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.
Copyright ©2002 Medical Device & Diagnostic Industry
