State of the KISS?

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I visited the dive shop I got certified and the owner who has been diving rebreathers was carrying KISS. He also dove another, but when I found out the KISS unit was $5000 and they said you could stay down 4 hours, I thought to myself, It won't be long before rebreathers really take off. although I'm not quite ready to take the plunge, I do plan to some day.

That is an honest primer to a curiosity, which I tried to research and ask questions about, that got me in some unforeseen problems. Keep in mind, I'm new, so even what I think might be smart questions, may be stupid, but hey. I got to start some place. Here goes.

I checked some published information on the risks of various rebreather models, and the KISS coincidentally had the best safety record. However, the company that published the risk analysis, was making a lot of statements about "rebreather created by none engineers" the importance of certain types of certifications and, well, My background is in a lot of that stuff, but within medical devices, which got me even more curious, since, after all, these are "life support" but clearly not medical devices. Please, I'm not trying to invite FDA into regulating anything, it was just a thought. Anyway I saw some serious holes in some of the purported logic and risk FMECA of this other company, and tried to understand exactly how electronics are assemble to prevent "latent failures" and what kinds of quality controls, Quality management systems are appropriate for making these.

At this point in the discussion/question, I seemed to hit some kind of hot button with the other websites moderator, so they never post my questions and I never get an answer.

Its a simple fact that if rebreathers are made in larger quantities (which I expect will continue to be the case as demand grows) what kinds of controls over the manufacturing process need to be considered? As a competitor to KISS incidently pointed out in their Failure Mode and Effects Criticality Analysis, Kiss is among the safest if not THE safest. Why is that?

I'm very knew to this, but I am involved heavily in developing quality management systems, and I love diving. I'm not really looking for job in rebreathers (yet) but I'm fascinated with how these things are made, and what kinds of things are most critical to manage right in their design and manufacture to minimize failures.

Sorry for the long email. I
 

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