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On Sat, 22 Jul 1995 giii01@In*.Co* wrote: > What really is interesting to me is when I put out a warning > about an unregistered class three medical device which has not > been subjected to the FDA's federally mandated PMA process, I George brings up an interesting point here when he refers to decom software as a "medical device". I work for a US company that manufactures medical diagnostic instruments. Our products are defined as Class II, i.e. not life support systems, they are for assisting in diagnosis only. They still must be reviewed by the FDA and approved for sale; such approval does not mean that they are actually tested, only that supporting documentation from the manufacturer has been analyzed. The FDA does not have the resources to actually test every medical product! Invasive devices or life support systems are Class III devices, and are subject to fairly intense scrutiny, which seems reasonable to me. Please take these next comments as coming from "devils advocate" point of view, meant to stimulate discussion and *not* attack anyone :-) George is defining decom software as a Class III medical device. To my knowledge, at this time the FDA has not yet taken a look at dive software (anyone know otherwise?). While I agree that decompression tables are certainly part of a life support system, one could argue that tanks and regulators are as well. Is he saying that the FDA should evaluate and certify all critical pieces of scuba equipment? Of course it should be noted that DOT has for years tested and certified high pressure gas cylinders such as scuba tanks. Open circuit gear has been around a long time, with millions of units having been produced and used without incident (though like anything made by humans, there are occasional failures) and I for one do not want the government "certifying" dive gear. But as gear becomes more complex, and more "technical", the situation becomes less clear. And, as the number of decom tables and programs proliferate, one may wonder how to determine if a designers tables can be trusted. Now, I am not a "technical diver"; the most I ever take underwater is a housed camera. I am interested in various developments in the technical diving community because inevitably, just as race car disk brakes eventually turned up in the family sedan, some of the more sophisticated dive equipment in use today will eventually turn up in various forms for use by the recreational community, such as rebreathers. For me, to determine if I should "trust" a set of decom algorithms designed by someone I don't know is a decision that is no different than when I first got certified; I evaluate the evidence and make the decision for myself. I have only been diving 8 years. When I was certified I looked at the tables PADI was promoting, did some research and realized that while there was a risk, it was very small. When I went to buy my first computer, I choose an EDGE because there was in fact real research behind the design that I could read about. Again, I recognized that there was a risk in using it; the risk seemed minimal if it was used within the design parameters, and some common diving sense was applied. Perhaps George was describing decom software as a Class III medical device to draw our attention to the fact that we are literally trusting our life to lines of software code that may not have been evaluated by any independent testing agency, and that certainly fall under the category of a life support system. If that is his point I can only say that it is a point well made. Ultimately it is the individual diver who has the responsibility to educate themselves and make their own decisions as to what gear or tables to rely on. George, while I agree with your characterization of decom software programs, I don't want the FDA extending their jurisdiction over them. *I am not saying you are proposing this!* Perhaps his point is that one should be extremely careful relying on complex computer programs too heavily, as opposed to the mechanical simplicity of open circuit demand valve regualators. Anyone else have their own thoughts on this? Barry Brisco Singapore
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