Hospitals No Longer Allowed To Fix Machine That Costs Six Figures 34
An anonymous reader quotes a report from 404 Media: The manufacturer of a machine that costs six figures used during heart surgery has told hospitals that it will no longer allow hospitals' repair technicians to maintain or fix the devices and that all repairs must now be done by the manufacturer itself, according to a letter obtained by 404 Media. The change will require hospitals to enter into repair contracts with the manufacturer, which will ultimately drive up medical costs, a person familiar with the devices said.
The company, Terumo Cardiovascular, makes a device called the Advanced Perfusion System 1 Heart Lung Machine, which is used to reroute blood during open-heart surgeries and essentially keeps a patient alive during the surgery. Last month, the company sent hospitals a letter alerting them to the "discontinuation of certification classes," meaning it "will no longer offer certification classes for the repair and/or preventative maintenance of the System 1 and its components." This means it will no longer teach hospital repair techs how to maintain and fix the devices, and will no longer certify in-house hospital repair technicians. Instead, the company "will continue to provide direct servicing for the System 1 and its components." [...]
In a brochure for hospitals, Terumo advertises both its device and its maintenance program: "Advanced, precision medical equipment requires genuine parts and top-quality, specialized service -- just as getting the best medical care from qualified specialists. Terumo Cardiovascular Service has the unrivaled expertise, experience, equipment, and parts to provide the optimal level of planned service and repairs needed. Use Terumo Cardiovascular Service and avoid exposure to liability issues." A spokesperson for Terumo told 404 Media that the company "saw declining participation in this program and determined that the best way forward was to require servicing through Terumo Cardiovascular's genuine in-house Service team to continue to ensure Terumo devices are properly maintained."
"Terumo Cardiovascular's Biomed Certification Program was originally structured to train non-Terumo personnel (hospital Biomeds) to service Terumo heart-lung machines and associated hardware. Properly maintained medical devices are necessary for optimal performance which is essential for quality of patient care and outcomes," they added. "Hospitals' existing Terumo Cardiovascular Biomed certifications will remain valid through their expiration dates but will not be renewed once they expire." "It's no secret that America's healthcare system is the most expensive, and this is one of the reasons why. These machines are actually highly reliable, we've had a low cost of service for it over the last few years. And when something isn't right, we have people in-house who can fix it," a source familiar with Terumo machine repair said. "But the cost of having a service contract with a manufacturer, you're probably talking 10 times the cost. It's not a big deal having a contract for one device, but when that starts happening across many devices, it adds up in the end. If you took every hospital in America and said for every medical device in the hospital, you need to put it on an OEM [original equipment manufacturer] maintenance contract, it would tank your financial system. You just can't do that."
The company, Terumo Cardiovascular, makes a device called the Advanced Perfusion System 1 Heart Lung Machine, which is used to reroute blood during open-heart surgeries and essentially keeps a patient alive during the surgery. Last month, the company sent hospitals a letter alerting them to the "discontinuation of certification classes," meaning it "will no longer offer certification classes for the repair and/or preventative maintenance of the System 1 and its components." This means it will no longer teach hospital repair techs how to maintain and fix the devices, and will no longer certify in-house hospital repair technicians. Instead, the company "will continue to provide direct servicing for the System 1 and its components." [...]
In a brochure for hospitals, Terumo advertises both its device and its maintenance program: "Advanced, precision medical equipment requires genuine parts and top-quality, specialized service -- just as getting the best medical care from qualified specialists. Terumo Cardiovascular Service has the unrivaled expertise, experience, equipment, and parts to provide the optimal level of planned service and repairs needed. Use Terumo Cardiovascular Service and avoid exposure to liability issues." A spokesperson for Terumo told 404 Media that the company "saw declining participation in this program and determined that the best way forward was to require servicing through Terumo Cardiovascular's genuine in-house Service team to continue to ensure Terumo devices are properly maintained."
"Terumo Cardiovascular's Biomed Certification Program was originally structured to train non-Terumo personnel (hospital Biomeds) to service Terumo heart-lung machines and associated hardware. Properly maintained medical devices are necessary for optimal performance which is essential for quality of patient care and outcomes," they added. "Hospitals' existing Terumo Cardiovascular Biomed certifications will remain valid through their expiration dates but will not be renewed once they expire." "It's no secret that America's healthcare system is the most expensive, and this is one of the reasons why. These machines are actually highly reliable, we've had a low cost of service for it over the last few years. And when something isn't right, we have people in-house who can fix it," a source familiar with Terumo machine repair said. "But the cost of having a service contract with a manufacturer, you're probably talking 10 times the cost. It's not a big deal having a contract for one device, but when that starts happening across many devices, it adds up in the end. If you took every hospital in America and said for every medical device in the hospital, you need to put it on an OEM [original equipment manufacturer] maintenance contract, it would tank your financial system. You just can't do that."
Wow (Score:5, Interesting)
First the McFlurry machine, now this. Well, McDonald's (finally) got the right to repair their machines, maybe Hospitals will too someday. I mean, doing open-heart surgery has to be almost as important as making soft ice cream - right? :-)
US Copyright Office allows McDonald's to fix broken ice cream machines [usatoday.com]
Re:Wow (Score:5, Insightful)
John Deere. This is their business model, and you can expect it to be the new standard for doing business here.
Re:Wow (Score:4, Insightful)
Now, understand that big pharma uses the exact same strategy to keep people on as many pills as possible.
The "health care" industry is a "sick care" industry. It's not interested in curing your disease if it doesn't come with a long term revenue stream.
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Re: Wow (Score:2)
At least for 4 more years. Zero common sense is happening in America until then
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Re:Wow (Score:4, Interesting)
I'd make it simple: If you do not sell parts for the device, if you disallow 3rd parties from providing parts, if you don't allow training and such, then you are obligated to provide the repair service for free.
I mean, not providing training is one thing, you can always get the equivalent of Haynes doing a tear down and building their own manual/repair guide.
Parts might be a bit more difficult.
There's generally enough vehicles on the road and enough parts commonality to justify 3rd party manufacturing of parts, but for something like a heart machine, there might only be a couple hundred in the world.
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Don't worry, after the first lawsuit or two from not having technicians and parts available NOW at the hospital and I bet the the manufacturers lawyers are gonna tell em to go back to the old way or find new legal representation.
Legal contracts for guaranteed uptimes, or repair windows are more and more brutal the higher up the "this shit is literally keeping people alive" ladder you go. No, Dell's "24 hour repair or replace" isn't going to cut it, the hospitals will demand sub hour turnarounds. Or if they
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No the franchise owners got the right to repair. The McDonald's corporation stood in the way for decades allowing one company a monopoly status on the machines as it was easier to deal with them than all of the franchise owners.
Right to repair is dead (Score:3)
Re: (Score:2)
Trump has no stated position on R2R.
The states that have passed R2R are Massachusetts, Colorado, New York, Minnesota, Maine and California.
All are blue states (voted for Harris).
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In full honesty, I think all it would take would be for Fox News to point out that it's associated with blue states. And maybe that it "stifles American innovation at John Deere".
Terms of Sale (Score:3)
One doesn't purchase machines that cost 6 figures without the maintenance and training services as a part of that contract. So, Terumo Cardiovascular is renegotiating the terms? Fine. I hope they have their checkbook out.
The machine is highly reliable (Score:3)
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All of medtech has hard "expiry date". At the very least, accounts for mechanical/etc wear. Device may not be deployed after the expiry date.
If it were only to prop up the sales, the manuf could have simply shortened the "expiration" of their devices. They could have even installed some cheaper non-critical elements to justify the shorter life cycle.
I'd guess they done that already, but now want to extract even more from system.
The machine that goes "Ping!" (Score:3)
Is it the machine that goes "Ping!"? I bet it is.
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A lease? (Score:2)
Think this needs to just shift to becoming a service.
Never heard of 'device as a service'. Probably a reason for that. If the customer is paying for a service then you're responsible for dealing with the device.
Of course then the company would need to immediately replace them, like by already having backups nearby anywhere units are rented.
Then it'd make more sense to have the people using the hardware be employees of that company too. Where did our guilds go?
Oh, right... centralizing power lets people m
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Never heard of 'device as a service'.
If you've never heard of equipment leasing, you probably don't have anything of value to add to this discussion.
Nothing new here (Score:2)
Two other possibilities (Score:2)
1. Terumo's machines are highly reliable and easy to fix. Awesome. But that has other effects that aren't so great. It means they don't sell very many of them, and training classes just don't bring in a lot of revenue. Great for the customers, unless the company is running so lean that they're facing bankruptcy. If that's the case, they need to charge the customers more through maintenance co
There's another, more likely, possibility (Score:2)
Their lawyers and/or insurance company may have told them to stop the practice. The medical industry is VERY heavily impacted by the money-grubbing legal profession ("If you or anyone you know has ever...call the offices of ... and we can get you MONEY!") and it's VERY possible that the company has been advised by lawyers, or has had DEMANDS from their insurers, to stop allowing anybody but their own staff to repair these systems. I'm not in the medical industry, and I do not have any info on this particula
Is this bad? or is it click bait? (Score:1)
Does anyone here actually understand FDA compliance and responsibility for medical devices?
Discontinuing a training program greatly reduces their AND the hospitals liability.
I am honestly surprised the FDA even allowed a training certification for a life safety device.
Just because a company stops doing something does not mean they have malicious intent. Maybe they are going to start including maintenance in the cost of the device instead of charging people? Or maybe they are going to displace the cost of th
Max downtime guarantees? (Score:2)
Healthy competition... (Score:1)
It'll drive up the price of healthcare.... (Score:2)
If the hospitals want to maintain their astronomical profit margins
Need a Right to Repain anything you own. (Score:2)
No more of this farm bull crap. If I buy a physical object, I should be able to do anything I want to it - break, repair it, turn it into art, etc.
They do not own the items I buy, I own them. That is what BUY means.
WWLRD? (Score:2)
What Would Louis Rossmann Do?
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Something stupid, and irreversible.
so done (Score:1)
it's time for capitalism to die, this is too retarded. Fuck jails too, it's time to deal with the problem the civilized way, beheadings in the public square for message-sending purposes. The tards need to be told a few times.
"I'm sorry sir." (Score:2)
"I simply can't offer you a Blood McFlurry today; our machine's down."