[SystemSafety] Operational logging for medical devices

[Peter Bernard Ladkin]

On 2018-11-26 14:14 , Olwen Morgan wrote:
> 
> Aircraft have flight recorders and I've worked on software a neonatal ventilator that had
> operational logging......
> Any views?
I suggest that operational logging is essential for any software for which reliability or safety is
key. Furthermore, the design of such logging is not trivial if you want it to be trustworthy,
although the implementation could well be straightforward when you have the design right. Or not.....

Only if you have a trustworthy operational history can you evaluate it to see whether your kit works
as intended. It should be, but isn't, common practice to evaluate such a history.

BTW, speaking of operational logging, in a couple of days the preliminary report on the accident to
Lion Air flight JT610 (the specified 30 days are up on Wednesday). Some data from the FDR have
already been made public. Very much not fun. I would suggest to make sure you are in a robust frame
of mind before reading. https://www.satcom.guru/2018/11/first-look-at-jt610-flight-data.html

The only thing it makes sense to do is pull the circuit breaker. Or circuit breakers if you don't
know which one. But then you have to (gulp!) hand-fly the aircraft, maybe against aerodynamic forces
which you haven't experienced if pilot's little helpers have been on all the time you have been
training and flying. Such as with the multi-crew commercial licences now used for many first
officers in some airlines. Imagine having 250 hours time (for your MCL), mostly playing with the
computers, and then being faced with THIS.

PBL

Prof. Peter Bernard Ladkin, Bielefeld, Germany
MoreInCommon
Je suis Charlie
Tel+msg +49 (0)521 880 7319  www.rvs-bi.de





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