| President, Electronics, Software Design | Expert Speaker in Wearables, Wireless, Medical Devices, Consumer Products |
We are starting to see smart toilets enter the market or get close to entering the market. They include sensors such as electrocardiogram, body temperature, and photoplethysmogram to measure blood oxygen level.
What do you think? Is it a medical device or just a health-tracking device?
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The medical device community was very quick to identify exactly how to classify the toilet. It depends upon the claims, and the claims are in the instructions for use, the web site, and other marketing material. It was designed to give medically accurate heart health indications. If it does any diagnosis, it will be a medical device. If it only indicates that you should see a doctor, it will not be a medical device.
The blood Oxygen measurement, for example, could be a medical device all by itself, however there are pulse plethysmographs sold that are not medical devices, because they do not claim to diagnose or even give accurate blood Oxygen numbers.
The Apple watch and the AliveCor’s KardiaMobile make accurate ECG measurements. Both claim to detect atrial fibrillation, and both are classified as medical devices as a result (the Apple Watch is not a medical device, but the ECG app is).
The smart toilet was developed at the Rochester Institute of Technology for demonstration purposes. It was not used for diagnosis, and it does not have any claims, therefore it is not a medical device. If the creators put it on the market to sell, I would expect they would want to make claims similar to Apple and AliveCor, in which case it would be a medical device.
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