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scrublover

Turbo Monkey
Sep 1, 2004
2,946
6,354
43 vented C19 patients at the moment, down from our high of 60 or so. We have six CRRT machines, with 8-10 patients needed CVVHD. So they are getting a shift or two each, then the machine gets swapped to someone else.

Vents and PPE we are doing OK with for the time being. Granted, we are trying to conserve as much as possible. We've a much larger supply of PAPRs now, and many more of us are using respirator masks, or longer use P95 masks that we already had.

We'll see if this is just a momentary dip or something more long term. I suspect we'll see a nice long wave of ups and downs for some while.

Am honestly surprised we haven't gotten nailed as badly as we feared, especially being only an hour away from NYC.
 
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scrublover

Turbo Monkey
Sep 1, 2004
2,946
6,354
Our overall numbers are similarly down a bit from the peak last week. (Local maximum?) Still 3 on ECMO + similar count of vented.
We didn't start any ECMO - my little place only has two setups, not counting the CT surg OR setup, so they really didn't want to go there...

We've been doing a lot of proning. Heparin protocol for all the elevated d-dimers, Levo/Vaso/Propo trifecta for nearly everyone.
 

iRider

Turbo Monkey
Apr 5, 2008
5,654
3,100
I don't know what flies in yerp, but we had to have a process that guaranteed quality. Sampling just proved it. A positive test just demonstrated you fucked up and resulted in millions of dollars of discarded product and lengthy pain in the ass RCCA. The goal was to never fuck up, and we did a really good job of that, at least with sterility. Particulates on the other hand were problematic. Filling an abrasive powder was challenging.
Same rules apply here. If the environmental monitoring shows particles you have to discard everything that was handled at the time. The training our students receive are more for hospital pharmacy cleanrooms though where personalized drugs for e.g. cancer treatment are mixed. Lower financial but higher personal consequences.
 

iRider

Turbo Monkey
Apr 5, 2008
5,654
3,100
Your consideration is wrong. do you realize iso defines like 7 or 8 classes of clean room?
I know. In Europe cleanrooms are regulated by the EU GMP classification with classes D to A. For pharmaceutical production this is outlined in the European Pharmacopoeia if you are interested.
 

ALEXIS_DH

Tirelessly Awesome
Jan 30, 2003
6,147
796
Lima, Peru, Peru
well.. some official data in developing countries.

Day 37 of lockdown. It was reported today 42% of the people in the contry has no job or zero income at this point.

Thousands have been seen walking 200-300 miles (!), leaving the main cities and moving to back to the countryside (supposedly to the house of family members as they cant afford housing/food anymore).
 

Inclag

Turbo Monkey
Sep 9, 2001
2,752
442
MA
Member Berries anyone?

Study Raises Questions About False Negatives From Quick COVID-19 Test

Yea, so those 5 minute tests everyone is clamoring about deploying..... if they are anything like the one that Abbott is currently pushing through FDA expedited authorization then get ready to write those off as not super helpful. The sensitivity is quite low with them unfortunately.

In other words, they are only effective if you're already in really bad shape.....
 

Toshi

Harbinger of Doom
Oct 23, 2001
38,474
7,826

Excellent article for the lay press!

Statistician John Cherian of D. E. Shaw Research, a computational biochemistry company, made his own calculations given the test’s sensitivity and specificity — and estimated the proportion of truly positive people in the Stanford study to range from 0.5% to 2.8%.

Adjusting for demographics, Cherian’s calculations suggest that prevalence could plausibly be under 1% and the mortality rate could be over 1%.

The “confidence intervals” in the paper – that is, the range around a measurement that conveys how precise the measurement is – “are nowhere close to what you’d get with a more careful approach,” he noted.

Assuming a sensitivity of 72%, this is a histogram of possible true positive rates, according to statistician John Cherian.

Even if the test were completely accurate, there would still be sampling problems in the Stanford study, critics said.
 

Toshi

Harbinger of Doom
Oct 23, 2001
38,474
7,826

n= 368 male vets, 3 arms (control, HCQ, HCQ + AZ). Not randomized but retrospective cohort with propensity score adjustment.

Hazard ratio of death in HCQ vs control group was 2.61 (1.10-6.17). HR of death of HCQ + AZ vs control group was 1.14 (0.56-2.32, p=0.72).

"increased risk of overall mortality in the hydroxychloroquine-only group persisted after
adjusting for the propensity of being treated with the drug."

"That there was no increased risk of ventilation in the hydroxychloroquine-only group suggests that mortality in this group might be attributable to drug effects on or dysfunction in non-respiratory vital organ systems."

(If this sounds like a negative trial to you then good, you've comprehended the message.)
 

jonKranked

Detective Dookie
Nov 10, 2005
86,150
24,670
media blackout

n= 368 male vets, 3 arms (control, HCQ, HCQ + AZ). Not randomized but retrospective cohort with propensity score adjustment.

Hazard ratio of death in HCQ vs control group was 2.61 (1.10-6.17). HR of death of HCQ + AZ vs control group was 1.14 (0.56-2.32, p=0.72).

"increased risk of overall mortality in the hydroxychloroquine-only group persisted after
adjusting for the propensity of being treated with the drug."

"That there was no increased risk of ventilation in the hydroxychloroquine-only group suggests that mortality in this group might be attributable to drug effects on or dysfunction in non-respiratory vital organ systems."

(If this sounds like a negative trial to you then good, you've comprehended the message.)
and there will be no repercussions for those pushing it.
 

Inclag

Turbo Monkey
Sep 9, 2001
2,752
442
MA
reminds me of our discussion about ensuring things work before they get shoved on the market without appropriate vetting.
???

This product went through all of the rigor of any other FDA device. Accelerated doesn't mean corners cut. It means you have FDA on speed dial and your submissions and information requests get as immediate response as one can get from FDA as opposed to the typical 90 day decision time for just a decision on a 510k which completely ignores all of the other long lead bureaucratic interaction one can have with the FDA prior to a 510k submission.

Full verification and to the extent one can conduct validation also occurred (obviously no notable time has passed for useful post market surveillance etc).

Lastly, to my awareness this test never claimed sensitivity to low viral load, but elevated levels, and some tests will lose sensitivity if below certain levels. This is why RNA PCR testing is the gold standard and why testing has been such a shitshow. I would need to see the product insert to assess the final claims, but Abbott has too much riding on the line to BS.

My issue and why I originally brought up the Abbott 5 minute test was because every god damn politician and sports league commissioner was talking about this test as if it was going to transform detection of the virus without understanding the science, claims, and uses. The test still serves a purpose, but until benchtop automated rapid PCR equipment and assays get FDA clearance, exisiting equipment is reconfigured, and new units are built and distributed we're stuck with manual/lab equipment test methods. Thankfully I'm aware that FDA is approving some of these new machines so the process of rejiggering and distributing has started.

The challenge as I see it now is that this is pretty complex equipment and as you are probably aware, low volume and high precision capital medical equipment usually requires a small army of technical product specialists in order to maintain and debug it. Now Siemens, Abbott, Quest, Thermo, etc. will be producing in far greater volumes and the number of units will exceed the capacity of their support teams. In addition to the fact that folks are pretty much grounded and travel is far more limited. Overall it's good that more equipment that can test faster will soon start to become available.

PS, my previous discussion with you was about devices not intended to be marketed.
 

jonKranked

Detective Dookie
Nov 10, 2005
86,150
24,670
media blackout
???

This product went through all of the rigor of any other FDA device. Accelerated doesn't mean corners cut. It means you have FDA on speed dial and your submissions and information requests get as immediate response as one can get from FDA as opposed to the typical 90 day decision time for just a decision on a 510k which completely ignores all of the other long lead bureaucratic interaction one can have with the FDA prior to a 510k submission.

Full verification and to the extent one can conduct validation also occurred (obviously no notable time has passed for useful post market surveillance etc).
it doesn't? because what you said previously definitely is cutting corners vs a highly accelerated regulatory pathway.

"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.
 

Inclag

Turbo Monkey
Sep 9, 2001
2,752
442
MA
it doesn't? because what you said previously definitely is cutting corners vs a highly accelerated regulatory pathway.
Dude, that was reference to getting devices and products into a clinical setting. Very different stuff than production and marketed products....