We are looking at a new HIS/LIS system. My understanding is that transfusion administration systems used by nursing to match units to patients should be FDA approved. The vendor disputed that, saying that they had checked with the FDA and they did not require approval. I find it hard to believe that is true--does anyone have definitive information about any applicable FDA requirements? Thanks!

I think the system (LIS/HIS) must have FDA approval. . . if that matching function is part of the system it should be acceptable HOWEVER you will need to validate that it works as anticipated. YOU could always contact the FDA and get their official take on the matter. I would not take the vendor's word for that.

I have read that there is a different track on these kinds of systems, depending on whether it is a 'blood bank' associated system or a 'pharmacy' associated system. The author of the article seemed to be saying that a pharmacy system could be used for blood product transfusion ID based on a different approval process, but I would definitely check it out thoroughly before putting it into place. Several years ago, we (nursing, pharmacy, lab) met with a team from a company that was pitching a system for our pharmacy and ID for blood product administration was one of the things they were putting out as a selling point. When I asked some specific blood bank related questions, it became obvious from the answers that they really didn't have much knowledge of blood bank regs. I think checking with the FDA and asking for contacts in other facilities using the same system would be prudent. As David says, you would definitely need to valid it yourself as well.

I think David is absolutely correct. Any software that is used in the delivery of blood or blood products must be FDA 510K (the number of the FDA reg) cleared. If you find a HIS/LIS system that meets this reg then you would have to validate it just like any other piece of BB software.

In my current position I function as an Application Coordinator for general lab and have BB software experience. At this time I'm not aware of any HIS/LIS system that can do it all. BB systems are usually "bolted on" to the lab software. Mostly due to the complexity of the FDA reg and the validation process.

If you know of a system that "does it all" pleas post and me know.

Yes, blood administration does require FDA 510K approval. Vendors will tell you that their system can do it without the FDA approval, but I would NOT risk it.

The info that I have read states that if the BB software has "electronic crossmatch" function, then it needs FDA approval. The hand-held barcode readers that go with phlebotomy to ABO/Rh/AbScr to transfusion also need FDA approval. A medication administration record system that also allows for transfusion does not need FDA approval. I will try to find that article (maybe letter) stating this.

Yes, Blood Bank software used for testing/resulting requires FDA approval, and systems used for blood administration also need FDA approval. Medication systems oddly don't need it, and it is thought that since the blood administration is bundled together with it that it must not be required, but I don't agree. And the couple systems I have seen that did not have the 510K could've used it, because there was a lot wrong with them in my opinion.

Bill, if you can find something in writing, I would love to see it.

The info that I have read states that if the BB software has "electronic crossmatch" function, then it needs FDA approval. The hand-held barcode readers that go with phlebotomy to ABO/Rh/AbScr to transfusion also need FDA approval. A medication administration record system that also allows for transfusion does not need FDA approval. I will try to find that article (maybe letter) stating this.

The folks from our not yet live HIS system thought they could use their new medication administration system for transfusions.

They were totally unaware of 510k. It turned out that they could not "read" codabar labels and since our blood center still uses codabar we dodged that bullet.