FDA Proposed UDI: AIDC Requirements


Mental Telepathy AIDC.
Photo by Nadya Smolskaya

Linear barcodes2D barcodesRFIDManipulated DNA stands?  Microscopic pattern recognition?  Mental telepathy?  Which Automatic Identification / Data Capture (AIDC) technology(ies) can you expect on the medical devices you buy in the U.S. supply chain in the future?  This is the second in a multi-part series of essays examining various aspects of the recently proposed Unique Device Identification (UDI) rule by the U.S. Food and Drug Administration (FDA) (see last week’s essay, “FDA Proposed UDI: A Revolution In Number Assignment”.

The proposed FDA UDI rule requires the use of human readable and at least one AIDC technology to carry the new standardized identifier on all non-exempt devices and/or their packages.  An AIDC technology is a way of encoding and presenting a small amount of information (in this case, the UDI identifier itself, lot number and, in some cases, version, expiration date, serial number, date of manufacture, etc.) so that it can be “read” repeatedly with an extremely high level of accuracy by a low-cost and portable device that can detect and decode the information and present it to a computer system exactly as it was prior to encoding.  Because the FDA UDI identifier would be a numeric or alphanumeric code, it lends itself easily to many (all?) of the AIDC technologies that are in common use today (particularly linear and 2D barcodes and RFID).

In the proposed rule the FDA makes a strong point about not specifying, or even limiting, which AIDC technologies manufacturers (labelers) should use.  Here’s how they define it:

“Automatic identification and data capture (AIDC) technology would be any technology that conveys the UDI or the device identifier of a device in a form that can be entered into an electronic patient record or other computer systems via an automated process.  AIDC technologies most often use bar codes, RFID, or near field communication, but this rule does not specify the technologies that may be used and does not prohibit the use of any particular technology.  We believe it is best to leave decisions concerning the selection and use of any particular AIDC technology to issuing agencies, the labeler, and the health care community in order to avoid unintentional interference with the development and adoption of new and improved AIDC technology.”

This is somewhat counter to the thinking I expressed last fall in my essay “Should Regulations Dictate Technology?” where I discussed this same issue as it relates to drugs:

“…I think it is laughable to think that the FDA’s [linear barcode] mandate [in 2006 for drug packages] would stifle technical innovation as some did back then.  What that ‘technical innovation’ would have led to if that argument had been embraced by the FDA back then is significantly reduced efficiency in handling drugs by distributors, pharmacies and hospitals who would have been forced to deploy multiple [AIDC] technologies and multiple business processes to deal with every “innovation”—or whim—that drug manufacturers would have chosen to invest in.

Now that some time has passed and regulatory needs have evolved, with this new review [of the 2006 FDA rule that mandated linear barcode on all drugs] the FDA can let the industry help them determine if some alternate technology has some important benefits that linear barcodes do not have.  Considering that we are now looking at the need for serialization within the U.S. [pharma] supply chain because of the California pedigree law and potentially a new Federal law, a new carrier technology to replace the linear barcode [on drugs] seems quite timely.

Just like it did with linear barcodes [on drugs] in 2004, the FDA should now select a logical new carrier technology and mandate it, giving [drug] manufacturers at least two years to deploy the necessary system changes.  But once the new carrier technology mandate goes into effect, every [drug] manufacturer must use the same, single carrier technology on all saleable units.  That way the downstream supply chain organizations can invest in a single technology to read the NDC and perhaps the serial number, lot and expiration date (if so mandated now or in the future).

It is the movement by the industry in unison that is the real benefit of carefully mandating a single technology for identifying drugs in the supply chain.  It is the key to maintaining and even improving supply chain efficiencies.”

However, given the wide diversity of medical devices compared with drugs and their packaging, I’m a little more inclined to agree with the approach that the FDA has identified for UDI AIDC technologies.  As long as every device manufacturer and repackager selects non-proprietary AIDC technologies that are in line with current recommendations by the FDA-accredited issuing agencies (probably organizations like GS1, HIBCC and ICCBBA), and downstream stakeholders (like distributors and hospitals), I hope we won’t see a proliferation of many wildly unique technologies being used.


On the other hand, I guarantee you that this stance by the FDA is already exciting all of the bizarre AIDC technology innovators out there and all each of them need to do is convince a single device manufacturer to use their proprietary technology to encode the UDI.  And who can complain?  FDA isn’t going to limit it.  GS1, HIBCC and ICCBBA can’t enforce either.   With that, every downstream organization  in the supply chain would have to pay the “innovator” to buy their proprietary reader and then juggle it at each stop in the supply chain and at bedside along with the barcode reader and RFID reader(s) that will be needed for everything else.

Q:  Nurse to supply manager, “Which one of these readers do I need for this version of this medical device for this patient?

A:  “I don’t know; just try each kind of reader until you get some kind of a read.  If all that fails, try your personal cell phone.  Maybe it’s one of those!”

Don’t get me wrong.  I’m definitely not opposed to technical innovation.  I just see great value in an arbiter who has the clear authority to differentiate between what constitutes true innovation and what is just “$$innovation$$” taking into consideration the complete set of uses of AIDC in the supply chain.

Who will be the innovation referee?  Who will be the technology gate-keeper to the supply chain?  Not the issuing agencies, not HDMA, not NACDS, not the hospital Group Purchasing Organizations (GPOs), and now, not the FDA.

I get why the FDA doesn’t want to be the arbiter of innovation.  They may feel like they aren’t really qualified, and they are probably tired of people from the AIDC industry complaining that their regulations are way behind the curve.  But I’ll bet they don’t hear that from companies that are further downstream in the supply chain.

Do you have an alternate view?  Who/what do you think will end up limiting the AIDC technologies once the FDA doesn’t?  Don’t think we need an “innovation referee”?  Think we need more innovation in AIDC used on FDA regulated things, not less?  Let’s hear it.  Please leave a comment below and convince me.  I still have an open mind on the issue.


2 thoughts on “FDA Proposed UDI: AIDC Requirements”

  1. The problem with “non-proprietary” AIDC marking schemas are they are in the public domain and can be copied with ease. The FDA requirement for UDI is that it be “unambiguously unique” Anyone can follow GS1 instructions to create a DataMatrix AIDC. It is a free how to playbook.

    But, DataMatrix marks cannot be applied to ALL instruments because of their limitations on curved surface. Furthermore the quiet zone requirement associated with those marks consumes considerable “real estate” from the instrument which when combined with the curved surface limitation, effecively makes it “extraordinarily difficult to read”.

    Today the world’s two largest instrument manufacturers use DataMatrix to identifify their product. They admit it is only applicable to 70 -80% of their devices. I doubt the FDA will grant “not technologicaly feasible” exemptions for all of them.

    SignaKey has a proprietary AIDC that can mark even the most curved surfaces with a 85% ECC with no quiet zone restrictions.

  2. I was involved with this issue a few years back while at Walgreens and have been away for awhile. But, in answer to the question Dirk poses above on who the “innovation referee” should be, seems to me a good place for this may be “VICS” Voluntary Interindustry Commerce Solutions. Their mission is: “VICS’ vision for the future is a world in which products move through the Global Supply Chain, seamlessly and efficiently, maximizing value for manufacturers, retailers and suppliers. To achieve this, we engage communities of interest to sit in open, safe forums to develop standard business guidelines based on real-world needs and processes.” These are the folks that made EDI a reality many years ago.

    Just a suggestion.

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