Tell HN: Duty of care • Hacker News Board

Re: Tell HN: Duty of care

#51

Post by SentinelLdnma » Wed, Nov 09, 2022, 3:10 PM UTC

currycurry16 wrote: post #45

chroma wrote: post #42

I am very suspicious of this post. First, there's your story. To describe it as vague would be an understatement. What was the medical device? If the device does something important for the patient, wouldn't a big red button also be dangerous? You wouldn't want it turned off accidentally. Also the machine needs a button or switch to turn on , right? So why not have that component be the physical switch? And if the ki…

But why?

I'm a deep state employee of an as yet unacknowledged three letter agency whose propaganda blog received no traffic from this page until grandparent posted the link. I am a master strategist, playing chess in dimensions string theorists only dream of.

Re: Tell HN: Duty of care

#52

Post by SentinelLdnma » Wed, Nov 09, 2022, 3:13 PM UTC

gumby wrote: post #50

SentinelLdnma wrote: post #49

Earlier quoted context omitted.

This occurred before the device was submitted for its first 510(k) approval. Also, companies have some discretion in what changes they re-submit to the FDA and what the decide to just document internally. There are guidelines, like if you change the OS you better resubmit, but there is a wide swath of gray area. The FDA is not looking at every code/hardware change request. They audit your process. Edit: typos

Yeah, I'm on the small molecule side but did a combo device years ago and was shocked at how slack the device rules were compared to the drug side.

Agreed. Class III hardware is well controlled (i.e., implants), but software (any class) and lower-class hardware is loco. My device was Class II.

Re: Tell HN: Duty of care

#53

Post by SentinelLdnma » Wed, Nov 09, 2022, 4:26 PM UTC

dehrmann wrote: post #39

Imagine a touch screen e-stop in a machine shop.

One of these days someone will try it. Spank them.

Re: Tell HN: Duty of care

#54

Post by mixmastamyk » Wed, Nov 09, 2022, 7:17 PM UTC

chroma wrote: post #42

I am very suspicious of this post. First, there's your story. To describe it as vague would be an understatement. What was the medical device? If the device does something important for the patient, wouldn't a big red button also be dangerous? You wouldn't want it turned off accidentally. Also the machine needs a button or switch to turn on , right? So why not have that component be the physical switch? And if the ki…

Wow, the game is afoot.

Re: Tell HN: Duty of care

#55

Post by seehafer » Fri, Nov 11, 2022, 11:16 PM UTC

SentinelLdnma wrote: post #52

gumby wrote: post #50

Earlier quoted context omitted.

Yeah, I'm on the small molecule side but did a combo device years ago and was shocked at how slack the device rules were compared to the drug side.

Agreed. Class III hardware is well controlled (i.e., implants), but software (any class) and lower-class hardware is loco. My device was Class II.

This change would have certainly increased overall risk so a new 510(k) would have been required if this device was already commercialized.

And had your management not backed down, and tried to push this through as a Letter to File, you'd have been well-within your rights to blow the whistle to FDA. There's not a FDA employee alive that wouldn't go "hold on there chief" to a device change of this magnitude.