FDA Guidance on Apheresis Platelets

[spavlis]

HELP!

I am reviewing the current FDA Guidance on Automated Apheresis Platelets. ( I know, it was effective Dec 2007, but ISBT became a little time consuming than I anticipated. )

Anyway, I am curious on how small donor centers are handling the QC monitoring portion of the guidance. I had recently attended a FDA Conference, where the CSO said " For donor centers that collect under 60 products a month, it's expected that they QC ( pH and platelet count) every product." Could this really be true??????

This whole statistical plan the FDA has developed seems to only be an advantage to the larger donor centers. It's becoming burdensome for us small hospital based donor centers.

Please tell me that someone has developed an alternate plan to this QC monitoring nightmare !

thanks

stephanie

[RR1]

You could try phoning some of the smaller donor centers- may get a better response to this.