[Open Design + Hardware] Liability in hacking medical equipment

Sun Nov 10 15:30:54 UTC 2013

hi Greg,
thank you for your quick reply. Just to make the issue more clear I'll copy
an example Jesper made in relation to bicycles.

John goes to makers-space, receives some advice from the manager, and based
> on that advice, John makes some changes to the bicycle's brakes. Then John
> is involved in an accident with his bicycle, because it suddenly can't
> brake.
>
> If he hadn't made any changes, John would probably be able to sue the
> bicycle manufacturer. Now, the manufacturer would likely claim that the
> accident was not because of the original product, but because of the
> changes John made. Will John now be able to sue the makers-space?
>

2013/11/9 Greg Austic <gbathree at gmail.com>

>   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
>

-- 
>>>>>>>>>>>>>>>>>>>>>>>>
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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