Has anyone started producing pheresis platelets with a 7-day outdate?

I spoke with my blood center yesterday. It is my understanding that the FDA requires that a variance be applied for in this case. One of the apheresis equipment vendors is creating a downloadable form to assist the process.

As soon as all the paperwork is taken care of, we will see the seven day platelet apheresis products.

I am disappointed that the Tampa project to pre-pool and culture randoms is "dead in the water" with the FDA. We need some help with the bacterial detection issue on the randoms. There is an editorial in this month's Transfusion discussing a platelet apheresis product that was pH'd as normal but caused a septic reaction in a patient. The article called for apheresis manufacturers to use culture methods available and stop using insensitive tests such as pH and glucose.

Meanwhile, there are a handful of very large hospitals in my area that are still non-compliant with AABB and CAP over the random platelet testing issue. We all know that 'swirling' is not the best, but is it really so bad compared to pH and glucose insensitivity? If you have any hard numbers on the differences, please share.

We collect apheresis platelets in our institution using the Gambro equipment and the BactiAlert for bacterial detection. We will be applying for the variance and hope to have 7 day platelets by the end of the summer or early fall.

In regards to pH and glucose the original studies were done using those methods on platelet concentrates only and not on apheresis platelets. The article in Transfusion has to do with using the pH and glucose method on apheresis platelets.

florida blood centers has now been appovered on the 7 day platelets they have had a good turn out with it. if u go to there web site i beleive its on there