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Re: [IP] FDA stops sale of insulin pumps, paperwork why!!!

>     This is a bad thing to stop people from getting a pump over a paperwork
> problem. There is NOTHING medical wrong with the disetronic pump, why does
> the FDA stop the sale of a pump .... over a paperwork problem... so  fine
> them some money and tell them to fixed the paperwork.

DISCLAIMER- This is a statement of my beliefs, based on my limited
experience in the Medical Device Industry.  While I have tried to keep it
relevant to diabetes and pumps, I can anticipate that it might spark
conversations better held in other forums.  Please consider before
replying to the entire list, or just to me.

Thanks in Advance,

	I work in the Medical Device Industry, and in fact, my job is to
keep the paperwork happy for the FDA (so that they don't hold up our
products on the way to market.)  While it may seem stupid and petty in
some regards, I actually am /GLAD/ to know just how everything had to be
documented in full detail before the FDA would allow a pump to be
sold.  Letting things "slip" is simply not acceptable.   What if no one
noticed that in some meeting months and months ago, someone mentioned that
a certain assembly needed further testing, and somehow it never got
followed up?  I know it's a pain in the neck for the manufacturer (I'm the
one who actually DOES this part of the work for my department, and it's no
fun.)  But in the end, our entire company can have confidence that we have
followed up every problem, dotted every "i" and crossed every "t", in
order to insure that any patient or doctor who relies on our devices
receives an instrument that is well thought out and developped.  These
devices to which we trust our lives are very complicated, and the only way
to communicate all the details is through a paper trail, simply
"trusting" that all the engineers remembered to think through and discuss
every detail involved is not enough.  It's not enough for the FDA, it's
not enough for me, and I hope it's not enough for you.  Yes, the red tape
is annoying.  The delays are frustrating.  But ultimately the FDA's job is
to insure OUR safety in areas that we cannot see to judge.  I would rather
that they be over-zealous on my behalf, than fail to catch what could be a
fatal problem.

(stepping down off her "queen of the engineering documentation
files"-soapbox now....)

Jessica Marder
email @ redacted
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