[SystemSafety] Operational logging for medical devices

[Martyn Thomas]

It's not enough to have a log - an investigator needs enough verified
system documentation to be able to understand what the log entries
really reveal and with what integrity. For example, if an infusion pump
logs that a particular dose rate was entered, how sure can an
investigator be that this was genuinely the value entered by the user
and displayed to the user for checking purposes?

Martyn

On 26/11/2018 13:14, Olwen Morgan wrote:
> Aircraft have flight recorders and I've worked on software a neonatal
> ventilator that had operational logging. One thing that bothered me is
> that the rest of the engineers in the company often said of the
> logging that it was not safety-critical and therefore didn't need to
> be developed as strictly as the bits that controlled the air flow to
> the patient.
>
> With modern solid-state storage devices, it is straightforward to
> write an operational log to non-volatile storage but AFAI can see
> (possibly wrongly, please correct me if so) the medical device
> regulators seem to look at it only in cases where it is deemed
> essential. Given that the marginal cost of adding such logging is
> quite low, I'm inclined to think that there should be a general
> presumption that logging is required unless it is proven not to be
> needed.
>
> Any views? 

-------------- next part --------------
A non-text attachment was scrubbed...
Name: signature.asc
Type: application/pgp-signature
Size: 488 bytes
Desc: OpenPGP digital signature
URL: <https://lists.techfak.uni-bielefeld.de/mailman/private/systemsafety/attachments/20181126/fdd37846/attachment.sig>