[jcims]

I'm shocked that you're shocked lol.

$100 for a somewhat specialized, durable medical device that has to meet regulatory standards and will be used daily, possibly for years, by healthcare providers to do patient assessments?

A 3D printed option is going to require a 3D printer, appropriate filament and should be unit tested to ensure it's within spec. The durability is going to be suspect no matter what. It's an awesome project and I'm sure would be a welcome addition to the 'boostrap humanity' catalog of 3D printed parts, but for everyday doctors plunking a hundo on a good tool is going to be a no-brainer.

[nomel]

> has to meet regulatory standards

Genuinely curious, what standards exactly, for a stethoscope?

[filoleg]

A commercially sold hospital stethoscope is a legally marketed medical device made under a manufacturer quality system, with labeling/instructions, device listing/registration obligations, adverse-event/complaint processes, cleanability expectations, liability, warranty, consistent materials, and repeatable acoustic performance.

An open-source 3D-printed stethoscope is a cool project, but unless it is produced and controlled as a medical device, it is not equivalent to what hospitals are buying for daily patient care.

Personally, if I was a hospital or a doctor, it would be a no-brainer for me to go with the commercially sold stethoscopes. All those factors I listed above, if neglected, can end up costing a lot more in terms of consequences. I would rather pay a fixed extra overhead price per unit to sleep well, knowing I don't have to worry or think about those factors at all. And, I would assume, most of the patients would be in favor of that as well.

[nomel]

What standard exactly, for a stethoscope?

I know nothing of this, but it looks like stethoscopes are Class 1 medical devices with 501(k) exemption, and fall under the "Good manufacturing practices" guidelines of Quality System Regulation (21 CFR 820), but that seems pretty squishy.

[conception]

CFR 21 being labeled squishy is a first for me.

[nomel]

CFR 21 is the whole thing. I'm specifically referring to Part 820, within the context of a stethoscope.

[conception]

Fair

[lukko]

In the UK it would be Class Im - so low risk device that sits outside the body, with a measuring functionality.

[nomel]

To get an idea for required rigor, this is also what eye glasses fall under, in the UK.

[duskwuff]

> $100 for a somewhat specialized, durable medical device...

And one which is treated as a status symbol, at that. Part of the reason a good stethoscope costs more is because it looks nicer, not just because it works better.

[harvey9]

You can get a basic littman for not much. I could afford one when I was a rookie EMT and I've still got the same one many years later.