microwave ffp validation

[yiams]

Blood Bankers, We have a Helmer waterbath for thawing FFP. We are very pleased with it but we've been getting pressure about finding something which would be faster. Our current waterbath requires about 25 minutes to thaw from 2 to 8 FFP.

We have debated 5 day plasma but there's no decision yet. I'm pushing for it really hasn't caught fire.

I've been asked to research a microwave device. I've looked at these forums for information and will contact some company representatives next week.

My main question is regarding validation. What do we have to do to validate a microwave device? does the manufacturer provide guidelines? does the distributor provide guidelines? Or can we just plug in the device and let 'er rip? How often do we have to repeat any validation steps? Monthly? annual? When repaired?

I'd appreciate any specifics about using these things.

Thanks,

Randy

[tbostock]

Hi, Randy. I wouldn't recommend "letting 'er rip"...LOL Never met an inspector that was fond of that.

I'm not familiar with the microwaves for thawing plasma, but as a general rule, validation should be performed before installation and after major repairs. No need to revalidate on any regular basis, your monthly/quarterly QC on the instrument should suffice. I usually start with the user's manual and test that it does what it says it does (for example, if it says it thaws a unit within 10 minutes, I would test that). If there is a timer on the equipment, I check that it is accurate against a stopwatch. As with most reagents/equipment approved for BB, the FDA has ensured that it has been tested within an inch of its life, so no extensive studies needed.

If you do get one, post on here how you like it; I may be looking at one when we become a trauma center and will need faster thawing.

[tcoyle]

Hello,

We do have a microwave in place for thawing FFP. I did a pretty extensive validation that included thawing units of a certain volume. If you would like more information, please send me an email and I would be happy to give you more details. Terri

[clmergen]

I think the Helmer's that agitate the plasma are as quick as the microwaves or at least within a few minutes of each other. I can typically get plasma thawed in under 20 minutes. And if you have ever cleaned up a plasma that broke in the microwave, you would think twice about the purchase.

[tcoyle]

Thawing plasma in the microwave takes 5-7 minutes for two units. A far cry from the twenty of the water bath.

[eric1980]

Someone here in BBT gave me a website which tells me some information on microwave FFP thawer. I recall that it says something like the FFP will be placed in a tray so that if it leaks, you simply take out the tray and pour the leaked FFP away. So I think you could simply wash and dry the tray before continuing to thaw more FFPs.

[RR1]

Please could someone enlighten me on this:does the microwave thaw the plasma evenly throughout? Just asking as my only experience with microwaves is for food. As I recall when trying to thaw and heat the odd frozen curry etc..you get left with a solid frozen lump of matter in the middle and piping hot stuff peripherally, which you then have to stir and heat again.

Do plasma thawing microwaves agitate whilst thawing?

many thanks

[tcoyle]

The plasma thawer we have does not have a tray in the bottom. The FFP sits in a bag holder that is on the wall of the device. While the product is thawing, it does agitate (clockwise and counter-clockwise), to eliminate the chance of a hot spot.

[clmergen]

I don't recall the microwaves thawing that fast when I used one. And the one I did use did leak a broken FFP all over the bottom and made scrambled eggs that smelled stronger than bleach could cover up. I still prefer the Helmer thaw bath.

[John C. Staley]

As a general rule I have usually considered myself a moderate level techno-geek but microwaving FFP was something I never considered. I know there are number of facilities that would not trade their microwave for all the water baths out there but that was just one advancement I had no faith in. Like others have said, I've seen what they do to food I simply did not want to take the chance not to mention the time, effort and expense of validating one.

:pcproblem

[RR1]

Just for interest-how would you validate a microwave for plasma thawing?

[bbanker2]

RR1, We use a microwave plasma defroster. It came with a "Certificate of Calibration" and a "Certificate of Thaw Tests." We checked the temperature of all units after thaw for 3 months. 16-25 degrees Celcius is the acceptable range. We have been through 2 inspections since then and so far no one has suggested we do anything differently.

[RR1]

RR1, We use a microwave plasma defroster. It came with a "Certificate of Calibration" and a "Certificate of Thaw Tests." We checked the temperature of all units after thaw for 3 months. 16-25 degrees Celcius is the acceptable range. We have been through 2 inspections since then and so far no one has suggested we do anything differently.

Thank you for your reply bbanker2.

When the microwave is serviced does the company produce a report of heat distribution throughout the cabinet/ or a mapping of the microwave bursts to show exactly where the 'points' of energy are concentrated?

Uneven energy bursts could result in a reduction of therapeutic efficacy by overheating certain parts of the bag, but the agitation would give you a false sense of security as the temperature after agitation may be within requirements. ( i'm just brainstorming!!)