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Medical Device Recalls Involve Software Flaws in Almost 1/4 Cases–Why the FDA Needs Engineers Just the Rest of the World

Posted Jul 25 2012 5:59pm

This should be no big secret with the status of software today and it’s not always something overlooked at the manufacturer either as it could be new data platforms not performing a they should if the device connects to the internet or a computer.  I made one comment for a long time and I know it happens out there but it’s unspoken but sometimes you have marketing and executives of companies push the developers and mind you they are probably geared up working at 100% already, but they want certain deadlines met and in today’s world, you better not rush the developers.

You can certainly push a developer to possibly release a product before “they” are satisfied and it works fine..until….and that’s a big until as it could mean anything.  I know I used to push myself to get updates out as fast as I could but luckily there was no executive group pushing me to do so, just me and my work ethics and I would slow things down as needed too.  When you have shareholders wanting their dividends and for the most part, digital illiterates company officers working with marketing, things get bent and pushed.  This is a software solution at the link below but it is exactly what happened at Allscripts, with too much code and not enough time and promises made to shareholders.  Sometimes in software development you never know what you are going to run in to.  Those algorithms came back screaming.   

Also to add a little more here this is why it is also important to have enough software engineers on staff at the FDA, they need them just like anyone else and even more so as they protect the consumers.  BD




CDRH says about 24% of device recalls involve software flaws. “Many software platforms lack robust code validation”, the Center’s Office of Science and Engineering Laboratories (OSEL) says in its latest annual report. “In medical devices that contain software, it can be extremely difficult to assess if a firm follows their processes for design controls, especially in the areas of validation, risk/hazard analysis, and design changes”, the report says.

http://www.mddionline.com/article/software-flares-cause-24-device-recalls


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