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According to the Wikipedia entry on the Therac-25, it was "In response to incidents like those that the IEC 62304 standard was created, which introduces develop
by dangom 8y ago
According to the Wikipedia entry on the Therac-25, it was "In response to incidents like those that the IEC 62304 standard was created, which introduces development life cycle standards for medical device software and specific guidance on using software of unknown pedigree".
For those working in safety and quality control of medical systems, how much does compliance to those specifications actually diminish the chances of another Therac-25 incident?
Considering that automation continues to increase, from automatic patient table positioning up to diagnose-assisted AI, are there new challenges when it comes to designing medical systems in order to keep them safe and maintainable? How likely is it for the FDA or the equivalent agencies around the globe to authorize the use of open source systems?
- pjmlp 8y ago> How likely is it for the FDA or the equivalent agencies around the globe to authorize the use of open source systems? Actually they already authorize stuff like Qt. Computer systems where human lives are put in risk belong to what is called High Integrity Computing. There are very strict coding standards, where even C looks more like Ada than proper C. https://ldra.com/medical/ https://ldra.com/medical/ https://www.qt.io/qt-in-medical/ https://www.qt.io/qt-in-medical/ https://www.vectorcast.com/testing-solutions/software-testing-embedded-medical-devices-fda-iec-62304 https://www.vectorcast.com/testing-solutions/software-testin... Source code availability is not an issue, because it is part of the certification process to provide it. The problem is having the money to pay for a certification, which becomes invalid the moment anything gets changed, namely compiler being used, source code, or if any of the third party dependencies gets updated.