[SystemSafety] Medical devices (UK / EU)

[Olwen Morgan]

This one's a no-brainer.

There ought to be such a register for all implanted devices, 
electrotechnical or otherwise. I'd hazard a guess, possibly optimistic, 
that the administration costs of such a register would be recouped by 
reduction of the social costs associated with caring for patients whose 
implanted devices go wrong.

Olwen


On 26/11/2018 09:41, Peter Bernard Ladkin wrote:
>
> On 2018-11-26 07:59 , Michael J. Pont wrote:
>> This news report may be of interest to some on this list:
>> https://www.bbc.co.uk/news/health-46337937
> Yes, the International Consortium of Investigative Journalists, with which The Guardian, NYT, and
> Asahi Shimbun and I think the Süddeutsche Zeitung are partnered, has released a number of reports.
> One in The Guardian today is
> https://www.theguardian.com/society/2018/nov/25/revealed-faulty-medical-implants-harm-patients-around-world
>
>
> Only some of the reports concern electrotechnical devices. Medical devices are regulated differently
> in terms of safety from others. Some electrotechnical standards are in the IEC 60601 series. But
> each country has its own approval procedures for such devices as well. When I look at the IEC WWW
> site there are a number of TCs with responsibility for various features of medical devices:
> https://www.iec.ch/perspectives/government/sectors/medical_devices.htm
>
> I have some information about pacemakers from one colleague who works for one of the few companies
> who make them. From what he has described, his company's procedures are pretty much a paradigm for
> dependable digital kit. FM on the code and HW; detailed analysis of each and every "event" which
> occurs with one of their users, as well as following events which occur to users of other companies'
> equipment.
>
> 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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