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May 2021 - Vol 14, Issue 5
Arduino-based medical products?
The proliferation of simple to use Arduino platforms and plug-in modules has greatly simplified the process of getting a proof of concept solution with minimal effort and cost. In some cases, this solution can be rolled into a custom platform that can move towards production. Unfortunately, with few exceptions, Medical products are not one of those cases.

Arduino sketch is an open source platform that was born out of a desire to teach people to learn to code. Arduino based sketch files allow coders and non-coders alike to create and quickly get working very complex software features and modules. The problem with this is that the vast majority of the actual code needed to make everything work is buried under multiple layers of abstraction. An Arduino sketch file that runs about 100 lines of code can do amazing things, but that is because the code that does all those amazing things may be comprised of tens of thousands of lines of code that is not visible in the sketch file.

There is a term called “SOUP” (Software of Unknown Provenance). While some software libraries provided by device manufacturers are high quality, Arduino software, by its nature, can best be classified as SOUP in medical applications. While not strictly prohibited in the medical device software standard, IEC62304, software of unknown provenance requires significant additional effort to analyze, test, document, and justify. It usually takes less time and effort to rewrite the software to the IEC62304 standards, or to use validated libraries from reputable IC manufacturers. This is highly dependent on the use case and safety classifications of the product using the Arduino software. A good summary can be found here of the device safety cases and applicability of SOUP to a medical device.

For Class A devices that are not safety critical, this is likely not an issue and "SOUP" can be used with adequate testing and justification. For Class B and C devices that ARE safety critical (most medical devices), this can pose a serious risk and is not recommended.

Can Arduino sketches be used for medical products? When there is no chance of causing injury, then possibly yes. If the software has any risk of causing injury or death, then the risk is too high and it becomes impractical to use the Arduino sketch as the basis. Ultimately, ask yourself this question: Would I trust my life to "SOUP"?

CEPD can help both to answer that question and with the conversion or determination of acceptability of Arduino code in a particular application.
-CC
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The Staff of CEPD, Inc.
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