There’s also what appears to be a fairly robust resale market-- the model this woman has ranges from $200-$600 on eBay (at first glance), and it’s definitely a high-end one. I can’t imagine that they’d be too hard to repair with the right set of eyeballs and tools tossed at them. It looks to be a single hydraulic piston with a couple of adjustment screws for the positioning of the ‘bones’. The next step up in the lines of product seem to have integrated microcontrollers and wizardry that might be manufacturer-only, though.
This is a problem with a long history. My first career was in nursing, and I had a lot of contact with diabetics, and others, that had amputations that required prosthetic legs.
The insurance companies will only provide replacements after years sometimes. This doesn’t take into account the realities of them breaking, or the patient’s changes.
If a patient changes weight, like loses or gains, the prosthetic is kind of useless because it won’t fit the stump anymore. I had one patient loose a lot of weight after a stroke. She was a double amputee, that had used her legs since she was a child. We had to teach her how to use a wheelchair because no amount of doctors notes, appeals, or requests, would get the insurance company to cover a new set. She had a couple years in a wheelchair, severely limiting her life, before they would replace them.
We could not find any place to repair them. I called all over the state. Her son found someplace out of state, that he was going to take her, and probably pay full cost on. She was lucky he had a profession he could make that happen.
This issue was one that came up again and again for the decade I nursed. This and the stupid hearing aid issue drove me up the wall at the injustice of it all.
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That might be a good longer-term solution, but of course learning how to walk with a different kind of prosthesis is probably going to require going through rehab again. And I’m guessing that the insurance company is going to have issues with that. Another part of a long term solution is not prescribing such a non-durable piece of medical equipment.
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I haven’t spoken specifically to my co-worker about it but i think he drives a regular car without any modifications. I know that he can drive bikes just fine, he used to have a big Harley though he got rid of it earlier this year.
Talking to him he has mentioned that some of the things he struggles with is balancing on his feet if he’s not able to clearly see around him. So stuff like being blindfolded and standing is pretty difficult/impossible for him using the flexfoot, but not sure what other stuff he can’t do.
The company’s promotional video:
eta: I don’t see much to fail, except for that fancy titanium spring. Good spring steel would be heavier, sure, but if it lasts much longer?
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Can they drive with them?
She was able to drive a stickshift car with a prosthetic left foot. The gas pedal might be harder, I don’t know.
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The human interest reporters at your local TV station could also help apply pressure to the insurance company and the manufacturer.
A reporter contacting the manufacturer’s PR department for an on-the-record statement about the quality of your product that breaks down after 10 months despite being on a three year replacement cycle could get them sweating.
Asking the insurance company’s PR department why they’re requiring the patient to go for over two years with busted feet rather than putting pressure on the manufacturer or ponying up for a (better) replacement and seeking reimbursement from the manufacturer should get the attention of higher-ups.
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Car companies don’t seem to have a problem offering paid repairs out of warranty. It’s actually seems to be pretty profitable.
Insurance companies often use the Medicare replacement schedules as their guidelines, those are often based on older technologies. Even so, the prosthetic should be designed to work based on the lifetime expected under the typical replacement schedule, even if that means offering paid repair to make it possible.
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I see where you’re coming from but I don’t think it’s really equatable to car repair. Practically everyone has a car, they’re designed to be maintained, and dealerships offer wildly overpriced maintenance as a fundamental part of their profit model. A prosthetics manufacturer has a smaller, highly specialized, widely distributed customer base which is accessible only through insurance. Their customer is the provider (prosthetics monger?), not the individual amputee, and their products are high-end of the market and engineered for a certain lifespan and price point.
As soon as they start offering service for their feet they have to plan when to shut their doors for good. Sales of new products drop into the basement. They have to build new facilities and hire/train new staff to handle the new repair-based line of business-- sinking tons of money into a venture that killed their ability to do business in the first place. They have to worry about liability issues from repairing equipment that’s been in service longer than it was engineered to be in service: Did this part fail and a person broke their leg and sue because of the screw a maintenance guy replaced, or because the design itself was never tested to long-term lifespan specs? How provably so? If so, when is every foot in worldwide service recalled and replaced, at crippling/lethal expense to the manufacturer? Given that expense, would manufacturers even recall dangerous feet at all, or just leave them out there as timebombs to slightly offset impending bankruptcy? It’d be disastrous. The company doesn’t live in a vaccuum, it’s part of an unfortunate system created by private insurance.
Well there’s your problem. They should be engineered to work for the life of the standard replacement cycle. Providing paid post warranty repair and replacement parts should just be part of doing business in the industry. Cars, for example, are rated to last longer than their warranty period, as are most products. Warranty period is not the expected lifespan of a product.
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As I just pointed out on the ‘Christian Hospital $1m cost for a premature baby’ thread…
Equally to the point, the hospitals’ customers are largely NOT its patients - its customers are the insurance companies, who are also highly concentrated. Doubles the effect on prices.
… on prices AND practices.
I hate insurance companies so much I swear to god the feeling has its own taste.
…which is probably about three years, since that’s how often insurance replaces them.
100% agreed on principle alone for most every product. Sadly that’s a huge goalpost movement for the companies involved and would probably require legislation and a court battle resolved in their favor. The law of the land says a dude can’t even be required to make a gay couple a dumb cake.
She mentioned getting satisfactory warranty service from the company in the past, but this is a couple years later.
Back in 1982 I mef Willow, who had an artificial leg. She’d lost the original to cancer. But she’d walked from Maine, and the plastic around the knee joint was starting to crack. I think I got her some tape, sayinv something about how I’d buy glue, but worried about it getting iinto the joint and stopping it from working. She stopped walking so.much.
But, yes, she said something about how a replacement wouldn’t be paid for.
This was an old style artificial leg, more about blending in than being strong, unlike all the metal legs of today that make people look like cyborgs but appear to be much stronger.
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She really should report the failure to the FDA. If the product is that shoddy, they could initiate a recall.
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I’d love to get a correction from someone who actually knows this area; but I’d be a bit pessimistic about it coming to that in this case.
Aside from some deeply unflattering history involving rather more life-critical ‘devices’; I suspect that whatever failed in this prosthetic foot is a section 890.3420 ‘External limb prosthetic component’; which makes it a class I device, non-implanted, non life-sustain/support, and most likely 510(k) exempt, eligible for summary rather than individual malfunction reporting; and exempt from GMP requirements except records (820.180) and complaints (820.198).
That’s not an outright “for entertainment purposes only” level waiver; but unless I’m much mistaken it’s about as lenient as you can get while still being classified as a medical device. More broadly, my understanding of the regulations is that they particularly focus on device defects that cause deaths or serious injuries; which makes ones that quietly but visibly become unfit for purpose both a lower priority compared to the ones that end in someone bleeding out or succumbing to chromium toxicity; but potentially out of scope. Failing to meet device life expectancy claims is a lot more dramatic with implanted devices; but less of an issue(from the perspective of medical device regulation, it obviously poses a major problem for the user) for devices that can be simply and safely swapped.
What surprises(but not surprise surprises) me is that the insurer isn’t required to ensure that their replacement schedule and the device’s lifetime match up.
It’s standard practice to levy copays or generally jerk you around; but I don’t think anyone would take a “we cover refills of 30 day drug supplies not more than every 60 days” policy seriously. In the sane, just, world that we definitely do not inhabit it seems like that sort of absurdity would be clearly analogous to having a replacement cycle longer than the device’s warrantied lifespan.
If they want to do 3 years; it had better be a 3 year supply of prosthesis. If they decide that only Val-U-Limb is in-network, well, those SKUs are only 6 month supplies, so the replacement schedule had better match.
(edit: none of the above is to say that she shouldn’t file the most poison-penned form FDA 3500 she can, a failure of which no record officially exists definitely won’t see any traction; but I wouldn’t expect it to bubble to the top of the pile.)
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Oh, I get it. I used to work in Class III medical devices, and I know prosthetics aren’t regulated the same way. Still, I’d file the paperwork, anyway, and maybe also with the FTC to see if there are other reports of premature failure.
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Well maybe. I ride a bike to work and I do my own maintenance. I can pay mechanics to work on my bike but it would be off the road too long, and many of them do really bad work.
When its your own feet which need to be maintained, learning how to do it yourself may be the best way in the long run.
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Blatchford appears to be a UK company.
Consumer protection in the UK is pretty good in general.
From this site in Australia the product is given a 36 month warranty. See p42.
Same from Canada.
https://www.ortoped.ca/en/echelonvt-sup-r-sup.html
Same in Norway. Service and Parts list included.
Honestly I would suggest she and her technician contact head office and not the American subsidiary.
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The Department of Veterans Affairs might be a place to look too.
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