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Medicine Technology

Hospitals No Longer Allowed To Fix Machine That Costs Six Figures 46

Posted by BeauHD from the concerning-trends dept.
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."

Hospitals No Longer Allowed To Fix Machine That Costs Six Figures More | Reply

Hospitals No Longer Allowed To Fix Machine That Costs Six Figures

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  • Wow (Score:5, Interesting)

    by fahrbot-bot ( 874524 ) on Wednesday January 22, 2025 @06:28PM (#65110969)

    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)

      by spazmonkey ( 920425 ) on Wednesday January 22, 2025 @06:33PM (#65110973)

      John Deere. This is their business model, and you can expect it to be the new standard for doing business here.

      • Re: (Score:3, Insightful)

        by hsthompson69 ( 1674722 )

        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.

        • Many (but not all) of things for which "big pharma" makes the most money "keeping people on pills" are things that could be solved by purchasing a barbell one time, learning how to use it, and doing so on a regular basis. People find the pills to be more desirable even if the weight set costs less than one month's supply

          • Re: (Score:2)

            by tragedy ( 27079 )

            Yes, lifting weights will definitely cure people of type 1 diabetes, congenital heart defects, cystic fibrosis, sickle cell anemia, hemophilia, heart defects, resistant hypertension, organ failure due to physical accidents or infection, numerous types of infectious disease, etc., etc. Or maybe, just maybe exercise is not some kind of magical fix-all for every health condition. There's no denying that exercise improves general healthy, but peoplething who think that it will fix everything are just some kind

            • Yes, lifting weights will definitely cure people

              Not sure what you're arguing about. OP has your point presented succinctly as the first few words of their point.

              And their point is still valid.

              • Re: (Score:2)

                by tragedy ( 27079 )

                Sorry, I didn't realize I needed sarcasm tags for something that blindingly obvious. I'll make sure to include those next time for people with poor reading comprehension skills.

                And their point is still valid.

                No, their point is, overall, pretty ridiculous. Sure exercise can help with a lot of things. That even includes things like chronic pain where, for example, building up muscle can relieve stress on other areas, but most chronic conditions basically require people to keep taking medication and replacing the pills with exercise does no

      • At least for 4 more years. Zero common sense is happening in America until then

    • The right to repair it doesn't help in the medium or long term if they're removing the training to do so, or the supply of spare parts, I think McFlurry machines are rather lower risks and lower tolerances than heart & lung machines

      • Re:Wow (Score:4, Interesting)

        by Firethorn ( 177587 ) on Wednesday January 22, 2025 @06:56PM (#65111027) Homepage Journal

        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.

        • 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

    • 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)

    by rsilvergun ( 571051 ) on Wednesday January 22, 2025 @06:30PM (#65110971)
    it was a priority of the previous administration. It is very much not of the current one. Quite the opposite really.

    • 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).

      • What do we really expect to happen, then?

        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".
      • Dude he's replacing the FTC chair that was pushing it with a corporate shill. He doesn't have a stated position because it's too complicated and idea for the average Trump voter and frankly too complicated for his senile old can't make it through a 1 hour town hall meeting ass, but it's painfully obvious what his administration is going to do

        Face it if you voted for Trump you fucked up. You're not going to get Mass deportations, you're not going to get lower grocery prices or lower gas prices, You're not

  • Terms of Sale (Score:3)

    by PPH ( 736903 ) on Wednesday January 22, 2025 @06:47PM (#65111003)

    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:4, Insightful)

    by Retired Chemist ( 5039029 ) on Wednesday January 22, 2025 @06:55PM (#65111021)
    What this means is that they cannot sell many more machines because the ones already out there work. So, in order to keep making money they are trying to gouge their customers on maintenance. Unfortunately, once you have invested a large amount money in a capital asset, you have little choice but to keep it. What the hospitals should do is get together and set up their own training and certification system and tell the manufacturer to go hell.

    • 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:4, Funny)

    by Local ID10T ( 790134 ) <ID10T.L.USER@gmail.com> on Wednesday January 22, 2025 @06:55PM (#65111025) Homepage

    Is it the machine that goes "Ping!"? I bet it is.

  • 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

    • 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.

  • I was FAA-certified to install, repair and calibrate airport weather stations. The company that manufactured the stations decided that it was more profitable to handle all the biannual calibrations and effectively decertified all their independent help.
  • While there's the usual crowd here that attributes this to moneygrubbing evil, there are two other possibilities:

    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

    • 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

  • 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

    • Agree. This is a really stupid thing for people to be conflating with right-to-repair.

      Also do you really want Jane-Sue or Jim-Bob the hospital maintenance person messing with a machine that is literally keeping you alive during surgery, or would you prefer the company that made it, and designed it and literally only supports that machine is making sure its running properly?

      Hell no I wouldn't....I'd want to know that thing was factory maintained by people who are intimately familiar with it. Not someone who did a remote study course.

      But, if people have a problem with this, I highly encourage them to boycott its use during their next open heart surgery.

  • Max downtime guarantees? (Score:3)

    by misnohmer ( 1636461 ) on Wednesday January 22, 2025 @08:23PM (#65111173)
    Do they offer maximum downtime guarantees as part of the service contract? With monetary penalties of course for every hour of downtime above the guarantee. This machines make money for the hospital, so hospital can allocate fast response technicians, stock their own parts, to minimize down time. Once it's all exclusively done by the manufacturer, they control the downtime. As the sole provider and the manufacturer, they have the scale, so they could even provide temporary loaners if a repair requires longer time, or has to wait on parts, etc.
  • Used to prevent this sort of thing :-(

  • If the hospitals want to maintain their astronomical profit margins

  • 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.

  • What Would Louis Rossmann Do?

  • 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 simply can't offer you a Blood McFlurry today; our machine's down."

  • I would tell this company to go pound sand and look for an alternative.

    Unfortunately, the hospitals don't care how much this is going to cost the patient, they will keep the machines and pass the cost (and more) to the patient.

  • The summary says that the company could not afford to keep the training and certification program going, because the hospitals were not sending enough technicians. So in the future, everyone will have to get the company's techs instead.

    Not clear how this drives up the costs.
    Sounds like you have to pay, one way or another,
    and hospitals did not want to pay for the training.
    Perhaps they could not even hire any technicians
    to even go get trained. So now they will pay directly.
    Is that more expensive than keeping

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