[Open Design + Hardware] Liability in hacking medical equipment

Greg Austic gbathree at gmail.com
Sat Nov 9 19:59:01 UTC 2013


This is an interesting question...

I don't have a specific answer, but just to clarify... if the products that
you are making are 3D printable and/or manufacturable on-site, can't you
just make the design and let the users themselves actually make the object
(push the button on the 3D printer, for example)?  That way, you are not
selling them anything, you're just providing them a space to create their
own products.

Greg


On Sat, Nov 9, 2013 at 12:49 PM, anNa seravalli <anna.seravalli at mah.se>wrote:

> Hi guys,
> I am writing you with a question that I got from Jesper a friend that is
> involved in a maker-space in Roskilde, Denmark. It a nutshell is about how
> to deal with liability when organizing workshops where people is invited to
> hack their own assistive technology (please scroll down for a more detailed
> description of the issue).
>
> Do you have any tips, contacts, experiences that could help with this?
>
> ciao!
> anNa
>
>
> 2013/11/8 Jesper Holck <jesper.holck at roskilde-festival.dk>
>
>>  Hi Anna,
>>
>> As promised, I send a few words describing our concerns about liability.
>>
>> As part of our makerspace in Roskilde, we're planning to also work with
>> assistive technology devices (hjælpemidler, hjälpmedel). In Denmark, and I
>> guess in Sweden also, these are under heavy regulation, and manufacturers
>> must get their products certified. In Denmark, they are classified as
>> medical equipment.
>>
>> You are of course allowed to make small repairs, decorations, and
>> maintenance of assistive devices. But you are not allowed to make
>> constructive changes. Or rather, if you make constructive changes, you
>> should get a new certification of the device.
>>
>> I talked to the Danish "lægemiddelstyrelse" (the Danish governmental
>> office for medicine and medical equipment) and they said, that we as a
>> makerspace may be liable for the changes our users make to their assistive
>> devices.
>>
>>
>> Warm regards,
>> Jesper
>>
>>
>> --
>> Jesper Holck
>> Project Manager
>>  <http://orangeinnovation.dk>
>> www.orangeinnovation.dk
>> www.twitter.com/orange_inno
>> www.orangeinovation.dk/blog
>>
>> Skype: jesper.holck
>> Mobile: +45 29467652
>>
>> Roskilde Office:
>>
>> Havsteensvej 11
>> DK-4000 Roskilde
>> Tel.: +45 4636 6613
>> Fax: +45 4632 1499
>>
>>
>> Cph Office:
>>
>> The Hub, Nørrebrogade 52 B
>> DK-2200 København N
>>
>>
>>
>>
>>
>
>
> --
> >>>>>>>>>>>>>>>>>>>>>>>>
> Anna Seravalli
> PhD Candidate Research Fellow
> MEDEA Collaborative Media Initiative
> Malmö University
>
> +46 72 744 55 24
>
> medea.mah.se
> prototypingalternativefutures.wordpress.com
>
>
>
>
>
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>


-- 
Greg Austic

2198 Seminole Dr.
Okemos, MI 48864
(919) 545 1083

www.austiclabs.com
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