'Project BioMed' Fights for the Right to Repair Medical Devices (securityledger.com) 30
Long-time Slashdot reader chicksdaddy writes:
One of the less-reported stories of this pandemic is the myriad of ways in which COVID has exposed changes to the medical device market and the increasingly draconian software licensing practices that have made servicing and repairing medical devices much more difficult, slow and expensive. In its latest episode, Security Ledger Podcast goes behind the scenes of Project BioMed, an effort headed up by repair site iFixit to democratize access to repair and servicing information for medical devices including (and especially) ventilators and respirators.
Kylie Wiens, CEO of iFixit, talks about the critical role played by biomedical technicians, who keep hospital equipment up and running, and about the growing efforts by medical device OEMs to deny hospitals and biomeds access to the information they need to service equipment. The podcast also interviews Jonathan Krones, an Assistant Professor at Boston College and one of an army of volunteers, including hundreds of librarians and archivists who sorted through and cataloged hundreds of thousands of pages of medical device servicing information donated by biomedical technicians as part of the project.
Kylie Wiens, CEO of iFixit, talks about the critical role played by biomedical technicians, who keep hospital equipment up and running, and about the growing efforts by medical device OEMs to deny hospitals and biomeds access to the information they need to service equipment. The podcast also interviews Jonathan Krones, an Assistant Professor at Boston College and one of an army of volunteers, including hundreds of librarians and archivists who sorted through and cataloged hundreds of thousands of pages of medical device servicing information donated by biomedical technicians as part of the project.
Please, please, please, please!!! (Score:4, Informative)
Just got the outrageously expensive Minimed 670g insulin pump. The sensors were designed by a bond villain for awkwardness to apply expense, and likelihood to fail at roughly $30 for a one-week sensor that won't stay on. the glucose test strips for the "ContourNext" meter that broadcasts to that pump are roughly $3/each.
The Wal-mart available Freestyle tst strips are less than $1/each, and the Fr4estyle 10-day sensor stays on and costs roughly $40. But you can't swap them and have them talk directly to the insulin pump, those communication standards are "proprietary" and "approved by the FDA only for defined use". There are similar issues with the Dexcom sensor talking to a Minimed pump, and *many* diabetics prefer the Dexcom sensors for ease of use and reliability. It used to be possible to crosshook Dexcom sensors to the older Minimed 522 pump through your cell phone, but Medtronic deliberately disabled that with their last "update"
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But - this is a medical device. Only an authorized technician can repair it properly. Joe the shade tree mechanic is going to screw up the repair and harm you. The FDA is in the business of protecting you from yourself and deplorable morons like Joe.
We have to relax and let experts do their thing. They're know the issues better than us and can make better decisions. That's the logic behind letting the FDA regulate these devices.
I don't agree with it personally. I believe when we buy something that we b
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This is more of a private property issue, and what’s weird is that the same people who tend to come down hard on private property rights, tend to support the large companies remaining in control of property that you bought and paid for.
If 90% of people don’t care about right to repair, the 10% that do have no option, as the 90% determine what the companies will make requirements.
The minority needs to be protected from the apathy of the majority, as said apathy annihilates what choices we
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But - this is a medical device. Only an authorized technician can repair it properly. Joe the shade tree mechanic is going to screw up the repair and harm you. The FDA is in the business of protecting you from yourself and deplorable morons like Joe.
We have to relax and let experts do their thing. They're know the issues better than us and can make better decisions. That's the logic behind letting the FDA regulate these devices.
I don't agree with it personally. I believe when we buy something that we buy it, and can do whatever we want with it. But those are the arguments, and if you're going to win you need to address them head-on and make convincing counter-arguments. Plus, deal with the fact that medical experts are currently highly respected and saying that you know better than them is going to entail significant blowback.
Actually - no. Most biomeds would tell you that the vast majority of med device repairs are dead simple, as the devices are designed to be easily serviceable and to have long lives. You know what's _not_ easy to fix? A Microsoft Surface or an iPhone 10. Arguments about safety are scare mongering - there is no data that supports the conclusion that repair done by OEMs - at far greater cost - is any safer or more effective than repair done by in-house biomeds working for the customer.
A heart monitor is no macbook (Score:1)
Medical devices are different: there literally is a life at stake. Which is why there is a lot of expensive and cumbersome red tape by the FDA associated with them. One
Re: A heart monitor is no macbook (Score:2)
My question is this - who is responsible for the harm? If you mess with your medical device, who pays to fix your health, who pays whom if you die?
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option 1, you mess with the device, and as a result there is a chance you live and are healthy,
option 2, you don't mess with it, and so you die or become unhealthy.
Which option should you take?
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However; there's a lot of finger pointing at the FDA regulations and restrictions, only some of which is warranted. Yes, the FDA does regulate and restrict some repairs or modifications, but far more of this is the medical device vendors deliberately restricting the repair to in-house technicians, mostly for reasons of cash flow. It's a revenue stream for them. There are many trained biomedical equipme
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How many "trained biomedical equipment repair specialists" do you think are working in a typical hospital?
How many hospitals have work areas that are adequately equipped to repair reflow solder devices, inspect boards to ensure there are no cold solder joints, and do all the other kinds of repair that is typical of a modern, high-tech device?
The FDA regulations are nominally there to ensure that the devices are practically certain to work safely and as intended in all authorized uses. A few decades ago, it
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Then have replaceable boards, just like in computers. Pull bad board out, insert working board, send bad board back to manufacturer.
It solves both problems. The end user can fix the machine and the company can look at the bad board, repair it, and send it back out as refurbished.
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Where does the end user get that working board? What moneys are exchanged in the return, refurbishment, and eventual resale of the failed board? How do those costs compare to the current situation?
It seems to me that you have merely shifted the repair problem from a line- or field-replaceable unit to a depot-replaceable unit, and you have not addressed the question of calibration that may need to be performed when a board (or individual component) is replaced.
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The end user buys the board from the manufacturer or authorized seller of equipment. This is no different than how it's done now. If you have a bad keyboard (for a laptop) you can either buy the part and repair the system yourself or pay for an authorized third party to do the repair.
As for refurbished parts, you can buy refurbished parts and machines. There used to be a store which sold refurbished KitchenAid mixers. Everything from the low end to top of the line was a minimum 25% less than regular pric
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As I said, you simply moved the problem from the box to the board. Most of the cost is probably in the boards anyway.
What you suggested (a startup process like a printer's) is not calibration [wikipedia.org], but something like automatic adjustment. For any kind of medical device, one wants high-confidence traceability to reference standards, meaning real calibration. As a concrete example, a doctor cannot just hope that a pump dishes out the right dose of drugs. Built-in self-test is usually also required, but that se
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How many "trained biomedical equipment repair specialists" do you think are working in a typical hospital?
Well, when I worked at a hospital (250 beds) in the early 90s there were 2 full timers and 2 part timers that kept the IV pumps, suction pumps, O2 tank regulators, etc. working. Anything part of infrastructure - like the O2 or suction "built in" to the walls, etc. was the regular facilities department, occasionally contracted out. The big stuff is usually leased - X Ray machines, CAT scan machines, sonogram machines, EEG machines, etc. - and so they'd simply log it and call the leasing co to come fix or r
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Used to design medical electronics (Score:3, Interesting)
I wasn't even allowed to patent my work, because it was NIH funded and therefore would be public domain anyway. I wanted the patents for my resume, and so that companies wouldn't try to proprietize my designs (which happened!) I wasn't even allowed to speak with the patent attorney from our various funding agencies, to make sure they knew about my prior art.
Seeing my designs show up in other people's work without credit was one problem. The fact that they didn't know how to tune the circuitry, and made potentially dangerous component replacements was a *big* problem. Electrolytic capacitors don't block DC voltage in series if the polarity gets reversed, and an ordinary AC signal spends half of its time with negative voltage. The result is a half-rectified DC current, amplitude modulated by the size of the AC signal. This is *bad* for nerves. Let's just say there was a lot of screaming on my part when I found out they'd been doing this with my original design.
Nice little hospital that you have there ... (Score:2)
it would be a shame if you tried to repair what you have bought from us .... OK: not quite the same as a Mafia protection racket, but the effect is the same: forcing the hospitals to pay inflated prices to the supplier, it also means that repairs can take much longer. I agree with a previous poster that some these things being fixed badly could hurt people in a way that a broken macbook will not, but that should be solved by good repair documentation & diagnostic tools. The cost of having broken (or par
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Better alternative. (Score:3)
The cost in medical devices is in development, testing and certification. It only makes sense that should the device fail that it should be replaced by the manufacturer free of charge. I'm against everyday people repairing these devices not because I don't want them to be able to repair the device but because if they fuck it up it could literally kill someone.
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if they fuck it up it could literally kill someone.
This, exactly.
Now if you'll excuse me, I have to to a brake job on my shitbox car.
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I don't want them to be able to repair the device but because if they fuck it up it could literally kill someone.
Do you think that the people doing the repair don't know this? What happens if there is a broken machine, a very ill patient, and there's no means for the people there to repair the machine that could help them survive? It could literally kill someone.
The inability of the people on site to repair these machines could kill someone.
There's already lots of places for medical care to kill someone. I can certainly understand the desire to not introduce another. Here's the situation though, we saw a potential
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I'm against everyday people repairing these devices not because I don't want them to be able to repair the device but because if they fuck it up it could literally kill someone.
Nobody said anything about "everyday people". You are aware that if a, say, surgeon fucks up while treating you, you are just as dead, right?
welcome (Score:3)
Dear Medical Community,
Welcome to our world.
Signed,
Farmers of America
Right? (Score:2)
If it is a Right, then there is no need for anyone to do anything other than exercize their right (and kill anyone who refuses to co-operate).
Sounds to me like they want a "License" which is en entirely different thing.
While I'm all for right to repair (Score:2)
The key dist
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Who exactly is legally liable if you perform a botched repair on an FDA-approved medical device, which then ends up killing a patient?
That one is easy. If the device was designed according to the state-of-the-art with regards to repairability and the service manual gave the correct information, then the insurance of the hospital pays. Same as, say, a surgeon botches a job or another MD does or even a nurse does it. Now, this can then be "accident" or the equivalent of "malpractice". In the second case, the repair technician loses their license. What, you think the manufacturer never messes up a repair job, never delivers defective equipme