Does anyone have any ideas about how to validate a new Plasma Thawing System? I recently purchased a Helmer QuickThaw DH8 Plasma Thawing System and need to validate it before putting it into use. Thanks!

This attached document may help you.

Benoît

ISBT Guidelines for validation and maintaining the validation state of automated systems in bl.pdf

OK here I go!!

A plasma thawing device is a MACHINE not an instrument. As such it is very simple and does one thing and only one thing, it thaws plasma. To do this it maintains a temperature in a defined temerature range. So; does it maintain that temp range? YES or NO. Does it circulate the heated fluid? YES or NO. Does it thaw the plasma: YES or NO. If all three answers are YES then you are good to go. If one or more answers happens to be NO then send it back and get another.

'nough said.

Blood bankers have taken this whole validation nonsense to levels normal people would never consider. It is past time to take a step back and really look at what you are doing, why you are doing it and determining if it is worth the time and expense (value added! I hate these two words but the seem to be appropriate here).

:explosion

Has anyone who has purchased an ArkBio Plasma Defroster experienced any problems with inconsistent thawing times of products?

Well said John . . . I agree that validation is out of control. I won't go into why I think this is so, but I wholeheartedly agree with you.

OK here I go!!

A plasma thawing device is a MACHINE not an instrument. As such it is very simple and does one thing and only one thing, it thaws plasma. To do this it maintains a temperature in a defined temerature range. So; does it maintain that temp range? YES or NO. Does it circulate the heated fluid? YES or NO. Does it thaw the plasma: YES or NO. If all three answers are YES then you are good to go. If one or more answers happens to be NO then send it back and get another.

'nough said.

Blood bankers have taken this whole validation nonsense to levels normal people would never consider. It is past time to take a step back and really look at what you are doing, why you are doing it and determining if it is worth the time and expense (value added! I hate these two words but the seem to be appropriate here).

:explosion

I completely agree with you John. Unfortunately, the AABB assessor who visited me this week did not.

The AABB assessor is not always correct. You can always defend your operation if you do it logically. If you have proven your system maintains the appropriate temperature for thawing, provides some sort of circulation/agitation and the product is thawed, I would say that "validates" your thawer. Submit that to AABB as your response. If your thawer has a temp alarm you may want to show that it will sound at whatever temp it should. Some folks can't see the forest for the trees. I think this might be a tougher nut to crack if you used a microwave . . .

David is correct. Challenge the assessor's finding. I can't count the number of times over the years I have not seen eye to eye with an assessor/inspector and have challenged their findings. I've won a few and lost a few but have always enjoyed the battle.

David you are right on two accounts just because a person is an assessor doesn't mean they are always right and we Blood Bankers are out of control with validation stuff.

Lehooke, if you can prove that the machine is "working as designed" and you and your staff are comfortable that there is no compromise in patient care that should suffice.

I can't believe so many of you Blood Bankers would consider the notion that we are capable of overdoing anything. Validation is such a critical part of our dotting-the-eyes-and-crossing-the-tee's mentality for so many years, that I am not able to sleep without killing at least one tree per month producing at least one doument just in case the inspector might ask to see something that I did not fully document.

After all, it's for "the children" ...

Larry, you seem to have more concern for your sleep than any one I've ever heard of. I hope your last comment was "tongue in cheek". Otherwise I'll feel obligated to light a candle for you.

Does any one have a procedure for pooling cryo?

Here is the validation that we used for our Helmer.

The main thing you need for your assessor is a document that shows you thought about what the device does, how you will use it, and what could go wrong, you tested for all that, and you are satisfied with the results. The only place I ever cited for failing to complete validation did tons of work and had lots of paper, but failed to document that they reviewed the results and determined that everything was OK for use. It doesn't have to be complicated. As John said, temperature is maintained; plasma is thawed successfully; water is circulated; timer, alarm, and temperature indicators work properly; it meets our specs, let's use it!

Helmer DH8 waterbath 2007.doc

Does any one have a procedure for pooling cryo?

Here is our procedure for pooling cryo. I hope it helps!

Thaw CRYO SMART.doc

Here is the validation that we used for our Helmer.

The main thing you need for your assessor is a document that shows you thought about what the device does, how you will use it, and what could go wrong, you tested for all that, and you are satisfied with the results. The only place I ever cited for failing to complete validation did tons of work and had lots of paper, but failed to document that they reviewed the results and determined that everything was OK for use. It doesn't have to be complicated. As John said, temperature is maintained; plasma is thawed successfully; water is circulated; timer, alarm, and temperature indicators work properly; it meets our specs, let's use it!

dO YOU NEED TO SET UP A PROGRAM AS PER YOUR REQUIREMENT? (MINUTE CYCLE). IS IT SET INITIALLY OR EACH USER CAN CHOOSE THEIR OWN? I WANT TO SET AND MAKE SURE USER CAN NOT CHANGE IT.

Did you calibrate helmer thermometer against NIST or both checked temp. of both same time by keeping in the water?

are those plastic covers are one time use like thawing bag? or you can use more than once?

Thank you in advance.

Thanks alot

I am not sure what you mean by setting up a program. I don't think you can set the minutes and block anyone from changing them. You probably have to set the number of minutes by procedure.

We calibrated the Helmer thermometer against an NIST thermometer using the same protocol as we use for any other thermometer.

The bags are essentially single use. I have occasionally used them more than once when the inside of the bag did not get soiled/wet and we were rapidly thawing multiple units of cryoprecipitate.

Thanks for the reply

We constantly change the thaw time on our Helmer. If I am thawing 4 bags that are 300+ mL I need closer to 20 minutes. If I have 2 bags that are closer to 280mL, then I set it for 16.

We do the same thing that you do.

OK here I go!!

A plasma thawing device is a MACHINE not an instrument. As such it is very simple and does one thing and only one thing, it thaws plasma. To do this it maintains a temperature in a defined temerature range. So; does it maintain that temp range? YES or NO. Does it circulate the heated fluid? YES or NO. Does it thaw the plasma: YES or NO. If all three answers are YES then you are good to go. If one or more answers happens to be NO then send it back and get another.

'nough said.

Blood bankers have taken this whole validation nonsense to levels normal people would never consider. It is past time to take a step back and really look at what you are doing, why you are doing it and determining if it is worth the time and expense (value added! I hate these two words but the seem to be appropriate here).

:explosion[/QUOT

i like to know if we need to send the water in plasma thawer for bacteria cultur i mean routinely as part of maintanance ? or keeping record water change is enough.

We keep a record of changing the water monthly for our brand. (open system) I believe at our other campus which is a closed system it gets changed every six months.

We keep a record of changing the water monthly for our brand. (open system) I believe at our other campus which is a closed system it gets changed every six months.

we worreid about the frozen plasma leakage to the water bath and comtaminating the whole water bath. how do we check if the water is clean before the next water changing time ?

If the plasma has leaked you will know it. You should be putting it into an overwrap bag too. It the bag does break and leak then you change the water at that point.

we usually put them in a plastic bag . but not everyone will be honest to change the water when plasma leak happen . so do we need to have process to check the water if is clean or not please share your policy

thank you