[Open Design + Hardware] Liability in hacking medical equipment

[Greg Austic]

I don't know the answer, but here's some people I would consider asking who
have lots of experience with maker spaces and/or open hardware - at least
they could brainstorm more people to ask:

http://www.oshwa.org<http://www.oshwa.org/research/brief-history-of-open-source-hardware-organizations-and-definitions/>-
they have some legal resources which are used to help hardware
designers
bring products to market in an open way.

James at Schoolfactory - james at schoolfactory.org.  He interacts with lots
of makerspaces and does some work on the legal and organizing side of
things.  He may also know or direct you further (and he's usually pretty
responsive).

Those folks may even be on this list, I don't know :)  Anyway, I hope that
helps!

Greg



On Sun, Nov 10, 2013 at 10:30 AM, anNa seravalli <anna.seravalli at mah.se>wrote:

> 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
>
>
>
>
>


-- 
Greg Austic

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

www.austiclabs.com
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