I started the "thread" on oscillating ventilators/FDA.
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. 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.
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.
Joanne Kocourek
The University of Chicago
jskocour(AT)midway.uchicago.edu