Mike Schmidt pointed out that the European governing body, which is the IMDRF (International Medical Device Regulators Forum), is trying to work together with the United States on establishing so-called "harmonization" on both sides of the ocean.
Mike pointed out that as long as the original design of the machine is not changed, then it appears a unit will not need a new UDI code.
Who cares, you might ask?
Of course anybody in their right mind would be happy to know that patient safety is protected, but beyond that, does it really matter to health care providers?
I think it does. It means that in the year 2016, a health care provider buys a CT scanner and keeps it for five years. Then in the year 2021, they can sell that machine in the open market. It means that the buyer of the second-hand machine can replace parts that need to be replaced and continue to use the machine.
This is good for the CFO at the hospital because it means the machine has value in five years. It is good for banks and leasing companies that want to offer financing to their clients. It is good for in-house service personnel who want to keep the machine to use the parts.
It is also good for the OEMs given their aggressive refurbishing programs.
In short, it is good for everybody.
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Phil is a member of AHRA, HFMA, AAMI and the Cryogenic Society of America. He has contributed to a number of magazines and journals and has addressed trade groups.
Phil's proudest achievement is that he has been happily married to his wife Barbara since 1989, who helped him found DOTmed in 1998.
