Temperature Mapping

[jayjay]

I am from the UK and have been told that the FDA requires temperature mapping to be performed over 20 days with a reading taken every 4 hours. Can anyone tell me if this is correct for the US?

Joan

[Eoin]

Wow! Overkill or what?

Mapping here is two 24hr periods - loaded and unloaded. Validated if OK, then temp monitored - continuously with audible, local and remote telephone alert.

Will look forward to reply from our US cousins.

[webersl]

I'm in a Hospital based Transfusion Service in the US (not a blood collection or manufacturing center). I am not familiar with the term "Temperature Mapping". FDA requires blood and blood products to be continuously monitored (alarms). Temps must be recorded at least every 4 hours for the entire life of the product. Don't know if that helps.

[RR1]

I'm in a Hospital based Transfusion Service in the US (not a blood collection or manufacturing center). I am not familiar with the term "Temperature Mapping". FDA requires blood and blood products to be continuously monitored (alarms). Temps must be recorded at least every 4 hours for the entire life of the product. Don't know if that helps.

To perform a temperature map on a fridge or storage area, we have to place calibrated data loggers in different areas of the equipment to record temperature variations over a minimum 24hr period. The data is analysed to see if the cabinet is temperature stable throughout, or whether there are hot or cold spots that may have an adverse effect on conponent storage.

This is required to be performed on all newly installed equipment, any significant changes to current (e.g new compressor), and annually.

[redstaff2003]

so if the newly acquired ref has 4 levels you have also to have 4 data loggers in place over the period of 24 hours?...what happen next if ref having differences in temperature? just curious..

antonio m.

[RR1]

If there are 4 levels we would place loggers on top four corners, bottom four corners and one in central position of middle shelf.

We do see differences in temps, my sample fridge for instance has logged high (>10'C for 12hr periods) on top shelf. I have adjusted thermostat, but then this just brings the lower positions out of temp (<1'C). Since I can't balance the temps (I don't think this fridge is adequate anyway), the samples need to be stored somewhere else and I will have to write a QI to justify my actions.

We see this with blood fridges too, where shelves may have to be removed to prevent these areas from being used. I used to think this was all overkill, but temp mapping really does give you a good indication of fridge performance. Pharmaceuticals are required to perform this, and in the UK this is required to be performed on blood storage equipment to comply with BS436 standards..

Edited June 22, 2009 by RR1

[Malcolm Needs ☆]

Within the Blood Services in the UK (or, at least within the NHSBT) we not only have to temperature map fridges and freezers that contain blood*, blood components*, blood products*, patients' samples* and reagents*, but also things like 37oC incubators used to incubate tests, such as antibody investigations. I agree with those criteria marked with an asterisk; they require temperature mapping.

I have often wondered to myself, why, if we are using positive and negative controls with each batch of tests, we bother to temperature map the incubators or, alternatively, if we know that the incubators are temperature mapped, why we are putting up controls.

In addition, we also have to note down the serial number of the electronic pipette we are using to set up these tests and controls.

In most, if not all Laboratories that are performing blood transfusion tests, positive and negative controls are used. In such Laboratories, therefore, it would be known immediately if the pipette and/or incubator had gone out of spec, because the controls will not work!

I know that if I were to receive a transfusion, I would rather rely on controls than on temperature mapping of incubators and pipette serial numbers. I would, therefore, humbly suggest that temperature mapping of incubators and recording pipette serial numbers is a complete waste of time invented by a beaurocrat not working in a Laboratory!

Edited June 22, 2009 by Malcolm Needs
Spelling- for the umpteenth time - I wish I had listened to my English teacher!

[RR1]

I wouldn't have thought that a small incubator would need mapping- the temperature probe would be calibrated to traceable standards and should give adequate indication of the overall temperature within that area. A larger incubator may need mapping unless there are multiple calibrated temperature probes sited within.

As for pipettes these need calibrating-and if these are verified regularly, I don't see why you would need to record serial numbers each time you use them. As usual, I am sure this requirement is just being interpreted in the most complicated way possible....by NHSBT quality folk.

Edited June 22, 2009 by RR1

[Malcolm Needs ☆]

Do you know Rashmi, I think you could be right!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

That notwithstanding, these are the hoops through which we have to leap.

Amazingly, every now and again, we get to do some work on patients' samples, despite this beaurocratic nonsense.

[RR1]

As I have said before, unless you complain via your deviation/ complaints system, improvements will not be made. People are just running around like headless chickens over these quality issues. We need to think of what we are trying to achieve...then simplify it.

[Malcolm Needs ☆]

As I have said before, unless you complain via your deviation/ complaints system, improvements will not be made. People are just running around like headless chickens over these quality issues. We need to think of what we are trying to achieve...then simplify it.

Rashmi, you have known me for a few years now. Do you honestly think that I have not uttered the odd polite syllable about the situation (or do you still think of me as a shrinking violet)???????????

:confused::confused:

[RR1]

Dear, quiet, shy,, Malcolm !!!

Do you actually fill in QI forms daily about these issues? if so then-

Your Quality System is not working !!!- get these folk to join this forum and discuss.

[Malcolm Needs ☆]

Rashmi, I KNOW our Quality System is not working, and, no, not every day, because I would never get the results on the patients out to you!

[webersl]

CAP is an org in the US that is allowed to inspect on behalf of the FDA in certain institutions. (Ours is one.) CAP has a bunch of points on temperature monitoring, this is just one:

Is there evidence that all large refrigeration units maintain the proper temperature throughout the unit?

We normally accomplish this by having the temperature continuously recorded, and alarms connected to, both the top shelf and the bottom shelf. (A very large unit would require more.)

[RR1]

Our refrigeration units are continuously monitored and alarmed too, but we are still required to perform mapping.

Another reason to temp map is so you know where to locate your alarm and monitoring probes- basically the areas with higher fluctuations.

[Malcolm Needs ☆]

webersl, I'm afraid top and bottom would not really be enough, even for a fairly small unit. You also need to do mapping at front and back.

Many units have considerable temperature differences in this area.

[Alternatives]

As Rasmi clearly explained, mapping require calibrated data loggers within your equipment. This work should help you to determine where are your cold and hot spot, where to place your temperature sensor, and set up correctly your thermostat. I don't have in mind any regulation about the number of data logger to be used; close to the fan, the door, everywhere basically where you have some products (top, bottom...). Opening doors should be also written during this study. It's just to give you an idea of homogeneity of temperature inside your fridge, so don't turn crazy with tons of data! But it could give you some surprises!

Think also to realise it long enough to be representative of your daily activity (night, day, high and low activity...etc).

Benoît

[RR1]

Hi Benoît, do hospital blood banks in Canada have to temperature map their fridges too?

Edited June 23, 2009 by RR1

[webersl]

webersl, I'm afraid top and bottom would not really be enough, even for a fairly small unit. You also need to do mapping at front and back.

Many units have considerable temperature differences in this area.

Though not required in the US, I would be very interested in looking into this. Unfortunately, we do not have the number of data loggers required. Hmmm. I could use Safe-T-Vue 6's (temperature indicators) in multiple locations throughout the fridge - and see if any of them got activated.... Sounds like a good project for a student.

[Alternatives]

In Canada, i have just found very quickly 2 requirements regarding mapping.

First one is from the Canadian Standards Association 902-04: "9.4.4 Refrigerators for whole blood and blood component storage should be equipped with an air-circulating fan or have the capacity and design that ensure the maintenance of the appropriate temperature throughout the refrigerator cabinet."

Second is from Canadian Society for Transfusion Medicine: "3.4.2.1Refrigerators and freezers for blood component and blood product storage shall be validated to maintain an appropriate temperature throughout the storage area.

[RR1]

Though not required in the US, I would be very interested in looking into this. Unfortunately, we do not have the number of data loggers required. Hmmm. I could use Safe-T-Vue 6's (temperature indicators) in multiple locations throughout the fridge - and see if any of them got activated.... Sounds like a good project for a student.

You could try this, but unless these indicators have excellent calibration and sensitivity, you may not observe anything significant.

I tried to get hold of some temperature change indicators -but was informed by various fridge suppliers that these are difficult to calibrate and therefore they don't supply them in the UK.

Our loggers are set to record temperatures every 5mins.

But as you say- could be a good project for a student.

[Malcolm Needs ☆]

Though not required in the US, I would be very interested in looking into this. Unfortunately, we do not have the number of data loggers required. Hmmm. I could use Safe-T-Vue 6's (temperature indicators) in multiple locations throughout the fridge - and see if any of them got activated.... Sounds like a good project for a student.

I think that you will find that, if the inspectors want it to, this is required in the US! I'm sort of being cynical here (most unlike me, as Rashmi will aver), but there can be quite a big difference between the front and the back of a fridge/freezer in terms of temperature (I didn't believe this either, until I saw some irrefutable evidence).

I do agree with you that you probably don't have sufficient data loggers (they are not cheap), but the inspectors may well have the power to turn round to you and say, "BUY MORE". They most certainly do in the UK.

I sympathize with the student you have in mind, but, having said that, I sympathize with anyone given such a soul destroying (but necessary) job.

[RR1]

You may think I am a bit sad....but I actually enjoy mapping my equipment! It brings me a lot of pleasure when the data is within range.

[Malcolm Needs ☆]

In Canada, i have just found very quickly 2 requirements regarding mapping.

First one is from the Canadian Standards Association 902-04: "9.4.4 Refrigerators for whole blood and blood component storage should be equipped with an air-circulating fan or have the capacity and design that ensure the maintenance of the appropriate temperature throughout the refrigerator cabinet."

Second is from Canadian Society for Transfusion Medicine: "3.4.2.1Refrigerators and freezers for blood component and blood product storage shall be validated to maintain an appropriate temperature throughout the storage area.

Hi Alternatives,

With due respect to you, I would forget the first requirement, because unless you undertake temperature mapping, you cannot prove that, even with an air-circulating fan, the fridge/freezer will maintain the temperature (even a fan oven has to have food put in certain areas for proper cooking).

Again, despite the fact that the storage area has the capacity and design that ensures maintenance of the appropriate temperature throughout the refrigerator cabinet, how do you know it is actually working properly, unless you undertake temperature mapping?

Believe me, I know it's a pain, but I really do understand why we have to undertake this process.

[Malcolm Needs ☆]

You may think I am a bit sad....but I actually enjoy mapping my equipment! It brings me a lot of pleasure when the data is within range.

Goodness me Rashmi, never let it be said that I would accuse you of being a BIT sad!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

:):):):):)

You keep feeding me the lines, as they say.......................................................