Medical Devices: A Nickel a Name

Originally Published MDDI January 2002

EDITOR'S PAGE

Medical Devices: A Nickel a Name

The new global medical device naming system is a welcome idea, but its cost may scare off manufacturers.

One of the mantras frequently heard during the dot-com mania was "Information Wants to Be Free." Undoubtedly that philosophy played not a small role in the demise of many an Internet enterprise. Strange as it may seem today, two years ago a lot of investors believed you could make gobs of money by giving away your product or service for nothing.

Most of us have returned to our senses, but there is still a problematic allure to the concept of free information. Although Internet companies now want to charge users for everything, many of their customers don't want to pay, and don't feel they should have to. So the struggle is to find a balance between free and paid information.

A similar issue has been a small but persistent thorn in the side of manufacturers for many years. First they are told that there is some universal set of standards to which their processes and products must comply. Then they are told how much they have to pay to get copies of those standards. Overall, the sums are small, and there is no disputing that standards development is expensive. But doesn't it seem a bit wrong that you can't find a copy of ISO 9000 on the Web?

FDA ran up against this issue several years ago when it considered adopting the ISO 9000 standards as its new quality system regulation. One of the reasons the agency demurred was the fact that the ISO standards are copyrighted. Since government documents are not copyrighted, and therefore freely distributed, such an approach was problematic at best.

The agency is now expressing a similar concern about the new Global Medical Device Nomenclature, or GMDN. The goal of this naming system is to develop a universally accepted way to identify medical devices. It's a great idea, and FDA has been an important partner in the development process. The system should be valuable not just for regulatory purposes, but for trading, tendering, inventory, and similar commercial functions.

Now the agency is reportedly ready to phase in the new system as a supplement to its current naming scheme. Eventually, the GMDN would completely replace the current system.

The only problem, however, is money. Like other standards, the GMDN, also known as ISO/TS 20225, is copyrighted and will cost manufacturers money to obtain. FDA is worried, it seems, that this could prevent small manufacturers from accepting the system.

We did a quick search for a copy of the GMDN documents and found a CD-ROM for sale by one standards organization for the equivalent of $430. There are about 7000 primary terms in the system, which works out to a little more than a nickel a name. Viewed in this light, that's a real bargain. But having to buy them all at once is not if you only need one name.

We don't begrudge standards bodies their right to recover the costs of developing these standards. But if this were an ideal world, they would consider another Internet idea that's regaining popularity— micropayments. If you are only charged for what you use, who could object? Somehow, though, we have the feeling that this may be another idea whose time will never come.

The Editors

Copyright ©2002 Medical Device & Diagnostic Industry