[SystemSafety] Medical devices (UK / EU)

[Olwen Morgan]

Just to offer another perspective on this, I honestly believe that there 
should be greater regulation of cosmetic implants.

As is well known to many on this list, I did not start life as a woman. 
When I had my GRS surgery, my surgeon asked me if I wanted breast 
implants. I didn't and have never regretted that decision. If you want 
silicone-assisted boobs, it is cheaper and safer to put the silicone 
fillers in your bra rather than in your breasts. I think of it as 
applying Ockham's Razor to personal medical decisions.

We encourage preventive safety measures elsewhere, so why not reduce the 
scale of risks associated with medical devices by using them only where 
they are clinically necessary? I'd support regulations that said if you 
want implant surgery that is not clinically necessary, then you should 
compulsorily insure against the costs of having to sort things out when 
problems arise. Of course, in order to calculate economically efficient 
insurance premiums, you'd need an implant register that was open, on an 
anonymised basis, to insurance company actuaries. For that to work, 
though, the register would need to contain complete patient histories 
related to implants, which may worry some patients.

Olwen

PS: There is *absolutely no truth* in the rumour that I got my 
bra-fillers on a special offer - three for the price of two :-)


On 26/11/2018 10:26, Olwen Morgan 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
>> 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 7319www.rvs-bi.de
>>
>>
>>
>>
>>
>>
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