Posted May 5, 201510 yr comment_60138 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.
May 5, 201510 yr comment_60142 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?
May 5, 201510 yr comment_60151 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.
May 6, 201510 yr Author comment_60165 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!
May 7, 201510 yr comment_60211 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.
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