Do you consider this a Blood Product Storage Device and perform quarterly alarm checks?

No. It is a frozen product thawing device. (And we document in our computer system what the water temperature was during the thawing process.)

Donna

Hi Donna,

I am curious about your last statement - "And we document in our computer system what the water temperature was during the thawing process." Do you use a thawer that alarms when it reaches unacceptable temps?

JB

We do alarm checks as per the manufacturer's instructions.

Hi Donna,

I am curious about your last statement - "And we document in our computer system what the water temperature was during the thawing process." Do you use a thawer that alarms when it reaches unacceptable temps?

JB

We use a Helmer 4-unit model that does alarm when it reaches unacceptable temps. However, when we change (ie: "process") our frozen product into a thawed product in our BB computer (HCLL), there is a required field where we must document the temperature of the thawing bath (obviously, for QC documentation.) (Is this what you were asking, Joan?)

Donna

Hi Donna,

Yes it does, I was thinking that I was missing something in my process.

JB

Ours is set at 35.5C and the alarm at 36.5C. The alarm needs to go off before 37C to be in compliance with regs.

Ours is set at 36.0C and the high alarm at 36.8C. The baskets will lift and the product will be out of the water before it is too hot. The only time the alarm has sounded is when we tested it.

:cool:

Do you perform quarterly checks on both the high alarm and the low alarm? The manufacturer only indicates a high alarm check but if this is considered a blood product storage device (according to CAP inspector) then wouldn't we be required to do both?

set at 36.4 and will alarm at 37.1

Do you perform quarterly checks on both the high alarm and the low alarm? The manufacturer only indicates a high alarm check but if this is considered a blood product storage device (according to CAP inspector) then wouldn't we be required to do both?

I'm having trouble understanding how a CAP inspector can consider a plasma thawer to be a storage device. Isn't that like calling a platelet centrifuge or an apheresis instrument a storage device?

:)set temperature is 33.5 and high alarm is 36.5 on the Helmers.

Recently we had a FDA inspection in which they focused on equipment preventive maintenance and quality control. They requested from us a list of equipment for the blood bank and reviewed our QC SOPs and also the manufacturer's Operator and Service Manuals. When the Operator's or Service Manual listed a recommended quality control or preventive maintenance the FDA looked for these and cited us for not having some of these recommended PMs in place, as well as, for not documented these recommendations. In the case of the Helmer Plasma Thawer, there is a preventive maintenance schedule indicating the frequency of performance with the statment by the manufacturer "Maintenance tasks must be completed according to the following schedule". For the "QuickThaw Plasma Thawing System", that we use, it requires weekly cleaning of the chamber and basket, quarterly lubrication of the moving parts, quarterly temperature calibration for the temperature controller readout, quarterly high temperature alarm and annual checking of the bearings for the basket. Also, we have our annual electrical check that is required.

They actually spent over 3 days just on equipment alone and we had to work very closely with our contracted Bio-Medical department to correct our deficiencies, as Bio-Medical department was documenting performance electronically and not very well (documenting the PMs and QC that they were responsile for was done, but not what the readings were or not documenting electronically who performed testing).

It was quite an experience, as there were some preventive maintenance recommendations that were impossible for my staff to perform. Some of the citations were resolved after phone calls to the manufacturer indicated that our original Service manual was outdated and the preventive maintenance shcedule was changed so that an anuual preventive maintenance performed by the manufacturer covered a particular preventive maintenance requirement (from semi-annual to annual). Also, although we had a cleaning schedule defined in some of our SOPs, we did not document these cleanings, so we had to develop a new form or revise forms for documenting these cleanings (if it wasn't documented, it wasn't done).

But I digress....

We have our high alarm going off at 36.7 degrees and our set point at 35.5, which in our case the actual temperature is a little higher (within 0.5 temperature allowable difference). We thaw both FFP and Cryo in this thawer. When I looked in the CFRs, temperatures of storage are not listed as 1.0 degrees or 6.0 degrees, but simply as 1 and 6 degrees. We all know that if we listed the storage temperature of blood as 6.1 degrees, we would be cited because it would be out of range. Using the same logic, if you have your high alarm point set up as 37.1 or higher, then these temperatures would be out of range and potentially you could effect the potency of the thawed product if it reached 37.1 degrees, which the FDA could construe as being a reportable error. Remember, it just has have the potential to effect the potency of the unit to be reportable. If someone would like to put this question to the FDA, be my guest.

Edited August 24, 201014 yr by conwaysbb
spelling or syntax errors

Our is set at 36.0 and it goes off at 36.5 allowing .5 degree before reaching 37C.

When we validated our plasma thawer, we wrote our policy to include all PMs and form for documenting all of them(including temp. when we do quarterly temp. calibration).

Does anyone set and do a low alarm test on their plasma thawer? The argument for setting a low alarm [alarm sounds if the temp drops below 30C] is that regulations state frozen plasma components must be thawed between 30 and 37C.

When we clean out the thawer, we observe the temperature at which the time readouts turn to zero. At this point you can lower the baskets and the thawer is ready to go. Ours is set for 34.1 on the low side.

:clap: