While browsing the web for medical devices that appear to run on Windows operating systems, I came across the Baxa ExactaMix Compounder. One could use a compounder for parenteral nutrition. These devices do run a "Microsoft Operating System" according to Baxa. Interestingly, the product page contains a link to a Baxa-authored whitepaper titled Preventing Cyber Attacks (PDF). At first glance, I was pleased to see that Baxa actually offers guidance on this issue, but the content of the whitepaper raises alarms. This excerpt in particular is unsettling (my emphasis added): FDA regulations require manufacturers to �Validate all changes, updates, and patches, including operating systems, before installing them to ensure the safety and effectiveness of the medical devices.�1 Baxa ExactaMix Compounders have been verified and validated only with the software that was installed by Baxa. Thus, any changes to the original, validated image, including installation of antivirus software, ...