>In other words, EVERYONE is "in" unless they specifically opt out!
>
>I wonder how many people know of the availability of such bracelets and exactly where to get them?


Alternative scenario:

a little girl is hit by a bus. she's lost a lot of blood. the ambulance has arrived. the medics note they she doesn't have a bracelet.

in this alternative scenario, only those with a bracelet can receive the PolyHeme.

the little girl is then rushed to the hospital for a real blood transfusion. she hast lost too much blood and doesn't receive the new blood in time.

she dies. all the while, PolyHeme sat in the ambulance.


I see a bigger problem with the alternative problem than with the situation as it is.

Here's a PolyHeme FAQ I found:

http://irb.ucsd.edu/notices/polyheme/FAQs.htm

Thanks for pointing this out. It is an interesting technology.

But I can not find fault with the related FDA policies as you have.