Late last month, the FDA finalized a new tracking system that requires medical device manufacturers to put a unique identifying number on all products. With the implementation of this system, the U.S. Food and Drug Administration hopes to improve on the shortcomings of its current reporting process for malfunctioning devices.

Most notably the agency took some heat from critics in 2007, when defibrillator wires made by Medtronic were fracturing in patients. Doctors raised the alarm early on, but it took many months for the FDA to react and recall the product.

The UDI system will have a far-reaching impact on the medical device industry, and manufacturers are understandably apprehensive about the challenges ahead.

To get an expert's reaction to the final rule, DOTmed News consulted Dr. John Smith, partner at international law firm Hogan Lovells, which counsels medical device clients throughout the premarket regulatory process.

DMBN: So what are your impressions of the final rule?

JS: This has been under consideration for a while, and it was clear that it wasn't a question of if but when FDA was going to finalize the UDI rule and the related guidance for the global unique identification database. As I'm sure you know, there were some important changes between what FDA had proposed and what was finalized in the final rule.

DMBN: What were some of these changes?

JS: The system is, like the classification of medical devices, risk-based, in that higher-risk medical devices will need to comply first. There will also be a pragmatic component in that where there is direct marking of a medical device required, there is further extension, if you will, of the actual date when they need to comply — that's put off for another two years.

DMBN: Tell me more about the concerns around the direct marking requirement and why the FDA changed that.

JS: There had been a lot of concern about the direct marking requirement. The question was, would the marking have some untoward impact on the product? Now, implants and software are no longer required to be directly marked.

Manufacturers pointed out that if someone is implanted with a medical device, there is already a system that traces it to the point of implantation. Usually there are cards provided to the patient with the same information that's recorded in the patient's chart such that both the patient and health care provider will have info on the implant — the serial number, the lot number, etc.

The upshot is that it's already possible in most instances to determine what was implanted and given to patients if there was a problem. In light of concerns of what the direct marking would do, the agency elected to modify the final rule to reflect the industry's comments.

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.