ShahidSha

There's a new link in the Blogroll on the right nav bar to the web log (blog) of the health care IT guy, Shahid Shah. Shahid's posted some interesting things about software technology in health care. Check him out.

Last week Shahid picked up on a some FDA news that I missed (conferences tend to do that to me). It seems that Utah Medical Products
sued the FDA over a dispute as to whether Utah Medical was operating in
compliance of the FDA's QSR (Quality System Regulation) or not - you
might guess that the FDA's position was that they were not. Anyway, the
big news is the ruling handed down by Judge Bruce S. Jenkins in favor
of Utah Medical, against the FDA. You can
read Utah Medical's press release on the ruling here. From the judge's opinion:

The safety of the products manufactured by Utah
Medical has never been at issue. Even though product safety is a non-issue,
the relief originally sought by the United States was to stop Utah Medical’s
products from entering commerce because of alleged persistent deficiencies
of Utah Medical in complying with the applicable quality system regulations
(21 CFR § 820), and asserting that a failure to comply by definition
produced an adulterated product and subjected the product and the persons
responsible for the product to regulatory action. In short, the United
States asked that Utah Medical be ordered to stop the sale of product until
Utah Medical complies with the regulation 21 CFR § 820 and in a manner
that has been found acceptable to FDA.
[Emphasis in the press release.]

The basic regulation proscribes a process that vendors must
follow that is intended to ensure the quality of resulting products.
The FDA typically provides considerable flexibility in how the process
is implemented. Flexibility in how one implements the process is
critical given the many types of products that full under the
regulation - from drugs to artificial joints, patient monitors, and
software. After years of implementing the QSR in a very specific way
for medical devices, many device vendors seem to forget they have the
option to use a different approach when it comes to connectivity
features based on general purpose computing technology. This results in
unnecessarily long times to market with higher product costs. External
symptoms include device vendors manufacturing their own personal
computers, the inability to apply Windows operating systems patches in
a timely manner, and other silliness.

Having developed large scale software applications in compliance with the QSR, Shahid offers some interesting observations on the above ruling.