The New FDA Platelet Guidance: Switching 7 Day Platelets

by Dr. Frances Compton

There has been much debate over the new FDA Guidance for Industry regarding platelet bacterial testing (issued Sept 2019 and updated Dec 2020). This guidance requires blood center implementation of one (or more) of several new platelet testing options in order to mitigate bacterial contamination of platelets meant for transfusion.

New FDA guidance for platelet bacterial testing: https://www.fda.gov/media/123448/download

Some background information: As platelets are conventionally (we can talk more about this conventional storage method another time) stored at room temperature, they are particularly vulnerable to bacterial growth. Therefore, this new guidance enforces stricter bacterial testing methods in order to reduce the risk of septic transfusion reactions.

With the new FDA guidance comes a new (and pretty exciting) change for platelets; the potential for a 7 day shelf-life. Prior to this, platelets outdated in 5 days, a very short shelf-life for such a valuable product. There were ways to extend the expiration date to up to 7 days, but it involved additional, secondary, testing. Now, Carter BloodCare will be distributing 7 day apheresis platelets with no additional testing needed – all of the bacterial mitigation testing is done up front by Carter BloodCare! This is called “Large Volume Delayed Sampling” (LVDS) and is one of the testing options described in the new FDA guidance.

While this is an exciting change for hospitals and blood centers alike, the 7 day expiration date does come at a cost. Remember, the point is to decrease the risk of bacterial contamination of transfused platelets; so the testing that we do up front just became MUCH more involved. All other options either have a 5 day expiration date or will require additional testing at the hospital.

So, exactly what testing will we be doing before we distribute these new 7 day platelets? Are you ready for this? FYI, the changes to our process are underlined:

  1. Collect apheresis platelet(s)

  2. Wait 48 hours after collection

  3. Sample 16 mL from each platelet bag

  4. Culture using aerobic AND anaerobic media

  5. Wait for a minimum of 12 hours of incubation time prior to release

It is important to remember that the expiration time still includes testing and incubation times. Carter BloodCare feels strongly that it is to the benefit of our hospital partners that we do all of the testing up front in order to be able to provide a 7 day platelet that does not require additional testing.

These changes are happening now! We started this new LVDS testing process on June 22, and, therefore, our first 7 day platelets were distributed June 25. Look for them on your shelf, and know that there is a lot we are doing in order to provide these life-saving blood products!