Platelet Bacterial Detection FDA Guidance – What You Need to Know
by G. Paranjape, M.D., Medical Director of Clinical Services, Carter BloodCare
Current FDA regulations per the Code of Federal Regulations (21 CFR) enacted in May of 2016, require that if hospitals have a positive bacterial culture on a platelet component or a patient after transfusion, they must attempt to identify the organism and notify the blood center that collected the component. There is no current FDA mandated bacterial testing of platelet products. Platelet components are currently tested for bacteria at the time of preparation under AABB standards, not FDA regulations.
However, FDA has published its second draft guidance on this issue in March 2016. If and when finalized, FDA will require all transfusion facilities to implement it within one year of the date of final publication.
Currently apheresis platelets or pre-pooled platelets (AcrodoseTM) are tested for bacteria via a culture method by most establishments and the guidance would mandate that. The following requirements would be added for transfusion services, because of findings that most remaining patient bacterial sepsis cases involve day four or day five apheresis platelets.
If using pathogen-inactivated platelets, no further action would be needed on day four and five.
Apheresis Platelets and Pre-Storage Pooled Platelets Previously Cultured:
Perform rapid testing on day four or five with an FDA-cleared rapid bacterial detection device within 24 hours prior to transfusion, or
Perform a culture-based test on day four and release either after the incubation period specified in the testing device instructions for use, or after 12 hours if the testing device has no specified incubation period and the establishment has in place measures to promptly alert the receiving establishments in the event that the distributed platelet product is subsequently identified as positive for bacterial contamination. If releasing the product during the incubation period, FDA recommends conducting a rapid test with an FDA-cleared rapid bacterial detection device.
Additionally, the guidance discusses testing whole-blood-derived platelets that were not tested by a culture-based method (either as a single unit or as a pool) or FDA-licensed rapid test (which is not available at this time for this product) while also discussing ways to extend the shelf life to seven days, for apheresis/pre-pooled and pathogen-inactivated platelets.
The final publication date of the guidance is unknown at the time of this newsletter distribution.
Reference:
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion
Draft Guidance for Industry – For Comment Purposes Only
March 2016
Click here to read the full FDA guidance.