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Gulf Coast Regional Blood Center’s Approach to the FDA Platelet Guidance Talking Points  

Platelets play a significant role in hemostasis and sustaining life during an emergency where bleeding is present. To ensure better quality and safety of platelet transfusion, the FDA issued a new recommended BACTERIAL SAFETY guidance that must be implemented by Oct. 1, 2021. Gulf Coast Regional Blood Center is in the final planning stages of compliance with the guidance.  

The Blood Center will implement both Large Volume Delayed Sampling (LVDS), using storage bags approved for seven-day storage, and Pathogen Reduced (PR) technology to enhance the safety, purity, and potency of apheresis platelets stored at room temperature. This decision comes after a careful review of our supply chain in conjunction with customer survey feedback provided since 2019.  

Effective Oct. 1, 2021, Gulf Coast Regional Blood Center will provide a mix of LVDS platelets and PR platelets to maximize the safety and availability of our regional platelet supply. However, as our regional demands change based on technology strategy, we will adjust PR production as needed. 

One of the challenges you might face is that if you donate platelets regularly, you might not be able to give the donation type that you used to. This is due to the larger volume being required for platelet testing. If this happens, you are no longer large enough based on Total Blood Volume (TBV) to donate the types you may have donated in the past.

Gulf Coast Regional Blood Center is sampling a larger volume of the platelets to test for bacterial contamination and are taking these samples from the platelet bags later than in the past. This will give a better chance to detect bacterial growth, which then gives patients in local hospitals a safer product. 

Pathogen Reduced (PR) platelets involve treating the units with a special UV light that kills bacteria, viruses, and any other potential pathogen while at the same time, not harming platelets and their ability to help you maintain hemostasis.  To make PR platelets, specific platelet collection targets are needed. 

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