UDIs Make Stage 3 EHR Certification Draft

Stage 3 EHR Certification Draft

William A. Hyman
Professor Emeritus, Biomedical Engineering
Texas A&M University, w-hyman@tamu.edu
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The draft 2015 ONC Certification Requirements for EHRs, released on March 20, 2015 in advance of its Federal Register publication, includes among other things that EHRs have Unique Device Identification (UDI) capability for implanted medical devices. I first addressed the potential for UDI inclusion in EHRs here back in 2013. While Meaningful Use seems to move fast at times, there is equal evidence that there is slow and presumably careful deliberation. The present proposal is a better result for UDI, and possibly for healthcare and medical device safety, then the recent report in the Wall Street Journal that CMS has rejected–at least for now–the inclusion of UDIs in federal claim forms.

UDI is an FDA program that will, over time, require most medical devices to have a unique numerical identifier in human readable form as well as in one of several machine readable formats such as one-dimensional bar codes. More exotic formats may also be seen such as 2-D bar codes or RFID. There will also be an FDA Global Unique Device Identification Database (GUDID) with specified device information linked to the UDI. GUDID is currently dark until, we are told, it becomes sufficiently populated.

As described in the Certification rule it is proposed that the EHR enable a user to record, change, and access a patient’s implantable device list, which would consist solely of one or more UDIs associated with a patient’s implantable devices. How the user will do the recording is not specified, but scanning using the associated bar code (or other machine readable technology) would seem to be the only practical method for getting in accurate data and facilitating its subsequent use. This will require scanning technology that for now can read three different 1-D formats of different lengths, but presumably that will be worked out. Changing a UDI would presumably be a manual process, and raises all of the complex questions of who can change an EHR, and how changes would be tracked.

The UDI will be included in the Common Clinical Data Set which is part of interoperability of EHRs (ie data exchange). (Note that this is not the only use of the term interoperability which will be the subject of a future post). The EHR would also be required to be able to separate the UDI into its distinct data elements which are:

  • Device Identifier
  • Batch/lot number
  • Expiration date
  • Production date
  • Serial number

These elements progress from identifying the device generally to identifying a specific unit of the device.

Further, the EHR would have to be able to retrieve the “device description” that was provided by the manufacturer from the GUDID. How this might be accomplished is not specified but the wording appears to rule out that the user could just copy the number into the GUDID web interface since this then would not be a function of the EHR. Being able to click on the UDI and go directly to the GUDID would be ideal. Electronically transferring the device identifier into an on board module would also work, but would be more cumbersome. Whether or not GUDID device descriptions are sufficiently useful remains to be seen.

It certainly makes sense for a patient record to explicitly include information on their implanted devices, and for this information to be readily reviewable and exchangeable. Entering such data in a paper record has long been done and often with peel off labels. It has also been done incorrectly as in when devices are identified by a common or generic name rather than the actual brand name, and in some cases the common name has actually been the brand name of a different device. UDI should prevent that type of error. I am less sure that there will be much looking up of patient specific device descriptions in the GUDID or how useful that would be, but since the GUDID is there (or will be) it might as well be easily accessible. It is also envisioned that patient records could be searched for devices perhaps as part of a recall or outcome research. This was also the idea behind having the UDI in CMS claims data with the advantage that such data is centralized as opposed to having to search across multiple disparate EHR systems.

Time may tell if UDI lives up to all of its hype, but only if someone actually studies the value, rather than just asserting it.