William Hyman: Despite the Hype, UDI Remains a Work in Progress

As I noted in a June blog on unique device identification (UDI), there was a proposal under consideration that would have required electronic health records (EHRs) to have the ability to capture UDIs–at least for implantable devices which are the first devices mandated to have UDIs. Whether this capture was to be automatic–which would make sense–or manual–which would be awful–was not specified.

Now the Office of the National Coordinator (ONC) has issued the 2014 Edition Release 2 Final Rule, and UDI did not make the cut. The rule document is 187 pages which makes it a fun read, especially since the table of contents does not have page numbers–but you were going to read the whole thing, weren’t you?

Making good use of word search for “unique device “ saves the day and brings the reader to page 101. (Interestingly, searching for UDI yields nothing even though the term UDI is in fact used.) The explanation of why UDI was not included begins with a reiteration of the premise that UDI will enable all sorts of wonderful things such as “help reduce device-related medical errors and provide other significant patient safety, health care quality, and public health benefits.”

The final rule reports on public comments about the capturing UDI proposal, including the complaint that it was premature and that it wasn’t applicable to the ambulatory setting since most implantations occur in hospitals. As is almost always the case for a proposed rule, some commentators thought it was too demanding, while others thought it was not demanding enough. For example, there was a suggestion that the capture be automated, but others complained about the cost of the widespread deployment of appropriate scanner technology. What will constitute appropriate scanning technology remains to be seen, especially since there are multiple approved UDI formats. While no EHR UDI requirement was adopted this time around, the final rule declares an intention “to propose a UDI-focused certification criterion” the next time.

It should be remembered that the ONC sets minimum performance requirements for EHRs, and therefore any EHR vendor could provide UDI functionality if it wanted to or if the customer base got sufficiently organized to demand it. However, a risk of early adoption might be that when there is a new rule, what has already been provided may not meet it, and therefore would require revision in the next EHR iteration. Thus, there may be some rational motivation to wait, despite all the claimed value of having UDIs in the EHR.

An alternative to built-in UDI capture is manually entering the UDI in a free-format notes function. The challenge here is the length of the UDI which makes typing it in a high-risk task. In this regard, a wrong UDI could have safety implications if EHR-embedded UDIs are actively used for anything. Once in the EHR , whether the UDI could be captured from the notes is an open question. More generally, with paper records, ID stickers from devices have been literally stuck into the record for years. How is this done in an EHR?

Not surprisingly, using UDIs for good purposes, as opposed to just having them, is a work in progress. If you are young enough, you may see the claimed benefits actually have proven value.

William Hyman, ScD, is professor emeritus of biomedical engineering at Texas A&M University. He now lives in New York where he is adjunct professor of biomedical engineering at The Cooper Union.

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