The bill to mandate unique IDs for medical devices is expected to be signed into law as a part of a Food and Drug
Administration bill currently making its way to President Bush's desk. I've not read the bill, but this is what supporters contend:
Modernization Act portion of the FDA Amendments Act of 2007, would
enable universal tracking and easier location of products in the case
of a recall, say supporters of the provision. It would also allow
hospitals to better compare products in specific categories.
Since all medical devices (except things like, you know, tongue depressors) already require unique serial numbers, and furthermore all medical device vendors are required to maintain a device history file for each medical device, I don't see how this legislation will improve tracking or recall of devices. And enabling hospitals to “better compare products in specific categories” seems like fantasy.
for some manufacturers. “One of the complications the FDA will have to
face is that medical devices include everything from Band-Aids to very
complicated implantable devices,” said Joe Pleasant, chairman of the
Coalition for Healthcare eStandards–an advocacy organization that has
worked with the FDA on the issue. “I think what the agency may try to
do is say requirements will be different depending on the class of the
The potential benefits that I've heard suggested from this are all dependent on the creation of an industry wide numbering scheme ($$), electronic systems for vendors to track products and issue/manage recalls ($$$), and similar systems for each medical device user so that device usage can be tracked and reconciled with vendor data ($$$$$).
Now these are laudable goals, but somebody – I mean besides those who envision profitable new business models out of all this – should evaluate how realistic all of this is and what any return on investment might be. Oh wait, the FDA's already done this.