X-Message-Number: 4964
Date: Wed, 11 Oct 1995 08:02:45 -0700 (PDT)
From: Joseph Strout <>
Subject: FDA restrictions loosening?

Hi Mike,
	
	I remember your (justified) anger about the mechanical CPR aid 
which you claimed could never be approved in the U.S., because FDA 
requires informed consent, and patients in cardiac arrest are seldom able 
to give it.  So I thought of you when I read a blurb in Science yesterday:

	Apparently, experimental devices can be used in life-threatening
situations without informed consent if special permission is given by an
institution's review board.  This has been fairly rare and atypical in 
the past, but new guidelines being proposed should make it easier.  (It 
is interesting to note that the example described in the article involved 
cooling head trauma patients to reduce ischemic damage.)

	I don't have the article in front of me, so I apologize if I have 
misrepresented anything, but I'm sure you'll want to read for yourself 
anyway.  Would these new guidelines offer hope for getting the CPR device 
approved?

-- Joe

,------------------------------------------------------------------.
|    Joseph J. Strout           Department of Neuroscience, UCSD   |
|               http://www-acs.ucsd.edu/~jstrout/  |
`------------------------------------------------------------------'


Rate This Message: http://www.cryonet.org/cgi-bin/rate.cgi?msg=4964