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I am aware of a cover-up regarding a broadly deployed consumer medical device made by a giant American healthcare co., intended for internal use, which containe

I am aware of a cover-up regarding a broadly deployed consumer medical device made by a giant American healthcare co., intended for internal use, which contained levels of lead exceeding allowed levels. Millions of units were shipped, many of them targeted at children. They screwed up using their materials management solution, and miscalculated. They realised about 18 months after it had hit the market. The revised product is safe. Regulatory bodies are aware but are sitting on it, as disclosure would be almost as damaging reputationally to them as to the manufacturer.

vintagedave 7y ago
> which contained levels of lead exceeding allowed levels... many of them targeted at children You know the catchphrase, "think of the children", often used to justify some kind of overreach? In this case, please, _think of the children_ and for the sake of us all, even anonymously, get that info to the media.
- madaxe_again 7y ago
  I’m sitting on the fence. In this case, they were very, very marginally over the allowed levels, and it was essentially down to a bug in the standard, which when implemented in software allowed a product to qualify for an exemption when it shouldn’t have. In this particular case the lead is all pretty well away from where the device comes in contact with the body, so the health risk is pretty minimal. It’s still in the “shouldn’t have happened” category, and the manufacturer in question reported themselves, and steps have already been taken to prevent a recurrence, and similar potential bugs have been identified and addressed. It’s tough. There is a lot of political opposition from bad or amoral players to any regulation. They’re faced with the choice of voluntarily opening themselves up to fierce criticism over a, in the grand scheme of things, minor issue, or sweeping it well under the carpet, learning from it, and moving on, and spreading their reach for regulation and enforcement. It’s a trolley car problem if I’ve ever encountered one, and I am not confident that I could make a good call.
  - dannyw 7y ago
    If something actually poses limited to no risk (e.g. marginally over a limit, which should have a level of tolerance built into it anyway); then it doesn't sound like that big of a deal.
  - acheron 7y ago
    and spreading their reach for regulation and enforcement. And after all, this is the most important thing for a regulatory agency.

vintagedave 7y ago

> which contained levels of lead exceeding allowed levels... many of them targeted at children You know the catchphrase, "think of the children", often used to justify some kind of overreach? In this case, please, _think of the children_ and for the sake of us all, even anonymously, get that info to the media.

madaxe_again 7y ago
I’m sitting on the fence. In this case, they were very, very marginally over the allowed levels, and it was essentially down to a bug in the standard, which when implemented in software allowed a product to qualify for an exemption when it shouldn’t have. In this particular case the lead is all pretty well away from where the device comes in contact with the body, so the health risk is pretty minimal. It’s still in the “shouldn’t have happened” category, and the manufacturer in question reported themselves, and steps have already been taken to prevent a recurrence, and similar potential bugs have been identified and addressed. It’s tough. There is a lot of political opposition from bad or amoral players to any regulation. They’re faced with the choice of voluntarily opening themselves up to fierce criticism over a, in the grand scheme of things, minor issue, or sweeping it well under the carpet, learning from it, and moving on, and spreading their reach for regulation and enforcement. It’s a trolley car problem if I’ve ever encountered one, and I am not confident that I could make a good call.
- dannyw 7y ago
  If something actually poses limited to no risk (e.g. marginally over a limit, which should have a level of tolerance built into it anyway); then it doesn't sound like that big of a deal.
- acheron 7y ago
  and spreading their reach for regulation and enforcement. And after all, this is the most important thing for a regulatory agency.