DMBN: What are some of the logistical difficulties of implementing this new system?
JS: There will be products that will need to be directly marked — a huge undertaking.

The manufacturers will need to develop UDIs for the labeling, and for those non-implant non-software devices, the devices will need to be individually marked as well.
There's also the global unique device identifier and the database — there's a whole separate guidance about that. Whenever you set up a new system like this, there will always be implementation challenges.

DMBN: What is the estimated cost of implanting this system?

JS: If you look at the federal register, it has a complex cost benefit analysis. They're saying the total present value of cost over 10 years is in the hundreds of millions range, between $642.2 million and $737.7 million, depending on the discount rate.

DMBN: Can you point to some concrete benefits of this system?

JS: In theory it's an advantage to have something like this, but it's always easier to gauge the cost burden than the benefits.

That said, this system will be particularly useful for devices that are reprocessed and reused. Some devices can be reprocessed and reused, but only a few times. It can be difficult if you don't know what device you've got, and how many times it's been through reprocessing.

Without having the product clearly marked and identifiable, how do you trace all that? There's a utility to all this because now you're going to have fairly granular tracking of all these devices to know where the devices might be. If there's a problem with devices from a particular lot, you could call out those devices using their UDIs.

Traceability is an issue for any medical product — it comes down to, can you identify that individual product, at what cost, and what's the utility of doing so? Here, with the devices there's been a policy decision made that the benefits to having this UDI outweigh the drawbacks.

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