Ahhh, yes.... I remember writing you about a child parents that might be
looking to talk to another child about being vented.
>We actually use a negative pressure Hayek Oscillator at home for our
>daughter Kristen. It ventilates VERY effectively! The difficulty is the
>unit weighs 110 pounds and can not be easily transported to and from
>school. The manufacturer has an application in to the FDA for approval of
>a homecare size model of the ventilator that weighs 23 pounds. Our (the
>doctors) goal is to have Kristen attend school a full day. This will only
>be possible with ventilatory support at school, hence the need to obtain a
>portable unit. So, I need to petition the FDA to allow us to use a
>non-approved ventilator.
First, I'm still perplexed about the vent your daughter is using. I thought
that oscillating vents were only used by infants, or someone one step away
from ECMO. ????? Can you fill me in why a positive pressure unit will
not work?
Second, good luck on any quick approval on this. Of course, I'm sure it's
already in the works. But, as you know the FDA is extremely slow on just
about everything. But, this administration has been doing some good on
cutting the red tape, and we might get up to speed with the rest of the
world someday.
Another problem here is the medical industry itself. But, the HFOV is being
accepted much better then the jet ventilators. Most people were never put
on those until they were just about dead. Many could have made it through
their problems had doctors been more recepted of new technology.
Oh yes, there is another big problem, and that is with HFOV's themselfs.
There have been many reports showing that these vents can have problems with
ramdom radio frequencies. This would of course be a bigger challenge for
vents that have these problems on a portable usage.
> If the request is denied then I will have to give
>serious thought to diaphragmatic pacing which in the CCHS population is
>frought with morbidity. Not a great option.
I studied up on this years ago when it was first successfully being done by
someone in Virgina? I might be in a void on this, but I have heard very
little of it since. I would like to check out the long time usage of this,
nerve burnout? etc.
>The hard part here is learning what I have to do to petition the FDA for
>compassionate use of the homecare unit. The pray for approval of the
>petition.
Boy, that sounds like a tough nut to crack on your own. I would suggest
backing up the efforts of those that have a more vested interest in these
vents. (Yes, sad to say $$$$$$.) They of course have some experience with
this, or get the people that have been around the block already.
Ed