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A Tale of Two News Stories
News story #1: New York City auctioned off extra ventilators due to cost of maintenance. Yes, they did. Hundreds of them. Ventilators acquired by “Mini Mike” Bloomberg in 2006, in response to a new far-eastern flu strain. As part of that response, and in anticipation of an epidemic, New York City stockpiled ventilators and facemasks. Over the next ten years, their regular maintenance schedule pointed up the fact that the ventilators were aging (I expect parts became more difficult to obtain, and more expensive, as well), and they were subsequently auctioned off by the deBlasio administration.
This episode speaks to something I’ve always known to be true, which is that “stockpiling” critical medical machinery and electronics really isn’t a cost-effective and, over time, perhaps not even a clinically effective option. The equipment is cripplingly expensive, and the cost of having it on hand, lying around at a hospital, just-in-case, simply isn’t feasible. Stockpile it for too long, and you end up with a bunch of creaky old gear that may not work when it’s needed, and probably won’t interface or play nicely with the rest of the state-of-the-art equipment that’s in place when you do.
For better or worse, hospitals are nearly always running at full capacity with the equipment that they have, and cooperative inter-hospital-borrowing is a fact of life. Hospital stockpiles of expensive equipment with obsolescence and needy maintenance issues simply isn’t the norm. I’d even go so far as to say that with certain things “shortages” are more the norm, along with a fair amount of just-in-time inventory management. Hospital administration is trying to run a business, and, for better or worse again, has a balance sheet, and other factors, to consider.
Which does, if such stockpiles of medical equipment are desirable, leave them at the mercy of other entities, most likely agencies of government. Which have their own set of issues to consider, and perhaps don’t do stockpiles of expensive and sometimes proprietary or outdated electronic medical equipment all that well, either. I don’t know what the answer is, but I’m pretty sure, as with most other things, political grandstanding ain’t it.
News story #2: Some doctors moving away from ventilators for virus patients. Crimenutely. Maybe the only reason they’re doing this is just that they don’t have enough ventilators for the patients who need them. But wait! Didn’t Governor “The Sky is Falling” Cuomo just say that no-one who needed a ventilator didn’t have one, and that no-one who needed an ICU bed didn’t have one? Yes, he did just say that, amid revisions of numbers and data which indicate that the medical establishment, although stretched and in need of reinforcement, just may be up to the task, even in New York.
More likely, to quote from the article, it’s down to the fact that “doctors are still learning the best way to manage a virus that emerged only months ago. They are relying on anecdotal, real-time data amid a crush of patients and shortages of basic supplies.”
And as they do that, and as they adjust and learn, the hope is that care and outcomes will improve.
What doctors have noticed is that although the mortality rate among ventilator patients is always high, because it’s among the lastest of last resorts, the mortality rate among COVID-19 patients on ventilators is more than 80%. And
some health professionals have wondered whether ventilators might actually make matters worse in certain patients, perhaps by igniting or worsening a harmful immune system reaction.
“We know that mechanical ventilation is not benign,” said Dr. Eddy Fan, an expert on respiratory treatment at Toronto General Hospital. “One of the most important findings in the last few decades is that medical ventilation can worsen lung injury — so we have to be careful how we use it.”
The dangers can be eased by limiting the amount of pressure and the size of breaths delivered by the machine, Fan said.
Boy howdy. Takes me back to a time in almost 40 years ago when my fourteen-year-old stepson, who’d already “died” three times, was brought back to life again and spent weeks on a ventilator in Mercy Hospital in Pittsburgh with a traumatic head injury, numerous broken bones, collapsed lungs and just about every other hurt you can imagine. Although Michael was a big, strapping boy, he was put on a pediatric ventilator (less pressure, smaller breaths) for, as I understood it then, exactly the reason Dr. Fan describes above. Michael’s care was so innovative at the time that his team of doctors wrote it up and published it in a medical journal.
Once again, I don’t know the answer. But once again, I’m pretty sure that just about anything said by a politician, or even by a statistician whose numbers keep changing and who can’t really explain all that clearly why that is, isn’t it.
And I hope, daily, to see some evidence of humility, grace, and honesty on the part of those running this show, as they deal with what increasingly looks like a plethora of “unknown unknowns,” things they didn’t even know that they didn’t know, at the same time that they were acting with such certainty, and as if they knew absolutely everything. I think I occasionally see glimpses of such in “Deborah” but not in many others who occupy the various podia so excruciatingly for so many hours a day. (“Tony” looks as though he’s enjoying the situation and the attention a little too much, IMHO.) More than anything, I long for ideas, for open minds, and for leaders willing to roll up their sleeves and to find some other way of managing this mess besides simply declaring the country “closed” for an indefinite number of months, and then bribing us into submission with small amounts of our own money that ultimately won’t help very many people all that much when all is said and done.
Meanwhile, I’m becoming inclined to trust what amounts to crowd-sourced information that comes from physicians who are, in the words of the linked article, “relying on anecdotal, real-time data” rather than relying on charts and spreadsheets assembled and presented by talking heads in what increasingly appears to be a parallel universe. It may not be the best way to run textbook medical science and to do “controlled clinical trials,” but it may just be the best thing we have right now.
Who(m) do you trust?
Published in General
That’s my wish also. Protocol thinking is difficult to work around. It is taking a risk, which the medical field is adverse to in normal times.
Anyone in the manufacturing business, if they have dabbled in aerospace, medical, automotive, or military work has had to confront this head on, and there are international management and operational standards at play, along with federal laws and regulations, all attempting to maintain this balance. Anyone who has gone through ISO 9000 or any of its many kindred standards implementations would find this familiar. I don’t know if such auditing standards exist for hospitals and medical practices.
In the manufacturing world, though, to pass your audits you have to have have published maintenance schedules for all of your critical equipment (and then follow those schedules, and document that you are following them), and this includes any equipment you keep on hand that you are not currently using – you still must maintain it at some level, just in case you ever do need to use it. This may be as simple as an annual cleaning, or (in the case of any kind of test equipment, or high-precision tooling), annual calibration checks. This is rather critical as you might have to fire that stuff up again to make new parts for old equipment still in the field, and the new parts had better be just as they were when you were last manufacturing in volume. Federal regulations mandate that all critical components continue to be available for service needs for at least 10 years following their last production use (after that, you’re off the hook).
This is relatively easy to do with physical parts, so long as you maintain the dies, casts, molds, and so forth. This is NOT so easy to do with the electronics – many many electronic controllers use proprietary chipsets that take at least a year to have made, and are extremely costly to re-run once they go out of production. My own company used to make an engine interface for aftermarket needs on Ford trucks, but Ford used a proprietary data bus with a proprietary comm chip, and we haven’t been able to order those since 2004, when Ford modernized and went to CAN. When we ran out of those chips in 2015, that was it for being able to support those older trucks, and replicating that design would require a six-figure investment, for which there is little demand.
I’m sure that is a factor for medical equipment too.
It sure is. Maintenance schedules must be published, and compliance recorded, and equipment labeled with date and initials of the last time it was done, in the correct interval (quarterly, semi-annually, annually, etc.). There are all sorts of audits, both internal and external, which make sure that’s actually being done.
In addition, almost every piece of such equipment must have a current maintenance contract (usually for hardware and for software, now that everything is a computer of one sort or another). Without current coverage, vendors usually won’t provide software and OS updates or any sort of preventive maintenance, and contracting for such on an “as needed” or hourly basis is even more exorbitant than the maintenance contract itself. The maintenance contracts ratchet up their cost annually, and usually include some sort of clause which compels the customer to stay current within one or at most two software versions of the most current, in order to continue supporting it. And, of course, there’s the day that always seems to come when completely new hardware is required to support the new release of software. And the customer must acquire it in order to continue support. And so on.
I’m not suggesting that the above isn’t a good thing. Certainly, if I’m hooked up to a piece of medical equipment that might save my life, I want it to be well-maintained, functional, and up-to-date.
But it’s part of the story of why it’s largely untenable for hospitals to stockpile much of this sort of equipment.
Ventilators require airtight seals. Seals get brittle with age. Those may need to be periodically replaced, but little of the rest of the equipment should be greatly affected by sitting assuming that they are kept clean and dry. As long as they still function, being old isn’t the same as being obsolete, no matter what the salesmen tell you. Replacing the seals periodically should suffice. That can become more expensive over time, but we aren’t talking decades. We are talking from Bloomberg’s administration to deBlasio’s.
Good post, She.
Thanks. What you’re saying is largely true, at least in a practical sense. But hospitals and the medical establishment don’t run so much on practicality anymore. They runs on rules, inspection, compliance, certification, training, and fear of lawsuits. And dragging a bunch of out-of-date, poorly maintained, even though functional, ventilators out of a closet and putting them into service is a prospect to send shivers up-and-down the spine of any VP of Risk Management I’ve ever known. “But it was an emergency,” isn’t an excuse that washes all that well in that environment. All one has to do is look at Dr. Fauci and his response to the hydroxychloroquine issue, to see how far a hospital would get with that.
The first thing we do, let’s kill all the lawyers.
— William Shakespeare, “Henry VI”
There might be a couple of other factors at play though.
I had kind of hoped that ISO 9000 had withered and died by now. I guess not.
SkipSul (View Comment):
Yes, I’ve had this happen with things at home. Left on the shelf, by themselves, nobody bothering them for a couple of years, and then plug them in, and “Blammo!” One of the reasons I dislike working with electrical things so much.
This is a huge problem, and I think one of the key reasons that hospitals “dump” surplus equipment whenever they can–at my own hospital, it often went to third-world-countries or veterinary offices. In the years since I’ve retired, veterinary offices have upped their game to the point where their IT infrastructure is almost as sophisticated as the human equivalent, so I don’t know if they’re even so interested anymore. But it was also often donated to missionary efforts in places like Haiti and Sudan where, no matter its shortcomings, it was miles better than what they had.
Even when I retired, ten years ago now, there were dozens of interfaces between hospital systems (small community hospital, very IT-savvy). And even though it’s possible to run much of the equipment in non-interfaced, standalone mode, doing so mitigates many of the advantages we’ve come to rely on in patient care. So, yes, that’s another hairball of many parts, to consider.
That hadn’t occurred to me, but you’re right. What a mess that was, and probably remains, too.
Not.
Although this year’s conference was postponed, from last week until sometime in August. So you haven’t missed it! (It’s in Orlando, if you’re feeling nostalgic.)
It actually has improved (I forget what iteration they’re up to now) over the horrid “20 points” originally barfed out.
But… You can still be ISO-compliant and make the best concrete life-vests in the world.
I thought about the communications aspects, and the ventilators themselves do not have a lot to tell anybody except:
You don’t need that real-time. Once a minute is probably fast enough. A dinky little 8051 would get bored (if microprocessors could get bored) reporting that. And while it would be nice to have it talk to the nurses’ station, a buzzer and a light that blinks should be plenty in ICU conditions.
Ideal? No. Workable? Sure.
As for governments rejiggering materials … they really need to restrain themselves. Or be restrained. They can barely control themselves with the money they extort from the populace. Other peoples’ money is even worse.
Yes, but if you’ve settled on a particular brand / monitoring protocol / or some other specific factor (and remember: doctors and hospital admins are usually not IT savvy), you can very easily get into a situation where been herded into a situation where you’ve obsoleted your entire inventory without realizing.
That would be why the stockpiled stuff is for emergency use.
(I’m just arguing to be arguing. Engineer’s prerogative. I don’t have any details on Gtech’s comm features. They might not have gotten there yet.)
Speaking of obsolescence:
There is a connector company well known (well known ≠ well loved) called Deutsch. For ruggedized connectors, ones that could handle immersion, salt fog, chemical spray, and even heat, they were king for about 20 years. They priced themselves accordingly – a customer specced a Deutsch connector on a custom controller, and that connector’s cost exceeded the parts cost and labor of the entire rest of the product.
Many companies in my industry to this day will refuse to use products without Deutsch connectors – and they’ve invested heavily in their harness shops in all the crimpers, applicators, presses, and other tooling necessary.
However, Deutsch connector systems have some severe drawbacks: they are very bulky, Deutsch refused to consider other form factors or shapes, and the amperage per pin is terrible compared to newer competing designs. Their patents have expired now.
Other companies like Molex have made tougher, smaller, less-expensive connectors that can carry a lot more current – but they cannot penetrate the market because the customer base doesn’t want to invest in new tooling (nevermind that they would save a lot of money in the long run).
So we offer them choices: get our module with Molex, or pay 2x the price (and set aside more physical space) for Deutsch. Most go with Molex, but there are still some who will rigidly stick with Deutsch, even as the market moves further and further away.
Oh, my. Shades of IBM. Token-ring network, anyone? Anyone?
Sometimes, obsolescence (or at least not keeping up) is a feature, since the same procedures can be used as earlier and the regulatory issues don’t need to be faced. At one point in my life, I was consulting with IBM on instrumentation and controls for Pharmaceutical companies. One company we worked with made Black Widow Spider antivenin (I had always heard it called antivenom, but they called it antivenin).
They did it as a good will gesture since the quantity needed was low and only needed to make a new batch every 5 years or so.
They showed us the ‘lab’ where the batches were made. It was a room not much bigger than a closet with a locked door. Every time they needed a new batch, they would order a new batch of spiders and take them into the ‘lab’ where they would open the process notebook and follow the approved procedure. When done, they would bring out the antivenin and lock the door.
The lab was sort of creepy. The wooden boxes that had contained the spiders still had various dead spider parts in them.
We know you are, and we love you for it. But you’re arguing from a rational perspective. And as I’ve pointed out somewhere here, reason has nothing to do with it . . .
We can be thankful to the FDA and other cumbersome bureaucracy for keeping Microsoft’s wild OS update system in check to some degree. Microsoft wants to take over your computer and add, remove, or break features as it wishes, when it wishes. However some of its big customers are subject to government regulation that allows only officially approved and certified versions of all software, including the OS, to be used. Those customers can’t upgrade just because Microsoft says it’s time to jump. So Microsoft has had to cede some control over the upgrade process to those customers, and that sometimes has spillover benefits to other customers who would like to maintain control. Microsoft still does its best to keep “Home” users from benefiting from that kind of stability.
When I covered ISO 9000 in my supply chain classes, I emphasized that it was not a quality control program. In principle you can make absolute trash and be compliant if you document and execute well on the trash target.
When you read the news on military affairs, one often sees the term OPTEMPO used a lot. Operational Tempo. As used in the papers, the term is almost always used in terms of our troops, the amount of time they have “boots on the ground” deployed, and the effect that has in the capability of the force.
But, Army guys (okay, probably military guys) have a different definition. What is the OPTEMPO on the system? All the hardware we buy–and, that I’ve seen given as much consideration as–is purchased as a system. So, with a given OPTEMPO, we know that a Humvee will need X number of new tires, Y amount of new glow plugs, and the powertrain will wear out and need to be replaced after Z amount of hours of OPTEMPO.
So, when you hear such and such weapon system or transport platform will cost the American taxpayer a bazillion dollars, that’s usually the price of the system over its entire lifecycle. And yes, we do cashier/retire certain systems at certain times because the costs of maintaining that system after that amount of OPTEMPO is more expensive than buying a whole new system and programming its parts/maintenance/repair parts over a new lifecycle.
The fact that any non-military procurement system doesn’t have that same view is, quite literally astounding to me. I’m a guy who, over the 5+ years I was in the mechanized infantry, participated in quarterly drawing oil samples from vehicles in the fleet, so that we could run them through the AOAP (Army Oil Analysis Program), so that the source and probable cause of any metallic (microscopic) shavings in the oil could be determined and requisite preventative maintenance performed.
I chuckle that the sustainment Admiral in the WH COVID briefs is viewed to be knocking it out of the park–“that guy has an encyclopedic knowledge about ventilators, where they’re at, and whether they’ll be enough.”
Nah. That dude just knows OPTEMPO.
Idea: One of these days our trash collection service will require all trash to be ISO 9000 compliant.
There was an interesting situation back in the 1990s when ARDS, which resembles this disease, was being treated with an 85% mortality at Mass General. There was a consideration of using ECMO for these cases. The use of ECMO costs, at the time at least, $100,000 per case. A western hospital chain was considering offering this treatment which was new. They decided to try to optimize care using a protocol first. They designed a protocol based on the best they could find. The EHR system included a decision support option and it provided a recommended list of orders, which could be overwritten but the doctor had to sign off on the variation. After a month or so, they had 85% compliance with the eventual protocol. Some instances of free lancing improved things and the protocol was adjusted. Using this, they got the mortality of ARDS down to 45%. That was one reason I was an enthusiast about EHRs until Obamacare preempted them for surveillance and rationing.
I once sat through a cardiac surgery post grad course at the College of Surgeons that I used to attend every year. Two guys who were cardiac surgeons at a missionary hospital in Africa gave a talk on doing surgery for mitral valve regurgitation. That condition used to require valve replacement but in recent years, valve remodeling has gotten popular. There are now devices that can be sewn in to make the valve ring smaller in diameter and restore function. The stretching is usually associated with heart failure and the ventricle dilates and enlarges the valve ring. Anyway, the device keeps the ring from dilating. The trouble for the mission was that the device cost about $5,000 each. The surgeons discovered that they could take the disposable metal rod that was used to stiffen endotracheal tubes; it is malleable, bend it to the shape they wanted, and use it for the surgery. It worked fine and was free.
Yes. And. An early defensive answer by Secretary Azar alluded to a history of a long-term program that allocated federal dollars to hospitals for the extremely rare man-made or natural biological disaster. The right answer is to federally underwrite lots of little piles, at least down to the county level, rather than one massive federal pile. We can analogize to the DoD underwriting or outright supplying equipment to each state’s National Guard. Did we have such a medical equipment program, and if so what went wrong or right with it? That is a question for the formal After Action Review, for real institutional learning leading to greater readiness, in material, training, and procedures.
I think, in general, that IT departments at most hospitals have a pretty good grasp of what you’re describing. Unfortunately, healthcare, like my only other two areas of employment experience, academia and law, is full of multiple separate chains of command and authority, and IT often wasn’t even involved in, let alone in charge of, purchases of clinical equipment by other departments. In fact, other departments would deliberately skirt IT, viewing us as a stumbling block and an obstacle, because of our tendency to view things in systematic terms, and our desire to find out what the OPTEMPO (if I’m understanding the term correctly) of a particular purchase would be, and to get the details of costs over its life nailed down before signing on the dotted line. There was much muttering about non-clinical people telling doctors and nurses what to do. I’m sure you know the drill.
The old model flew quite well for many years, and then the sort of interconnectedness, interoperability and interfacing that @skipsul describes in #7 became not only desirable, but required, and after several disastrous and expensive purchases in which the equipment purchased simply couldn’t function with the rest of what we had, and it was left to the poor IT sap (often me) to explain this to the furious department head in question, hospital administration mandated that all such purchases have an IT person on the selection committee, and that the VP of IT had to sign the contract too. After that, things improved somewhat.
Fascinating thread to read – thanks to those who have contributed to the discussion.
There is talk that the reason for this is the way the virus attacks the body.
Short story:
The virus kicks the iron out of a person’s hemoglobin.
Iron is what O2 binds to in order to be transported throughout the body. No iron, no O2 transport.
The lungs, in addition to expelling CO2, is also the primary expulsion for Iron. This look like scarring in lungs in chest film.
Pneumonia shows up in film as 1 lung or 2, while COVID (apparently) shows up in both lungs all the time.
This theory also explains why the anti-malarials seem to work as well.
I’ve seen that argument in places like Twitter but have yet to see any scientific discussion. My own hemoglobin 02 study was 50 years ago so I don’t want to go beyond that. Of course, when red cells break down, the iron is stored and reused. The heme molecule becomes bilirubin.
https://allaboutblood.com/2011/08/30/haemoglobin-catabolism/
Criminently Mrs. She, everything is cattywampus these days.