2005D-0330 Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
FDA Comment Number : EC3
Submitter : Mr. Rick Raley Date & Time: 12/05/2005 05:12:01
Organization : Heartpumper, Inc.
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
The 21 CFR 640.25 General Requirements allows for platelet storage of a 'pH of not less than 6.0 at the storage temperature of the unit', when the temperature is normalized to 37 degrees Celsius the pH can remain well into the acidotic ranges. Delivery of any acidotic (less than pH 7.2) components or admixtures to haemostatic and/or physiological compromised patients can cause extreme stress upon the circulatory physiology or potentiation of degrading clinical conditions. Maximal platelet physiological response to normal aggregation stimuli is seen at a pH range of 7.2 to 7.4. At lower pH, platelet responsiveness is diminished to the point of total inhibition of aggregation at ph 6.5 and below. Storage of platelet components should be kept at no less than pH of 7.2 to optimize platelet responsiveness and homeostatis of those patients receiving this blood component.