EHR Meets UDI
COMMENTARY
William A. Hyman
Professor Emeritus, Biomedical Engineering
Texas A&M University, w-hyman@tamu.edu
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Unique Device Identification (UDI) is a congressionally mandated Food and Drug Administration (FDA) program1 under which most medical devices distributed in the US would eventually have a unique, readable, alpha-numeric, device identifier. Currently UDI is under deadlines established in the November, 2012 FDA Safety and Innovation Act (FDASIA). The FDA, in its recent report2 on implementing a variety of initiatives under its postmarket surveillance agenda, gives June 30, 2013 as the date for finalizing the UDI rule. This will begin a multi-year phase-in of UDIs for various devices.
UDIs are said to have a wide range of potential benefits including playing a role in identifying device related adverse events, and in turn, helping the FDA identify product problems more quickly, better target recalls and improve patient safety. A key component of UDI contributing in this way, and in several other potential ways, is that the UDI must be captured by end users (i.e. providers) and made part of the patient’s medical record. Since such records are becoming increasingly electronic, this then becomes the electronic version of peel-off device labels that have sometimes been used to record device specific information in paper records. This data capture would be facilitated by electronic reading of the identifier, rather than having to manually record a long alpha-numeric string, or perhaps scan in the label with that information. While we are all familiar with such bar-code scanning, this has yet to be standardized in the healthcare environment and where it has been deployed (e.g. patient identification and drug delivery) clinical users may have to use several different scanners for different purposes. Of course the scanner is only one end of the data stream, there also has to be a record capable of receiving the scanned information and storing it in a standardized and searchable format. Also, you would want more than the UDI in the EHR, you would also want the device description as text. Ideally the description could be pasted in from the UDI by automatically reading the forthcoming FDA UDI database.
Students of Meaningful Use (MU) will no doubt notice that there is no current MU requirement to enable UDI capture. In fact there is no MU requirement to record any information about medical devices that were used on or in the patient, and none have been suggested for Stage 3. Furthermore, the FDA has not directly involved itself in EHRs (except for its interest in Decision Support Systems) even though it can be argued that EHRs meet the definition of a medical device. Lacking direct self-imposed jurisdiction the FDA has said that it will take steps to facilitate the incorporation of UDI into EHRs by providing UDI technical requirements and use cases to the ONC. Thus there is the implied expectation (or wish) that the ONC will incorporate a UDI capability into its rule making on EHR certification, even though it doesn’t fit into current or proposed MU requirements. As with many such initiatives, all we can do is wait and see how this plays out.