[SystemSafety] Operational logging for medical devices

[paul_e.bennett at topmail.co.uk]

On 26/11/2018 at 1:15 PM, "Olwen Morgan" <olwen at phaedsys.com> 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?
>
>Olwen

It has always seemed like a good idea, to me, that where operational
data can be gathered, it should be. Factors such as the raw sensor
values and health status of the sensor are all important to recount
if something doesn't go quite right. That way you can look back and
conduct a proper investigation of the root cause of any problems.

Of course, the that could lead to a lot of irrelevant data being gathered
if the recording scheme is not carefully set up. Questions such as the
time period the data should be recorded for around the unusual incident,
whether accurate time-stamping is required, who may access the
recorded data. It is, at least, another of those questions that should be
in the design check-list we have been discussing.


Regards

Paul E. Bennett IEng MIET
Systems Engineer
Lunar Mission One Ambassador
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