The FDA published a white paper
written by ECRI on the automatic identification of medical devices. You
may recall calls for the FDA to require barcoding of medical devices
like was recently required for drugs (here, here and here).
Congressmen, nonprofit associations and GPOs raised a clarion call to
barcode medical devices to improve patient safety. Legislators even
directed the FDA to provide a formal response.
This white paper is the FDA's response to calls to extend automatic
identification to medical devices. There are two key problems to calls
to barcode medical devices. First, Mike Dempsey of Radianse pointed out
that mandating a technology (barcodes) would work for some medical
devices and not at all for others. Second, as ECRI points out in the
white paper there is no research demonstrating that patient safety
would benefit due to the auto identification (unlike the research
that's been done with meds). So it seems there's some work yet to be
done before the FDA feels mandatory auto identification of medical
devices is justified.
[Hat tip: Biomed Listserv and William Hyman]