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CoVID-19

SkaredShtles

SkaredShtles

Michael Bolton
Sep 21, 2003
65,969
12,893
In a van.... down by the river
In the "tone deaf post of the day" category, I present to you this gem from someone I went to HS with:

"Still scratching my head as to why we can buy pot, booze, and wait in line for lottery tickets... BUT get fined for driving our ski boat on our lake???"

Keep it classy, lady... keep it classy. Perhaps she would like to speak to the manager?
 
Jozz

Jozz

Joe Dalton
Apr 18, 2002
5,900
7,453
SADL
SkaredShtles said:
In the "tone deaf post of the day" category, I present to you this gem from someone I went to HS with:

"Still scratching my head as to why we can buy pot, booze, and wait in line for lottery tickets... BUT get fined for driving our ski boat on our lake???"

Keep it classy, lady... keep it classy. Perhaps she would like to speak to the manager?
Click to expand...
Karen? Is that you?
 
canadmos

canadmos

Cake Tease
May 29, 2011
20,756
19,820
Canaderp
SkaredShtles said:
In the "tone deaf post of the day" category, I present to you this gem from someone I went to HS with:

"Still scratching my head as to why we can buy pot, booze, and wait in line for lottery tickets... BUT get fined for driving our ski boat on our lake???"

Keep it classy, lady... keep it classy. Perhaps she would like to speak to the manager?
Click to expand...
Boat....lake... at this time of year?


Florida?
 
Toshi

Toshi

Harbinger of Doom
Oct 23, 2001
38,528
7,855
IHME put the US peak on April 10, at under 2,000 deaths per day.

As of a few minutes ago Worldometers was reporting 2,190 today. This could be some catch up reporting from the weekend, sure, but it also may show that IHME's assumptions are not holding up.
 
canadmos

canadmos

Cake Tease
May 29, 2011
20,756
19,820
Canaderp
Toshi said:
IHME put the US peak on April 10, at under 2,000 deaths per day.

As of a few minutes ago Worldometers was reporting 2,190 today. This could be some catch up reporting from the weekend, sure, but it also may show that IHME's assumptions are not holding up.
Click to expand...
It looks like a bunch of places have jumped in deaths. Canada went from 63 yesterday up to 118 today...odd...or bad....
 
Westy

Westy

the teste
Nov 22, 2002
54,613
20,418
Sleazattle
Toshi said:
IHME put the US peak on April 10, at under 2,000 deaths per day.

As of a few minutes ago Worldometers was reporting 2,190 today. This could be some catch up reporting from the weekend, sure, but it also may show that IHME's assumptions are not holding up.
Click to expand...

One could argue their assumptions are correct as the data is well within their statistical error range.
 
kidwoo

kidwoo

Artisanal Tweet Curator
Aug 25, 2003
42,146
13,343
Squirtin ketchup n' mustard on charred flesh
Westy said:
Correct, and when one sees that range they should not expect to see the nominal line track very close to reality.
Click to expand...
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.
 
mykel

mykel

closer to Periwinkle
Apr 19, 2013
5,151
3,873
sw ontario canada
jonKranked said:
The firmware is probably common between the two devices but the hardware probably has significant differences.
Click to expand...
Maybe....

From teh comments -

Sigh. Can we at least RTFA? "What our firmware does is show that it is possible to re-program these devices in a way that doctors can use to effectively ventilate COVID patients. We have been able to confirm the functionality of the devices in instrumented patient circuits operated by experts in pulmonological measurement. And there are doctors who agree that, if they had an FDA-approved machine that could that can do what these machines are doing, then they could use them to clinically ventilate COVID patients in an ICU." (Emphasis mine.) The article makes it absolutely clear that the machines are capable of functioning as described. It isn't just a non-functional menu.
 
jonKranked

jonKranked

Detective Dookie
Nov 10, 2005
86,230
24,732
media blackout
mykel said:
Maybe....

From teh comments -

Sigh. Can we at least RTFA? "What our firmware does is show that it is possible to re-program these devices in a way that doctors can use to effectively ventilate COVID patients. We have been able to confirm the functionality of the devices in instrumented patient circuits operated by experts in pulmonological measurement. And there are doctors who agree that, if they had an FDA-approved machine that could that can do what these machines are doing, then they could use them to clinically ventilate COVID patients in an ICU." (Emphasis mine.) The article makes it absolutely clear that the machines are capable of functioning as described. It isn't just a non-functional menu.
Click to expand...
Just because the hardware *can* do it doesn't mean it's meant to. Medical devices have to (are supposed to) undergo rigorous validations (both software and hardware) to prove they can work the way they're supposed to for the amount of time they're supposed to (it's required by the FDA and other regulatory bodies). The last thing you want is a piece of hardware to fault out while hooked to a patient and the software to not throw an appropriate warning. That's not to say it can't be recommissioned for other uses but you need to understand the limitations of both software and hardware.
 
Jm_

Jm_

sled dog's bollocks
Jan 14, 2002
19,090
9,745
AK
At this point, I'm "meh", if they want to open up the country and a whole bunch of people die, it's literally the only way people will learn the lesson at this point. If significantly more don't die, then no harm no foul and everything gets back to normal slowly.
 
Inclag

Inclag

Turbo Monkey
Sep 9, 2001
2,752
442
MA
jonKranked said:
Just because the hardware *can* do it doesn't mean it's meant to. Medical devices have to (are supposed to) undergo rigorous validations (both software and hardware) to prove they can work the way they're supposed to for the amount of time they're supposed to (it's required by the FDA and other regulatory bodies). The last thing you want is a piece of hardware to fault out while hooked to a patient and the software to not throw an appropriate warning. That's not to say it can't be recommissioned for other uses but you need to understand the limitations of both software and hardware.
Click to expand...
Did you read the article to gain context? Also you are aware of the regulation role backs and expedited reviews/exemptions/expanded access/compassionate use guidance that the FDA has provided manufacturers and what all that means......

Per the FDA's Ventilator Supply Mitigation Strategies Letter to Health Care Providers

  • For any patient needing ventilatory support, continuous ventilators labeled for home use may be used in a medical facility setting depending on the features of the ventilator and provided there is appropriate monitoring (as available) of the patient's condition.
  • For stable patients, emergency transport ventilators may be used for prolonged ventilation in a medical facility setting.
  • For any patient needing ventilatory support, anesthesia gas machines capable of providing controlled ventilation or assisted ventilation may be used outside of the traditional use for anesthetic indication. Because of significant differences between the anesthesia gas machine and traditional critical care ventilators, use or supervision by an anesthesia provider is recommended. Refer to the manufacturers' websites for specific instructions on safe use of anesthesia gas machines for this indication.
  • Noninvasive Ventilation (NIV) Patient Interfaces capable of prescribed breath may be used for patients requiring such ventilatory support, including NIV Patient Interfaces labeled for sleep apnea.
  • Continuous Positive Airway Pressure (CPAP), auto-CPAP, and bilevel positive airway pressure (BiPAP or BPAP) machines typically used for treatment of sleep apnea (either in the home or facility setting) may be used to support patients with respiratory insufficiency provided appropriate monitoring (as available) and patient condition.
Click to expand...
Of course the hardware is different and under normal circumstances the laws that exist to use a different device for a new intended use would preclude a clinician from just using it, but that's not the point. The rules have been tweaked since the FDA is aware that maintaining status quo will only result in increased casualties under these current circumstances. Also, under expanded access/compassionate use which essentially is what is happening with these re-purposed CPAP devices, there are still institutional measures that are carried out as risk mitigation measures.

Good on this software/security expert to shed light on the possibilities of this existing CPAP device and it's potential benefit under these current circumstances. If the manufacturer (or perhaps their legal department) is afraid of stepping up to the plate to fulfill a need, then this initial legwork that has been done and the software patch to be released at least allows health care providers to explore and implement a path that could save lives.
 
jonKranked

jonKranked

Detective Dookie
Nov 10, 2005
86,230
24,732
media blackout
Inclag said:
Did you read the article to gain context? Also you are aware of the regulation role backs and expedited reviews/exemptions/expanded access/compassionate use guidance that the FDA has provided manufacturers and what all that means......

Per the FDA's Ventilator Supply Mitigation Strategies Letter to Health Care Providers



Of course the hardware is different and under normal circumstances the laws that exist to use a different device for a new intended use would preclude a clinician from just using it, but that's not the point. The rules have been tweaked since the FDA is aware that maintaining status quo will only result in increased casualties under these current circumstances. Also, under expanded access/compassionate use which essentially is what is happening with these re-purposed CPAP devices, there are still institutional measures that are carried out as risk mitigation measures.

Good on this software/security expert to shed light on the possibilities of this existing CPAP device and it's potential benefit under these current circumstances. If the manufacturer (or perhaps their legal department) is afraid of stepping up to the plate to fulfill a need, then this initial legwork that has been done and the software patch to be released at least allows health care providers to explore and implement a path that could save lives.
Click to expand...
yes i read the article and yes i'm aware of current efforts that are on-going to fast track urgently required devices (my company is involved in quite of a few of them). yes the rules have been tweaked but they haven't been completely thrown out. just because the FDA has said a group of devices indicated for one condition are now allowed to be used for something they previously weren't, it has no bearing on whether or not a particular manufacturer's device actually has the capability of doing that.

just because this guy has shown that the firmware can control the hardware in such a manner, doesn't mean the hardware is actually suitable for it. how thoroughly did he test the firmware? did he test the hardware at all or just demonstrate "oh it can do this"?

the comment you quoted isn't focused on the appropriate part of that statement:

mykel said:
Maybe....

From teh comments -

Sigh. Can we at least RTFA? "What our firmware does is show that it is possible to re-program these devices in a way that doctors can use to effectively ventilate COVID patients. We have been able to confirm the functionality of the devices in instrumented patient circuits operated by experts in pulmonological measurement. And there are doctors who agree that, if they had an FDA-approved machine that could that can do what these machines are doing, then they could use them to clinically ventilate COVID patients in an ICU." (Emphasis mine.) The article makes it absolutely clear that the machines are capable of functioning as described. It isn't just a non-functional menu.
Click to expand...
confirming the functionality isn't the same as testing and validating the functionality.

from the article itself:

"Security researcher Trammell Hudson analyzed the AirSense 10—the world’s most widely used CPAP—and made a startling discovery. Although its manufacturer says the AirSense 10 would require “significant rework to function as a ventilator,” many ventilator functions were already built into the device firmware. "

great, so the functionality is built into the firmware (which is most likely a byproduct of the same firmware being shared across multiple devices). is the hardware controlled by the firmware on this device even suitable for this? sure, it might be able to do it for a short time frame, but what happens if it fails after only a few hours? maybe the manufacturer isn't pursuing this because in the course of validating the hardware, they found it wasn't suitable for this task.

out of curiosity, i checked out the website for this airbreak firmware. it sounds like they're only trying to test their firmware, they make no mention of testing/validating the hardware itself, which is completely missing the mark in how medical devices are tested. he seems to be under the impression that all that's required is a firmware tweak, which is an extremely risky way of approaching this.
 
dan-o

dan-o

Turbo Monkey
Jun 30, 2004
6,499
2,805
jonKranked said:
yes i read the article and yes i'm aware of current efforts that are on-going to fast track urgently required devices (my company is involved in quite of a few of them). yes the rules have been tweaked but they haven't been completely thrown out. just because the FDA has said a group of devices indicated for one condition are now allowed to be used for something they previously weren't, it has no bearing on whether or not a particular manufacturer's device actually has the capability of doing that.

just because this guy has shown that the firmware can control the hardware in such a manner, doesn't mean the hardware is actually suitable for it. how thoroughly did he test the firmware? did he test the hardware at all or just demonstrate "oh it can do this"?

the comment you quoted isn't focused on the appropriate part of that statement:



confirming the functionality isn't the same as testing and validating the functionality.

from the article itself:

"Security researcher Trammell Hudson analyzed the AirSense 10—the world’s most widely used CPAP—and made a startling discovery. Although its manufacturer says the AirSense 10 would require “significant rework to function as a ventilator,” many ventilator functions were already built into the device firmware. "

great, so the functionality is built into the firmware (which is most likely a byproduct of the same firmware being shared across multiple devices). is the hardware controlled by the firmware on this device even suitable for this? sure, it might be able to do it for a short time frame, but what happens if it fails after only a few hours? maybe the manufacturer isn't pursuing this because in the course of validating the hardware, they found it wasn't suitable for this task.

out of curiosity, i checked out the website for this airbreak firmware. it sounds like they're only trying to test their firmware, they make no mention of testing/validating the hardware itself, which is completely missing the mark in how medical devices are tested. he seems to be under the impression that all that's required is a firmware tweak, which is an extremely risky way of approaching this.
Click to expand...
Remington could figure it out.
They have a century of experience ventilating people.
 
TN

TN

Hey baby, want a hot dog?
Jul 9, 2002
14,301
1,353
Jimtown, CO
SkaredShtles said:
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:
Click to expand...
What is the most irritating to me is, the folks griping about having to work from home.
 
Inclag

Inclag

Turbo Monkey
Sep 9, 2001
2,752
442
MA
jonKranked said:
yes i read the article and yes i'm aware of current efforts that are on-going to fast track urgently required devices (my company is involved in quite of a few of them). yes the rules have been tweaked but they haven't been completely thrown out. just because the FDA has said a group of devices indicated for one condition are now allowed to be used for something they previously weren't, it has no bearing on whether or not a particular manufacturer's device actually has the capability of doing that.

just because this guy has shown that the firmware can control the hardware in such a manner, doesn't mean the hardware is actually suitable for it. how thoroughly did he test the firmware? did he test the hardware at all or just demonstrate "oh it can do this"?

the comment you quoted isn't focused on the appropriate part of that statement:



confirming the functionality isn't the same as testing and validating the functionality.

from the article itself:

"Security researcher Trammell Hudson analyzed the AirSense 10—the world’s most widely used CPAP—and made a startling discovery. Although its manufacturer says the AirSense 10 would require “significant rework to function as a ventilator,” many ventilator functions were already built into the device firmware. "

great, so the functionality is built into the firmware (which is most likely a byproduct of the same firmware being shared across multiple devices). is the hardware controlled by the firmware on this device even suitable for this? sure, it might be able to do it for a short time frame, but what happens if it fails after only a few hours? maybe the manufacturer isn't pursuing this because in the course of validating the hardware, they found it wasn't suitable for this task.

out of curiosity, i checked out the website for this airbreak firmware. it sounds like they're only trying to test their firmware, they make no mention of testing/validating the hardware itself, which is completely missing the mark in how medical devices are tested. he seems to be under the impression that all that's required is a firmware tweak, which is an extremely risky way of approaching this.
Click to expand...
"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.
 
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