Last year when everyone was screaming they need ventilators a number of doctors and nurses were saying the ventilators were killing people. They only push the air in and the patient wasn't able to push the air back out. They said a C-PAP machine would be better since it sucked the air out. These docs and nurses were in NY and supposedly they were mandated to use the ventilators.
Vince.
toggle quoted message
Show quoted text
On 04/27/2021 06:38 PM, Gordon Gibby wrote: I¡¯m not an ICU doctor, and I¡¯m retired, but watching some of the
presentations recently have brought out some rather fascinating insights
People tend to die when they¡¯re put on the ventilators. One possible
reason is that oxygen is really bad in many ways for this disease. It
allows continued destruction of lung tissue and decreases systems in the
body that tend to control an out of control immune response
It was observed that people may do better if you use the most modest
amount of oxygen possible.
They called them happy hypoxic¡¯s. Blue as all get out but still doing OK
So in retrospect some of the things we have done will eventually turn
out to be counterproductive
This is a really bad disease for overweight people, a situation that I
resemble.
Another interesting factor seems to be that Africa is doing
astonishingly well. Why ??? There¡¯s something important there. Does
it have something to do with anti-malarial¡®s?
There has been an awful lot of political interference with just giving
medical care in the United States. I am astonished at how some people
behave.
Such is life. I¡¯m also studying the impact of Stalin. never knew much
about the guy. Learning a lot now.
On Apr 27, 2021, at 18:09, Arv Evans <arvid.evans@...> wrote:
?
Thanks Gordon. That clarifies a lot. Next question: Are cheap
ventilators
still needed...in the US, in India, or elsewhere?
What is the next step...if any?
Arv
_._
On Tue, Apr 27, 2021 at 3:50 PM Gordon Gibby <docvacuumtubes@...
<mailto:docvacuumtubes@...>> wrote:
Well let me see if I can straighten a few things out.
I¡¯m not completely sure about the website not being updated but I
think we had to freeze the design and there was some concern about
some thing about you can¡¯t release stuff outside of your release
to the FDA?
We had a outside group advising us on how to present material to
the FDA. In retrospect, I think we made some wrong turns there.
I wasn¡¯t really in charge of that aspect but I would have urged
for much earlier telephone calls to and from the FDA
representative to straighten out exactly what they wanted. There
was a lot of concern expressed by others that any conversations
with the FDA would just lead to mountains of additional
documentation required.
I don¡¯t think the actual events support the conclusion at all. I
may be wrong, but I think dad and I and others developed features
that the FDA simply didn¡¯t want and eventually had to be stripped
out to get it down to the simple thing that the FDA did want, and
that cost us precious time.
Acting on a guess as to the FDA¡¯s desires there was a choice to
try to find a manufacturer which I think hurt us badly. Again
here I think if we could do it over again we would have spent more
time just talking to the FDA and less time guessing their requests.
The major problem with the submission was that we had to jump a
lot of hurdles merely to find all of the standards that they
wanted us to certify compliance with. I screamed loud and hard
that we couldn¡¯t do anything without those standards document¡ª A
lot of the standards organizations charge a ton of money in order
to make money for themselves but one of our group was able to
discover ways to get us just about every standard we needed.
Oh my heavens above, I spent hours and hours reading these
standards and answering really simple and stupid questions about
our certification to those.
My background included both medicine and engineering, so I was
able to answer things lickety-split. others in the team were much
more cautious, overly so I believe, and moved much more slowly to
answer the reams of questions that we had to answer in the
certification questions.
Again, my observation of the FDA was that they actually were
bending over backwards, but the delays that our team sometimes
caused themselves due to overcautiousness, pushed us past the
initial Histeria and the final submission did not occur until
people were much less interested.
It¡¯s just my opinion but had we known that we could talk much more
freely with the FDA people, I think we would not have done much of
the exotic development that I personally did and we would have
submitted a much simpler design six weeks earlier and gotten it
approved. We were just operating in the dark. None of us had
ever dealt with the FDA before and people were terrified.
There was a huge problem that I tried to tackle that we had zero
legal protection for our volunteer developers and since most of us
no longer worked for the University of Florida, we were going to
be left hanging in the wind. I put a several day stop to the
work until the lawyers gave us some legal protection! Never
again will I begin a project for a university without demanding
legal protection from the get-go. The lawyers at UF actually did
Hercules an effort to get us protection, but they actually had to
run background checks on the list of people that I submit it,
because they were concerned for legal liability if they offer
protection to a known felons!
They did all of that in the background and got that back to us
within I think two or three days. I was very impressed and I think
in the end those lawyers deserve a lot of appreciation. It was
our stupidity to begin without having these legal items taken care of.
We had a wide range of skills working on this project. Some people
had vast experience covering lots of different areas, and others
were much more narrow in their expertise. The incredible hysteria
over the virus caused huge problems for us, with University of
Florida refusing access and refusing some persons even to be on
campus to work on this project. Some fairly surreptitiously
activities took place to try to get this project moved forward.
The number of people who stood up to help us is just
extraordinary. I was on the campus, and even much more so over
the Internet.
In the end, I think the FDA created a rather difficult system, but
had we more experience dealing with them I think we could¡¯ve
gotten through it six weeks earlier and had a big success.
On Apr 27, 2021, at 15:59, Jack, W8TEE via groups.io
<> <jjpurdum@...
<mailto:[email protected]>> wrote:
?
Arv:
Off topic, but one of my grad school buddies took a job in DC at
a small agency. A few months into the job, the director of the
agency came around and told everyone to let the "In Box" stack up
for the next few days. A few days later they had a "surprise
audit" by the GOA. The director took the opportunity to plead for
more workers because, as they could see by the In Boxes, they
were swamped. He got more workers.
When I asked why (remember we were econ students), he said:
First, there is zero reward to being efficient. Second, your
position on the DC Social Ladder was a function of how many
people you managed. The unimportance of efficiency is not unique
to Capitalism. My Comparative Systems prof spent two years in
Russia and became close friends with a Soviet bureaucrat who ran
a major rail line. When he was coming close to the end of the
current Five Year Plan, he was extremely short of his metric
ton/miles quota. No problem. He loaded up 400 gondola cars with
rocks and ran them back and forth between Moscow and Vladivostok
until he surpassed his quota. He was rewarded for exceeding his
quota.
I think there is a lot of similar crap going on in DC.
Jack, W8TEE
On Tuesday, April 27, 2021, 3:46:39 PM EDT, Arv Evans
<arvid.evans@... <mailto:arvid.evans@...>> wrote:
Jack
Maybe Pogo was right "*We have found the enemy, and he are us!*".
After all the FDA as a government entity is just the government
employees that we hired to do things in our name! 8-) 8-)
Arv
_._
On Tue, Apr 27, 2021 at 1:35 PM Jack, W8TEE via groups.io
<> <jjpurdum@...
<mailto:[email protected]>> wrote:
Arv:
I really don't know. All I know is that things were
progressing rapidly and I know Gordon had one working on his
coffee table! Then everything was turned over to the U of F
team so they could take care of all of the paperwork. After
that, the web site literally died. The last post that I have
saved was back in September. It probably didn't help that the
UF team's leader got frustrated with the rest of us and quit
"to write game code". His absence may have hurt the effort in
FL. Perhaps Gordon knows more...
Jack, W8TEE
On Tuesday, April 27, 2021, 3:20:43 PM EDT, Arv Evans
<arvid.evans@... <mailto:arvid.evans@...>> wrote:
Jack
Seemed that things died just after being submitted to the
University
of Florida. Was this killed by the FDA, or by the University
of Florida?
While it doesn't matter much now, it could be that politics
and funding
in academia contributed to the project's demise.
Might there be interest in India in taking over the project
(and willingness
at the University of Florida to release the information) so
that they (India)
could build their own ventilators?
To comment on an earlier comment...It only seems like the US
is the first
to be ask for help, but that is because our view from the US
makes it
seem that way. When anyone needs help the US politicians
automatically
give press conferences that make it seem like they are going
to do
something. But it rarely happens, is too little, too late,
or nothing happens.
If you observe this from a different country the view is
quite different.
Been there, done that.
Arv
_._
On Tue, Apr 27, 2021 at 11:36 AM Jack, W8TEE via groups.io
<> <jjpurdum@...
<mailto:[email protected]>> wrote:
Bob:
I've read back through the posts and did not find anyone
who said the FDA prevented other countries from using the
ventilator developed here. I am the owner of the
Ventilator group site you mentioned and worked with
Farhan and Gordon on the ventilator. Things moved along
quickly until the design was sent to the U of F medical
team who were preparing the documents for FDA. Somewhere
in that process, everything just died. I still think
glaciers move faster than the FDA on almost everything
except budget requests. If other countries want to use
the ventilator, seeing a "waiting for FDA approval"
whether they need it or not, is still an impediment. With
tens of thousands of people dying worldwide at the time,
I do not understand why FDA couldn't kick itself in the
ass and get things done.
--
Jack, W8TEE
--
Jack, W8TEE
--
Jack, W8TEE
--
K8ZW
|
