Can a medical device that costs pennies actually end up costing a hospital thousands of dollars? Perhaps. Consider this scenario: “Using latex gloves as an example, with 50 distributors each assigning their own item number to each box of latex gloves, and 50 medical treatment facilities (MTFs) receiving the product and each assigning their own item number to it, there could be 2500 different item numbers for the same product.” In this scenario, the hospital surely wastes money managing inventory.

Eastern Research Group Inc. (ERG; Lexington, MA) painted this picture for FDA in its “Final Report: Unique Identification for Medical Devices,” issued in March 2006. FDA recently cited this report when it invited the medical device industry to describe how a Unique Device Identification (UDI) system may be used for medical devices. Can a UDI for devices improve patient safety, FDA asks?

ERG presents the glove scenario in its discussion of tracking solutions devised by the U.S. Department of Defense (DoD). Apparently when it was centralizing its purchasing functions, DoD’s Defense Personnel Support Center encountered the following:

• Duplicate identifiers for different items.

• Costly maintenance of cross-reference tables.

• An inability to filter all product identification errors on documents transmitted by the MTFs, which in turn created other problems, including delayed payments to vendors.

To eliminate these inefficiencies, DoD began requiring that “all packages bear an industry standard bar code, down to and including the single-unit package,” reports ERG. DoD refuses to purchase items not in compliance.

Elsewhere in the report, ERG discusses UDI’s potential to improve error reporting. “A recent Harvard study of drug administration errors by nurses in their cardio-thoracic-surgery intensive care unit found that nurses routinely bypassed danger alerts and drug libraries as much as 25% of the time,” ERG writes. “As much as 8% of the time nurses gave medications without having a documented order. It’s conceivable that if nurses are making errors with simple procedures such as the administration of medication, that these errors are also occurring with the use of devices, especially those that are difficult to use.” UDI could provide the necessary data to identify solutions to such problems, ERG concludes.

But is a bar coding rule, similar to that enacted for drugs, needed for medical devices? Industry groups like AdvaMed and the Medical Device Manufacturers Association oppose a mandated UDI. They point to the “enor-mous diversity of medical devices,” writes ERG.

But it is simply that diversity that could trip up a voluntary UDI system. If firms are left to decide when and if to bar code as well as to determine code symbology and data structure, there may just be an enormous diversity of medical device identification.

Before you write FDA (comments are due within 90 days of FDA’s August 11 Federal Register notice), check out the work being done by GS1global Healthcare User Group (HUG; www.gs1.org/hug). It is no accident that the group’s fourth meeting was hosted by Medtronic and that the fifth and sixth meetings will be hosted by Tyco Healthcare and B. Braun, respectively. The group is working to standardize the automatic identification of all medical products. Law or not, bar code standardization is key to easing product identification at hospitals around the world.

Daphne Allen
Editor