FDA has today published its full proposed rules for the introduction of a unique identification system for medical devices, as aired extensively in the last few weeks. The document is an undeniably weighty tome and can be found here.
In summary, the FDA is proposing to establish a system which would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as those deemed lower risk.
The proposal is that:
- each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology.
- the UDI would be required to be directly marked on the device itself for certain categories of devices for which the labelling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labelling.
- information pertaining to each device would be submitted to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.
Simple enough? Indeed, but the actual implementation including development of new practices at the provider end and also the databasing infrastructure and monitoring sounds like the formation of an entirely new level of bureaucracy. And then there’s the commercial sensitivity, information being made publicly available also having potential use for competitive suppliers.
So the story has a significant way to go, but has to be a key measure in the identification and management of future implant issues, especially when combined with implant registry analysis.