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Westy

the teste
Nov 22, 2002
54,715
20,545
Sleazattle
I trash talked their models when they released them but to be fair, I've been pleasantly surprised.


What's terrible is that they're going to need to somehow start incorporating stupidity into what happens this summer and fall. We as a country and some individual states are about to truly show how exceptional americans are. I'm afraid UW innocently built a pandemic model when what we have is a collective country walking around with half its head blown off looking for pringles.
People's [mis]use of masks is fascinating.

The University of Washington just sent out a mass email explaining proper usage, I am grateful of that but shouldn't the government direction to use masks also include instruction?
 
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6thElement

Schrodinger's Immigrant
Jul 29, 2008
16,203
13,473
The University of Washington just sent out a mass email explaining proper usage,bbI am grateful of that but shouldn't the government direction to use masks also include instruction?
They were waiting for someone to give them instructions first.
 

kidwoo

Artisanal Tweet Curator

Pesqueeb

bicycle in airplane hangar
Feb 2, 2007
40,537
17,109
Riding the baggage carousel.

CN: Raoult’s group’s work is pure crap.
That certainly helps explain Trumps relationship with him. Shit birds of a feather.....

I bet Brian will never get Malaria.
 

jonKranked

Detective Dookie
Nov 10, 2005
86,388
24,862
media blackout
"The researchers are clear that Airbreak shouldn’t be used on any device treating a patient suffering from COVID-19—at least not yet. "

Formal V&V is not necessarily needed now for this product based on what has been discovered. A solid planning document, mitigation measures, monitoring plan, and some quick bench testing with a mass flow sensor and pressure sensor and a health institute in need that has the capacity to get this in front of the IRB should be able to get these in use rapidly as more formalized commercial products a dragging behind.

This is all presuming the thing doesn't blow up, but it's a fuggin blower. It's not like rocket science or black magic. Pretty simple stuff really and these findings open up the possibility for fast track use through an IRB approved process. This is a good thing.
this is all going on the viewpoint of the assessment of the firmware and a quick assessment that "oh it does these things" this kind of assessment won't be able to make a determination if there are critical hardware subcomponents missing, things like safety faults/sensors, etc (which given the lower price point, is highly likely), the kinds of things usually identified and required by an FMEA. this would still require more than just a quick benchtop test.
 

Inclag

Turbo Monkey
Sep 9, 2001
2,754
442
MA
this is all going on the viewpoint of the assessment of the firmware and a quick assessment that "oh it does these things" this kind of assessment won't be able to make a determination if there are critical hardware subcomponents missing, things like safety faults/sensors, etc (which given the lower price point, is highly likely), the kinds of things usually identified and required by an FMEA. this would still require more than just a quick benchtop test.
Try if you will to trust me. I have programs that are currently in limbo because MGH has converted all lab space to various types of research and their IRB will not review anything outside of the scope of Covid-19. I appreciate and understand that you have a perspective based on the work you do and I hear loud and clear what you're saying. What I'm saying is that there is a massive amount of leniency at the moment whereby the FDA and IRB'S are permitting devices, parts, PPE, and modifications to exisiting devices to help save lives at the individual institutional level. This has nothing to with FMEA's. This has everything to do with processes, procedures, and parties that are more heavily involved in the preclinical and clinical spaces filling gaps and addressing immediate needs. If an institute's prerogative is to devise a plan to modify some CPAP machines for immediate use, there is the capability and avenues available for them to achieve this with the construct of the current 'rules'. This has nothing to do with developing "products".

CPAP machines, veterinary products, 3D printed manifolds, origami masks using surgical dressing, and other things I've missed have all been fast tracked and approved for use at various institutions throughout this country without a sniff of V&V, FMEA, or being considered a regulated medical device. Think of it more along the lines of IDE exempt or IDE abbreviated procedure for early stage research. Also, don't worry. FDA is working overtime, and if they aren't getting down with what someone is trying to implement then it will need to go through the more traditional product path you are speaking towards.
 

jonKranked

Detective Dookie
Nov 10, 2005
86,388
24,862
media blackout
Try if you will to trust me. I have programs that are currently in limbo because MGH has converted all lab space to various types of research and their IRB will not review anything outside of the scope of Covid-19. I appreciate and understand that you have a perspective based on the work you do and I hear loud and clear what you're saying. What I'm saying is that there is a massive amount of leniency at the moment whereby the FDA and IRB'S are permitting devices, parts, PPE, and modifications to exisiting devices to help save lives at the individual institutional level. This has nothing to with FMEA's. This has everything to do with processes, procedures, and parties that are more heavily involved in the preclinical and clinical spaces filling gaps and addressing immediate needs. If an institute's prerogative is to devise a plan to modify some CPAP machines for immediate use, there is the capability and avenues available for them to achieve this with the construct of the current 'rules'. This has nothing to do with developing "products".

CPAP machines, veterinary products, 3D printed manifolds, origami masks using surgical dressing, and other things I've missed have all been fast tracked and approved for use at various institutions throughout this country without a sniff of V&V, FMEA, or being considered a regulated medical device. Think of it more along the lines of IDE exempt or IDE abbreviated procedure for early stage research. Also, don't worry. FDA is working overtime, and if they aren't getting down with what someone is trying to implement then it will need to go through the more traditional product path you are speaking towards.
oh believe me i have plenty of visibility to things that are fast tracked right now and requirements that are being waived. PLENTY. everyone is assessing anything that could possibly be retrofit, even in my field. i'm talking specifically about this one guy's ready fire aim approach. he's only looking at one piece, not the entire puzzle, and is potentially exposing himself to a lot of liability in the process.
 

Fool

The Thing cannot be described
Sep 10, 2001
2,815
1,545
Brooklyn
So y'all and your neighbors out there cheering for your local front line workers every night at 7pm?

I live on a pretty dense block, and it warms the small, black, 0-kelvin chunk of greasy giblet in my chest ever so slightly to see the turnout of my neighbors making the effort to applaud the overworked, undersupplied (and glob knows unwilling) folks out there serving up your groceries, taking care of your sick-ass neighbors, and loading up refrigerator trucks full of corpses day in and day out while I sit here pumping a bike internet site full of bullshit while I am supposed to be working.

Also last week, the ice cream man was still making the rounds. Today there are police vans circling playing recordings telling people to stay inside, wear masks, don't make unnecessary trips, etc, in the Blade Runner future I never the fuck wanted.
 

stevew

resident influencer
Sep 21, 2001
40,696
9,677
So y'all and your neighbors out there cheering for your local front line workers every night at 7pm?

I live on a pretty dense block, and it warms the small, black, 0-kelvin chunk of greasy giblet in my chest ever so slightly to see the turnout of my neighbors making the effort to applaud the overworked, undersupplied (and glob knows unwilling) folks out there serving up your groceries, taking care of your sick-ass neighbors, and loading up refrigerator trucks full of corpses day in and day out while I sit here pumping a bike internet site full of bullshit while I am supposed to be working.

Also last week, the ice cream man was still making the rounds. Today there are police vans circling playing recordings telling people to stay inside, wear masks, don't make unnecessary trips, etc, in the Blade Runner future I never the fuck wanted.
that government check will be dispensed in tips...
 

6thElement

Schrodinger's Immigrant
Jul 29, 2008
16,203
13,473
So y'all and your neighbors out there cheering for your local front line workers every night at 7pm?

I live on a pretty dense block, and it warms the small, black, 0-kelvin chunk of greasy giblet in my chest ever so slightly to see the turnout of my neighbors making the effort to applaud the overworked, undersupplied (and glob knows unwilling) folks out there serving up your groceries, taking care of your sick-ass neighbors, and loading up refrigerator trucks full of corpses day in and day out while I sit here pumping a bike internet site full of bullshit while I am supposed to be working.

Also last week, the ice cream man was still making the rounds. Today there are police vans circling playing recordings telling people to stay inside, wear masks, don't make unnecessary trips, etc, in the Blade Runner future I never the fuck wanted.
Stay safe, I'll take post vaccine rain checks for the planned MTB trip if later this year still can't work.
 

canadmos

Cake Tease
May 29, 2011
20,876
19,975
Canaderp
Privileged Michiganders... born with a silver spoon... not used to being told what they can and cannot do. It's kind of irritating hearing them gripe about it. :mad:
Related?

 

jimmydean

The Official Meat of Ridemonkey
Sep 10, 2001
41,544
13,667
Portland, OR
Michigan protester:

one woman attending suggested she didn't entirely trust the social distancing recommendations being made by "the so-called scientists" like Dr. Anthony Fauci, adding that she believes "very strongly in herd immunity."
 

6thElement

Schrodinger's Immigrant
Jul 29, 2008
16,203
13,473
Michigan protester:

one woman attending suggested she didn't entirely trust the social distancing recommendations being made by "the so-called scientists" like Dr. Anthony Fauci, adding that she believes "very strongly in herd immunity."
These fuckers should have to go stack body bags and coffins.
 

jonKranked

Detective Dookie
Nov 10, 2005
86,388
24,862
media blackout

Adventurous

Starshine Bro
Mar 19, 2014
10,441
9,098
Crawlorado
Michigan protester:

one woman attending suggested she didn't entirely trust the social distancing recommendations being made by "the so-called scientists" like Dr. Anthony Fauci, adding that she believes "very strongly in herd immunity."
Bitch please, we all know that prior to this, she hadn't even heard the term "herd immunity", nevermind believed in it.

Though maybe I'm wrong, and the sheople are becoming self-aware.
 

maxyedor

<b>TOOL PRO</b>
Oct 20, 2005
5,496
3,141
In the bathroom, fighting a battle
Bitch please, we all know that prior to this, she hadn't even heard the term "herd immunity", nevermind believed in it.

Though maybe I'm wrong, and the sheople are becoming self-aware.
Nah, the antivaxers have been blabbering about herd immunity for decades. To be fair, they have a point, prior to these so called vaccines from so called “scientists”, literally nobody died from small pox, polio, measles, mumps, rubella, tetanus, the flu or got HPV, thanks to herd immunity

or wait...