5 ms·

So.. one of the smokescreens Taylor uses is that their proprietary control software is necessary to ensure the sterilization procedures happen correctly, so the

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.

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.