Our surgeons are wanting FFP super quick in traumas.  We do not keep FFP thawed ahead of time and only use FFP, not thawed plasma for 5 days.  We currently have a Helmer DH2 which takes about 30 minutes to thaw 2 units.  Does anyone use a microwave plasma thawer?  How do you like it? Does it really thaw in about 5 minutes?

 

In reviewing the Joint commission stds   Standard QSA.05.14.03 #2 states that the lab thaws frozen plasma between 30 to 37 degrees and protects outlet ports from water contamination.

 

I know we wouldn't have an issue with the microwave and water contaminating the ports, but, does this standard apply to the microwave thawer?

If anyone is Joint commission accred. please let me know how you comply with this standard.

 

Thanks,

Natalie

Yes we have had a microwave plasma thawer for a few years and we LOVE IT. Thaws in about 6-7 minutes, depending on the size of the unit. Couple limitations:

Can't thaw cryo in it: not FDA approved for cryo

Can't thaw the long, folded FFP units in there, they don't fit in the holder.

It's expensive...but totally worth it in my opinion.

We have a Helmer water bath unit as well for the cryo and folded FFP units.

We have a microwave too.   We also convert our FFP to thawed plasma, so we keep several units (A's and O's) thawed and ready for use.

For those of you who have the microwave plasma defroster, how did you validate it?

See attached validation.  For thawing the FFP, we saved units of FFP that were thawed and not used.  We refroze them and kept them on the quarantine shelf until we did our validation and used them.

Validation of Microwave Plasma Thawer.doc

Thank you so much Terri.  The rep told me that we didn't need to wait for him to come and that we could just turn it on and go.  I know better than that, but I didn't have a clue what to do for validation since I can't do factor assays here.

Hi Terry, I was just curious, is a thawed unit of FFP still good for five days using this microwave?  

Hi Terry, I was just curious, is a thawed unit of FFP still good for five days using this microwave?  

 

I don't see why not; studies showed that clotting factors were not affected by the microwave process.

For those of you who use this microwave, do you know if there are any "options" in the size of plasma carriers?   Or larger straps to hold a larger unit inside of the carrier?   Or, is it just 1 size fits all (such that if you are receiving large FFP from your supplier, they may not fit into the carrier)?

Thanks,

Brenda Hutson

For those of you who use this microwave, do you know if there are any "options" in the size of plasma carriers?   Or larger straps to hold a larger unit inside of the carrier?   Or, is it just 1 size fits all (such that if you are receiving large FFP from your supplier, they may not fit into the carrier)?

Thanks,

Brenda Hutson

Sorry, I need to clarify.....I am asking with regard to the ARK Bio Microwave (I see from reading that the Tropitronics Microwave does have various sizes of bagholders available).

Thanks,

Brenda

Brenda,

The microwaves that you mentioned are the same thing.  Tropitronics is the US distributor for ARK Bio.  I was very confused when I started looking into this.

We had one a very long time ago, maybe 15 - 20 years ago.  The thing I remember was the wretched smell you'd get when one broke while thawing.  Then you'd open the door to have to clean a mess that looked like scrambled eggs.  

 

Now we keep lots of thawed plasma for traumas, but we're a big facility and have the luxury.

No you can't fit the really large bags of FFP in the bag holders.

 

I heard a lot about liquid (never thawed) plasma at the AABB Annual Meeting.  Good for about 28 days. Very exciting. I want it now.  

Hi Terri,
We had our microwave installed yesterday and when I told the rep that I had gotten a validation document from someone that already had one, he replied "It must have been Terri Bostock".  Apparently he thinks highly of you!  I'm now in the process of figuring out how best to keep our smaller bags in the holders without having to buy the smaller holders.  Tried a couple of suggestions he had, and working on which one will work the best for us.

Hi Terri,

We had our microwave installed yesterday and when I told the rep that I had gotten a validation document from someone that already had one, he replied "It must have been Terri Bostock".  Apparently he thinks highly of you!  I'm now in the process of figuring out how best to keep our smaller bags in the holders without having to buy the smaller holders.  Tried a couple of suggestions he had, and working on which one will work the best for us.

 

At least I'm famous (or maybe infamous....) somewhere. 

We (Finally) got our microwave!  It has been on order since January and we got it late last month and the rep came and did the install/inservice on October 14.   The policies are going through med staff and med exec this month so hopefully we will be allowed to use it...soon!!!

 

I'm going to replicate your validation worksheet Terri!

We (Finally) got our microwave!  It has been on order since January and we got it late last month and the rep came and did the install/inservice on October 14.   The policies are going through med staff and med exec this month so hopefully we will be allowed to use it...soon!!!

 

I'm going to replicate your validation worksheet Terri!

What a coincidence!  We ordered ours in January and got it in October also!  My boss told me that she wouldn't believe it was really here until she actually saw it on the bench!  Well, seeing is believing.

Good Afternoon,

 Terry would you mind to send me your Microwave validation. I cannot get it to open on your previous posting. Thank you

I seem to remember being required to do yearly QC on microwave thawed units involving measuring several coagulation Factor survival levels (probably VIII and IX?) - is  that still required?  Do you still have to send out this QC once a year on a microwaved thawed unit to keep your unit validated?

On ‎10‎/‎16‎/‎2013 at 4:56 PM, SRMC BB said:

Our surgeons are wanting FFP super quick in traumas.  We do not keep FFP thawed ahead of time and only use FFP, not thawed plasma for 5 days.  We currently have a Helmer DH2 which takes about 30 minutes to thaw 2 units.  Does anyone use a microwave plasma thawer?  How do you like it? Does it really thaw in about 5 minutes?

 

In reviewing the Joint commission stds   Standard QSA.05.14.03 #2 states that the lab thaws frozen plasma between 30 to 37 degrees and protects outlet ports from water contamination.

 

I know we wouldn't have an issue with the microwave and water contaminating the ports, but, does this standard apply to the microwave thawer?

If anyone is Joint commission accred. please let me know how you comply with this standard.

 

Thanks,

Natalie

I have worked in a number of other hospitals besides my current one, and this was the first place that used a microwave.  I just never liked the thought of "microwaving" FFP.  While they are fast, they can also be very problematic so we got rid of ours and replaced it with 2 DH4's.  Our problems with microwave include units not being size that fits into sleeve exactly right, so it might slip out of the holder......or FFP with bubbles in detection area which actually caused the microwave to burn the plastic (because it never detected the end temperature it was looking for).  I know there are people that love them....I am just not one of those people.  

Brenda Hutson

On 6/3/2017 at 3:27 PM, applejw1 said:

I just read a warning letter from the FDA directed toward the manufacturer of ARK BIO Plasma defroster in Canada.  Apparently, as of 3/7/17, they were warned against marketing a medical device without FDA clearance.  Earlier versions were cleared but the have since "adulterated" the device which requires new submissions for clearance.

I have never used the device but am looking into something water-less due to the problems of potential microbial growth in water (even with an additive).

Thanks for the info.

I noticed that thawed FFP is being kept for five days. In my facility we do 24 hours. What is the reg for 5 days and what do you have to do to begin holding it 5 days?

On Monday, June 05, 2017 at 11:42 AM, AMcCord said:

Thanks for the info.

This is what I'm hearing: Now the factory is very tied up with a FDA review.  Ark Bio-Medical Canada Corp. reports that they are working with the FDA to resolve this issue.  I think it is mostly involved with documentation.  There have been no problems related to the methodology with the hundreds of units in place.

I ordered a microwave from Ark Bio-Medical in 2016 and waited a year to receive one.  It is true they have had a manufacturer of some of their parts go out of business and it has taken time to find another.  They have found a new manufacturer and are in production, however now all the paperwork must be re-approved by the FDA and that is where the problem lies.  They have complied with all FDA requests but are awaiting approval.  In the mean time the distributor just installed one he had in stock for us and we love it!  It works very well.  We were instructed to make sure the sensor in the microwave was not placed on the side of the unit with a bubble.  We are a small hospital and it has saved us over $3000 dollars a quarter in wasted plasma.  Now we thaw on demand and it takes about 8-10 minutes to get a fairly large size unit ready.  We still have the Helmer water bath plasma thawer for cryo and units that do not fit the carrier but the microwave is great in a trauma.  We are also taking the temp of every unit we thaw upon completion at least for a while.  I am an old blood banker and I was very skeptical at first but so far we love it!!

In my previous place of employment we had bought a microwave for plasma thawing. We had a lot of trouble with the unit bags staying on also the plasma didn't seem to always thaw evenly  Before long, and after having tried it for a few months, every scientist in our lab opted for the water bath rather than the new microwave.