3 ms·

There are so many of these situations in medical devices. It's just the tip of the iceberg.

mewse-hn 3y ago
So.. one of the smokescreens Taylor uses is that their proprietary control software is necessary to ensure the sterilization procedures happen correctly, so they can trot out the argument "if you tamper with our machine you could kill somebody". But it's a damn ice cream machine. The stakes get a bit riskier when it comes to medical devices because it's much easier to imagine the scenario where you tamper with a pacemaker, you're going to kill somebody. You tamper with a dialysis machine, you're going to kill somebody. Same problem, different stakes.
- gruez 3y ago
  >so they can trot out the argument "if you tamper with our machine you could kill somebody". >But it's a damn ice cream machine. It's a machine holding fluids that are highly conducive to bacterial growth, and is a pain to clean because it has tons nooks and crannies. Someone dying (if there's a preexisting condition) or getting seriously sick due to subpar cleaning is very plausible. People get sick from improperly maintained ice machines[1], and those are arguably simpler and are holding less hazardous liquids (plain water rather than milk). [1] https://pubmed.ncbi.nlm.nih.gov/29382408/ https://pubmed.ncbi.nlm.nih.gov/29382408/
  - hgsgm 3y ago
    And yet restaurant operators are allowed to open close their refrigerators and freezers at will, not subject to third party refrigerator maintenance company monopoly.
    - gruez 3y ago
      ...because they're not part of a franchise. Part of being a franchisee is that you're accepting the standards/regulations of the franchisor in exchange for use of their brand. I think it's very reasonable if mcdonalds had some sort of regulation like "all soda fountains must be disassembled and cleaned every 24 hours", and enforced that through hardware interlocks.
      - iancmceachern 3y ago
        Exactly, it's what they're selling (consistency and management). What I don't agree with is the proprietary lock out. Franchise owners should be able to replace the pump header with generic options.
        deleted 3y ago
        [deleted]
        ghostpepper 3y ago
        Who guarantees the generic replacement is up to par? McDonald’s or the franchisee? Who suffers a greater cost if it turns out not to be?
        iancmceachern 3y ago
        For medical devoces its the manufacturer, and it's notified body. It's no different than for the origami manufacturer. It's all covered in ISO 13485 (and another similar standard for the software portion if your product contains software). It's called the risk based approach. You define what's called essential performance or your device, things it must do or the patient or caregiver is harmed. You then do a FMEA to determine what failure modes exist, and what the result of each failure is. You then make sure you have mitigation in place for each of those situations. You then document that all, get it signed off internally, by the FDA, by your notified body, and by the test house (for 14485, FCC testing, etc). All that makes up the stack of documents that allows you to sell a medical product. It's no different if it's a generic product or a new novel one, same process same standards. For food machinery it's also thr FDA for things like design and materials, and it's the local health department for those items. It's a similar but different ISO standard you need to meet depending on the specific machinery.
        mcpackieh 3y ago
        Should they also be allowed to swap out their cola products with generic brands? RC Cola instead of Coca Cola won't hurt anybody (much safer than tampering with a dairy machine!), but franchisees are made to buy Coca Cola specifically. Agreeing to this sort of thing is part of the deal of being a franchise.
- rrauenza 3y ago
  https://www.npr.org/2023/08/22/1195207118/listeria-frugals-milkshakes-tacoma-three-dead https://www.npr.org/2023/08/22/1195207118/listeria-frugals-m... > Poorly cleaned ice cream machines at a Washington-based burger joint were linked to a listeria outbreak earlier this year that landed six people in the hospital, three of whom died. Two of those who were hospitalized told investigators they had milkshakes from the same restaurant before getting sick.
- iancmceachern 3y ago
  You have it wrong. The stakes are actually higher for the ice cream machine. Inproper use of the ice cream machine could kill dozens. A pacemaker malfunction would just kill one at best. It's why airliners need to have triple redundant systems, doubke fault tolerant. Medical devices only need to be double redundant, single fault tolerant. I (dont) love it when people whonhave not ever designed a real medical device that's actually on the market make claims about what it's like to design a real medical device that's actually on the market.
ska 3y ago
Not saying it doesn't happen, but the situation in medical devices is more complicated.
- iancmceachern 3y ago
  It's not really more complicated, just different. It's funny, the F in FDA stands for food, so you still need to deal with the FDA and its regulations, just different ones. Its really more of a paperwork/comiance thing than anything. I.e. genaric drugs. Source- I've designed medical devices and food processing equipment for 20 years.
  - ska 3y ago
    I shouldn't have been so terse. I didn't mean to suggest that the regulatory side didn't exist in commercial food equipment, obviously it does. OP seemed to suggest that medical devices was rife with situations parallel to McDonalds/Taylor, and that just doesn't seem to be the case; partially because the landscape is more complex in terms of who pays, how liability is distributed, and how the maintenance work is done, etc. Which isn't to say device industry doesn't have lots of its own problems, they just look different.
    - iancmceachern 3y ago
      I am OP, and the parent commenter to this comment both. I was making exactly the opposit point you are. I have actually worked directly with the manufacturer of the pumps in those machines (Watson marlow), and also designed and saw through to clinical release many similar complex medical devices with the same exact pumps. The situation is nearly identical between these two examples, it's just the names of the forms you need to fill out are different, and the division of the company that supplies your components is different, but it's all the same thing just a different name.
      - ska 3y ago
        Ok, I confused myself somehow about who I was replying to, my apologies. The OP is jmsflknr though, no? However, my point was not meant to be about the pump design nor the regulatory bodies involved, so I think we are just miscommunicating. My fault for quick replies. I was responding to "There are so many of these situations in medical devices." by which I took you to mean that there are many parallel situations the the McDonalds/Taylor issue in the linked article and the franchises inability to keep them in service, or accept 3rd party help in doing it; I read this as the core point of the article. When I said "things are more complicated" I meant the relationship between the various entities and how systems get deployed, managed, maintained, etc. doesn't look the same. So is that what you meant? It's possible you just mean there are similar technical issues in the pumps, something I'm happy to accept you have direct experience in; in that case I just misread you. If you had said there are similar (identical) pumps in some medical devices I would have understood it that way. It read to me like you were making a far broader claim.

So.. one of the smokescreens Taylor uses is that their proprietary control software is necessary to ensure the sterilization procedures happen correctly, so they can trot out the argument "if you tamper with our machine you could kill somebody". But it's a damn ice cream machine. The stakes get a bit riskier when it comes to medical devices because it's much easier to imagine the scenario where you tamper with a pacemaker, you're going to kill somebody. You tamper with a dialysis machine, you're going to kill somebody. Same problem, different stakes.

gruez 3y ago
>so they can trot out the argument "if you tamper with our machine you could kill somebody". >But it's a damn ice cream machine. It's a machine holding fluids that are highly conducive to bacterial growth, and is a pain to clean because it has tons nooks and crannies. Someone dying (if there's a preexisting condition) or getting seriously sick due to subpar cleaning is very plausible. People get sick from improperly maintained ice machines[1], and those are arguably simpler and are holding less hazardous liquids (plain water rather than milk). [1] https://pubmed.ncbi.nlm.nih.gov/29382408/ https://pubmed.ncbi.nlm.nih.gov/29382408/
- hgsgm 3y ago
  And yet restaurant operators are allowed to open close their refrigerators and freezers at will, not subject to third party refrigerator maintenance company monopoly.
  - gruez 3y ago
    ...because they're not part of a franchise. Part of being a franchisee is that you're accepting the standards/regulations of the franchisor in exchange for use of their brand. I think it's very reasonable if mcdonalds had some sort of regulation like "all soda fountains must be disassembled and cleaned every 24 hours", and enforced that through hardware interlocks.
    - iancmceachern 3y ago
      Exactly, it's what they're selling (consistency and management). What I don't agree with is the proprietary lock out. Franchise owners should be able to replace the pump header with generic options.
      - deleted 3y ago
        [deleted]
      - ghostpepper 3y ago
        Who guarantees the generic replacement is up to par? McDonald’s or the franchisee? Who suffers a greater cost if it turns out not to be?
        iancmceachern 3y ago
        For medical devoces its the manufacturer, and it's notified body. It's no different than for the origami manufacturer. It's all covered in ISO 13485 (and another similar standard for the software portion if your product contains software). It's called the risk based approach. You define what's called essential performance or your device, things it must do or the patient or caregiver is harmed. You then do a FMEA to determine what failure modes exist, and what the result of each failure is. You then make sure you have mitigation in place for each of those situations. You then document that all, get it signed off internally, by the FDA, by your notified body, and by the test house (for 14485, FCC testing, etc). All that makes up the stack of documents that allows you to sell a medical product. It's no different if it's a generic product or a new novel one, same process same standards. For food machinery it's also thr FDA for things like design and materials, and it's the local health department for those items. It's a similar but different ISO standard you need to meet depending on the specific machinery.
      - mcpackieh 3y ago
        Should they also be allowed to swap out their cola products with generic brands? RC Cola instead of Coca Cola won't hurt anybody (much safer than tampering with a dairy machine!), but franchisees are made to buy Coca Cola specifically. Agreeing to this sort of thing is part of the deal of being a franchise.
rrauenza 3y ago
https://www.npr.org/2023/08/22/1195207118/listeria-frugals-milkshakes-tacoma-three-dead https://www.npr.org/2023/08/22/1195207118/listeria-frugals-m... > Poorly cleaned ice cream machines at a Washington-based burger joint were linked to a listeria outbreak earlier this year that landed six people in the hospital, three of whom died. Two of those who were hospitalized told investigators they had milkshakes from the same restaurant before getting sick.
iancmceachern 3y ago
You have it wrong. The stakes are actually higher for the ice cream machine. Inproper use of the ice cream machine could kill dozens. A pacemaker malfunction would just kill one at best. It's why airliners need to have triple redundant systems, doubke fault tolerant. Medical devices only need to be double redundant, single fault tolerant. I (dont) love it when people whonhave not ever designed a real medical device that's actually on the market make claims about what it's like to design a real medical device that's actually on the market.

ska 3y ago

Not saying it doesn't happen, but the situation in medical devices is more complicated.

iancmceachern 3y ago
It's not really more complicated, just different. It's funny, the F in FDA stands for food, so you still need to deal with the FDA and its regulations, just different ones. Its really more of a paperwork/comiance thing than anything. I.e. genaric drugs. Source- I've designed medical devices and food processing equipment for 20 years.
- ska 3y ago
  I shouldn't have been so terse. I didn't mean to suggest that the regulatory side didn't exist in commercial food equipment, obviously it does. OP seemed to suggest that medical devices was rife with situations parallel to McDonalds/Taylor, and that just doesn't seem to be the case; partially because the landscape is more complex in terms of who pays, how liability is distributed, and how the maintenance work is done, etc. Which isn't to say device industry doesn't have lots of its own problems, they just look different.
  - iancmceachern 3y ago
    I am OP, and the parent commenter to this comment both. I was making exactly the opposit point you are. I have actually worked directly with the manufacturer of the pumps in those machines (Watson marlow), and also designed and saw through to clinical release many similar complex medical devices with the same exact pumps. The situation is nearly identical between these two examples, it's just the names of the forms you need to fill out are different, and the division of the company that supplies your components is different, but it's all the same thing just a different name.
    - ska 3y ago
      Ok, I confused myself somehow about who I was replying to, my apologies. The OP is jmsflknr though, no? However, my point was not meant to be about the pump design nor the regulatory bodies involved, so I think we are just miscommunicating. My fault for quick replies. I was responding to "There are so many of these situations in medical devices." by which I took you to mean that there are many parallel situations the the McDonalds/Taylor issue in the linked article and the franchises inability to keep them in service, or accept 3rd party help in doing it; I read this as the core point of the article. When I said "things are more complicated" I meant the relationship between the various entities and how systems get deployed, managed, maintained, etc. doesn't look the same. So is that what you meant? It's possible you just mean there are similar technical issues in the pumps, something I'm happy to accept you have direct experience in; in that case I just misread you. If you had said there are similar (identical) pumps in some medical devices I would have understood it that way. It read to me like you were making a far broader claim.