We feel obliged to reply to the letter regarding our previous comments on the use of open-source software for image post-processing, and explain our point of view some more. As we previously emphasized, post-processing software is very useful and can enhance insight in a patient's anatomy before and after endovascular aneurysm repair. In fact, detailed analysis using such technology may provide additional or alternative diagnoses and improve patient care. Naturally, a free software tool that can provide this added value is a great asset.
However, certification and approval for clinical use is mandatory throughout the western world. The developers of Osirix stated in their website “Warning: OsiriX, being a free open-source software (FOSS), is not certified as a commercial medical device for primary diagnosis. Hence, there are no FDA/CE-1 certifications. In US and Europe, you can only use OsiriX as a reviewing, research or teaching software, not for primary diagnostic, used in clinical workflow and/or for patient care”. Certainly, part of the cost associated with paid post-reconstruction software has gone into the certification for clinical use. Also, it has been previously published that different software programs can provide comparable reconstructions to a certain level, but differences occur at a more detailed level.
1
In the presented case report, and often in our practice, the information provided by post-processing is very influential and may change decisions and treatment radically. Usage of non-approved software for this purpose poses deontological issues in our view, even if usage of this specific software tool is moderately supported by literature. We do not doubt the quality and potential of Osirix open-source, but will prefer a CE-1 certified software for our patients.
Reference
- Comparison of three software programs for three-dimensional graphic imaging as contrasted with operative findings.Eur J Cardiothorac Surg. 2012; 41: 1098-1103
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Published online: May 22, 2012
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