The use of Unique Device Identifiers in Healthcare

Monday 12th and Thursday 13th September saw a very interesting public meeting organized by the US FDA, entitled "Unique Device Identification (UDI) for Postmarket Surveillance and Compliance".

Rather than looking at details of the rule currently being developed for the unique identification for medical devices (details of which can be found at http://www.fda.gov/udi) the meeting looked at how UDIs would be used in the real world.

Whereas Pharmaceuticals is looking to reduce or prevent counterfeiting by the use of serialization (see our recent webcasts on serialization - "Strategic Management of Product Serial Identifiers" and "Serialized Labelling: Impacts on the Business Model"), in the medical devices sector there is a global drive to be able to uniquely identify medical devices at all point in the supply chain, at point of initial use and throughout the life of the device. Whereas pharmaceutical products are clearly identified (e.g. via the National Drug Code [NDC] in the US), this is not the case for medical devices.

At the moment medical devices are identified inconsistently my manufacturer, model, product name, hospital allocated item number, SKU# etc. As the public meeting heard, the ability to uniquely identify what a medical device is has significant benefits in terms of:

• More accurate device registries (e.g. of implantable devices)
• Faster and more focused product recalls
• Fewer patient/device errors (ensuring the right patient receives the right device)
• Better post marketing surveillance and adverse events reporting

Key to this will be not only the use of the UDI, but the development of data standards which will allow the significant therapeutic attributes of devices to the standardized. This will allow data to be analyzed by specific device model and attributes(e.g. drug coated stents versus polymer coated stents) and different models from different manufacturers to be compared in terms of patient outcome.

The tracking of devices via the Electronic Health Record (EHR) or Personal Health Record (PHR) is one of the most significant steps to enable all of this - where the EHR records the Unique Device Identifier to be recorded, and thereby linked to model number and manufacturer, to the batch/lot or serial number where required, and a host of other associated device data available from a manufacturers database.


This is part of a global initiative to uniquely identify medical devices via a Global Medical Device Nomenclature - which is important when you consider how important it is for a German cardiac specialist to know exactly what sort of heart pacemaker is implanted in the Australian tourist who has just been rushed in the emergency room!

Although we're most likely a year away from finalizing the FDA rule on UDI, and two years away for initial requirements for Class III devices, the use of UDI heralds the possibility of a new era in reduced hospital errors, better device safety, faster recalls, improved safety signal detection and the abilty to use real evidence - and not marketing hype - to know what the best device is for any given patient.


Details of the public meeting program and presentations can be found on the US FDA website at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm263947.htm