During the June meeting of the GHX Global Data Standards Users Group, Indira Konduri with the FDA’s Center for Devices and Radiological Health shared a cartoon that depicts how many of us have felt about the status of the proposed Unique Device Identification (UDI) rule. In the cartoon, a student asks his teacher, "When can I stop making wild guesses and start making educated guesses?" Well, that time is now. Last week, in a rare display of bipartisanship, Congress sent a bill to the president’s desk that will require publication of the proposed UDI rule by the end of the year. That rule will require manufacturers to uniquely identify their devices through distribution and use. The FDA Safety and Innovation Act also requires the final rule to be published within six months after the close of the comment period on the proposed regulation and, more importantly, for "devices that are implantable, life-saving and life-sustaining" to bear the unique identifiers no later than two years after the regulation is finalized.
In a post last week, I mentioned that this should be a wake-up call for suppliers – at least for those that make implantable devices, the first to be impacted – to start taking steps to comply with the pending regulation. But healthcare providers should also take notice and start thinking about how they will eventually capture and use the identifiers. After all, if they don’t use the identifiers, much of the intended value of UDI will be lost.
This is the first in a series of blog posts that will explore what suppliers can and should be doing now to get ready for UDI, and why it is equally important for providers to pay attention, especially with the likelihood that they, too, could be faced with regulatory requirements around UDI.
But first, let’s spend some time looking at the origin of the UDI rule, what the FDA hopes to accomplish, and what the rule will likely require and when.
The origin of the UDI rule dates back to 1999 when the Institute of Medicine published the To Err is Human report, which found that as many as 98,000 people die in hospitals each year as a result of preventable medical errors. Five years later, in an effort to minimize medication errors, the FDA issued the medication barcode rule, to enable healthcare professionals to scan barcodes to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time. The rule mandated that certain human drug and biological product labels contain a bar code consisting of the National Drug Code (NDC). At the time, the FDA looked into creating a similar rule for medical devices, only to find that there was not a comparable standard identifier, like the NDC, for devices. That set the wheels in motion for inclusion of language mandating UDI in the FDA Amendment Acts (FDAAA) of 2007.
The NDC was originally created in 1969 to serve as part of an out-of-hospital drug reimbursement program under Medicare and to identify drugs during commercial distribution. But over time, recognition of the applicability of the NDC for supply chain operations, such as purchasing and inventory control, and patient safety has grown. The UDI has similar broad value, and the FDA recognizes that an identifier that can be used for multiple purposes is likely to be more widely used by healthcare providers, which can help achieve the FDA’s patient safety objectives.
As part of the rule development process, the FDA has worked to avoid many of the pitfalls of the medication barcode rule, which is still not being used by the majority of healthcare providers, even six years after it went into effect. Unlike its predecessor, the UDI rule will:
In an attempt to create a system that is not overly prescriptive, the rule will be technology neutral, allowing use of a variety of auto id and capture (AIDC) carriers, including linear barcodes, 2-dimensional barcodes and RFID (the medication rule was limited to linear barcodes). It will also accept identifiers that are part of the ISO 15459 series of standards, which includes both GS1’s Global Trade Item Number (GTIN) and HIBCC’s Labeler Identification Code (LIC).
The FDA Safety and Innovation Act puts the proposed and final rule on a timetable, but there are still some uncertainties around exactly when suppliers will need to comply. If we compare the new legislative language to the timeline the FDA has been using for a while, here is a potential scenario.