[Insight-users] Re: [vtkusers] Use in medical devices

[Luis Ibanez]

Hi Steve,


Open Source packages such as ITK and VTK are used
in Medical Devices that have approved by the FDA.

Linux is also commonly used in medical devices.


It is a common mistake to believe that Open Source
software can not be used in medical devices. This
erroneous believe is the result of a misunderstanding
of the FDA guidelines for development of software
to be used in medical devices.


In short terms, medical device manufacturers can use
software from third parties as long as they validate
that the software behave as intended in the medical
device. The degree of validation required for a package
is relative to the confidence that such package may
have developed in the industry.


In the case of open source toolkits such as ITK and VTK,
the high level of quality control maintained through the
nightly dashboards, and the fact that the code is available
for review by thousands of users provide a high level of
confidence in the quality of the software. That implies
that toolkits such as ITK and VTK will require less validation
than a software package that has been developed only by
2 or 3 programmers, and whose code has never seen the public
light.


For details on FDA approval and its relationship with ITK and VTK
please consult the following Wiki page:

http://www.itk.org/Wiki/FDA_Guidelines_for_Software_Developement

----


Just to cite some concrete examples:

GE Health Care have products that use VTK:
http://www.gehealthcare.com/usen/fun_img/pcimaging/products/microctscanner.html
http://www.gehealthcare.com/usen/fun_img/pcimaging/products/specimicroct.html
http://www.gehealthcare.com/usen/fun_img/pcimaging/products/microview.html



It is also very common to develop medical devices
on top of Linux platforms (which of course, is Open Source Software):


GE:
http://www.gehealthcare.com/usen/aw/products/ctsoft.html
http://www.gehealthcare.com/usen/oncology/products/seopenspeed07t.html
http://www.gehealthcare.com/usen/community/mr/products/signa_excite_11/products/fiesta_3dc.html

SIEMENS:
The MAGNETOM series uses the Real-Time version of SUSE Linux:
http://opensource.sys-con.com/read/261639.htm
http://www.healthcare.siemens.com/magnetom/portal/default.asp?
http://www.technewsworld.com/story/52892.html

The RIS/PACS system Syngo is built on top of Linux:
http://www.medical.siemens.com/webapp/wcs/stores/servlet/PressReleaseView~q_catalogId~e_-1~a_catTree~e_100005,13839~a_langId~e_-1~a_pageId~e_70134~a_storeId~e_10001.htm


===



    Regards,



       Luis




=====================
Steve Robbins wrote:
> Hello,
> 
> Is anyone aware of software using VTK or ITK that has passed  regulatory 
> approval as a "medical device", e.g. by FDA, CE marking, or  similar?
> 
> Thanks,
> -Steve
> 
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