Right to Repair Advocates Accuse Medical Device Manufacturers of Profiteering (vice.com) 55
A new Motherboard article interviews William, a ventilator refurbisher who's repaired at least 70 broken ventilators that he's bought on eBay and from other secondhand websites, then sold to U.S. hospitals and governments to help handle a spike in COVID-19 patients.
He's part of a grey-market supply chain that's "essentially identical to one used by farmers to repair John Deere tractors without the company's authorization and has emerged because of the same need to fix a device without a manufacturer's permission..." The issue is that, like so many other electronics, medical equipment, including ventilators, increasingly has software that prevents "unauthorized" people from repairing or refurbishing broken devices, and Medtronic will not help him fix them... Faced with a global pandemic, hospitals, biomedical technicians, right to repair activists, and refurbishers like William say that medical device manufacturers are profiteering by putting up artificial barriers to repair that drive up the cost of medical care in the United States and puts patient lives in danger. They describe difficulty getting parts and software, delays in getting service from "authorized" technicians, and a general sense of frustration as few manufacturers appear ready to loosen their repair restrictions during the COVID-19 crisis.
For the past decade, medical device manufacturers have refused to sell replacement parts and software to hospitals and repair professionals unless they pay thousands of dollars annually to become "authorized" to work on machines. The medical device industry has lobbied against legislation that would make it easier to repair their machines, refused to release repair manuals, and used copyright law to threaten those who have made repair manuals available to the public. The technicians who are unable to gain access to repair parts, manuals, and software are not random people who are deciding on a whim to try to fix complex medical equipment that is going to be used on sick patients. Hospitals and trained professionals are regularly unable to fix the equipment that they own unless they pay for expensive service contracts or annual trainings from manufacturers.
While hospitals deal with a resurgent coronavirus that is overtaxing intensive care units across the country, their biomedical technicians are wasting time on the phone and in Kafkaesque email exchanges with medical device manufacturers, pleading for spare parts, passwords to unlock diagnostic modes, or ventilator repair manuals.
The article notes that newer medical devices even have "more advanced anti-repair technologies built into them. Newer ventilators connect to proprietary servers owned by manufacturers to verify that the person accessing it is authorized by the company to do so."
He's part of a grey-market supply chain that's "essentially identical to one used by farmers to repair John Deere tractors without the company's authorization and has emerged because of the same need to fix a device without a manufacturer's permission..." The issue is that, like so many other electronics, medical equipment, including ventilators, increasingly has software that prevents "unauthorized" people from repairing or refurbishing broken devices, and Medtronic will not help him fix them... Faced with a global pandemic, hospitals, biomedical technicians, right to repair activists, and refurbishers like William say that medical device manufacturers are profiteering by putting up artificial barriers to repair that drive up the cost of medical care in the United States and puts patient lives in danger. They describe difficulty getting parts and software, delays in getting service from "authorized" technicians, and a general sense of frustration as few manufacturers appear ready to loosen their repair restrictions during the COVID-19 crisis.
For the past decade, medical device manufacturers have refused to sell replacement parts and software to hospitals and repair professionals unless they pay thousands of dollars annually to become "authorized" to work on machines. The medical device industry has lobbied against legislation that would make it easier to repair their machines, refused to release repair manuals, and used copyright law to threaten those who have made repair manuals available to the public. The technicians who are unable to gain access to repair parts, manuals, and software are not random people who are deciding on a whim to try to fix complex medical equipment that is going to be used on sick patients. Hospitals and trained professionals are regularly unable to fix the equipment that they own unless they pay for expensive service contracts or annual trainings from manufacturers.
While hospitals deal with a resurgent coronavirus that is overtaxing intensive care units across the country, their biomedical technicians are wasting time on the phone and in Kafkaesque email exchanges with medical device manufacturers, pleading for spare parts, passwords to unlock diagnostic modes, or ventilator repair manuals.
The article notes that newer medical devices even have "more advanced anti-repair technologies built into them. Newer ventilators connect to proprietary servers owned by manufacturers to verify that the person accessing it is authorized by the company to do so."
who's responsible if someone dies? (Score:5, Insightful)
Most of the cost of medical junk is the certification and other documentation. If someone repairs it onsite and does it wrong and kills someone, who's responsible? Someone is going to sue and they'll probably argue that the device manufacturer should have made their device hard to repair to keep it properly certified
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I have actually read the paperwork that i had to sign before outpatient surgery. The hospital basically disclaims all liability including the equipment, personnel, and techniques. No warrantee express or implied.
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I imagine that if you look closer there will be something to the effect of "to the extent allowable by law."
Re:who's responsible if someone dies? (Score:4, Informative)
Yes, but that means *nothing*.
Pretty much every "service contract" has the "we don't take any responsibility for anything" clause in it. It's not enforceable in court. It's just there to fool the small percentage of people that believe it *is* enforceable, and keep them from filing a lawsuit.
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If this disclaimer really worked as you describe, hospitals would not spend money on certified equipment, they'd just go with the cheapest knock-off they can find on ebay or alibaba. Using a product fixed by someone who is not certified is very similar - they might know what they are doing, and I guarantee you the hospital can still be sued if the patients dies because the hospital bought their ventilators on someone on ebay who put it together from junkyard parts.
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Re: who's responsible if someone dies? (Score:2)
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So, for an outlook we'd be going from 'Death' to 'maybe Death'?
Sure, I'd take that bet.
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If the alternative is certain death... umm... yeah. If you basically give me the choice between using a technology that might kill me and not using it and me dying, the choice is pretty easy.
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So you're saying hospitals should clearly label those "might kill you" devices and use them as last resort, when they can be certain you will die anyways? Should they also designate a few "might kill you" surgeons to use when they are short staffed too - you know, the cafeteria busboy who watched a reality show about medical procedures is better than no doctor, right? How about medications, should the hospital stack up on drugs from questionable sources and factories known to have safety issues which might
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When your choice is no life saving equipment or equipment that was repaired in an emergency, it's a no brainer.
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Damned if you do, damned if you don't (Score:4, Insightful)
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If you don't allow third party repair, the seller will squeeze you for all you've got, and if you do, shady service people with their low prices will make shoddy repairs. You either need to strike a balance, or somehow completely subvert the adversarial nature of capitalism.
No, there is a third choice. To use a car anology, you don't have to go either the dealer or the cheapest body shop in town for repairs. You can go to a body shop with a reputation for providing good service. The existence of high-quality repair shops is not contrary to capitalism: some people are willing to pay more for the better reputation.
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Now imagine that your loved one dies because the hospital used a ventilator they got on ebay from HandyEddie who taught himself how to fix ventilators using junkyard parts. Hospital says they did that because they could get 10 ventilators from Eddie for the same price as they would have gotten a certified one from a medical supplier. Would that make you feel better?
How do you even know there WAS someone messing wit (Score:3)
> If someone repairs it onsite and does it wrong and kills someone, who's responsible? Someone is going to sue and they'll probably argue that the device manufacturer should have made their device hard to repair to keep it properly certified
When it's discovered that a seal was installed upside down, how do you even *know* that someone was doing unauthorized work on it? The presumption would be if there is a defect, it probably came from the factory that way.
I rooted my phone, after choosing which phone
Re:How do you even know there WAS someone messing (Score:4, Informative)
From reading the maintenance logs for the device?
What, you thought that mission-critical devices don't have detailed maintenance/repair logs kept for everything that's ever done? And yes, the parts and such will have a paper trail that outweighs the patient....
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Do you learn about proper logging when you take the training to repair these devices?
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What insures an unauthorized repair is logged?
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If the tamper seals are broken on a ventilator or other device in the ICU, should the device be used with a broken seal?
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Bullshit article (Score:2)
>> Right to Repair Advocates Accuse Medical Device Manufacturers of Profiteering
What ? no.
What bullshit article is this ?
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There is a simple solution to this. Here's a form. Signing it means that we'll not be held liable in case you die because the thing we used to keep you alive didn't work out as planned.
Not signing it means that we will not use the thing and you die.
Your choice.
So What. (Score:5, Insightful)
I am ok with companies who want to keep their equipment proprietary. What I don't want to see is a law stating that only company X can fix said equipment. If your company doesn't provide for the sale of a maintenance manual, then you can't sue if someone reverse engineers one and makes that available to the public.
Junk products (Score:4, Insightful)
Maybe if the companies don't want customers doing repairs, the manufacturer should be doing them. ASAP. They should not be selling unfixable things, they should lease them, and assume all maintenance costs.
I mean really, this is getting ridiculous. Corporate America needs to eventually be told to STFU and deal.
Because unfixable things is a *liability* which corporate America has gradually shifted onto the customers, while also lightening their wallets. Something that I have paid for and cannot fix is basically worthless to me -- junk. Actually worse than junk, it is a liability because I am on the hook for it.
I thought our system was supposed to be all about risk vs reward. What I see is a lot of reward and no risk at the highest levels of our economy.
Right to rent (Score:4, Insightful)
"Sale" will become a thing of the past eventually. It's already happening with software .. most of the software my companies buy are not even available for purchase (Autodesk, Adobe, etc. too many to list)
How to stop that, especially for hardware? We may end up with laws that prohibit restrictions on tinkering with hardware rented from manufacturers.. but if you make a product and warranty it .. wouldn't you want that control? But then in the case of hardware if someone tinkers with the product they rented, would you as a manufacturer want it back?
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Stopping it for "hardware" won't do the trick. Most thingies these days come with ASICs or FPGAs. The manufacturers will simply embed their whizzies in those and claim they are software and hence not restrictable. We need blanket protection covering software and hardware and manuals and anything else that goes into a gizmo.
It's to ensure a standard. (Score:5, Informative)
The reason medical devices are so tied to vendor is largely legislative (the EU has software as a medical device regulations).
When a device comes on site, it is warranted and supported by the vendors. When an engineer turns up to examine it, they have the full weight of the support of the company behind them, escalation chains, manuals on exactly how each piece should be put together.
When released in a configuration, the vendor takes liability for the device, should an event be due to incorrect build quality or maintenance.
When they train people to repair these devices, they give the same resource to those people (including having engineer support should things not go to plan). They treat these people as sufficient to repair (faulty repair would be the liability of the person doing it, but the general liability for build quality and keeping the device certified as a medical device is still on the vendor).
If you knowing use a non-certified device in a hospital environment, you stand a good chance off losing your career. If you do that, and something goes wrong, you stand a good chance of spending a long time behind bars.
In the case of some random person selling on the grey market, with unauthorised repairs, then that device does not meet medical device regulations, so using it in a clinical environment is extremely risky.
That being said, in the event of a killer outbreak (say COVID) where the numbers of fatalities are going to massively escalate without basic intervention of a simple device, then suspending the regulations on that class of device (as long as it's simple enough) makes sense, with the calculation being that big numbers will die by that lack.
With a complex device, I'd not trust people in general to tinker (you know, as users do in the core IT infrastructure; doing something on the home PC was simple enough, therefore they know enough to be let loose with admin privs on the core server and network architecture because they read about a trick on the internet that sysadmins don't want you to know about that makes things better, What could possibly go wrong).
Half of the treatment path through a hospital is keeping tabs on risk. How risky is each intervention at each point in the patient pathway.
As soon as you have an uncontrolled device, with no known history, your risks are out the window. What it it was in contact with some contaminant that would normally require it to be junked? A horde of things like that.
Tractors, cars, household goods.. I'm all for allowing repair of those by people of a general qualification, but medical devices.. That's a whole other ball game of complexity.
Re:It's to ensure a standard. (Score:4, Informative)
To a point, yes. And I even agree with that goal. The problem comes when a device manufacturer allows only their own personnel to work on a device, and then makes it extremely expensive to get that person on site to do the job. Or, as with the current COVID situation, bans travel of their Field Support Engineers entirely, leaving my device broken for potentially months on end. As a Biomed, I could attend training for the repair of said device (and have, for some), and do the repair in-house. That is, if the device manufacturer allows non-company people to be trained. And even that is expensive, and can take months to get.
And before you say a company's FSE is better than I could be, I've actually watched them break my devices worse than when I called for service, and then charge me for what they broke. How is that better than what I could do, given the same training?
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I'm all for allowing repair of those by people of a general qualification, but medical devices..
I think fundamentally the point isn't who should be allowed to repair something, it's more a case of whether vendors should be allowed to hold hostage the repair of the device at an exorbitant fee.
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You could always regulate the fees charged, and the SLAs
No Such Thing (Score:2)
There is no such thing as "right to repair" and absolutely no need for "license to repair".
When you buy something you then own it and can do whatever the bloody hell you want with it limited only by legally enforceable conditions of sale that were disclosed and agreed to in writing by both parties as part of the contract of sale. Conditions of sale that are not disclosed before sale or are not agreed to in writing between the parties at time of sale are not binding on the purchaser.
Ignorance of the Law by
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Alas, these devices have hardware precauctions against repair ("tampering") included. Or, the software requires an encryption key. Or needs to phone home every time it's used (yay if you need to save lives when the 'Net is down).
It's not a new thing: decades ago, car manufacturers started sealing a bunch of unrelated parts into a block, turning a 5-minutes simple repair into something that requires sophisticated training and equipment, just so non-authorized repair shops can't do that.
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Your friend buys Whizzy Tater Twaddler 1.5 from Mega Tater, Inc. It fails. He takes it to you and you agree to fix it. You do so. Your friend takes it home and it Twaddles his little finger in unspeakable ways. I'd tell you what they were but they are unspeakable. He decides he must sue due to respect for his finger. Do you take it like a man or turn around and accuse the company?
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Maybe back in the dark ages of the eighties. Modern electronics is much more difficult to repair without the manufacturer's secret documentation, and is often designed in such a manner as to render repair deliberately as difficult as possible.
How about don't buy it from them in the 1st place? (Score:2, Troll)
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Yes, precisely a cartel. Now, in the interest of cartel busting, you'll be wanting to change the laws which force manufacturers to dive into the deep end of the lawyer pool in order to protect themselves over the inevitable lawsuits when something goes wrong. Then you'll be wanting to change the rules of the executive branch agencies that interpret those laws and promulgate rules to enforce the laws.
Too bad you're not home yet. Those devices are usually special purpose and you won't be seeing oodles of comp
It's not just medical devices. (Score:5, Insightful)
While there may be special considerations for the certification of medical devices, many manufacturers are starting to profiteer by making it impossible for anyone to repair their equipment, whether it is cars, farm machinery, cell phones, and even household appliances. These people join the hateful ranks of people like the printer vendors who turn off their cartridges when they still contain ink, or make it impossible to use aftermarket supplies in their equipment. We can have some effect by refusing to buy from these people, but most consumers don't discover this until it is too late. Also, with some classes of product -- like farm equipment -- there are very few choices for the consumers. This is one of the rare occasions when I think government should get involved to guarantee the right of equipment owners to fix their own stuff.
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Regulation, Device Manufacturers (Score:1)
I'm a medical equipment manufacturer. The FDA regulates me *exactly the same* as a company that produces drugs people ingest. Even though my equipment is completely noninvasive and could not feasibly ever injure anyone or make anybody sick. You could literally put a raw chicken breast in it and still nobody would get sick.
Due to FDA regulations, if I were to provide instructions for you on how to replace the hard drive and reinstall Windows and our (proprietary) software on your medical equipment, I'd have