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Do bar codes hold promise for medical devices? Could their use reduce medical errors, speed up product recalls, and bring efficiencies to inventory and billing? While most would answer yes to these questions, not everyone feels that such codes are worth the costs of implementation.

AdvaMed, the Advanced Medical Technology Association, argues against mandatory requirements for bar coding medical devices. Recent calls for bar code rules, such as the one voiced by Premier Inc. and other hospital purchasing groups, "demonstrate a fundamental misunderstanding of the nature of medical devices and... fall far short of justifying the enormous cost of such a requirement," wrote AdvaMed's Janet Trunzo in a letter to FDA May 19.

Trunzo correctly points out that medical devices comprise a diverse group of products. Tongue depressors and implants are both considered medical devices, yet they are couldn't be any more different in terms of technology, risk, and cost. One universal requirement may not take into account the special needs of each.

Also, medical devices may not be subject to the same sort of mix-ups that drugs can be. "There is a well-documented problem: the misadministration of drugs due to similarity in appearance and name," she writes. "There is a dearth of literature which identifies the application of bar codes on medical devices as a as a means go improve patient safety." These points are hard to dispute.

But in saying that FDA’s bar coding rule for drugs makes better sense, Trunzo paints too simple of a picture for drugs. "Drug packaging is relatively uniform lending itself to the application of bar codes," she writes. Even if that statement were true, it doesn't mean that a more-complex system of packaging is reason enough to forgo bar coding.

But we know that the packaging of drugs in the United States does not follow one universal model. Consider, for instance, the diversity in drug packaging. Drugs are supplied in bottles, vials, ampules, blisters, pouches, strips, tubes, and syringes, for instance. Printing bar codes on all these packages is proving to be a challenge. In addition, drug companies are also weighing whether or not to supply products in hospital unit doses (HUDs), a significant leap in packaging technology for many companies.

Rather than comparing apples to oranges - or, rather, medical devices to drugs - medical device firms should be asking themselves, Would bar coding make my product safer? If the answer is yes, the cost may be worth it.

Daphne Allen

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