Lbiggs Posted May 5, 2015 Share Posted May 5, 2015 Looking into the requirements for such a contract and wondering if anyone out there knows a way around the FDA registration requirement for being a "distributor" of blood products in such a contract? Any information is greatly appreciated. Link to comment Share on other sites More sharing options...
kate murphy Posted May 5, 2015 Share Posted May 5, 2015 I'm not exactly sure what you're asking. From the term "LifeFlight" I'm assuming moving blood around the country?Blood is flown around on commercial aircraft all the time. I don't think FedEx or Delta Dash is FDA registered. As far as FDA registration/license - nobody will do business with you if you as a blood center are not licensed. So what exactly do you want to know? Link to comment Share on other sites More sharing options...
David Saikin Posted May 5, 2015 Share Posted May 5, 2015 is this a group that wants rbcs available to transfuse in flight? Link to comment Share on other sites More sharing options...
tbostock Posted May 5, 2015 Share Posted May 5, 2015 Good question; I would think you might have to register with the FDA if you are supplying units to an EMS provider for patient transport. Link to comment Share on other sites More sharing options...
Lbiggs Posted May 6, 2015 Author Share Posted May 6, 2015 Called the FDA today and as long as we send the blood such as sending it to a department, obtain storage temperature records and a physician signature for the uncross matched units if they are given; we are not required to maintain an FDA registration. We will still "own" the units. Several hospitals around the states provide this service. Now for the policy building. Going to be a busy week! Link to comment Share on other sites More sharing options...
kate murphy Posted May 6, 2015 Share Posted May 6, 2015 oh, I see - same as transfusing in an ambulance. Link to comment Share on other sites More sharing options...
tbostock Posted May 7, 2015 Share Posted May 7, 2015 We don't allow transfusing in ambulances because there is no nurse present. The helicopter we do because a nurse is on the team. In my state (NY) they are just starting to allow EMTs and paramedics to be able to transfuse but there are many questions about training and competency....who does it, who maintains the records, etc. So we are still allowing nurses only for now. Link to comment Share on other sites More sharing options...
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