[SystemSafety] Medical devices (UK / EU)

Martin, BJ BJ.Martin at novasystems.com
Mon Nov 26 12:02:15 CET 2018


Is it simply as picked by ICIJ: no firm and competent regulatory oversight means initial and continuing design safety quality varies from vendor to vendor.

Many design faults identified in reports sound like FTA/FMECA fodder rather than subject to physiological variations.

High risk systems with high commercial stakes need pre-release regulation of acceptable risk. Is it not proven time and time again - self regulation rots. Product liability fears rely on damages outweighing potential gains.

Open Service defect reporting accountability is surely  bare minimum for medical devices with life critical failure potential. Do no harm...indeed.

No hypocritical oath but - take note AV tech supply chain.


BJ Martin

Sent from my iPad

On 26 Nov 2018, at 9:27 pm, Olwen Morgan <olwen at phaedsys.com<mailto:olwen at phaedsys.com>> wrote:



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<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<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<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<http://www.rvs-bi.de>









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