The Medical Device Industry Searches for Identity

Originally Published MPMN September 2006

EDITOR'S PAGE

The Medical Device IndustrySearches for Identity

In an effort to make sure that patients are getting the right drugs at the right times, FDA requires all pharmaceutical manufacturers to use bar codes on their medications sold to hospitals. Simply by scanning the bar code, potential life-threatening mistakes may be avoided.

Now FDA wants to find out if requiring the use of unique device identifiers (UDIs) would be a good idea for medical devices. The agency is seeking public comment on how the healthcare industry can benefit from their use.

Andrew von Eschenbach, FDA’s acting commissioner, says: “It is essential that we monitor the performance of medical products after they are approved and make sure that we quickly discover any potential problems that might arise.” He says the agency is focusing more attention on the kinds of systems and processes needed to do this.

Daniel Schultz, director of FDA’s Center for Devices and Radiological Health, says UDIs may help in reducing medical errors, facilitating device recalls, and improving medical device adverse-event reporting. They may also encourage cost-effectiveness by improving delivery and supply-chain efficiency.

But should the model that the pharmaceutical industry employs be used for medical devices? Stephen Ubl, president and CEO of AdvaMed, doesn’t think so. He says that because medical devices are so diverse, adoption of any standardized rules should be voluntary.

He says UDIs “should only be required where there is a clearly defined patient-safety issue to be addressed, as was the case with the mandatory bar code rule for drugs.” Certain situations in the pharmaceutical world do not apply to medical devices, Ubl says. “In [the pharmaceutical] case, there is a well-defined problem: confusion between similar-sounding drug names, similar packaging, and limited shape and color differentiation between drugs, which has led to numerous drug administration errors. These types of problems generally do not exist for medical devices.”

But medical devices have their own problems. In its Request for Comments, FDA cites the example of sterile and nonsterile implants. Some of these products are shipped sterile and some are shipped nonsterile because the hospital plans to sterilize them prior to use. This could cause problems in the hospital due to errors in distinguishing between the two. UDIs could help users choose the right product.

Another example the document cites is that of devices that are not intended to be used together, such as certain implants and MRI systems. A UDI could identify compatibility issues.

However, maybe the question shouldn’t be whether to use UDIs, but which types and how. According to Brad Sokol, already about 50% of all medical device manufacturers are incorporating RFID into their products. Sokol is the author of an industry study, RFID & Emerging Technologies Guide to Healthcare.

The agency is seeking public comments until November 9, 2006. You can let FDA know what you think by going to www.fda.gov/dockets/ecomments.

Susan Shepard, Managing Editor

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