Medical Device Touchscreen Input

T

TimTim

#1
Hello,

I could use some help understanding the single fault safety requirements surrounding the use of a small touchscreen in a medical device (such as the touchscreen in your smartphone).

A touchscreen input device has a single chip which monitors and communicates when the user touches the screen. I don't think it would be possible to find such a chip and screen that could be considered "component with high-integrity characteristic", and it is easy to imagine a scenario where a touch event is incorrectly reported.


  1. Does this mean that a normal capacitive touchscreen cannot be used to control a device which is in direct contact with a patient and could harm him if operated incorrectly?
  2. Would you therefore need to employ a second touch technology such as resistive or infrared?
  3. What if there is an emergency stop button alongside the screen?
  4. Any examples of touchscreen used in patient critical medical devices?
Many thanks!!
 
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T

TimTim

#3
Sagai. Thanks for the response!

I suspect that the risk with the device you show might be lower, since it only displays images and doesn't have the direct ability to harm the patient. Does this sound right to you?

I have been looking and found a couple devices. One, an infusion pump, is an interesting example, because it has been recalled due to touchscreen issues. (Hospira Symbiq). Other than that, I have found a couple electrosurgical units (Bowa ARC 400, and a couple from EMED), and many ventilators.

Do we think that all of these devices have redundant touch technologies for single fault safety? Or just that the risk analysis has determined that if an error occurs, the user will have enough time to reach to it and correct it before serious injury occurs?
 

sagai

Quite Involved in Discussions
#4
The thing is that is a diagnosis purpose radiology viewer thing and that is pretty much dangerous, physicians can cut the patent based on the view displayed. It is true it does not directly control a hardware device.
I would go towards your second option and look into hazardous scenarios based on your own device along with an involvement someone having domain knowledge in medical science.
Cheers!
 
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