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Unique Device Identification – UDI

fdalogodhhsThis is going to be a BIG deal.

FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID).

Source: Unique Device Identification – UDI

The goal of this regulation is that anything that is placed in a human including dental implants and fillings will have a unique identifier assigned for tracking.

There are two hoped for benefits from UDI:

Recall of defective products. If it is determined that a particular pace maker, dental implant or batch of composite has some sort of manufacturing error it can be recalled and patients can receive some sort of repair. Just like we do now with automobiles.

Improved research. With more and more “big data” coming to medicine and dentistry researchers will be able to track which devices have the best long term results, which have the most complications or even better which devices are most likely to be effective with specific patients. This aspect will be a huge bonus for dentists. In the past we have relied on limited clinical trials and anecdotal evidence of the “works well in my hands” type. In the future we could have more scientific evidence based on actual patient results.

Other industries such as automotive and aeronautics have been dealing with this type of process for years. The systems they use are often called TNT for “Track and Trace”.

As you might imagine getting such a huge new undertaking started has been a challenge. It is and will continue to be a much bigger issue in medicine than in dentistry. That means dentistry will most likely be an afterthought. Never the less it does seem to be coming and dentists will eventually need some sort of TNT in our offices to comply.

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