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Embedded Linux On a Digital Stethoscope
An anonymous reader writes "A team of electrical and computer engineering students at Calvin College is designing a digital electronic stethoscope running uClinux as its operating system. While there are many embedded devices built on Linux operating systems, medical devices running open-source software are extremely rare because of the perceived difficulty in obtaining FDA validation. The device is in its early stages of development, but major hardware choices have been made, and the team has recently released a Project Proposal and Feasibility Study."
littmann make a variety of stethoscopes including digital ones, and have done for some time.
However, dont believe the hype. They are of very limited clinical value. No hospital cardiology diagnosis these days would be based on auscultation. (echocardiography would be used). For taking BP the traditional tube plus ear-pieces 'scope more than suffices.
When the seagulls follow the trawler, it's because they think sardines will be thrown in to the sea
has been done, although without Linux, but thats made up for with some SW patents.
http://www.medicom.bang-olufsen.com/sw435.asp
The problem is that the sound quality is too good for conservative doctors, so they had to make a function that imitates the sound from an old tube stethoscope.
There are electronic stethoscopes available, but they are expensive and noisy. The ability to electronically produce a clean sound from a stethoscope would have some niche uses, primarily in the educational area. It would be nice to be able to allow a gaggle of interns to hear a patient's heart rather than to have each of them have to listen individually with their own stethoscope. I wonder if the designers have included Bluetooth in the original design. As was already mentioned there may be pros and cons to recording stethoscope sounds; I tend to believe that recording the sounds would become desirable for some doctors. Doctors tend to record and document everything as it is, and this could make it practical to record stethoscope sounds, Yeah, the prototype may be big, heavy, and a battery pig; that means that there are many opportunities to reduce its size, weight, and power consumption.
Although the original design does not include waveform diagnostics, analysis, and display capability, that could be added later at little cost.
I work for a manufacturer in the pharmaceutical industry and I hear people say things like Linux and/or Open Source is a problem with the FDA, but I haven't seen anything yet to back that up. Period.
To "validate" software with the FDA, you really only need to do three things:
1) Make your software/system/device secure
2) Have control over the system
3) Document #1 and #2
There are people who come from an old guard that have all sorts of misconceptions about what can and can't pass FDA regulations. It seems to stem from a gross misunderstanding of what the regulations actually say.
I've read the portions that deal with computers and electronic information. There is absolutely nothing in it to suggest open source even remotely is an issue. I suspect this is an urban legend started by companies selling proprietary software.
Regardless, the regulations (Part 11) are the FDA Bible and so long as you can satisfy the requirements in them which basically boil down to the three I listed above, then you are in compliance.
To convince yourself this is true, read this.