Platelet contamination testing at issue

[Mabel Adams]

They are holding a big meeting in Baltimore to discuss using the kit that is approved for testing random plts for bacterial contamination near the time of issue for testing pheresis plts. I hope this would mean they would extend the expiration date of the pheresis plts.

I am concerned that no one at the meeting will represent the needs of small, remote, rural hospitals. The test needs to be done within 24 hrs before issue. It takes 30 min to do one unit. It requires 500 microliters of the product which means you would have to have a tubing sealer (or they will have to redesign plt bags). I doubt the 20 bed hospital 3 hours away has or wants to get a tubing sealer for 1 plt a year. If we test the plt can they give it within 24 hrs? If we weren't already FDA registered would doing this test make it so we had to be? Will we have to test all 5 of our plt units daily so we have one to issue emergently rather than waiting 30 min for the test? Will we still be able to ship the plts back to the big hospitals in the city if we have done this test on them? If we have done it 3 times? Will our computers have ways to document it? How will we keep track of a test that is good for only 24 hrs? Stickers on the bag, notes in the computer? Will ISBT require a new product code once the test is done? What if it is done a second time? Will this be more like a crossmatch test or more like disease testing in terms of manufacturing?

OK, that's all the questions I can think of. Maybe others will have more. If anyone here is going to the meeting, please take these issues with you. I assume it will be open for comment online also in the future.

[BANKTECH]

Will this need done 24 hrs before issue if the units (pheresis or random) are tested 24 hrs after collection? We currentlt use Pall eBDS for all out units (pheresis, random, and pre pooled).

[Mabel Adams]

I believe they are discussing this test to be added to what is already done for pheresis plts. They may decide not to require it at all, I suppose, or maybe it could be in place of the current testing. As a place a lot of hours from my supplier, I wouldn't want to have one of my only units of plts turn up positive after I get them so I would prefer they kept doing the initial testing I think. Or maybe they will be able to replace that test with this one and do it earlier or faster.

[Smarty pants]

The test you are referring to is, I believe, Verax, distributed by Fenwal. They've gained some ground trying to sell the product as an additional method to ensure patient safety (they have data showing that 1 in 15,000 (or some such) platelet products that tested negative at 24 hours, end up positive at expiration. So, they're trying to drum up some business.)

Most of my answers are guesses, but logically based answers.

I would imagine that this would be considered just like additional disease testing, but you could probably define it however you want ... and I would be it would be in addition to the initial platelet culture performed by your supplier. I don't know why you'd need to be registered to do an additional test like this - but it is sometimes difficult to apply logic to FDA decisions.

So long as you do not enter the product or compromise its sterility - I can't see why your blood supplier wouldn't let you return it for "fresher".

Seems like the easiest way to "keep track" of a test that needs to be performed every 24 hours - would be to start out your day performing the test on all products in your inventory so that you're then covered until the next morning. Sort of like morning QC.

Tubing sealers aren't really all that expensive (a couple grand) and you'd probably find that there are other things you never realized you could use them for ???

All that said ... I wouldn't start to panic just yet. Fenwal has been trying to gain momentum in the industry for a couple of years, and I don't see anything changing overnight just yet. It could still happen, FDA is very concerned with bacterial contamination ... but I think it will still take some time.

[jayinsat]

The test you are referring to is, I believe, Verax, distributed by Fenwal. They've gained some ground trying to sell the product as an additional method to ensure patient safety (they have data showing that 1 in 15,000 (or some such) platelet products that tested negative at 24 hours, end up positive at expiration. So, they're trying to drum up some business.)

Most of my answers are guesses, but logically based answers.

I would imagine that this would be considered just like additional disease testing, but you could probably define it however you want ... and I would be it would be in addition to the initial platelet culture performed by your supplier. I don't know why you'd need to be registered to do an additional test like this - but it is sometimes difficult to apply logic to FDA decisions.

So long as you do not enter the product or compromise its sterility - I can't see why your blood supplier wouldn't let you return it for "fresher".

Seems like the easiest way to "keep track" of a test that needs to be performed every 24 hours - would be to start out your day performing the test on all products in your inventory so that you're then covered until the next morning. Sort of like morning QC.

Tubing sealers aren't really all that expensive (a couple grand) and you'd probably find that there are other things you never realized you could use them for ???

All that said ... I wouldn't start to panic just yet. Fenwal has been trying to gain momentum in the industry for a couple of years, and I don't see anything changing overnight just yet. It could still happen, FDA is very concerned with bacterial contamination ... but I think it will still take some time.

I was always under the impression that once you start making aloquots from units, which is what you'd have to do to remove a sample for testing, the FDA considers you a manufacturer, thus opening you up for FDA inspection/regulation. Using a sterile docker/tube sealer would throw you into that catagory wouldn't it?

[BANKTECH]

Yes, I think the use of sterile docker throws you into FDA inspection too

[Mabel Adams]

And you are doing a test that is definitely tied to the safety, purity or potency of the product. Of course, so is the crossmatch and you don't have to be registered with the FDA to do that--yet.

We have a tube sealer and will continue to have, but I don't think our region's 25-bed hospitals would feel that a couple thousand dollars is a small amount for something they would use once or twice a year. I think we could come up with some sort of plan when we have to send them plts but I want their concerns to be heard along with all of us at 100-300 bed hospitals that are remote from our suppliers by several hours. If the trade-off is longer dating on plts then that might be worth it.

[Barbarakym]

Yes, I think the use of sterile docker throws you into FDA inspection too

Only if you are making a new product. To pool a 2 bag plt or divide a unit.. I don't think you are FDA inspection material. To WASH products, to combine products...to make a new product (10 cryo into 1 bag)... then yes.

Any inspectors out there who can clarify?

[jerriemc]

My concern is isn't there a potential to introduce bacteria into the bag of platelets when you get an aliquot for testing?