I think the issue here is patient safety for medical
DEVICES.
I was griping about this issue to a friend of mine who
works in IT in a hospital. He is familiar with the
FDA regulations. He told me a story that gave me some
perspective. Perhaps its an urban legand, but I don't
think so.
At one point, a radiation therapy equipment vender was
trying to change from a hardware control system to a
software control system for one of its machines. For
awhile they use a software method with a hardware
backup. It seemed to work great. Occasionally the
equipment would freeze up, and the users would simply
reboot. The vender apparently didn't realize this was
happening. Then the day came with they removed the
hardware backup controls and went to software only.
Not long after, the machine encountered a software
glitch and delivered a lethal dose of radiation to a
patient, who subsequently died.
I turned out that when the machine was freezing up, it
was a conflict between the software and hardware
controls. But the real moral of the story is that
software is an integral part of the functioning of a
machine. The FDA *SHOULD* regulate such machines for
patient safety.
Now, in our situation, we are trying to take that
machine and turn it into a toaster, or web browser, or
perhaps part of a non-radiology software package. It
would be unreasonable for the FDA to evaluate all
these non-devices use of the brains of their regulated
software. My guess is that if someone took the
imaging software and used it in a means that was not
connected to a DEVICE, that they would be able to
defend themselves in court.
But is it worth it? Why don't we just develop another
option? I have found a way to imbed a web browser in
CPRS so that it will fetch any image referenced in an
HTML-formatted note. If someone would work on the
scanning end of things (which I don't think is part of
VistA imaging anyway), we would be all set.
Just some thoughts.
Kevin
--- Thurman Pedigo <[EMAIL PROTECTED]> wrote:
> This seems to have become dysfunctional. Is
> PaperPort FDA approved?
> Practices, including mine, use it all time (have for
> years) to store paper
> copies. Perhaps the FDA issue IS overblown as is so
> common with HIPAA. What
> we need is capability to store (and effectively
> retrieve) a PDF, or other
> acceptable standard. Perhaps the standard needs a
> sledge.
>
> thurman
>
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