Problem Identified, So Why Is Identification a Problem?

Do your eyes hurt yet? Mine do. (My fingers would have hurt, too, had I not copied and pasted this list directly from FDA’s weekly Enforcement Page.)

Seeing these serial numbers made me realize just how challenging recalling items can be. Imagine cash-strapped hospitals with skeleton staffs trying to fit in quick studies of stock rooms for such human-readable codes. Recalls simply run the risk of being incomplete.

Still not convinced. OK, here are some more serial numbers from the list: 36241, 36242, 36243, 36244, 36245, 36246, 36247, 36248, 36249, 36250, 36251, 36252, 36253, 36254, 36255, 36256, 36257, 36258, 36259, 36260, 36261, 36262, 36263, 36264, 36265, 36266, 36267, 36268, 36269, 36270, 36271, 36272, 36273, 36274, 36275, 36276, 36291, 36292, 36293, 36295, 36297, 36298, 36299, 36300, 36324, 36325, 36326, 36327, 36328, 36329, 36330, 36331, 36332, 36333, 36334, 36335, 36336, 36338, 36339, 36340, 36341, 36342, 36343, 36344. . . .

OK, I will stop. (But you cannot be too mad—I did not include the entire lists.)

Clearly, more-specific automatic identification of medical devices is needed. FDA’s motivation behind Unique Device Identification (UDI), discussed at a public workshop February 12, is to ease recalls of lots or even specific items. As FDA’s senior advisor for patient safety Jay Crowley says in this issue’s Bar Code Supplement, for medical devices, “we need a common understanding and a common visibility. [For instance] there are a lot of device recalls, and we need to be able to do them better—efficiently and effectively.”

Panel speakers and audience members largely agreed. Said one panelist: “Not having a UDI to reference in a recall makes it time consuming.”

One compelling statement came from the audience: “First, do no harm—but providers do—one-hundred-thousand deaths because of errors. Infections, too. And now there is the Medicare loss of coverage [for certain hospital-acquired infections]. We need to scan products to protect patients.”

Debates did emerge over what package levels should be coded as well as over the official nomenclature that would be used to guide UDI activity. One panel member spoke of encoding shelf packs, but Crowley pointed out that FDA doesn’t even use that term.

Listening to and watching FDA’s live feed, I got the sense that stakeholders all understand that recalls are tough to pull off and that patient health continues to be at risk.

We’ve identified the problem—now let’s identify the products!

Daphne Allen

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