FDA/Compassionate Use
Joanne Kocourek (jskocour(AT)midway.uchicago.edu)
Mon, 18 Aug 1997 07:30:13 -0600
Has anyone ever petitioned the FDA for use of a non-approved (application
for approval submitted) ventilator? If so, please tell me how to do this?
WHo do I write? What supporting documentation do I need? We are desperate
to obtain use of the Hayek "homecare" Oscillator by Breasy Medical.
Kristen successfully uses the large hospital unit now, but it weighs 110
pounds and can't travel to school. With the "homecare" size unit she could
attend school all day. If this unit is not in our home by spring the docs
want Kristen to be supported with diaphragmatic pacers (a system frought
with morbidity). So, our physician has advised that I can/should actively
seek use of the vent on a "compassionate need" basis.
Joanne Kocourek
The University of Chicago
jskocour(AT)midway.uchicago.edu