Re: Not intended for use in medical,

[jm59@prism.gatech.edu (John M. Mills)]

John Apa <japa@DIE_SPAMMER.dasd.honeywell.com> writes:

>Robert C. Leif, Ph.D. wrote:
>> To: Tim Behrendsen, Kaz Kylheku et al.
>> From: Robert C. Leif, Ph.D.
>> Vice President Ada_Med
>{snip}
>> This quote may provide an excellent opportunity in the medical device
>> business, which is NOT puny.  My question is, Does validation of an Ada
>> compiler on a platform provide significant evidence that the processor
>> produces valid object code?  Would any of the other Ada test suites help?

IMH(non-legal)O, respectively: no, and no.  I think these are simply the
wrong questions.

Based solely on what I've read in this thread, it seems very foolish to
even discuss programming language selection in this context.  My reading
was that Intel, for whatever reason, has served notice that some of their
products are inappropriate for an entire class of application in which the
likelihood and cost of litigation, as well as typical damage awards, are
extremely high [at present in the U.S.A.].  Should someone suffer injury
from a medical device based on such a product, and the designer of the
device be reasonably expected to have checked the appropriateness of his
or her processor selection, I would not wish to be the attorney defending
them.   Of course there is little risk of that, since I am not an attorney
and could not give legal advice.

However, I can make a pretty good guess what an attorney would advise such
a client while they were making their processor selection: avoid like the
plague any components for which the manufacturer has issued a disclaimer of
suitability for your product's intended use!

Regardless of whether the target processor (and/or the host of a cross-
development environment) would produce properly executing code, the
processor manufacturer has disclaimed assertion that their processor
would _execute_ such code in a proper fashion.  The same charges could
possibly be made against the target operating system (if any), run-time
environment, etc.

I am not in sympathy with the approach Intel seems to reflect in their
statement, and I suspect it might compromise their defense in any
liability action which might arise from use of this processor in a non-
medical, life-critical application -- which might include anything from
avionics to an emergency-response telephone system (or other processors, as
I understand the disclaimer was model-specific and one could ask: "Does
Intel thus imply that their 80* _is_ appropriate, and how did they determine
so?").  I only point out that this is a barndoor-sized exposure with hugely
expensive potential consequences.

-- 
John M. Mills, Senior Research Engineer   --   john.m.mills@gtri.gatech.edu
   Georgia Tech Research Institute, Georgia Tech, Atlanta, GA 30332-0834
        Phone contacts: 404.894.0151 (voice), 404.894.6258 (FAX)
            "Lies, Damned Lies, Statistics, and Simulations"