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I’d argue that the regulation for ‘alternative control enabled’ (ACE) pumps [1] is too vague. These devices should be ‘designed to reliably and securely communi

I’d argue that the regulation for ‘alternative control enabled’ (ACE) pumps [1] is too vague. These devices should be ‘designed to reliably and securely communicate with external devices’. These incidents were caused by the app crashing, resulting in the connection re-establishing itself frequently enough to drain the batteries [2]. How reliable should it be? Shouldn’t it include some stability measures? Manufacturers should have to submit their devices and software for certification of the technology before itself. Bluetooth and coding standards are mature enough at this point, and it’s time customers start demanding this from their products. [1] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=QFG https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/cla... [2] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206914 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res...

Spivak 2y ago
Reliability to the degree that medical devices need to be when you're sharecropping on someone else's shifting-sand platform is a game I'm glad I'm not paid to play. It in no way excuses the bad behavior, they chose to go this route and committed to the work it would take, but the results of the such certification would be outdated by the time you finish it. I think a "sacrificial device" is the right way to make reliable the unreliable parts. Big battery for running the pump, small battery for the smart device connection. If something happens and you drain the auxiliary device it's annoying but not life critical. Your phone and pump can both alert you indicator light/notification that the auxiliary device died.