-T-Vue 6).  The comment above regarding the Institution being allowed to decide whether something is storage or transport, is surprising to me (and it is the FDA that has the requirement anyway, not AABB).  While there may be some gray areas when it comes to storage vs. transport, some areas are not gray (and I do not think a cooler sitting in your OR for a "possible" transfusion, is a gray area).....but as I said, I know there are some places that monitor those at 10C instead of 6C; but they answer to their FDA Inspector and I will answer to mine (though consistency and clear guidelines by the FDA for this issue, would be really, really helpful    ).

What I instruct my staff to do in this situation is:

1.  Your best shot of getting Safe-T-Vue 6 to stay white is to put them on the units while they are still in the refrigerator.....before you ever take them out; that is when they will be the coldest (we also do this when setting up our emergency units when our pre-tagged units were just taken by ER or OR)

2.  Then when you take them out to pull segments (i.e. if performing an actual serological XM), or to perform electronic XM), place them on coolant polar packs (we always keep refrigerated packs available).  Works best if you can even sandwich between 2 coolant bags.

3.  Do what you need to do outside of the refrigerator, quickly (i.e. barcode scan in computer, pull segment, etc.) and get it back in the refrigerator as quickly as possible.

4. Once all serological and computer work completed, Tag units.  For Issue, I would again place on coolant packs.

We do very well if we follow that protocol.  But if you try to take the units out of refrigerator and do whatever you need to do "first;" then try to put on monitors, you will have a very hard time getting them to stay white long enough to even get them out of the dept.

Just some thoughts.....

Brenda Hutson, MT(ASCP)SBB

[ADeCesare]

We had a LOT of problems with the TempStrip 10 indicators last summer. I personally experienced the monitor changing to the blue color even on an iced unit, within about 10 minutes. I contacted the company, and they explained the process to me...which kind of made sense. Basically the liquid needs to be chilled to keep it from migrating into the white window, as soon as the indicator is activated. We've adjusted the way we activate and store the monitors and haven't had any problems since.

I can't really explain why the pre-activation and cold pack storage works better than just sticking them onto a prechilled unit of blood and then putting it directly between ice packs...but it does.

Here's part of the summary that I put together, for our staff to use in preparing the indicators:

"Although the package states that no conditioning is needed…special handling is required at the time of activation, so that the breach window will not turn blue even when blood units are stored appropriately.

BT10 strips contain an encapsulated blue liquid. The indicator is activated by squeezing the bubble to release the blue liquid.  The blue liquid changes the yellow activation window to green. The activated BT10 must then be cooled to 6° C or colder, in order to prevent the blue liquid from migrating into the white breach window.

• Immediately after activating several BT10 stickers, place them in the blood bank refrigerator, on top of a chilled “cold pack.”  (Don’t peel the paper backing off until applying it to a unit of blood.)"

 

[BBfuntimes]

Immediately after activating several BT10 stickers, place them in the blood bank refrigerator, on top of a chilled “cold pack.”  (Don’t peel the paper backing off until applying it to a unit of blood.)"

 

do you have a time limit once the stickers are activated and stored in refrigerator?

[ADeCesare]

14 hours ago, BBfuntimes said:

Immediately after activating several BT10 stickers, place them in the blood bank refrigerator, on top of a chilled “cold pack.”  (Don’t peel the paper backing off until applying it to a unit of blood.)"

 

do you have a time limit once the stickers are activated and stored in refrigerator?

We have found that they are good for about one month after activation. After that, there is a bit of blue showing in the white area, and we discard them then. (We write the activation date on the paper backing, so we know what's going on. This happens even if the stickers haven't been moved for a month, and we know the temp has stayed constant in the fridge.)

 

[DPruden]

On ‎11‎/‎18‎/‎2016 at 11:12 AM, mld123 said:

So we recently validated and switched from the Safe-T-Vue 10 to the 6 for our OR coolers.  I know there has been much talk about coolers being storage and not transport and I decided to switch to the 6.  Our OR coolers are validated to maintain temperature between 1-6 C.  We also use the Safe-T-Vues in case the OR decides to remove the units and leave them out for a while and return them to the cooler.  The problem is, the 6's are really causing us issues with turning red as soon as we put them on the units prior to issue.  We do not know when an OR issue is going to happen so cannot put the indicators on first and place the units back in the refrigerator.  Does anyone have any other hints to using these indicators?  We never had any issue with the 10's.

Thanks!!

We decided to stick with the Safe-T-Vue 10 indicators for our OR coolers.  Our logic behind this decision was our coolers for "storage" are validated to 1-6C and if the units remain in the cooler, we know the temperature will be maintained between 1-6C.  If the units aren't in the cooler, then they are in transport, and the indicator will show any temperature excursions above 10C.  We have had AABB, CAP, and FDA inspections and no one has had an issue with our logic. 

[R1R2]

3 hours ago, DPruden said:

We decided to stick with the Safe-T-Vue 10 indicators for our OR coolers.  Our logic behind this decision was our coolers for "storage" are validated to 1-6C and if the units remain in the cooler, we know the temperature will be maintained between 1-6C.  If the units aren't in the cooler, then they are in transport, and the indicator will show any temperature excursions above 10C.  We have had AABB, CAP, and FDA inspections and no one has had an issue with our logic. 

I agree with your logic!