Baxter Healthcare Corporation has received 510(k) clearance from the US Food and Drug Administration for the seven day storage of leukoreduced, apheresis platelets collected on the Amicus Separator and stored in Baxter's PL 2410 collection container. This clearance will allow for the transfusion of these platelets when coupled with 100% release testing for bacterial contamination using the bioMérieux BacT/Alert Microbial Detection System. It is licensed by blood centres as determined by the FDA.
“Extending the shelf life for platelets collected on Baxter's Amicus Separator will help to assure that an adequate supply of high-quality platelets are available for patients in need,” said Kevin McCulloch, general manager for Baxter's transfusion therapies business. “We will be working closely with blood centres around the country to ensure that implementation of seven-day platelets meets all expectations and requirements.”
In order to further reduce the risk of bacterial contamination in platelets, which can result in potentially fatal reactions in patients, blood centres have implemented bacterial detection testing. This testing extends the processing of platelet components by 24-48 hours, reducing the usable shelf life and further driving the need for a seven-day storage period, claims a company release.
Baxter will be conducting an extensive post-market surveillance study in order to comply with ongoing evaluation requirements. Individual blood centres wishing to secure licensure for platelets collected on the Amicus Separator and stored in Baxter's PL 2410 plastic container for up to seven days will be required to work with the FDA to obtain individual centre approval.
Platelets are transfused to people who are undergoing chemotherapy, cardio-thoracic surgery and for the treatment of other critical medical conditions. Of the approximately 2 million platelet doses transfused each year in the US, more than 70 per cent are collected via apheresis. Since only platelets are collected during a platelet apheresis donation, individual blood donors can donate one to three full therapeutic doses of platelets rather than the one-sixth of a therapeutic dose typically collected during a whole blood donation.
Baxter Healthcare Corporation is the principal domestic operating subsidiary of Baxter International Inc. Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with treatment of complex medical conditions, including cancer, haemophilia, immune disorders, kidney disease and trauma.