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EAB81

FDA Guidance - PLT Bacterial testing

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So, a vendor showed up this week talking about the "new FDA Guidance for platelet bacterial testing." All the info I've found thus far doesn't state that there would be mandatory testing for platelets. Does anyone have any other information regarding this that they would be willing to share? TIA

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The last guidance I could find was from 2018 and was only discussing ways for 5d plts to be extended for 7 days.  This was going to the BPAC for their input.   In 2016 their was a guidance for comments which would require bacterial contamination testing for plts on day 4 or day 5 if the product was in your control and was going to be transfused.  This guidance was put on hold the last I knew (which was also in 2016).  I'll see if I can find any further info.

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Yes there is a Guidance from the FDA regarding bacteria testing of platelets that has been a Guidance for awhile. One of the methods to be compliant in this is to use pathogen reduced platelets, or perform bacteria testing on platelets on day 4 and 5 prior to issue. I was told that the FDA is being told that they need to finalize this Guidance this year around October, I believe. 

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Our blood supplier does all of the bacterial testing for platelets. We're a relatively medium-sized hospital, and we only order platelets when the physician is going to give to a patient. So, they don't typically stay in our possession longer than 24 hrs. We don't order to keep on hold.

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I found the FDA Guidance for this which I have attached. There are a couple of ways that the FDA is saying will meet this Guidance. So if you don't keep platelets on hand you may not need to do anything if your supplier does the initial bacteria testing, but if you receive a platelet on day 4 or 5 of life you would have to check with your supplier to see if they would be performing that secondary bacteria testing on the platelets for those short date units.

Bacterial_Risk_Control_Strategies_for_Blood_Collection_Establishments_and_Transfusion_Services_to_Enhance_the_Safety_and_Availability_of_Platelets_for_Transfusion_Dr.pdf

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11 minutes ago, EAB81 said:

Our blood supplier does all of the bacterial testing for platelets. We're a relatively medium-sized hospital, and we only order platelets when the physician is going to give to a patient. So, they don't typically stay in our possession longer than 24 hrs. We don't order to keep on hold.

but if you get them the night before and infuse them on day 4 or 5; if they were in your possession you will have to perform the contaminate testing.  That is what that guidance indicates.  I commented quite liberally to the Feds,

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Right now this is a draft guidance, but everything I have read says it will be made a Guidance by this September.  I haven't seen anything yet on what the required implementation timeline they might be.

 

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The simplest solution and the clinically superior one is to use pathogen reduced platelets (at the cost of $100+ more per transfusion).  Bacterial testing will not prevent all bacterial contamination events in any case, and pathogen reduction pretty much will do that.  In addition, pathogen reduction is the future of transfused blood (and no lesser expert than Harvey Alter, the co-discoverer of both Hepatitis B and C, has stated this).  There will be viruses we don't know about and cannot immediately test for that come around the way HIV did, and pathogen reduction addresses these future pathogens, including present realities such as babesiosis, malaria, etc.  We then could stop testing for pretty much everything if we wanted to, including useless tests like syphilis, Zika, etc.  (These diseases are not known to be transfusion transmitted with current practices). That would save a little money, but awaits (1) pathogen reduction technology for whole blood and (2) the FDA and various states agreeing the redundant testing makes no sense from a clinical standpoint.  Good luck with the latter :).

We are close to 100% pathogen reduced for platelets in our center, and the cost was about $500,000 per year.  Of course, one or two cases of post-platelet transfusion sepsis in a patient with neutropenia will pay for that in avoiding ICU stays, etc.  

If you are a small hospital and transfuse a few platelets per month, the extra few thousand dollars per year for pathogen reduction is easily recouped in reduced staff training time for bacterial testing, logistic nightmares and other complexities. Plus it's a superior approach to reducing risk to patients.  To me, it's a no brainer, but your mileage may vary.

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Not being familiar with the method, I was wondering if it is unnecessary to irradiate pathogen-reduced platelets?  Also, apparently the FDA does not approve of it's use on pooled platelets.  Why is that?

Thanks, Scott

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There is a savings there then for our chemo patients.  I wonder if somehow the FDA would go so far as to say the primary culture at the blood center could be skipped?

Scott

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16 minutes ago, David Saikin said:

I disagree with this statement unless pathogen reduction will prevent lymphocyte activation. 

The Cerus Intercept system for pathogen reduction does this.

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On 7/19/2019 at 7:57 AM, David Saikin said:

I disagree with this statement unless pathogen reduction will prevent lymphocyte activation. 

It appears from the literature that these types of systems irreversibly inactivate RNA and DNA.  Whether the FDA will approve it as equivalent to irradiation to inactivate WBCs is the question.  I have not found anything that specifically mentions this.

Scott

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Pathogen reduction prevents lymphocyte proliferation and thus is practically speaking equivalent to irradiation.  Whole blood platelets are pathogen reduced in some parts of Europe, but the manufacturers have not put forward these methods for FDA approval in the USA.  A serious mistake and waste of resources.  In any case, apheresis platelets carry a higher rate of some transfusion adverse events (TRALI, for example) in French hemovigilance data, so why one would preferentially use pathogen reduced platelets that are single donor rather than pooled whole blood is beyond me.  We used to use 100% whole blood platelets as a socially responsible use of donor resources, particularly as apheresis platelets carry no proven health benefits for patients (donor exposure is a straw man in this instance, given the low risk of infectious disease transmission, and it's irrelevance in the pathogen reduction era).  We are using close to 100% apheresis simply because that's the only pathogen reduced platelet product available.  As I said, a terrible mistake in my view.  But better apheresis platelets than non-pathogen reduced is our decision.  We'd welcome use of whole blood pathogen reduced platelets as a much more responsible use of donor's time and safety given that whole blood platelets are essentially now a wasted, low cost scrap product.  Much less expensive, and we think safer than apheresis platelets for most patients.

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I agree with Dr. Blumberg that pathogen inactivated platelets are probably safer than the "cultured" platelets and that the psoralin compound used in the process currently approved by the FDA crosslinks DNA/RNA thus preventing proliferation of most organisms and WBCs. However, to my knowledge the FDA has not given blessing for pathogen inactivation to supplant irradiation yet. Reading a copy of the "prescribing information" from Cereus would answer this question.

However, it is expensive, $150-$200 premium on the current cost of the products.

It is not yet approved for pooled platelet concentrate products. (six-pack)

It is not yet approved for three products collected from a single donor (triple product).

It is not yet approved as a 7 day product.

There is about a 5-6 % decrease in the donors that qualify for giving two or three products at a time.  This is because the pathogen inactivation process decreases the platelet count by 5-6%. This means that blood centers will need to replace this number of donors in order to keep up with current product demand.

There are some who suggest the platelet efficacy of these products is diminished at as the product approaches day 5.  Whether or not this is seen clinically, I do not know but this would have a bearing on whether or not the product will be approved with 7 day out-date labeling,

There is a third option that can be entertained by the providers of these products.  That is "delayed high volume culturing".  This process makes it standard to obtain both aerobic and anaerobic cultures from each product.  This process has been used quite successfully in Great Britain to interdict contaminated platelet products. I understand this process would be approved for labeling the product with a 7 day expiration date, without the need for the consignee to do point-of-release testing (Verax).

I believe it is important for hospitals to discuss the product desired with their blood supplier.  Opening the discussion now will make for an easier transition when the guidance becomes final.  We expect to hear from the FDA on this topic later this year.

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